主办:上海医药工业研究院
   中国药学会
ISSN 1672-9188   CN 31-1939/R   SLYHAA

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  • Topic
    ZHANG Sainan , WANG Niansong, ZHANG Wei
    World Clinical Drug. 2025, 46(1): 1-7. https://doi.org/10.13683/ j.wph.2025.01.001
    The development of novel biologics provides a new therapeutic strategy for immune-related kidney diseases. Novel biologics such as anti-leukocyte differentiation antigen 20 monoclonal antibody, B lymphocyte stimulator/ a proliferation-inducing ligand-targeting drugs, and complement inhibitors provide more precise treatment for immunerelated kidney diseases by targeting specific molecules or receptors. However, further studies are needed in terms of therapeutic efficacy, safety, optimal dosage and applicability in different kidney diseases. This article reviewed the application progress of various novel biologics in immune-related kidney diseases, and aimed to discuss their therapeutic potential, existing evidence and future research direction.
  • Topic
    LIU Jun, WANG Nian, YU Yanan, WANG Zhong
    World Clinical Drug. 2024, 45(12): 1219-1225. https://doi.org/10.13683/j.wph.2024.12.002
    Traditional Chinese medicine(TCM) plays an important role in ensuring the health of the people, and its efficacy is a core reflection of its clinical value and significance. A scientific, detailed, and clear clinical trial protocol is of great significance for accurately assessing the clinical efficacy of drugs, which can fully reflect their clinical value, ensure the scientific, reliable, and accurate nature of clinical trials, and ultimately guarantee their successful completion. This article followed the design principles of clinical trial protocols, combined with the rich experience accumulated by our team in long-term clinical trial practice. From the perspective of how to reflect the clinical value of drugs, the determination of the purpose and the clinical positioning of the drug clinical trials, the selection of participants and the controls, the setting of corresponding statistical boundary values for clinical trial were discussed. And the selection of clinical efficacy outcomes which could reflect the clinical value and clinical significance of the drugs, the key design elements of clinical trial protocols - ''PICOS'' principle were comprehensively and deeply analyzed and discussed, aiming to provide a scientific, reasonable, and practical reference for the design of TCM clinical trial protocols that emphasize clinical value.
  • Topic
    ZHENG Gang
    World Clinical Drug. 2024, 45(10): 1016-1022. https://doi.org/10.13683/j.wph.2024.10.003
    Loss of protein homeostasis, genomic instability and inflammation all involve in cardiovascular aging, and which is closely related to the occurrence and development of cardiovascular diseases, such as atherosclerosis, heart failure, cardiomyopathy and other. Therefore, protein homeostasis, genomic stability, and inflammation may be therapeutic targets for age-related cardiovascular diseases. This article reviewed the mechanisms of protein homeostasis loss, genomic instability, and inflammation in cardiovascular aging, in order to provide new directions for the prevention, diagnosis, and development of new drugs for cardiovascular diseases in the future.
  • Topic
    ZHANG Qian , CHENG Dongsheng , WANG Niansong
    World Clinical Drug. 2025, 46(1): 14-18. https://doi.org/10.13683/j.wph.2025.01.003
    Chronic kidney disease(CKD) has long been an important global health problem, and renal anemia(RA) is one of the important complications of CKD, which is closely related to the increase of all-cause mortality and cardiovascular mortality in patients. The occurrence of RA is related to the deficiency of erythropoietin(EPO) production. EPO related drugs are an important treatment for RA and affect the prognosis of patients with CKD. This article reviewed the application progress of EPO related drugs in RA in recent years, in order to provide some reference for clinic.
  • Topic
    WANG Wei, FAN Ying, WANG Niansong
    World Clinical Drug. 2025, 46(1): 8-13. https://doi.org/10.13683/j.wph.2025.01.002
    Glucagon-like peptide-1 receptor agonist(GLP-1RA) has been widely used in the treatment of patients with type 2 diabetes mellitus. GLP-1RA can also help improve renal outcomes in patients with diabetic nephropathy(DN). GLP-1RA plays a renal protective role by inhibiting inflammatory response, reducing oxidative stress, alleviating damage induced by advanced glycosylation end products and improving metabolic abnormalities, and has great potential in preventing and slowing down the occurrence and development of DN. This article reviewed the clinical evidence and mechanism of GLP-1RA in DN, so as to provide reference for clinical use.
  • Pharmacy management
    LI Zhiyou , HU Jianxin , HE Jie , YUAN Bin , JIA Liming
    World Clinical Drug. 2025, 46(1): 81-86. https://doi.org/10.13683/j.wph.2025.01.014
    我国药品集中采购 ( 以下简称“集采”) 政策形成于经济市场化改革和医药卫生体制改革的重要时期,走过了从计 划采购、医院联合采购试点、地 ( 市 ) 扩大试点,省为单位、省际联合、国家组织六个不同阶段与药品集采政策变革、初 创、调整、拓展、融合、完善的发展历程相对应,政策发展以问题、需求为导向,从部门碎片化、局部效应,逐步向整体 性、系统化、综合成效转变。文章梳理了我国药品集采发展的历程,总结不同时期药品集采政策的特点,显示我国经济改 革和医药卫生体制改革相关政策与药品集采政策发展互为因果、相互协调,推动了药品供应保障治理体系现代化进程。
  • Topic
    FU Yujie, CHEN Xihui, LIU Minyu,
    World Clinical Drug. 2025, 46(2): 123-142. https://doi.org/10.13683/j.wph.2025.02.002
    Non-alcoholic steatohepatitis(NASH), as a chronic metabolic disease, is closely related to obesity, diabetes mellitus type 2, hyperlipidemia and other metabolic syndromes. Its pathogenesis involves multiple factors such as genetics, environment and lifestyle, especially metabolic disorders as the core driving force, which promote disease progression through oxidative stress, endoplasmic reticulum stress and inflammatory pathway activation. For the treatment of NASH, multiple potential therapeutic targets have been identified, such as metabolic regulation, blocking of inflammatory pathways, and anti-fibrosis. NASH may also progress to severe diseases such as cirrhosis and liver cancer, which poses a major threat to human health. In addition, NASH is often accompanied by other metabolic diseases, forming a vicious cycle that further increases the difficulty of treatment and the burden on patients. This article aims to comprehensively review the pathogenesis, therapeutic targets and drug research progress of NASH, and discuss its harm to humans, so as to provide reference for future research and clinical practice.
  • Review
    GAO Jie, DENG Yifang, LIU Minyu,
    World Clinical Drug. 2025, 46(1): 66-72.
    With the widespread use of antibiotics, the ongoing development of microbial resistance poses a significant threat to global health. Therefore, the search for new antibiotics or other antimicrobial resources has become the focus of global scientific research. Antimicrobial peptides(AMPs) have attracted much attention as excellent candidates for overcoming antibiotic resistance. AMPs are small molecular proteins that are naturally produced by all living organisms and play a crucial role in the host's innate immunity against a variety of microorganisms, including bacteria, fungi, and viruses. AMPs are widely found in various organisms such as microorganisms, plants, insects, and mammals. AMPs exert biological activity by targeting key molecules such as cell membranes, cell walls, DNA and proteins within cells. The wide range of sources and complex and diverse mechanisms provide a solid foundation for the wide application of AMPs. This article reviewed the classification of AMPs based on animal origin, the mechanisms and applications in pharmaceutical field, in order to provide professional reference for further research in related fields.
  • Review
    LI Guojie, DENG Yifang, LIU Minyu,
    World Clinical Drug. 2024, 45(11): 1187-1191. https://doi.org/10.13683/j.wph.2024.11.012
    Alveolar type Ⅱ epithelial cells(AT2), as alveolar epithelial stem cells, possess significant proliferative and differentiation potential, plays a crucial role in maintaining lung homeostasis and the repair of lung injury. Studies have shown that idiopathic pulmonary fibrosis would occur when the normal function of AT2 is disrupted and transforms into fibrosis-promoting phenotype. Being located on the mucosal surface, AT2 is inevitably exposed to environmental stress, which can have long-lasting effects and ultimately promote the development of fibrosis. At the same time, genetic mutations may also lead to impaired AT2 function and the occurrence of pulmonary fibrosis. Additionally, aging is also one of the significant factors that increase the pathological changes in AT2. The article discussed the regeneration process of AT2 and the pathways that lead to AT2 aging, apoptosis, and dysfunction.
  • Topic
    LIU Chang , FAN Ying , WANG Niansong
    World Clinical Drug. 2025, 46(1): 19-22. https://doi.org/10.13683/ j.wph.2025.01.004
    Iron metabolism disorder is common disorder in patients with chronic kidney disease, which leads to renal anemia(RA). Intravenous iron is an important treatment for RA, and commonly used drugs include ferric carboxymaltose, ferumoxytol and ferric derisomaltose. Based on the previous research results, this article reviewed the application progress of intravenous iron in RA, in order to provide some ideas for individualized iron therapy
  • Article
    LI Xiaobei , HOU Meiling , WANG Qingkai , JI Xiaowei
    World Clinical Drug. 2025, 46(1): 44-49. https://doi.org/10.13683/j.wph.2025.01.008
    Objective To observe the effect of modified Buyang Huanwu decoction combined with sacubitril valsartan on chronic cardiac failure(CHF). Methods A total of 120 CHF patients with Qi deficiency and blood stasis admitted to Cangzhou Integrated Traditional Chinese and Western Medicine Hospital from November 2021 to June 2023 were randomly divided into western medicine group(n=60) and Chinese and western medicine combined group(n=60). The western medicine group was treated with sacubitril valsartan on the basis of conventional treatment, and the Chinese and western medicine combined group was treated with modified Buyang Huanwu decoction on the basis of western medicine group, with a course of 3 months. Results After treatment, the traditional Chinese medicine syndrome score, quality of life score, N-terminal brain natriuretic peptide precursor, myocardial troponin T level and left ventricular mass index in the two groups were decreased compared with before treatment(P<0.05), the left ventricular ejection fraction and 6 min walking test were higher than those before treatment(P<0.05), and the above indexes in Chinese and western medicine combined group were better than those in western medicine group(P<0.05). The total effective rate of the combined group was obviously higher than that of the western medicine group(91.67% vs 76.67%, P<0.05). There was no significant difference in the incidence of adverse reactions between the combined group and western medicine group(8.33% vs 13.33%, P>0.05). Conclusion Modified Buyang Huanwu decoction combined with sacubitril valsartan has high curative effect on CHF, and can improve the heart function and quality of life of patients.
  • Review
    GE Jianing, GU Fenghua,
    World Clinical Drug. 2024, 45(12): 1303-1308. https://doi.org/10.13683/ j.wph. 2024.12.015
    Chronic bronchitis(CB) is a widespread respiratory disease, and its core pathogenesis revolves around the inflammatory response. A vicious cycle is formed between this inflammatory response and oxidative stress, leading to a series of complex pathological changes such as excessive mucus secretion, airway surface dehydration, and airway fibrosis remodeling. Among them, the molecular mechanisms are interrelated and jointly promote the development of the disease. This article comprehensively analyzed the role of inflammatory response in CB and its various pathological manifestations, aiming to provide improved ideas for existing treatment methods, stimulated the development of new drugs, and effectively transform basic scientific research results into clinical practice, so as to bring more effective treatment strategies for CB patients.
  • Article
    LUO Ruijing, PENG Yong, WANG Yingjie, LIU Jie, JIANG Zhuqian, WU Zongqin
    World Clinical Drug. 2025, 46(1): 50-54. https://doi.org/10.13683/j.wph.2025.01.009
    Objective To explore the clinical efficacy of Siwanfeng decoction in treating atopic dermatitis(AD) in children with heart fire and spleen deficiency syndrome. Methods A total of 70 patients with AD who met the inclusion criteria were randomly divided into treatment group and control group, with 35 cases in each group. The treatment group was given Siwanfeng decoction orally, while the control group was given levocetirizine hydrochloride oral liquid orally. The treatment course was 6 weeks. The changes in scoring AD(SCORAD) scores and clinical efficacy were compared between two groups. Results The total effective rate of the treatment group was 97.14% and 40% in the control group, and the total effective rate of the treatment group was significantly higher than that of the control group(P<0.001). After treatment, the SCORAD score in the treatment group was decreased than before treatment and the control group, and the difference was statistically significant(P<0.001). Conclusion Siwanfeng decoction has a good clinical efficacy in treating children with AD with heart fire and spleen deficiency syndrome
  • Pharmacy management
    JIANG Hao, WANG Yuhao, XU Wei
    World Clinical Drug. 2025, 46(1): 95-103. https://doi.org/10.13683/j.wph.2025.01.016
    Diagnosis-intervention packet(DIP) is a payment method with Chinese characteristics proposed by combining payment by disease with regional total budget and points. It is currently one of the hospitalization payment methods being promoted in China. This study collected literature on the practical effects of DIP, and used literature hotspot analysis and system review method to summarize the trend of DIP research hotspots and the comparison of effects before and after policy implementation, and put forward the relevant suggestions to improve the research on DIP
  • Topic
    ZHANG Zhuo , QIN Cheng , WANG Fang , YANG Xuesong , YE Jianzhou
    World Clinical Drug. 2025, 46(5): 439. https://doi.org/10.13683/j.wph.2025.05.003
    Atopic dermatitis(AD) is a common chronic inflammatory skin disease that seriously affects the quality of life of patients. Traditional treatments such as topical steroids and immunosuppressants have limited efficacy in some patients and are accompanied by adverse reactions. In recent years, biologics have provided new treatment options for patients with moderate to severe AD by targeting key inflammatory factors. Dupilumab, as the first approved biologic, significantly improved patients' skin symptoms and pruritus. Subsequently, drugs such as tralokinumab, lebrikizumab, and nemolizumab further expanded the options for targeted therapy. Biologics have shown promising prospects in improving the treatment outcomes of patients with moderate to severe AD, and are expected to further improve efficacy and affordability through personalized medicine, optimized dosing strategies, and cost control. This article reviewed the targets, mechanisms of action, and clinical research progress of major biological agents, in order to provide reference for the clinical treatment of AD patients.
  • Topic
    MA Longhao , CHEN Ye, DING Jinxi,
    World Clinical Drug. 2024, 45(11): 1125-1131. https://doi.org/10.13683/j.wph.2024.11.003
    Objective To evaluate the current medical insurance coverage of orphan drugs in China, sort out the reimbursement policies and treatment status of rare disease patients, and provide reference for improving the medical insurance treatment of rare disease patients in China. Methods The number of orphan drugs included in the National Reimbursement Drug List in 2023 was counted. The medical insurance reimbursement policies in 31 provincial capitals(excluding Hong Kong, Macao and Taiwan) were collected, and the status of medical insurance treatment for rare disease patients was evaluated by simulated calculation of Recombinant Human Coagulation Factor VIIa for Injection and Efgartigimod Alfa Injection. Results The coverage rates of medical insurance for rare diseases and medical insurance for drugs were 68.42% and 69.88%, respectively. On the whole, the medical insurance reimbursement for rare diseases patients was insufficient, and the proportion of personal self-sufficiency of general outpatients even reached more than 90%. Conclusion It is recommended that the we should increase the access of orphan drugs to medical insurance. Each province exploring and implementing the one-way payment policy for orphan drugs. At the municipal level, incorporating more rare diseases into the category of special diseases in outpatient clinics, to improve the level of protection and establish a multilevel security mechanism.
  • Review
    CHEN Kaidong, FANG Zeqing, LUO Huafei
    World Clinical Drug. 2024, 45(12): 1314-1322. https://doi.org/10.13683/ j.wph.2024.12.017
    Testosterone is one of the most important hormones in the human body, and the lack of testosterone in men can lead to mental and physiological and other dysfunction. The clinical efficacy and safety of testosterone supplementation should be determined through clinical trials, long-term observation, and drug interaction evaluation, with close monitoring of patient responses and associated adverse events. Transdermal patch and other testosterone controlled release preparations provide a better choice for the treatment of testosterone deficiency. This article reviewed the testosterone dosage forms, administration routes, clinical efficacy and safety in domestic and foreign markets, in order to provide reference for the use of clinical related drugs.
  • Topic
    LI Muzhi, WANG Sicun, DANG Haixia, LIU Jun, WANG Zhong, YU Ya'nan
    World Clinical Drug. 2024, 45(12): 1213-1218. https://doi.org/10.13683/j.wph.2024.12.001
    The holistic concept of traditional Chinese medicine(TCM) pays more attention to the ''sick person'', that is ''patient-centered diagnosis and treatment strategies''. The most recent iteration of the Measures for the Administration of Drug Registration points out that the therapeutic evaluation of TCM should select the indicators that align with the clinical principles and showcase its unique functional characteristics and advantages. At the same time, under the continuous promotion of modern evaluation systems, there has been a notable increase in innovative clinical trial methods of TCM. There is a growing trend towards utilizing more flexible and expedited clinical trial designs throughout the drug product lifecycle to enhance efficiency of the trials based on rational utilization. This paper took the clinical research of Di'ao Xinxuekang capsule in the treatment of chronic stable angina pectoris as an example, introducing the practical exploration of combining patient-centered clinical research approach with adaptive design, providing useful reference for the evaluation of TCM efficacy.
  • Recommendation
    World Clinical Drug. 2024, 45(11): 1105-1115. https://doi.org/10.13683/j.wph.2024.11.001
  • Article
    DUAN Juanhui, WANG Yong
    World Clinical Drug. 2025, 46(1): 38-43. https://doi.org/10.13683/ j.wph.2025.01.007
    Objective To investigate the therapeutic effect of calcium and zinc gluconate oral solution on osteoporosis in ovariectomized rats. Methods 72 SD rats were randomly divided into sham operation group, model group, positive control group and low, medium and high doses of Xingaite groups(3, 6, 12 ml/kg), with 12 rats in each group. Except for the sham operation group, the ovaries were removed to establish the osteoporosis model. The positive control group was given estradiol 0.1 mg/kg, and the sham operation group and the model control group were given the same volume of purified water by gavage for 99 days. The body mass of the rats was observed every 3 days. After treatment, bone mineral density(BMD), bone volume relative to tissue volume(BV/TV) and bone surface relative to tissue volume(BS/TV) were analyzed by micro-CT. Calcium, zinc and bone metabolism were detected by enzyme linked immunosorbent assay. Results Compared with the model group, the zinc-calcium group significantly inhibited the growth of body mass, increased the level of zinc, improved the bone loss of femur, increased trabecular number and connection and BMD, increased BV/ TV and BS/TV, and decreased the levels of osteocalcin and procollagen type Ⅰ carboxy-terminal peptide. Conclusion Xingaite can improve the microstructure of bone trabecular in ovariectomized rats, increase bone density, slow down the osteoporosis process in ovariectomized rats, and has a good effect on ovariectomized rats with osteoporosis.
  • Pharmacy management
    HE Jie , HU Jianxin , LI Zhiyou , YUAN Bin , JIA Liming
    World Clinical Drug. 2025, 46(1): 73-80. https://doi.org/10.13683/j.wph.2025.01.013
    Objective To explore the role and existing problems of centralized drug procurement policies in balancing medical, pharmaceutical, and medical insurance costs, ensuring safe and rational use of drugs by the public, and promoting the healthy development of the pharmaceutical industry. Method The relevant policies, literature, cases, and data were analyzed, and the impact and response of policies on various stakeholders and their reactions were interpreted from multiple dimensions. Result The policy of centralized drug procurement was formed during the period of China's economic marketization reform and medical and health system reform. While promoting the construction of the drug supply guarantee system, the policy has promoted the reform of the compensation mechanism of public hospitals and the medical service prices, promoted the balance of medical insurance funds and the modernization of the medical and health governance system. At present, centralized drug procurement has problems in policy implementation, quality improvement and expansion, slow adjustment of medical service prices, and increased difficulty in balancing the interests of the public, medicine, medical development, and fund security. It is necessary to improve the unified and efficient policy linkage and management coordination mechanism of medical insurance, healthcare, and medicine, and promote "value medicine". Conclusion The policy of centralized drug procurement and the reforms related to medicine, healthcare, and medical insurance are mutually causal and synergistic, promoting the modernization process of the governance system and governance capacity of the medicine, healthcare, and medical insurance.
  • Review
    JIANG Wanping, GU Wei
    World Clinical Drug. 2024, 45(11): 1192-1198. https://doi.org/10.13683/ j.wph.2024.11.013
    Ground-level ozone pollution poses an existential threat to the health of the human respiratory system, and the role and mechanism of ozone inhalation in the occurrence and development of airway inflammatory diseases are research hotspots. Inhaled ozone mainly reacts with the components of the airway surface liquid and then degrades, while producing reactive oxygen species, lipid oxidation products and other products, thereby stimulating alveolar macrophages and airway epithelial cells, activating cell signaling pathways related to inflammation and changing in pro-inflammatory lipid mediators. All these changes promote the occurrence and development of airway inflammation. This article reviewed the inflammatory phenotypes and related mechanisms of inflammation during the process of ozone-inhalation injury.
  • Topic
    ZHANG Qiannan , WANG Niansong, LI Junhui
    World Clinical Drug. 2025, 46(1): 23-28. https://doi.org/10.13683/j.wph.2025.01.005
    Secondary hyperparathyroidism(SHPT) is one of the most important complications of chronic kidney disease-mineral and bone disorder(CKD-MBD), which can significantly increase the risk of bone deformities, cardiovascular events, and death. In the current treatment of CKD-MBD SHPT, phosphorus binders, calcium-like agents, polynuclear iron-hydroxide and tenapanor have shown advantages. Novel active vitamin D analogues can effectively reduce the level of intact parathyroid hormone(iPTH). This article reviewed the recent progress of IPTH-decreasing CKD-MBD drugs in order to provide reference for clinical use.
  • Article
    XU Yuan#, WANG Jia#, YANG Yanhui , LI Rong , YANG Hu , SHAN Chunyan
    World Clinical Drug. 2024, 45(10): 1078-1084. https://doi.org/10.13683/j.wph.2024.10.013
    Objective To collect the medical records of patients with diabetic kidney disease(DKD) during the course of Shenyan Kangfu tablets, and to analyze the clinical features of Shenyan Kangfu tablets in the treatment of DKD and the improvement of renal function in the real world. Methods Based on the hospital electronic medical record information system, 503 cases of DKD patients with prescription Shenyan Kangfu tablets from October 1, 2016 to October 31, 2021 were collected to analyze the characteristics of the population taking Shenyan Kangfu tablets in the real world, the distribution of drug diseases, the improvement of renal function, the safety and the combined treatment plan, and to evaluate its efficacy and safety. Results The age of DKD patients taking Shenyan Kangfu tablets was mainly 30~80 years old, of which 50~60 years old accounted for 33.20% and 60~70 years old accounted for 30.22%. There were more males than females(67.40% vs 32.60%). The results showed that Shenyan Kangfu tablets could significantly reduce urinary protein, urinary albumin/creatinine ratio(ACR), glycosylated hemoglobin(Hb)A1c and other indexes at 24 h. After taking Shenyan Kangfu tablets for 3 months, 24 h urinary protein level increased, hemoglobin, serum albumin, HbA1c levels decreased. During 3 to 6 months, 24 h urinary protein, creatinine and HbA1c levels decreased. After 6 months, ACR levels increased and 24 h urinary protein and HbA1c levels decreased. No adverse reactions were recorded during the administration, and the safety was good. Clinical drug combinations mainly include blood glucose control drugs, blood pressure control drugs, lipid-regulating drugs, etc. Conclusion There are more DKD patients using Shenyan Kangfu tablet in clinical practice, and the preliminary results show that Shenyan Kangfu tablet combined with conventional western medicine treatment of DKD is safe and effective.
  • Article
    SONG Panpan, YU Lili
    World Clinical Drug. 2025, 46(1): 29-37. https://doi.org/10.13683/j.wph.2025.01.006
    Objective To investigate the effect of remimazolam on cognitive dysfunction induced by sevoflurane in rats by regulating Toll-like receptor(TLR)4/myeloid differentiation factor(MyD)88/nuclear transcription factor(NF)-κB pathway. Methods A total of 72 male SD rats were divided into A to F groups, 12 rats in each group. A group(50% air and oxygen mixture, 2 L/min) and other groups were treated with A group+2% sevoflurane to construct aged postoperative cognitive dysfunction rat model. After successful modeling, C groups to E were given(1.5 mg/kg, 3 mg/kg and 6 mg/ kg remimazolam+intraperitoneal injection of the same amount of 0.9% sodium chloride injection), respectively, F group was given(6 mg/kg remimazolam+intraperitoneal injection of 75 μg RS09). The rats in A group and B group were injected with the same amount of 0.9% sodium chloride injection in the tail vein and abdominal cavity. The escape latency,the number of crossing platforms and the histopathology of hippocampus were observed. The expression of ionized calcium-binding adapter molecule(IBA)-1 was detected by immunofluorescence staining. Enzyme-linked immunosorbent assay was used to detect the levels of neuron-specific enolase(NSE), interleukin(IL)-6 , central nervous system specific protein S-100β, and tumor necrosis factor(TNF)-α in hippocampus. Terminal-deoxynucleotidyl transferase-mediated dUTP-biotin nick end labeling staining was used to detect neuronal apoptosis. TLR4, MyD88, Cleaved caspase-3 and p-NF-κB p65 proteins were detected by immunoblotting. Results Compared with B group, the disordered arrangement of neurons and cell morphological changes of rats in C ~ E group were improved, the escape latency was shortened, and the number of crossing platforms was increased. Levels of NSE, S-100β, IL-6, TNF-α, the number of IBA-1 positive cells, neuronal apoptosis rate, and the proteins levels of TLR4, MyD88, Cleaved Caspase-3, and p-NF-κB p65 were significantly decreased(P<0.05). Conclusion Remimazolam may improve sevoflurane-induced cognitive dysfunction in aged rats by inhibiting the TLR4/MyD88/NF-κB pathway.
  • Topic
    CHEN Xinyang, CHEN Ye, DING Jinxi,
    World Clinical Drug. 2024, 45(11): 1132-1140. https://doi.org/10.13683/j.wph.2024.11.004
    Objectives To evaluate the current situation of improvement of the affordability of rare disease drugs in China, and to provide recommendations for the construction and optimization of the multi-level medical security system for rare disease. Methods The reimbursement policies of outpatient chronic and special diseases, major medical expenses insurance, City Customized Commercial Health Insurance and medical assistance in 333 cities in China were collected, and the affordability of 5 National Reimbursement Drug List(NRDL) rare disease drugs with annual cost of more than 100 000 yuan and 6 non-NRDL drugs with annual cost of more than 900 000 yuan were evaluated by World Health Organization/ Health Action International standard survey method. Results For the 6 high-value non-NRDL drugs only covered by the city customized commercial medical insurance(CCCMI), the payment years for these treatments was higher than 10 years, and the affordability was extremely poor. For 5 NRDL rare disease drugs, the affordability was poor(1.53— 3.97 years) only under outpatient chronic and special disease coverage. When the major medical expenses insurance was articulated, teriflunomide(0.81 year) and recombinant human coagulation factor Ⅷ(0.91 year) were affordable, and the payment years of the other three drugs have a certain decrease. Following secondary reimbursement through CCCMI and third reimbursement through medical assistance, human coagulation factor Ⅷ(0.64 year) and miglustat(0.84 year) were also affordable. And there was a significant difference in the number of payment years after the multi-level medical security system. Conclusion Multi-level medical security system can effectively improve the affordability of medication for patients with rare diseases. In this regard, it is recommended that non-NRDL rare disease drugs should be included in NRDL as soon as possible, and the link of various levels of reimbursement should be strengthened.
  • Topic
    LU Rui , CHEN Ye, DING Jixi,
    World Clinical Drug. 2024, 45(11): 1117-1124. https://doi.org/10.13683/j.wph.2024.11.002
    Objective To evaluate the availability of drugs for rare disease treatment in China and to provide suggestions for optimizing the supply system for the treatment of rare diseases in China. Methods The current status of rare disease drugs in China was analyzed by accessing databases and literature, and the availability rate of these drugs in tertiary hospitals and the national collaborative network of hospitals for rare disease diagnosis and treatment was evaluated by using the World Health Organization/Health Action International standard survey method. Results There were only 176 drugs in the two batches of rare disease catalogs, and 54% of those diseases had no drugs. The average preparation rate of 47 negotiated rare disease drugs in tertiary hospitals and hospitals of rare disease diagnosis and treatment collaborative network in the agreement period of the 2023 medical insurance catalog was only 6% and 14%, respectively. Conclusion The low availability of rare disease drugs in China is mainly due to the lack of research and development motivation of pharmaceutical companies and the high cost of drug management in hospitals. It is recommended to optimize the identification criteria of the catalog and preferential policies to strengthen the guiding effect of the catalog on the therapeutic areas. And to give priority to the special policy inclination of the whole process of super-rare disease drugs to guide their research and development to the market. Meanwhile, to issue the list of drug innovations for rare diseases and set up a centralized pharmacy to establish a supply system centered on the collaborative network hospitals.
  • Pharmacy management
    YAN Zile , LEI Qingqiang , HU Min,
    World Clinical Drug. 2025, 46(1): 87-94. https://doi.org/10.13683/j.wph.2025.01.015
    Objective To systematically review the literature on the accessibility of national medicare negotiated drugs and summarize its improvement. Methods CNKI, Wanfang, VIP, SinoMed, PubMed, Web of Science were searched to collect published literature about national medicare negotiated drugs accessibility, and analyze the content of the literature. Results 25 literatures were included, of which 17 focus on the impact of national medicare negotiated drugs accessibility, while the remaining 8 research the current status of national medicare negotiated drugs accessibility after the policy. Regarding availability, all of the literature found that the policy had a significant positive effect on the uptake of drugs, while 40%(10/25) found that there were some regional or institutional differences in the availability. Regarding affordability, only 60%(15/25) of the literature noted a sharp decrease in the price of national medicare negotiated drugs after the policy. However, 27%(4/15) mentioned that the out-of-pocket costs of most anticancer drugs were still high. Conclusion The National Price Negotiation policy has effectively improved drug accessibility, but it is still necessary to continuously promote the use of national medicare negotiated drugs and to improve the treatment of medicines in health insurance.
  • Article
    XIE Xiaofang, LI Yankong, ZHANG Guang, LIU Zesheng, LI Xin
    World Clinical Drug. 2024, 45(10): 1041-1045. https://doi.org/10.13683/j.wph.2024.10.007
    Objective To investigate the curative effect of modified Shaoyao and Gancao decoction combined with pregabalin in the treatment of malignant neuropathic pain(MNP). Methods A total of 140 MNP patients admitted to our hospital from September 2022 to September 2023 were randomly divided into western medicine group(pregabalin) and Chinese and western medicine combined group (pregabalin combined with modified Shaoyao Gancao decoction), with 70 cases in each group. The clinical efficacy, pain mediator levels, quality of life and adverse reactions were compared between two groups. Results The total effective rate of the combined treatment group(91.43%) was higher than that of the western medicine group(75.71%, P<0.05). After treatment, the levels of 5-hydroxytryptamine, Substance P, prostaglandin E2 and endothelin-1 in the combined group were significantly lower than those in the western medicine group(P<0.05). The score of quality of life(QOL) in the combined medicine group was significantly decreased(P<0.05). There was no statistical significance in the incidence of adverse reactions between the two groups(P>0.05). Conclusion Modified Shaoyao Gancao decoction combined with pregabalin can effectively relieve pain in MNP patients, improve clinical efficacy and quality of life, and have good safety.
  • Topic
    LU Wei, QIANG Yan, LI Congying
    World Clinical Drug. 2025, 46(5): 434. https://doi.org/10.13683/j.wph.2025.05.002
    Vitiligo is a common acquired skin mucosal pigment loss disease, and there is no cure. The pathogenesis of vitiligo is complex, involving multiple factors such as genetics, autoimmunity, and oxidative stress. With the deepening research on the pathogenesis of vitiligo, biologics targeting specific sites have been continuously developed, especially targeted treatments for immune regulation and anti-inflammatory response, which provide new ideas for the treatment of vitiligo. This article focused on the feasibility of using biologics as a new treatment method for vitiligo, in order to provide reference for exploring better treatment options.
  • Topic
    ZHENG Gang
    World Clinical Drug. 2024, 45(10): 1005-1009. https://doi.org/10.13683/j.wph.2024.10.001
    Neurohormonal signaling is one of the main mechanisms of cardiovascular aging, which specifically includes the renin-angiotensin-aldosterone system, β-adrenergic signaling, and insulin-like growth factor-1. Neurohormonal signals are not only involved in cardiovascular failure, but also associated with various cardiovascular diseases such as hypertension, atrial ffbrillation, and heart failure, and there may be a common mechanism between the two. This article reviewed the role of neurohormone signaling in cardiovascular aging, aiming to provide reference for the diagnosis, treatment, and new drugs for cardiovascular diseases in the future.
  • Topic
    ZHENG Gang
    World Clinical Drug. 2024, 45(10): 1010-1015. https://doi.org/10.13683/ j.wph.2024.10.002
    Mitochondrial dysfunction and cellular aging can accelerate cardiovascular aging through various pathways, leading to the occurrence and development of age-related cardiovascular diseases. Existing evidence suggests that both have the potential to become effective targets for delaying cardiovascular aging. This article reviewed the mechanisms of mitochondrial dysfunction and cellular aging in cardiovascular aging, in order to provide reference for the diagnosis, management and development of therapeutic drugs for cardiovascular diseases in the future.
  • Article
    WANG Minjie , WANG Xiaoyun, XIONG Mengting , HANG Minghui, SUN Dawei , XU Hao
    World Clinical Drug. 2024, 45(11): 1149-1154. https://doi.org/10.13683/j.wph.2024.11.006
    Objective To evaluate the clinical efficacy and safety of Tongluo Qutong plaster in the treatment of knee osteoarthritis(KOA). Methods A total of 480 patients with KOA were included by stratified randomization, and they were randomly divided into experimental group(n=360, external application of Tongluo Qutong plaster) and control group (n=120, external application of Qizheng Xiaotong plaster) according to the ratio of 3∶1. The treatment course of both groups was 14 days. The total score of Western Ontario and McMaster Universities arthritis index(WOMAC) was used as the main therapeutic index, and the TCM syndrome score, visual analogue scale(VAS) score were used as secondary efficacy indexes to evaluate the efficacy, skin irritation symptoms and adverse reactions of the two groups. Results After treatment, the total WOMAC score, TCM syndrome score and VAS score of knee pain in the two groups were significantly different from those before treatment(P<0.05), but there was no significant difference between the two groups(P>0.05). There was no significant difference in adverse reactions between the two groups(P>0.05). Conclusion Tongluo Qutong plaster is safe and effective in the treatment of KOA, which can significantly reduce knee pain, improve joint mobility and quality of life of patients, and has clinical value.
  • Article
    ZHANG Yu , GU Yuhan , WANG Zhuo , ZHENG Zhixin , ZHU Ping
    World Clinical Drug. 2024, 45(10): 1072-1077. https://doi.org/10.13683/j.wph.2024.10.012
    Objective To investigate the safety and efficacy of doxycycline in the treatment of lobular pneumonia infected by drug-resistant Mycoplasma pneumoniae(MP) in children. Methods Children with lobular pneumonia infected by drug-resistant MP admitted to our hospital from July 2023 to April 2024 were selected as the study objects, and their clinical manifestations, etiology detection, laboratory and imaging examination, clinical efficacy and safety were collected and analyzed during hospitalization. Results Among the 65 patients, there were 34 males and 31 females, of which 28 were ≥8 years old and 37 were <8 years old, with an average age of(7.73±2.41) years. The most common clinical manifestations were cough(65 cases, 100.0%) and fever(64 cases, 98.46%). The right lung was mainly involved in pneumonia(33 cases, 50.77%). The average course of treatment with doxycycline was(7.43±2.95) days, with a dosage of 2 mg/kg every 12 hours. After treatment, the average body temperature of 50 cases(76.92%) dropped to normal within(1.76±1.20) days, 55 cases(84.62%) showed significantly improvement in cough symptoms within(3.58±1.89) days, and 54 cases(83.08%) showed significant absorption in lung imaging, with an average time of(9.00±0.63) days. There was 1 case of rash and 1 case of pain during medication period. After discharge, follow-up was conducted until 3 months after medication, and no drug-related adverse reactions occurred. Conclusion Doxycycline is safe in the treatment of lobular pneumonia infected by drug-resistant MP in children with proper dose and short course of treatment, and can be appropriately selected in clinical pratice.
  • Recommendation
    LI Hongbo, YANG Ying, YU Yongfeng, LU Shun
    World Clinical Drug. 2025, 46(2): 107-122. https://doi.org/10.13683/j.wph.2025.02.001
    The clinical use of targeted agents has revolutionized treatment strategies for non-small cell lung cancer(NSCLC) patients carrying targetable mutations for two decades, and has resulted in significant survival benefits. In recent years, the types and clinical use of targeted agents have expanded, with breakthroughs in the treatment of advanced to locally advanced unresectable patients and perioperative adjuvant treatment of resectable patients. In advanced patients, the combination of targeted drugs with chemotherapy or dual-antibody drugs has also provided new options for first-line and subsequent treatment. Meanwhile, antibody-drug conjugates have made positive progress in the subsequent treatment of advanced patients. This article aimed to review the research progress of targeted drugs in the clinical application of intermediate and advanced NSCLC.
  • Article
    YU Ping , ZHANG Penghua , KE Hongqin , LIANG Huan , LIANG Wenbin , YU Zhifang
    World Clinical Drug. 2024, 45(12): 1258-1262. https://doi.org/10.13683/j.wph.2024.12.007
    Objective To explore the therapeutic effect of Dengtaiye granules combined with glycine theophylline sodium sustained-release tablets in the treatment of acute exacerbation of chronic asthmatic bronchitis. Methods 106 patients with acute exacerbation of chronic asthmatic bronchitis admitted to Shiyan Taihe Hospital from April 2021 to December 2023 were selected and divided into the control group and the treatment group, and 53 cases in each group. The control group was treated with glycine theophylline sodium sustained-release tablets, and the treatment group was treated with Dengtaiye granules combined with glycine theophylline sodium sustained-release tablets. The therapeutic effects, the improvement time of traditional Chinese medicine symptoms, serum inflammation indicators, and adverse reactions between two groups were compared after 7 days of treatment. Results The total effective rate of the treatment group was higher than that of the control group(96.23% vs 84.91%, P<0.05). The improvement time of cough, phlegm accumulation, wheezing, facial redness and irritability, and dry stools in the treatment group was shorter than that in the control group(P<0.05). After treatment, C-reactive protein, interleukin(IL)-6, IL-17, and tumor necrosis factor-α were decreased in the two groups(P<0.05), and the treatment group were lower than those in the control group(P<0.05).There was no significant difference in the incidence of adverse reactions between the two groups(P>0.05). Conclusion Dengtaiye granules combined with glycine theophylline sodium sustained-release tablets can achieve ideal therapeutic effects in the treatment of acute exacerbation of chronic asthmatic bronchitis. It can quickly improve the traditional Chinese medicine symptoms of patients, effectively reduce the inflammatory response in the body, and has high safety.
  • Article
    QIN Lei, XU Jie
    World Clinical Drug. 2024, 45(12): 1300-1302. https://doi.org/10.13683/j.wph.2024.12.014
    回顾性分析1 例难治性类风湿关节炎(rheumatoid arthritis,RA) 患者临床资料。患者35 岁,多关节疼痛5 年余, 类风湿因子(rheumatoid factor,RF)、抗环瓜氨酸肽抗体阳性,病程中接受托法替布、阿达木单抗等抗风湿、抗炎及调节 免疫等药物治疗,但效果欠佳。医生最后选用新获批的RA 用药泰它西普,患者疾病活动度评分、RF 水平明显下降,得 到临床缓解。该病例提示新型全人融合蛋白泰它西普作为一种新获批的RA 治疗用药,效果较佳,值得临床进一步推广应用。
  • Article
    JI Weiguo, LI Weiwei, SHAN Yan, LI Weiming, LU Haisong, HAN Kaixun
    World Clinical Drug. 2025, 46(3): 236-242. https://doi.org/10.13683/j.wph.2025.03.005
    Objective To explore the effect of Guifu Dingchuan granules as an adjuvant treatment of cough and asthma in the middle and advanced non-small cell lung cancer(NSCLC) with kidney Qi deficiency syndrome. Methods A total of 100 patients with cough and asthma in the middle and advanced NSCLC with kidney Qi deficiency syndrome in our hospital from December 2022 to January 2024 were selected and divided into control group(western medicine) and study group(Guifu Dingchuan granules combined with western medicine) according to simple sequencing random method, with 50 cases in each group. The clinical effect of the two groups was observed. The traditional Chinese medicine syndrome score, forced expiratory volume in one second(FEV1), peak expiratory flow(PEF), forced vital capacity(FVC), serum micro RNA(miR)-200a, miR-375, Leicester cough questionnaire(LCQ), quality of life questionnaire-core 30(QLQ-C30) and incidence of adverse reactions were compared before and after treatment. Results The total effective rate of the study group was higher than that of the control group(92.00% vs. 76.00%, P<0.05). After treatment, LCQ and QLQ-C30 scores in the study group were lower than those in the control group(P<0.05). The levels of FEV1, PEF, FVC, serum miR-200a and miR-375 in the study group were higher than those in the control group(P<0.05). There was no significant difference in the incidence of adverse reactions between the two groups(P>0.05). Conclusion Guifu Dingchuan granules can effectively improve the curative effect, improve lung function and quality of life in the adjuvant treatment of cough and asthma in the middle and advanced NSCLC patients with kidney Qi deficiency syndrome, and up-regulate the levels of serum miR-200a and miR-375 with high safety.
  • Article
    ZHANG Lu , LIU Shuzheng , ZHANG Rui , YANG Li'na , LI Zhuojun
    World Clinical Drug. 2024, 45(10): 1046-1052. https://doi.org/10.13683/j.wph.2024.10.008
    Objective To analyze the efficacy and safety of cefoperazone sulbactam sodium combined with high-dose tigecycline in the treatment of interleukin(IL)-6, procalcitonin(PCT) and other indicators in patients with complicated urinary tract infection. Methods A total of 156 patients with complicated urinary tract infection caused by carbapenem-resistant Acinetobacter baumannii(CRAB) admitted to the Affiliated Hospital of Tangshan Vocational and Technical College from August 2020 to December 2023 were selected as retrospective study objects. The patients were divided into the high dose group and the routine dose group according to the dose of tigecycline, with 78 cases in each group. The initial dose of tigecycline in the high dose group was 200 mg, and the maintenance dose was 100 mg, twice a day. The initial dose of tigecycline in the routine dose group was 100 mg, and the maintenance dose was 50 mg, twice a day. The clinical efficacy, clinical indexes negative time, the laboratory indexe[IL-6, IL-8, hypersensitive C-reactive protein(hs-CRP) and PCT], the negative rate of urine culture, the incidence of adverse reactions and the oxidative stress indexes[noradrenaline(NE), glutathione peroxidase(GSH-PX), angiotensinogenⅡ(AngⅡ)] and treatment satisfaction were analyzed between the two groups. Results The total clinical effective rate of the high-dose group was significantly higher than that of the routine dose group(P<0.05). The time of clinical symptoms disappearing, the time of urine white blood cell turning negative, and the time of fever reduction in the high-dose group were significantly shorter than those in the routine dose group(P<0.05). The levels of IL-6, IL-8, hs CRP, and PCT in the high-dose group were significantly lower than those in the routine dose group after treatment(P<0.05). The negative conversion rate of urine culture in the high-dose group was higher than that in the routine dose group(23.36% vs 12.82%, ꭓ 2 =3.431, P=0.009). The total incidence of adverse reactions in the high-dose group was higher than that in the routine dose group(P>0.05), and the overall treatment satisfaction rate in the high-dose group was higher than that in the routine dose group(96.15% vs 82.05%, P<0.05). The levels of NE, GSH-Px, and AngⅡ in the high-dose group were significantly higher than those in the routine dose group after treatment(P<0.05). Conclusions High-dose tigecycline combined with cefoperazone-sulbactam sodium has significant efficacy in the treatment of CRAB induced complicated urinary tract infection, and the adverse reactions are not significantly higher than that of the routine dose regimen, and is safe and effective.
  • Review
    MA Qing, JIA Jianqi, HE Qian
    World Clinical Drug. 2024, 45(10): 1099-1103. https://doi.org/10.13683/j.wph.2024.10.016
    Semaglutide was approved by the U.S. Food and Drug Administration on March 8, 2024 for the prevention of cardiovascular disease, heart disease, and cerebral apoplexy in adults who are overweight or obese. Semaglutide improves blood glucose and traditional cardiovascular moderate risk factor levels in obese patients, reduces ectopic adipose tissue that can lead to atherosclerosis and myocardial dysfunction, and improves the systemic pro-inflammatory and prothrombotic environment associated with obesity. This article intended to elaborate the mechanism of action, clinical research and safety of semaglutide in the treatment of cardiovascular diseases complicated with obesity from multiple ways and levels, so as to provide certain reference for clinical use.