Objective To analyze the application status, development trend and existing problems of the Data Monitoring Committee(DMC) in the research and development of new anti-tumor drugs. Methods Clinical trials of antitumor drugs that were registered and met the conditions in the drug clinical trial registration and information disclosure platform from January 1, 2013 to April 24, 2024 were collected. Descriptive analysis methods were used to analyze the application of DMC in different trial characteristics(trial status, research center, research scope, and research stage, etc.). Result A total of 5 320 valid trials were included. Among them, there were 1 018 trials(19.14%) that adopted DMC. The proportion of trials with DMC was relatively high in those that were actively suspended(28.04%) and actively terminated (22.05%). Among the types of drugs, the application rates of DMC in biological products(22.43%) and chemical drugs (16.39%) were higher than those in traditional Chinese medicine(8.16%). The application rate of DMC was higher in phase Ⅲ trials(56.46%) and multi-center trials(22.32%). In terms of indication sites, the application rate of DMC in clinical trials of new anti-tumor drugs for lung and mediastinum(31.41%) and urinary system(37.84%) was relatively high. Conclusion The application of DMC in clinical trials of new anti-tumor drugs in China is generally relatively low, but it is slightly higher in high-risk trials. It is recommended to enhance the awareness of the sponsors of setting DMC according to the characteristics of different clinical trials, form more perfect DMC guidelines, and give full play to the advantages of DMC in protecting clinical trials.

Objective To systematically analyze the current application status and characteristics of data monitoring committee(DMC) in clinical trials of cardiovascular drug development in China, and to provide reference for optimizing DMC application in clinical trials. Methods The clinical trial data of cardiovascular diseases registered from January 2013 to December 1, 2024 were collected from the Drug Clinical Trial Registration and Information Disclosure Platform. Descriptive analysis was conducted to analyze the application of DMC in different trial characteristics(trial status, research scope, study phase, design type, and indications). Results A total of 1 917 clinical trials were included, of which 192(10.01%) implemented DMC. The DMC application rate in international multicenter trials(76.98%) was significantly higher than that in domestic trials(4.18%). The DMC application rate was relatively high in phase Ⅲ trials(44.37%)and trials involving minors(44.00%), and biological products(34.27%) was higher than that for chemical drugs(7.63%) and traditional Chinese medicines(6.83%). Regarding indications, the DMC application rate of high-risk diseases such as congenital heart disease(100.00%) and pulmonary embolism(60.00%) was markedly higher than that of common cardiovascular diseases such as hypertension(1.69%) and coronary heart disease(7.08%). Conclusion The DMC application rate in cardiovascular clinical trials in China remains generally low, but it is more prevalent in high-risk trials. It is recommended to establish differentiated DMC implementation standards based on characteristics of different types of clinical trials, strengthen professional DMC training, and improve the quality control level of clinical trials.

Objective To systematically analyze the application of Data Monitoring Committee(DMC) in clinical trials for new pediatric drug research and development in China, and the influence of some key trial characteristics on the application of DMC. Methods Based on the clinical trial records of pediatric new drug research and development published in the "Drug Clinical Trial Registration and Information Disclosure Platform" from January 1, 2013 to April 28, 2024, the trial characteristics and the application of DMC in different trial characteristics were sorted out and analyzed. Results A total of 612 trial records were included, of which 141 items(23.04%) were clinical trials using DMC. Since 2018, DMC applications have continued to grow. In terms of trial characteristics, the application rate of DMC in international trials was significantly higher than that in domestic trials(70.80% vs. 8.89%). The DMC application rate in multi-center trials was significantly higher than that in single-center trials(25.57% vs. 7.23%). The DMC application rate in the trials with sample size ≥100 and active termination trials were higher, which were 27.87% and 63.16%, respectively. The proportion of DMC application in phase III trial was high(35.85%). The DMC application rate in clinical trials of injectable dosage forms(26.64%) was significantly higher than that of oral dosage forms(22.62%), topical dosage forms(12.50%) and other dosage forms(15.79%). Conclusion At present, the application rate of DMC in clinical trials for pediatric drug research and development in China is generally low, and the key trial characteristics have an impact on the application of DMC. It is suggested to formulate corresponding DMC application standards according to the specific needs of the project and clinical trial characteristics to improve the quality and level of the trials.

In recent years, with the continuous practice and exploration of data monitoring committee(DMC), it has become an integral part of large-scale, multi-center, high-risk clinical researches in the world. The development of DMC in China is still in its infancy, and the DMC system has not been widely promoted in most of the researches in China, including the field of traditional Chinese medicine. In October 2019, the first Chinese Medicine DMC(CMDMC) group standard "Technical Specifications for Chinese Medicine Clinical Research Data Monitoring" was officially released.The standard integrates and reflects the characteristics of traditional Chinese medicine research in different stages, and effectively improving and promoting the quality of traditional Chinese medicine clinical research. This paper will take "Phase Ⅳ clinical trial of Danhong injection for stable coronary atherosclerotic heart disease" as an example to present a complete CMDMC practice case, focusing on the purpose established by CMDMC in this study, the problems to be solved, the specific operation mode, key recommendations and decision-making mode, etc., and comprehensively explain the dynamic intervention and management of CMDMC in the whole process, full coverage and full tracking of clinical research. The aim is to provide a model reference for establishing a complete quality control and quality assurance system of traditional Chinese medicine clinical research and improving the quality of traditional Chinese medicine clinical research.

Objective To explore the mechanism of Wenzhen Yunqi decoction in improving cognitive dysfunction in rats with chronic fatigue syndrome(CFS). Methods The cognitive dysfunction model of CFS in rats was established by using the multiple chronic stress method. For 4 consecutive weeks, the rats were respectively administered Wenzhen Yunqi decoction, different doses of monomer kaempferol and the 0.9% sodium chloride solution by gavage. The results of water maze test, mouse tail suspension test and exhaustive swimming test were compared in each group. The levels of tumor necrosis factor(TNF)-α, interleukin(IL)-6, superoxide dismutase(SOD) and malondialdehyde(MDA) in hippocampal tissues of rats were detected by immunoenzyme-linked adsorption. The morphology of hippocampal tissue was observed by hematoxylin eosin(HE) staining. Results In Wenzhen Yunqi decoction group, the escape latency time decreased with the increase of training days. The stay time in the target quadrant and the number of platform crossings increased significantly,the number of tail suspensive struggles increased significantly, the static rest time decreased significantly, the exhaustion swimming time prolonged significantly, the level of SOD increased, the levels of TNF-α, IL-6 and MDA decreased, the tissue damage in the hippocampus improved significantly. All those improvements in Wenzhen Yunqi decoction group were superior to those in kaempferol group(P＜0.05). Conclusion Wenzhen Yunqi decoction can significantly improve the levels of inflammatory factors and oxidative stress factors in the hippocampal tissue of CFS rats with cognitive dysfunction, and alleviate the pathological changes of hippocampal neurons. Moreover, the therapeutic effect is superior to that of the monomer kaempferol, indicating that the overall improvement of traditional Chinese medicine compound has certain advantages.

Objective To analyze the therapeutic effect of Yinxie capsules combined with calcipotriol cream in treating psoriasis with wind-dryness syndrome and blood deficiency and its impacts on serum interleukin(IL)-17, leucine-rich α-2 glycoprotein 1(LRG)1, and lipocalin-2. Methods A total of 86 psoriasis patients with wind-dryness syndrome and blood deficiency admitted to Department of Dermatology, Honghu People's Hospital from August 2021 to July 2022 were selected and divided into Yinxie capsule group and control group according to random number table method, with 43 patients in each group. The control group was treated with routine symptomatic therapy and calcipotriol cream, while the Yinxie capsule group was treated with Yinxie capsules on the basis of the control group. The clinical efficacy, adverse reactions, recurrence after 1 year, the psoriasis area and severity index(PASI), IL-17, LRG1, lipocalin-2 levels, moisture content and sebum content in stratum corneum of skin were compared between the two groups. Results The total clinical effective rate of the Yinxie capsule group was obviously higher than the control group(P＜0.05). After treatment, the PASI scores, the levels of IL-17, LRG1, and lipocalin-2 in the both groups were decreased compared with those before treatment, while the moisture content and sebum content were increased, and the Yinxie capsule group was better than the control group(P＜0.05). There was no significant difference in the incidence of adverse reactions between the two groups(P＞ 0.05). The recurrence rate after 1 year of the Yinxie capsule group was obviously lower than the control group(P＜ 0.05). Conclusion The combination of Yinxie capsules and calcipotriol cream obviously improves the clinical efficacy of psoriasis, reduces the recurrence rate, and has good safety.

Objective To investigate the efficacy of imatinib in the treatment of breast cancer and forkhead box protein (FOX)A1, Golgi apparatus protei(GP)73 and tumor markers. Methods A total of 100 breast cancer patients treated in Shanghai hospital of traditional Chinese medicine from March 2021 to February 2023 were selected and divided into observation group and control group by simple randomization method, with 50 cases in each group. The control group was treated with paclitaxel combined with carboplatin, and the observation group was treated with imatinib based on the control group. Clinical efficacy, FOXA1, GP73, carcinoembryonic antigen(CEA), carbohydrate antigen(CA)125, CA153, estrogens and the incidence of adverse reactions were compared between the two groups. Results After treatment, the total effective rate of observation group was higher than that of control group (90.00% vs. 70.00%, P＜0.05). The FOXA1 level in both groups was higher than before treatment, and the observation group was higher than the control group(P＜ 0.05). The levels of GP73, CEA, CA125, CA153, estrone, estradiol and estrogen receptors in both groups were lower

Objective To explore the efficacy of imipenem combined with Yiyuan Qingfei decoction in severe pneumonia and its effect on serum leukotrienes(LT)B4, soluble urokinase-type plasminogen activator receptor(suPAR) and pentraxins(PTX)3. Methods A total of 108 patients with severe pneumonia in our hospital from July 2021 to July 2023 were selected and randomly divided into the control group(imipenem＋ambroxol) and the study group(imipenem＋ Yiyuan Qingfei decoction), with 54 cases in each group. All patients were treated for 2 weeks. The curative effects, traditional Chinese medicine(TCM) syndrome scores, inflammatory indicators, changes in LTB4, suPAR and PTX3 levels of the two groups were compared, and the occurrence of adverse reactions during the treatment course was recorded. Results After treatment, the clinical efficacy of the study group was higher than that of the control group(94.44% vs. 79.63%, P＜0.05), and the levels of TCM syndrome score, C-reactive protein, tumor necrosis factor-α, interleukin-6, interleukin-10, LTB4, suPAR, and PTX3 were all lower than those of the control group(P＜0.05). There was no significant difference in the occurrence of adverse reactions between the two groups(P＞0.05). Conclusion Imipenem combined with Yiyuan Qingfei decoction has a significant therapeutic effect on severe pneumonia and can effectively improve the levels of serum LTB4, suPAR and PTX3. It is worthy of promotion.

Objective To investigate the effects of butylphthalide soft capsules on the cognitive function and clinical efficacy of patients with Parkinson's disease(PD) and cognitive impairment. Methods A total of 124 elderly PD patients at Norinco General hospital from January 2021 to January 2022 were selected and randomly divided into control group and observation group, 62 cases in each group. The control group was treated with pramipexole hydrochloride and carbidopa and levodopa sustained-release tablets, while the observation group received the basic treatment combined with oral administration of butylphthalide soft capsules. Neurotransmitters, related factors, cognitive score scales, daily living ability, serum levels of microRNA(miR)-7, miR-128 and miR-221, and the microscopic structure of the left hippocampus of the two groups were analyzed. Results After treatment, the levels of norepinephrine, dopamine, 5-hydroxytryptamine and acetylcholine in both groups were increased, and the observation group was higher than the control group(P＜0.05). The levels of PD protein 7, and miR-221 in both groups were decreased, and the observation group was lower than the control group(P＜0.05). The levels of neurotrophin-3, brain-derived neurotrophic factor, mini-mental state examination, Montreal cognitive assessment, activity of daily living score, miR-7, miR-128, neurite orientation dispersion index and intracellular volume fraction were increased, and the observation group was higher than the control group(P＜0.05). There was no difference in the incidence of adverse reactions between the two groups(P＞0.05). Conclusion The butylphthalide soft capsules can effectively improve the cognitive function of patients with PD and cognitive impairment, alleviate the motor symptoms, which is safe and worthy of promotion and clinical application.

Objective To explore the efficacy of Buqi Jianpi formula combined with quadruple therapy in the treatment of Helicobacter pylori(Hp)-positive chronic atrophic gastritis(CAG) with spleen and stomach weakness. Methods A total of 93 Hp-positive CAG patients with spleen and stomach weakness syndrome admitted to the Gastroenterology Department of our hospital from January 2021 to June 2024 were selected and divided into the observation group(47 cases, with Buqi Jianpi formula combined with standard quadruple therapy) and the control group(46 cases, with standard quadruple therapy) according to simple sorting random method. Both groups were treated continuously for 2 weeks. The clinical efficacy, Hp eradication rate, serum pepsinogen(PG)Ⅰ, PGⅡ, PGⅠ/PGⅡ, gastrin(G)-17, gastroscopy pathological score and traditional Chinese medicine(TCM) syndrome score of the two groups were compared. Result After treatment, the total effective rate of the observation group was higher than that of the control group(93.62% vs. 78.26%, P＜0.05). The Hp eradication rate in the observation group was higher than that in the control group(95.74% vs.82.61%, P＜0.05). The PGⅠ, PGⅠ/PGⅡ and G-17 in the observation group were all higher than those in the control group(P＜0.05), while the PGⅡ level, gastroscopy pathological score and TCM syndrome score were all lower than those in the control group(P＜0.05). Conclusion The Buqi Jianpi formula combined with the quadruple therapy has a significant effect in the treatment of Hp-positive CAG patients with spleen and stomach weakness syndrome, which can improve the overall benefit and is worthy of clinical promotion.

Objective To investigate the efficacy of Xiangdan injection combined with omeprazole injection in the treatment of acute pancreatitis(AP) and the effects of on serum fatty acid binding protein(FABP)4 and high mobility group protein B1(HMGB-1). Methods According to the simple rank randomization method, 74 AP patients diagnosed in our hospital from April 2023 to April 2024 were divided into omeprazole group(omeprazole injection) and Xiangdan group(omeprazole injection combined Xiangdan injection), with 37 cases in each group. The clinical curative effect, inflammatory factor levels, immune function, intestinal mucosal barrier function, hemorheological indexes, and adverse reactions during the treatment were compared between the two groups. Results The total effective rate of omeprazole group was lower than that of Xiangdan group(56.76% vs. 81.08%, P＜0.05). After treatment, the remission time of abdominal pain, intestinal sound, abdominal distension and hospitalization time in Xiangdan group were shorter than those in omeprazole group(P＜0.05). The levels of procalcitonin, C-reactive protein, interleukin-6 and interleukin 8, diamine oxidation, D-lactic acid, endotoxin, hemorheological indexes, FABP4 and HMGB-1 in both groups were lower than before treatment(P＜0.05), and the reduction was more significant in Xiangdan group(P＜0.05). The levels of CD3＋, CD4＋and CD4＋/CD8＋ in both groups were higher than before treatment, and the increase was more significant in Xiangdan group(P＜0.05). Conclusion Xiangdan injection combined with omeprazole injection has significant efficacy in the treatment of AP patients, which can significantly reduce the levels of FABP4 and HMGB-1, reduce the inflammatory response of patients, improve the immunity and intestinal barrier function of patients, and improve hemorheology, with high safety.

Objective To explore and analyze the adverse drug event(ADE) signals of sacituzumab govitecan in the database of the Food and Drug Administration adverse event reporting system(FAERS) of the United States. Method Adverse event reports related to sacituzumab govitecan from the second quarter of 2020 to the first quarter of 2024 were selected from the United States FAERS database. The reporting odds ratio method in the ratio imbalance method in combination with the Bayesian confidence propagation neural network(BCPNN) method were used to conduct data mining and analysis. Result After screening, a total of 3 085 ADE reports were obtained. Among them, female patients accounted for a relatively large proportion(86.09%), and the age group was mainly 45～64 years old(25.35%). The reporting country was mainly the United States(34.20%). The outcome was mainly composed of mortality rate(26.65%) and hospitalization rate(28.75%). There were 145 positive signals related to ADE involving 26 systemic organ classifications.The frequency of occurrence of ADE signals was basically consistent with the instructions. The instructions do not mention serious adverse reactions such as hemorrhagic diarrhea, paralytic intestinal obstruction, large intestine perforation, febrile bone marrow aplasia and bone marrow failure, etc.. Conclusion When doctors us sacituzumab govitecan in clinical practice, it is necessary to conduct an assessment for the patient's medication use. During the treatment period, new adverse reactions should be vigilant, and timely intervention should be carried out when abnormalities are detected.

Objective To systematically introduce how to calculate the 50% effective concentration(EC50) of drugs using the Probit module in SPSS27.0 based on clinical research data, tproviding a reference for clinical researchers. Methods Taking a set of clinical data as an example, this study elucidates the specific steps of calculating the EC50 of drugs using SPSS27.0 and interprets the main output results. Additionally, the EC50 obtained by this method are compared and validated with those calculated by GraphPad Prism9.5. Results The EC50 calculated and analyzed by SPSS software are consistent with those obtained by GraphPad Prism9.5. Moreover, SPSS27.0 features simple steps and quick operations. Conclusion SPSS27.0 can be used to calculate and analyze EC50, which is convenient and fast in operation and is an ideal choice for clinical researchers who are not specialized in statistics.

Oxidative stress and inflammation are common factors that lead to the progression of chronic kidney disease(CKD) to end-stage renal disease(ESRD), and methylbardoxolone is an agonist of antioxidant and antiinflammatory factors such nuclear factor erythroid-related factor 2. It can increase the glomerular filtration rate(GFR) of patients with CKD. Methylbardoxolone has a good effect in increasing GFR. However, because it can increase the risk of cardiovascular events and proteinuria, and fails to improve the incidence of ESRD, it ultimately failed to become a therapeutic drug for CKD. This article reviewed the effects of methylbardoxolone in clinical trials of CKD drugs caused by multiple factors, aiming to provide a reference for its application.

Refractory gout(RG) is an end-stage disease progression of gout involving multiple joints and repeated acute attacks. The typical clinical features include chronic gout stone formation, multifocal bone erosion and progressive loss of joint function, which finally progresses to erosive arthritis. Western medicine for RG focuses on the regulation of inflammatory response and the reestablishment of uric acid homeostasis, among which biologics and new targeted drugs have become an important research hotspot for breaking through the traditional therapy. Traditional Chinese medicine includes prescription and external treatment in RG management, which can help to realize the regulation of local inflammatory microenvironment. This article compared and analyzed the progress of RG treatment with traditional Chinese and western medicine in order to provide new ideas for clinical treatment.

Objective To explore the application effect of pharmaceutical follow-up in patients with hyperthyroidism based on intelligent pharmaceutical monitoring system. Methods A total of 200 patients with hyperthyroidism in the outpatient and inpatient departments of our hospital from September to December 2023 were selected, and they were divided into two levels according to the severity of the disease: hyperthyroidism and hyperthyroid-related eye disease, and 50 cases in each level were collected for the study group and control group, respectively. The control group received routine pharmaceutical care, and the study group added a monitoring system on the basis of the control group to follow up the patients. After 6 months of follow-up, the intervention effects of each level in the two groups were compared respectively before and after follow-up. Results There were statistically significant differences in medication adherence and emotional scales between the two-level study group and the control group(P＜0.05). The incidence of adverse drug reactions in the study group was lower than that in the control group. Conclusion Compared with traditional pharmaceutical care, pharmaceutical follow-up based on pharmaceutical monitoring system can help improve medication compliance of patients with hyperthyroidism, reduce the risk of adverse reactions, and alleviate the psychological burden of the disease.