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.

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.

The disability caused by stroke is a serious public health problem that causes a heavy burden to the society. The convalescence of stroke disability is the key stage of functional recovery, but there is no effective drug treatment at present. In recent years, traditional Chinese medicine(TCM) has significant potential in the field of drug research and development. Based on the guidelines for the diagnosis and treatment of stroke recovery at home and abroad in recent years, combined with the current clinical research situation and potential problems of TCM research and development, this paper discussed the key link in the process of clinical research design, including clinical positioning, efficacy indicators, clinical test control, treatment course, and visiting perspective, and takes the clinical trial of Qizhi Tongluo capsule as an example to explain, aiming to provide objective and operable design elements for the majority of researchers in the field of TCM to carry out high-quality clinical research.

Objective To explore the mechanism of Jianpi Qinghua formula in improving catecholamine resistance in obesity by network pharmacology and molecular docking techniques. Methods The main active components and related targets of Jianpi Qinghua formula were screened by the database of traditional Chinese medicine system pharmacology and analysis platform. Catecholamine resistance targets associated with obesity were screened by the online human Mendelian genetics and GeneCards databases. The network topology diagram of "Jianpi Qinghua formula-active ingredient-target" and the protein-protein interaction network diagram were constructed by Cytoscape3.7.1 software to identify key targets. The intersection targets were imported into DAVID database for bioinformatics analysis. AutoDock Vina was used for molecular docking to screen and further verify the core chemical components of the formula. Results A total of 79 active ingredients and 661 targets were screened in the formula. A total of 1 337 catecholamine resistance targets and 262 intersection targets were identified in obesity. The key targets were signal transducer and activator of transcription 3, caspase 3, B-cell lymphoma-2 and serine-threonine kinase 1(AKT1). The results of the analysis of the Kyoto Encyclopedia of Genes and Genome showed that the improvement of catecholamine resistance by Jianpi Qinghua formula in obesity was related to the neuroactive ligand-receptor interaction, phosphatidylinositol-3-kinase/AKT1 signaling pathway and cyclic adenosine monophosphate signaling pathway. Conclusion The core components of Jianpi Qinghua formula of the potential mechanism may be 4',5-dihydroxyflavone, baicalein and jaranol in improving catecholamine resistance in obesity.

Objective To explore the effects of Sihong Quban decoction combined with photon skin rejuvenation technology on the degree of skin lesions and sebum content in patients with chloasma. Methods One-hundred patients diagnosed with chloasma in our hospital from September 2021 to September 2023 were collected and randomly separated into conventional group and combination group, with 50 cases in each group. The conventional group was treated with photon skin rejuvenation technology, while the combination group was treated with Sihong Quban decoction combined with photon skin rejuvenation technology. The clinical efficacy, degree of skin lesions, skin indicators, oxidative stress indicators, serum sex hormone indicators, and adverse reactions were observed after treatment. Results After treatment, the total effective rate of the combination group was 96.00%, the conventional group was 76.00%, and the combination group was obviously higher than the conventional group(P＜0.05). The skin color score, skin lesion area score, total skin lesion score, sebum content of skin lesions, pigmentation, pores, wrinkles, melasma area severity index score,malonaldehyde, follicle-stimulating hormone, luteinizing hormone, and estradiol levels of the two groups were obviously reduced compared to before treatment, and the above indicators(except for sebum content) in the combination group were obviously lower than those in the conventional group(P＜0.05). There was no obvious difference in sebum content between the two groups(P＞0.05). The skin moisture content, skin elasticity index, superoxide dismutase(SOD) and catalase(CAT) levels in both groups were obviously increased compared to before treatment(P＜0.05), and the combination group had obviously higher skin moisture content, skin elasticity index, SOD and CAT levels than the conventional group(P＜0.05). There was no significant difference in adverse reaction rate between the two groups during treatment(P＞0.05). Conclusion Sihong Quban decoction combined with photon skin rejuvenation technology can improve clinical efficacy, reduce skin lesions and oxidative stress response, improve skin condition, and regulate serum sex hormone levels in patients with chloasma.

Objective To investigate the effect and safety of Chinese and western medicine regimen containing centipede on clinical symptom and sign score, CT score and lung function in patients with interstitial lung disease(ILD). Methods A total of 102 patients with ILD who treated in our hospital from January 2021 to June 2022 were selected as the research objects and divided into the control group and the combined group, with 51 cases in each group. The control group was treated with standard western medicine, and the combined group was treated with standard traditional Chinese medicine containing centipede on the basis of the control group. The curative effect, clinical symptoms and signs scores, CT scores, and forced vital capacity(FVC) and carbon monoxide diffusing capacity(DLCO) after treatment were compared between the two groups. Results The total effective rate of the combined group was higher than that of the control group(P＜0.05). After 3 months of treatment, the CT score of the control group was (9.25±2.42) points, and the combined group was (7.26±1.48) points, the difference between the two groups was statistically significant(P＜0.05). The scores of clinical symptoms such as cough, asthma and fatigue in the combined group were lower than those in the control group(P＜0.05). After 3 months of treatment, the FVC and DLCO of the combined group were higher than those of the control group(P＜0.05). During treatment, the incidence of oral infection, arrhythmia, hoarseness and other adverse reactions in the combined group was 11.76%, which was not significantly different from 9.80% in the control group(P＞ 0.05). Conclusion The Chinese and western medicine treatment regimen containing centipede can improve the treatment effect of ILD patients, reduce clinical symptoms and signs such as cough and fatigue, improve lung function, and has high safety.

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.

Objective To investigate the effects of fecal microbiota capsules in the adjuvant treatment of low-risk membranous nephropathy(MN) and its influence on T cell subsets and renal function. Methods A total of 90 low-risk MN patients admitted to our hospital from January 2022 to January 2024 were selected and divided into control group and experimental group by random number table method, with 45 cases in each group. The control group was treated with routine treatment, and the experimental group was treated with fecal microbiota capsules on the basis of routine treatment. The intestinal flora distribution, flora disorder grade, T lymphocyte level, cluster of differentiation antigen(CD)4＋, CD8＋, CD4＋/CD8＋ levels and renal function related indexes were compared between the two groups before and after treatment. Results Before treatment, there were no significant differences in intestinal flora distribution, flora disorder grade, Tlymphocytes, CD4＋, CD8＋, CD4＋/CD8＋ and renal function indexes between the two groups(P＞0.05). After treatment, the number of lactobacillus, bacteroides, bifidobacterium, normal flora, number of degree Ⅰ disorder, T helper cell(Th)2, regulatory T cells, CD4＋, CD8＋, CD4＋/CD8＋ and epidermal growth factor receptor in experimental group were higher than those in control group. The levels of Coccobacillus and Escherichia coli, the number of degree Ⅲ disorders, Th1, Th17, urea nitrogen, serum creatinine, anti-phospholipase A2 receptor antibody and type Ⅰ platelet reactive protein 7A domain were lower than those of control group(P＜0.05). Conclusion Fecal microbiota capsules can help regulate the balance of intestinal flora, improve T cell subsets and renal function in the treatment of low-risk MN.

Objective To observe the effect of vericiguat combined with dapagliflozin in patients with heart failure with reduced ejection fraction(HFrEF). Methods A total of 98 patients with HFrEF in our hospital from January 2023 to January 2024 were selected and divided into combination group and control group according to random number table method, with 49 cases in each group. On the basis of conventional HF treatment, the control group was given dapagliflozin, the combination group was given dapagliflozin combined with vericiguat. Both groups were treated for 6 months. The clinical effect, adverse reactions, HF rehospitalization rate and major adverse cardiovascular event(MACE) were compared between the two groups. The cardiac function indexes, N-terminal brain natriuretic peptide precursor(NTproBNP), neutrophil-to-lymphocyte ratio(NLR), C-reactive protein(CRP), Minnesota living with heart failure questionnaire(MLHFQ) score, 6-minute walking test(6MWT) distance were compared between the two groups before and after treatment. Results After treatment, the total effective rate of combination group was higher than that of control group(93.62% vs 70.83%, P＜0.05). The LVEF level and 6MWT distance were increased in both groups, and the combination group was higher than the control group(P＜0.05). The levels of LVEDD, LVESD, NT-proBNP, NLR, CRP and MLHFQ score were all decreased, and the combination group was lower than the control group(P＜0.05). There was no significant difference in the occurrence of adverse reactions between the two groups(P＜0.05). The incidence of HF rehospitalization(6.38% vs 20.83%, P＜0.05) and MACE(12.77% vs 31.25%, P＜0.05) in the combination group were lower than those in the control group, respectively. Conclusion Vericiguat combined with dapagliflozin can significantly reduce ventricular remodeling and inflammatory response in HFrEF patients, enhance efficacy, improve quality of life and prognosis, and have good safety.

Objective To investigate the clinical effect of eltrombopag combined with standard immunosuppression in the treatment of aplastic anemia(AA) and its effect on GATA binding protein(GATA)-3, transforming growth factor(TGF)-β and soluble Fas(sFas) level. Methods A total of 175 patients with AA in our hospital from January 2020 to December 2023 were selected and divided into observation group(n＝88) and control group(n＝87). The control group was treated with standard immunosuppressive therapy, and the observation group was treated with eltrombopag on the basis of the control group. The clinical efficacy, GATA-3, TGF-β, sFas, platelet count(PLT), white blood cell(WBC), immune function and 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(92.05% vs 81.61%, P＜0.05). Serum levels of GATA- 3, TGF-β and sFas in both groups were significantly decreased(P＜0.05), and the observation group was lower than the control group(P＜0.05). The levels of PLT and WBC in both groups were significantly higher than before(P＜0.05), and the observation group was higher than the control group(P＜0.05). The cluster of differentiation(CD)4＋and CD4＋/CD8＋ in both groups were significantly decreased than before(P＜0.05), and the observation group was lower than the control group(P＜0.05), while CD8＋ was significantly increased than before(P＜0.05), and the observation group was higher than the control group(P＜0.05). During treatment, there was no significant difference in adverse reactions between the two groups(P＞0.05). Conclusion Eltrombopag combined with standard immunosuppressive therapy in AA is more effective, and can improve the serum levels of GATA-3, TGF-β and sFas.

Objective To investigate the therapeutic effect of ginkgo biloba diterpene lactone meglumine injection combined with acupuncture through tendons on hemiplegia patients with stroke and its effects on cyclic adenosine phosphate(cAMP), cyclic guanosine phosphate(cGMP) and brain-derived neurotrophic factor(BDNF) in serum. Methods A total of 150 stroke patients with hemiplegia in our hospital from March 2022 to March 2024 were selected and divided into observation group(conventional treatment＋ginkgo biloba diterpenoid lactone meglumine injection＋ acupuncture through tendons) and control group(conventional treatment＋ginkgo biloba diterpenoid lactone meglumine injection) according to random number table method, 75 cases in each group, and both groups were treated for 8 weeks. The clinical efficacy, serum cAMP, cGMP, BDNF, and scores of National Institute of Health stroke scale(NIHSS), Fugl- Meyer motor function assessment(FMA) and traditional Chinese medicine syndrome scores were compared between the two groups. Results The total effective rate of observation group was higher than that of control group(88.00% vs 70.67%, P＜0.05). Serum cAMP and BDNF in observation group were higher than those in control group(P＜0.05), and cGMP was lower than that in control group(P＜0.05). The NIHSS score of the observation group was lower than that of the control group(P＜0.05), and the FMA score was higher than that of the control group(P＜0.05). The syndrome scores of hemiplegia, tongue deviation, and speech astringency syndrome in the observation group were lower than those in the control group(P＜0.05). Conclusion Ginkgo biloba diterpene lactone meglumine injection combined with acupuncture through tendons has a significant effect in the treatment of hemiplegia after stroke. The two have a synergistic effect, which can regulate the levels of serum cAMP, cGMP and BDNF, and promote functional recovery.

Objective To investigate the effect of traditional Chinese medicine(TCM) fumigation and washing combined with laparoscopic natural orifice specimen extraction surgery on posterior anal function and pain index in patients with low rectal cancer. Methods A total of 94 male patients with low rectal cancer admitted to our hospital from September 2020 to October 2022 were selected. The patients were divided into two groups according to random number table method. The control group was treated with laparoscopic natural orifice specimen extraction surgery, and the study group was treated with TCM fumigation and washing intervention based on the control group. The urination function, incidence of postoperative anastomotic stenosis and anastomotic fistula and visual analogue pain score were compared between the two groups. Results After the intervention, the visual analogue pain score of the study group was significantly lower than that of the control group(t＝3.592, P＜0.001), and the detrusor pressure at maximum flow rate and the maximum urethral closure pressure were better than those in the control group(P＜0.05). Conclusion TCM fumigation and washing intervention can effectively reduce the postoperative pain of male patients with laparoscopic resection of low rectal cancer, and improve their urination function and postoperative rehabilitation quality.

Objective To investigate the effects of subcutaneous injection of granulocyte colony-stimulating factor(GCSF) combined with low molecular weight heparin(LMWH) on the clinical pregnancy outcome of freeze-thaw embryo transfer(FET) in patients with unexplained repeated implantation failure(URIF) during in vitro fertilization/ intracytoplasmic sperm injection(IVF/ICSI) cycles. Methods The data of URIF patients who underwent IVF/ICSI in the department of reproductive medicine of Handan central hospital from January 2017 to March 2023 were analyzed,according to the treatment methods, group A received subcutaneous injection of G-CSF combined with LMWH during FET cycle, group B received subcutaneous injection of G-CSF, group C received subcutaneous injection of LMWH, group D received conventional luteal support therapy. According to the patients' basic data, the propensity score matching was performed, and the caliper value was set to 0.02. The FET cycle characteristics, clinical pregnancy outcome, obstetric outcome and neonatal outcome and major adverse reactions were compared. Results There was no statistical significance in the characteristics of patients in each group during the FET cycle(P＞0.05). There were significant differences in embryo implantation rate, clinical pregnancy rate and β-human chorionic gonadotropin(HCG) positive rate among all groups(P＝0.002, P＝0.006, P＝0.007). There were no significant differences in term birth rate, preterm birth rate, twin rate, obstetric complications rate(pregnation-induced hypertension rate, premature rupture rate) and neonatal complications rate(macrosomia rate, low birth weight rate) among all groups(P＞0.05). Conclusion G-CSF combined LMWH subcutaneously can improve the embryos grow rate, clinical pregnancy rate and β-HCG positive rate of FET cycle in URIF patients, which is an effective treatment.

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.

Diabetic kidney disease(DKD) is a type of kidney disease caused by diabetes mellitus, which seriously affects the quality of life of patients and poses a major burden on the global health economy. Non-steroidal corticosteroid receptor antagonist(MRA) is a novel drug for the treatment of DKD, which has the potential to reduce cardiovascular events and delay the deterioration of renal function. Compared with traditional DKD agents, non-steroidal MRA can more effectively slow down the inflammatory reaction and fibrotic processes, and reduce the incidence of hyperkalemia. This article reviewed the recent progress of non-steroidal MRA's efficacy in DKD, aiming to provide safer and more effective treatment options for DKD patients.

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.