Objective To identify and investigate the quality of randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) in 11 non-key Chinese medical journals so as to learn about the current status and problems. Methods Eleven non-key medical journals of TCM from 1995 to 2000 were hand searched to identify the RCT and controlled clinical trials (CCTs). Each identified RCT or CCT was page by page verified by handsearchers based on the criteria developed by the Cochrane Handbook; the RCTs’ design, randomization method description, blind, baseline comparison, inclusion and exclusion criteria, diagnostic criteria,criteria for theraputic effectiveness, sample size, statistical method，described outcome, side effects, and follow up etc. were analyzed. Results In the related journals from 1995 to 2000, a total of 66 volumes and 390 issues were checked. As a result, 22 739 clinical studies were identified, of which 1 416 RCTs, only 24 (1.69%) were done with double blinding. There were 141 CCTs from 1995 to 2000, the total number of RCT increased from 95 to 1 416 and most of studies were on digestives diseases. Most of these studies had no detailed randomization method description, only 38 (2.68%) studies provided a methodology description. In addition, 1 220 (86.16% ) described outcome index, 1 203 (84.96%) used statistical method，934 (65.96%) had baseline comparison，828 (58.47%) described diagnostic criteria, 197 (13.91%) had inclusion and exclusion criteria，finally only 89 (6.29%) reported side effects. Conclusions Although the number of RCT has increased in the 11 non-key medical journals of TCM in the past six years, the quality of these RCTs needs to be improved.
Objective To explore the feasibility of breast cancer patients in China with 1–2 positive sentinel lymph nodes (SLN) to avoid axillary lymph node dissection (ALND). Methods A total of 328 patients who received sentinel lymph node biopsy (SLNB) in our hospital from 2010 to 2016 were collected retrospectively, and patients met the criteria of Z0011 clinical trials (which required no acceptance of neoadjuvant therapy, clinical tumor size was in T1/T2 stage, two or less positive SLNs were detected, received breast-conservation surgery, acceptance of whole breast radiotherapy after surgery and neoadjuvant systemic treatment) were enrolled to breast-conservation group. Patients met the criteria of Z0011 clinical trials, excepting the surgery (received non-breast-conservation surgery), were enrolled to non- breast-conservation group. Comparison of clinicopathological features between the breast-conservation group/non-breast-conservation group and the Z0011 ALND group was performed. Results Among the 328 patients, only 29 patients (8.8%) completely correspond with the results of Z0011 clinical trials. There was no statistical significance between the breast-conservation group and the Z0011 ALND group in the age, clinical T stage, expression of estrogen (ER), expression of progesterone (PR), pathological type, histological grade, number of positive lymph nodes, and incidence of non-sentinel node metastasis (P>0.05). A total of 81 patients were included in the non-breast-conservation group. It showed no statistical significance between the non-breast-conservation group and the Z0011 ALND group in expressions of ER and PR, and histological grade (P>0.05), while there was statistically significant difference in age, clinical T stage, pathological type,number of positive lymph nodes, and incidence of non-sentinel node metastasis (P<0.05). Patients in the non-breast-conservation group showed a lower age, higher percentage of lobular carcinoma and T2 stage, more positive lymph nodes, and high incidence of non-sentinel node metastasis. Conclusion It’s feasible for Z0011 clinical trials results to be used in the clinical practice of our country, but the actual situation of breast conservation in our country may lead to low adaptive population.
Objective To evaluate the clinical efficacy and safety of domestic cefepime in the treatment of acute bacterial lower respiratory tract infection. Methods A randomized, single-blind, controlled clinical trial was performed. The positive control was imported cefepime. The dosages of cefepime were 1g for moderate infection and 2g for severe infection, twice a day intravenously. The duration of the treatment was 7-10 days. Results Thirty-one patients were enrolled in the trial, of whom 30 were evaluable (15 in the triagroup and 15 in the control group). No significant differences were observed between the trial group and the control group with respect to the cure rate (40% vs. 27%), the effective rate (80% vs. 87%), the bacterial clearance rate (92% vs. 100%), and the incidence of adverse drug reactions (12.5% vs. 13%) (Pgt;0.05). Conclusion Domestic cefepime injection is effective and safe in the treatment of acute bacterial lower respiratory tract infection.
目的 为避免选择和发表偏倚,系统评价者应采用多种查询技术,并尽力获得未发表的研究.本文试图探讨,英特网检索对鉴定未发表和正在进行的临床试验是否有用.研究设计 利用七个Cochrane系统评价的查询策略回顾性地在英特网上检索未纳入的随机对照试验.方法 检索策略 以普通检索式"研究方法学 NEAR干预措施NERA 条件"、用AltaVista在英特网上搜索.测量指标包括搜索时间、英特网搜索已发表研究的回溯率、精确度(已发表和未发表的随机临床试验链接的网页比例)、英特网检索到的未纳入的未发表和正在进行的研究数.结果 用21小时查询了429个网页,找到14个链接到未发表的、正在进行的或最近完成的试验,至少有9个与4篇系统评价相关.英特网检索已发表研究文献的回溯率在0～43.6%,其链接已发表和未发表研究的精确度在0～20.2%.结论 未发表尤其是正在进行的试验的信息可在英特网上找到.潜在的问题是如何评价未经同行评审的电子出版物的质量.急需更强的搜索工具.建议用"Open Trial Initiative"定义英特网发表试验的语法,以加强试验登记的共同操作性.因此,专门的搜索引擎可找到更多有关正在进行和已完成的临床试验信息.
Virtual clinical trials are clinical trials conducted through computer simulation technology, which breaks through the limitations of traditional clinical trials and has the advantages of saving time, reducing costs, and reducing the risk of human trials. With the application of new computer technologies such as population pharmacokinetics, physiologically-based pharmacokinetics, quantitative systems pharmacology, and artificial intelligence, the field of virtual clinical trials in healthcare has become an important development direction. This article will give a preliminary review of the connotation, methods and future development trends of virtual clinical trials, aiming to provide reference for the application of new technologies and methods in clinical trials.
Artificial intelligence (AI) for science (AI4S) technology, the AI technology for scientific research, has shown tremendous potential and influence in the field of healthcare, redefining the research paradigm of medical science under the guidance of computational medicine. We reviewed the main technological trends of AI4S in reshaping healthcare paradigm: knowledge-driven AI, leveraging extensive literature mining and data integration, emerges an important tool for understanding disease mechanisms and facilitating novel drug development; data-driven AI, delving into clinical and human-related omics data, unveils individual variances and disease mechanisms, and further establishes patient-centric digital twins to guide drug development and personalized medicine. Meanwhile, based on authentic patient digital twin models, adaptable strategies are employed to further propel the development of "e-drugs" that mimic the authentic mechanisms. These digital twins of drugs are evaluated for drug efficacy and safety through large-scale cloud-based virtual clinical trials, and followed by rationally designed real-world clinical trials, thus notably reducing drug development costs and enhancing success rates. Despite encountering challenges such as data scale, quality control, model interpretability, the transition from science insights to engineering solutions, and regulatory hurdles, we anticipate the integration of AI4S technology to revolutionize drug development and clinical practices. This transformation brings revolutionary changes to the medical field, offering novel opportunities and challenges for the development of medical science, and more importantly, providing necessary but personalized healthcare solutions for humankind.
Early and mid-stage esophageal cancer can achieve a particular effect through surgeries or comprehensive treatment based on surgery. Once the esophageal cancer progresses to the advanced stage, it is still lack of effective remedy for the disease, and the patient's prognosis is poor. Immunotherapy has developed rapidly in recent years, bringing dawn to patients with advanced esophageal cancer. On July 31, 2019, the US Food and Drug Administration (FDA) approved KEYTRUDA (Merck) for the treatment of esophageal squamous cell carcinoma, and it became the first milestone drug for esophageal squamous cell carcinoma. In the paper, we will review the progress of immunotherapy in the treatment of advanced esophageal cancer on the basis of current clinical researches, which might provide ideas for further studies in the immunotherapy for esophageal cancer.
Population pharmacokinetics is a research technique based on computer simulation and data analysis, and it has been employed to investigate the dynamic behavior of drug metabolism in different populations. This approach could address practical challenges such as prolonged clinical trial durations, high costs, and increased difficulty in traditional clinical trials. By comprehensively analyzing differences in the internal drug metabolism processes across populations with varying physiological and pathological conditions, population pharmacokinetics has emerged as an effective method to optimize drug development and clinical applications. This article provides a preliminary overview of the essence of population pharmacokinetics, its application in clinical trials, and potential future trends. We hope to serve as a reference and guidance for the application of new technologies and methods in clinical trials.
The umbrella trial has received increasing attention in the design of clinical trials for oncology drugs in recent years. This trial design categorizes a single disease into multiple sub-types based on predictive biomarkers or other predictive factors, and simultaneously evaluates the efficacy of multiple targeted therapies. When compared with the traditional drug development model of phase Ⅰ, phaseⅡ, and phase Ⅲ randomized controlled trials, umbrella trials are a more scientifically rigorous trial design that can speed up drug evaluation to address the conflict between numerous untested drugs and diseases with a lack of effective treatment options. This article will focus on the concept, main characteristics, eligibility criteria, design and statistical considerations, ethical considerations, and future directions of umbrella trials, with the aim of providing methodological guidance for the design of clinical trials for oncology drugs.
Objective To evaluate the efficacy and safety of Salviae miltiorrhizae Injection (include Danshen Injection and Fufang Danshen Injection) for chronic cor pulmonale. Design A systematic review of randomized clinical trials. Method Randomized trials comparing Salviae miltiorrhizae Injection plus routine treatment versus muting treatment alone were identified by electronic and manual searches. No blinding and language limitations were applied. The Jadad scale assessed the methodological quality of trials. Results Thirty randomized trials (n=2 161) were identified. The methodological quality of all trials included was low. The combined results (RR and 95%CI) of symptom scores was 1.20 (1.15 to 1.26). Because of the significant heterogeneity, many other markers of the blood rheology can not be combined. The reason for heterogeneity should include the differences among cases and studies. Because of lacking enough studies, the conclusions about mortality and oxidants/antioxidants markers were not b. Only a few studies had reported adverse events. Conclusions Based in the review, Salviae miltiorrhizae Injection may have positive effect on symptom scores in patients with chronic cor pulmonale. But for mortality, the markers of blood rheology and oxidants/antioxidants, there is no reliable conclusion. However, the evidence is not b due to the general low methodological quality, the variations among studies and experimental markers themselves, and lacking of more relevant and important markers. Further large trials are needed.