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.
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.
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 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.
Clinical trial transparency, include clinical trial registration, unbiased reporting results and sharing individual participant data (IPD), is one of the most important revolutionary concepts following clinical epidemiology and evidence-based medicine in the medical field. Sharing IPD is a medical ethics issue reflected a new sense of worth and constructing new rules of clinical trials. Our viewpoint is that from the essential purpose of clinical research, IPD is a social public property. Sharing IPD is a one of the best ways for respecting the contributions of the participants, and one of the keys for changing face of clinical trials.
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.
Objective To assess the safety and effect of different intravenous chemotherapic regimens in patients with gastric carcinomas who had received gastrectomy. Method A systematic review of all the relevant randomized controlled trials (RCTs) was performed. RCTs were identified from Medline and Embase (1980-2001.4), Chinese Bio-medicine Database (1990-2001.1). Literature references were checked at the same time. We included randomized andquasi-randomized trials in patients with confirmed gastric carcinomas who had received gastrectomy comparing the effect of intravenous chemotherapy after gastrectomy with that of gastrectomy alone.Results Twenty trials involving 4 171 patients were included. Meta-analysis was done with fixed effects model. Heterogeneity analyses was performed also. The effects of intravenous chemotherapy with 5FU + MCCNU, 5FU + MMC, 5FU + BCNU or FAM after gastrectomy were failed to show have better effects than that of surgery alone. There were eleven trials which detailed the side effects according to the toxicity grade by WHO standard. The side effects halting treatment were haematologic and biochemical toxicity, debilitating nausea and vomiting. There were twenty-two patients died of chemotherapic toxicity. Conclusions Based on the review, there is no enough evidence to show that intravenous chemotherapy after gastrectomy have positive treatment effect on gastric cancer.
Cardiovascular disease is one of the diseases with the highest morbidity and mortality in the world. Tanshinone ⅡA is one of the main active components of Salvia miltiorrhiza, which can significantly improve heart function. In this paper, the mechanisms of cardiovascular protection by tanshinone ⅡA are reviewed, including reducing myocardial apoptosis, inhibiting inflammatory reaction, improving atherosclerosis, and inhibiting myocardial fibrosis and antioxidant stress, and the related clinical research of tanshinone ⅡA is evaluated, so as to provide reference for the following research and clinical application of tanshinone ⅡA in cardiovascular system.
Since the outbreak of the coronavirus disease (COVID-19), more than 200 interventional clinical trials have been registered in Chinese Clinical Trial Registry (www.chictr.org.cn) and the US Clinical Trials Registry (www.clinicaltrials.gov), testing or going to test treatments of COVID-19 in China from January 23rd, 2020 to March 5th, 2020. This situation has drawn attentions from various sectors of society. This article summarizes the basic design features of 249 registered COVID-19 clinical trials in China, compares them with National Clinical Trials Network practices in the USA, and describes a concept of national clinical trials network as a strategy to enhance quality and efficiency of clinical research in cases like COVID-19 outbreak as well as other disease fields.
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.