中药临床试验是中医药研究中发展较快的一个领域，临床研究协调员（CRC）在中药临床试验中有重要作用，其工作范围涉及到中药临床试验的各个方面。由于中药临床试验有着不同于西药临床试验的特点，CRC在中药临床试验中的作用也有其特殊性，对提高临床试验的安全性、科学性及试验数据的可信度方面起重要作用。
Objective To evaluate the anti-tussive effect of a total alkaloid agent extracted from Papaver Somniferum L. on simple chronic bronchitis of which the syndrome was counterflow ascent of lung qi according to traditional Chinese medicine (TCM). Methods Randomised, double blind method, placebo control and add on design were applied. Forty-five patients with counterflow ascent of lung qi of simple chronic bronchitis were randomly divided into two groups: treatment group (n=21) with alkaloid agent and control group (n=24) with placebo. Results The incidences of obvious coughing in treatment and control groups were 66.67% and 70.83% (P=0.763 3) respectively. The cough alleviation time of patients was 14.64±16.30 h and 15.12±15.28 h (P=0.795 6) respectively. The loss of cough rates on the third day was 28.57%, 16.67% (P=0.337 7) respectively. The average scores decreased were 4.29 and 2.88 (P=0.054 8) respectively. Conclusions The study indicates that total alkaloid agent extracted from Papaver somniferum L. has no significant anti-tussive effect on patients with counterflow ascent of lung qi of simple chronic bronchitis treated with cefaclor sustained release capsules simultaneously. The trial was interrupted by the advice from experts who disagreed with the selection of drug indication.
Compared with traditional medical devices, artificial intelligence medical devices face greater challenges in the process of clinical trials due to their related characteristics of artificial intelligence technology. This paper focused on the challenges and risks in each stage of clinical trials on artificial intelligence medical devices for assisted diagnosis, and put forward corresponding coping strategies, with the aim to provide references for the performance of high-quality clinical trials on artificial intelligence medical devices and shorten the research period in China.
ObjectiveTo review the characteristics of registered industry-sponsored clinical trials of pediatric drugs and vaccines in China and to provide references for promoting the development of new pediatric drugs. MethodsWe searched ClinicalTrials.gov and the Chinese Clinical Trial Registry for completed registered industry-sponsored clinical trials of pediatric drugs and vaccines from the database inception to September 11, 2022. Data including the date the trial was first posted, product type (drug or vaccine), sample size, and other information to describe the general characteristics of pediatric clinical trials were collected. The studies were divided into 2 phases based on the trial posted date, 2005―2010 and 2011―2022, reflecting the enactment of pediatric drug clinical trial policies in recent years. The quality of trial registration and the main characteristics of interventional trials in the 2 phases were then compared. Exploring the results attached to industry and non-industry sponsored clinical trials. ResultsData for 145 trials were collected, and the largest proportion (63.4%) involved vaccines. Randomized control trial (RCT) was the study type with the highest percentage (68.3%). The average report completion rate for registered interventional trials was 81.0%. Compared with 2005―2010, the percentage of average report completions, pediatric drug clinical studies, multicenter, RCTs, and double-blinded registered trials increased in 2011―2022. The proportion of positive outcomes in pediatric clinical trials sponsored by industries was higher than those sponsored by non-industry. ConclusionThe majority of completed pediatric clinical trials sponsored by industries are for vaccines, in line with the promotion of pediatric policies. The quality of trial registration has improved, but not significantly, and some characteristics of trial design have changed. The proportion of positive outcomes in pediatric clinical trials sponsored by industries is higher. And further promotion of pediatric clinical trials is needed.
The calculation of sample size is a critical component in the design phase of clinical trials incorporating health economic evaluations. A reasonable sample size is essential to ensure the scientific validity and accuracy of trial results. This paper summarizes the sample size calculation methods in the frequentist framework based on two health economic evaluation indicators: incremental cost-effectiveness ratio (ICER) and net benefit and examines these methods in terms of their applicable conditions, advantages, and limitations. The ICER method derives the sample size calculation formula by computing the ratio of incremental cost to incremental effect, while the net benefit method determines the economic viability of interventions by calculating incremental net benefit, subsequently leading to the formulation of the sample size calculation. Furthermore, this paper briefly discusses other sample size calculation methods, such as the classical Bayesian approach and the value of information analysis, providing a reference for calculating sample size in clinical trials with integrated health economic evaluations.
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.
“针刺临床试验干预措施报告标准”（Standards，for Reporting Interventions in Clinical Trials of Acupuncture，STRICTA）于2001年和2002年在5种期刊上发表。该指南以对照试验检查清单及解释的形式供作者和期刊编辑使用，旨在提高针刺临床试验报告的质量，尤其是对其中干预措施的报告，因而有助于对这些试验的解释和重复。随后对STRICTA的应用及影响的述评都强调了STRICTA的价值，也提出了改进和修订的建议。 为使修订过程顺利进地，STRICTA工作组、CONSORT工作组和中国Cochrane中心于2008年开始合作，召集成立的包含47名成员的专家小组对清单的修改稿提出了电子版反馈意见。在后来于弗莱堡（Freiburg）召开的见面会上，由21名专家组成的工作组进一步修订了STRICTA对照检查清单，并计划如何对其进行发布。 新的STRICTA对照检查清单作为CONSORT的正式扩展版，包含6项条目及17条二级条目。这些条目为报告针刺治疗的合理性、针刺的细节、治疗方案、其他干预措施、治疗师的背景以及对照或对照干预提供了指南。而且，作为修订工作的一部分，对每一条目作了详尽解释，并针对每一条目给出了良好报告的实例。此外，STRICTA中的“对照”（controlled）一词被替换成了“临床”（clinical），以示STRICTA适用于更广泛的各类临床评价设计，包括非对照结局研究和病例报道。修订的STRICTA对照检查清单有望与CONSORT声明及其非药物治疗扩展版一起共同提高针刺临床试验的报告质量。
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.
目的 临床观察盐酸氨基葡萄糖和依托芬那酯凝胶治疗膝骨关节炎（KOA）的疗效。 方法 2010年6月－2012年2月，将354例KOA患者随机分为盐酸氨基葡萄糖组（A组）、依托芬那酯凝胶组（B组）和盐酸氨基葡萄糖+依托芬那酯凝胶组（C组）。A组为口服盐酸氨基葡萄糖，750 mg/次，2次/d，疗程6周；B组为依托芬那酯凝胶外用，2次/d，6周为1个疗程；C组为在A组的基础上同时加用B组的方法。 结果 C组在改善行走疼痛、夜间静息痛、晨僵方面优于A、B组，A组优于B组，差异有统计学意义（P＜0.05）。总有效率A组为79.65%，B组67.28%，C组89.38%，差异有统计学意义（P＜0.05）。出现不良反应A组3例，B组3例，C组4例，均较轻微，无严重不良事件发生。 结论 盐酸氨基葡萄糖和依托芬那酯凝胶治疗KOA均安全、有效，联合应用时，疗效进一步增强。