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.
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。
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.
This article briefly introduces the management of clinical trials of investigational new drugs, hospital-made preparations, post-marketing drugs and other types of clinical trials. The WHO International Clinical Trial Register Platform (WHO ICTRP), Chinese Clinical Trial Register (ChiCTR) and Chinese Clinical Trial Registration and Publishing Collaboration (ChiCTRPC) are also described. People conducting trials are advised to apply the basic philosophy of evidence-based medicine in their implementation, which is considered to be one of the guarantees of the validity of clinical trials.
Evidence-based medicine (EBM) is a new technique for medical research. It is interesting to know how to publish a high quality paper after clinical trial by the criteria of EBM. This paper presents our experience on clinical trials as well as publishing EBM papers, including the aim of research, the design of study methods, the selection and application of statistical methods, the analysis of study results, feedback to the reviewer’s comments, and other technology related to the submitted manuscript, in order to improve the skill of publishing EBM study in our country.
To declare the clinical value of lowing serum LDL-C level in coronary heart disease by reviewing the history of its clinical trials in the last 4 decades.
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。