Clinical trials and evaluation of Chinese patent medicine for heart failure / 中国中药杂志

The present study systematically collected, analyzed, and evaluated randomized controlled trial(RCT) of Chinese patent medicine in the treatment of heart failure to provide references for follow-up clinical research design, guideline update, and policy formulation, and promote the improvement of clinical evidence quality. On the basis of the collection in the Traditional Chinese Medicine(TCM) Clinical Evidence Database System(EVDS), CNKI, VIP, Wanfang, SinoMed, PubMed, and Web of Science were searched for RCTs of Chinese patent medicine in the treatment of heart failure from database inception to December 31, 2020. The di-sease type, publication time, sample size, intervention/control setting, course of treatment, evaluation indexes, and methodological quality were analyzed and evaluated. A total of 1 631 RCTs were included, including 1 622 in Chinese and 9 in English. It was first published in 1995, with the largest number of publications in 2016. There were only 56 RCTs(3.43%) with a sample size≥200. Seventy-eight types of Chinese patent medicines were involved, including 49 types of oral drugs and 29 types of injections. There were 34 intervention/control protocols, which were dominated by Chinese patent medicine+conventional treatment vs conventional treatment, accounting for 28.51%(n=465). About 94.0% of RCTs reported the course of treatment, mainly 14-56 days. The evaluation indexes were mainly physical and chemical tests and symptoms/signs, and left ventricular ejection fraction(LVEF) was the most frequently used measurement index. In enumeration indexes, clinical efficacy(response rate) was used the most frequently. Methodologically, 92.0% of the research subjects were rated as high risk of blindness. There were only 13 RCTs(0.80%) reporting registered information. It is necessary to further standardize the design, implementation, and quality control of clinical studies in order to improve the quality of evidence and avoid research waste.

Clinical evidence analysis report of Chinese patent medicine in 2020 / 中国中药杂志

The present study collected, collated, analyzed, and evaluated randomized controlled trial(RCT) of Chinese patent medicine published in Chinese and English journals in 2020, and summarized clinical evidence of Chinese patent medicine in stages, providing references for follow-up clinical research and evidence transformation and application. On the basis of the collection in the Traditional Chinese Medicine(TCM) Clinical Evidence Database System(EVDS), CNKI, Wanfang, SinoMed, Cochrane Library, PubMed, and EMbase were searched for RCTs of Chinese patent medicine published in 2020, and their research characteristics and methodological quality were analyzed and evaluated. A total of 1 285 research papers on Chinese patent medicine(1 257 in Chinese/28 in English) were included, involving 146 054 patients and 639 Chinese patent medicines, including 526 oral drugs, 68 injections, and 45 external drugs. A total of 412 diseases in 23 types were involved, which were dominated by circulatory system diseases and respiratory system diseases, specifically, cerebral infarction and angina pectoris. The sample size ranged from 20 cases to 2 673 cases, and 57.67% of RCTs had samples sizes less than 100. Single-center trials were the main ones, and multi-center trials only accounted for 4.75%(n=61). In terms of methodological quality, 52.91% of the RCTs had unclear descriptions or incorrect application of randomization methods, and the implementation of allocation concealment and blinding methods has not been paid much attention. In conclusion, compared with the conditions in 2019, the number of RCTs published in 2020 has decreased, and the research interest in respiratory diseases has increased, while the quality control in the process of research design and implementation has not been improved. Therefore, it is necessary to strengthen the methodological training of researchers and promote the output of high-quality research evidence.

Lung squamous cell carcinoma-related genes cloned by using suppression subtractive hybridization / 中华外科杂志

<p><b>OBJECTIVE</b>To identify genes differentially expressed in human lung squamous cell carcinoma (LSCC).</p><p><b>METHODS</b>A subtracted cDNA library of human LSCC constructed by using suppression subtracted hybridization (SSH) method was screened. Clones representing mRNAs that were truly differentially expressed in LSCC but not in its adjacent non-cancerous tissues were identified by semi-quantitative RT-PCR in 12 patients with LSCC. Partial novel genes were detected by Northern blot.</p><p><b>RESULTS</b>Ten differentially expressed gene cDNA fragments of LSSC were obtained by SSH. Among them six were known genes; two sequences were identified but their functions were unknown (hypothetical protein); two were novel (GenBank accession numbers AF363068 and AY032661, respectively). The results from semiquantitative RT-PCR showed that the transcription expression level of PPP1CB, calumenin, S100A2, HSNOV1, OCIA and AY032661 was down-regulated in some LSCC cases, while the transcription of HSP90, ferritin, gp96 and AF363068 was up-regulated in others.</p><p><b>CONCLUSIONS</b>Six known genes identified by SSH technique have been implicated in the pathogenesis of lung carcinogenesis, or they are involved in immunological defense mechanism in human body. Two hypothetical proteins probably also play an important role in the pathogenesis of lung cancer. The function of the two novel genes in lung carcinogenesis are under investigation.</p>