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。
The therapeutic efficacy of Danshen and Jiangxiang in the treatment of ischemic stroke (IS) is relatively significant. Studying the mechanism of action of Danshen and Jiangxiang in the treatment of IS can effectively identify candidate traditional Chinese medicines (TCM) with efficacy. However, it is challenging to analyze the effector substances and explain the mechanism of action of Danshen-Jiangxiang from a systematic perspective using traditional pharmacological approaches. In this study, a systematic study was conducted based on the drug-target-symptom-disease association network using complex network theory. On the basis of the association information about Danshen, Jiangxiang and IS, the protein-protein interaction (PPI) network and the “drug pair-pharmacodynamic ingredient-target-IS” network were constructed. The different topological features of the networks were analyzed to identify the core pharmacodynamic ingredients including formononetin in Jiangxiang, cryptotanshinone and tanshinone IIA in Danshen as well as core target proteins such as prostaglandin G/H synthase 2, retinoic acid receptor RXR-alpha, sodium channel protein type 5 subunit alpha, prostaglandin G/H synthase 1 and beta-2 adrenergic receptor. Further, a method for screening IS candidates based on TCM symptoms was proposed to identify key TCM symptoms and syndromes using the “drug pair-TCM symptom-syndrome-IS” network. The results showed that three TCMs, namely Puhuang, Sanleng and Zelan, might be potential therapeutic candidates for IS, which provided a theoretical reference for the development of drugs for the treatment of IS.
Research on the Chinese medicine standardized calendar is not only required for the development of evidence-based pharmacy, but it is also needed in order to adapt to, and promote, clinical rational use of Chinese medicine. The experience of the clinical calendar is summarized in this article. This may provide some significant clues and basis for the design and conduct of research when constructing a Chinese medicine standardized calendar.
目的探讨袋形缝合术联合中药外敷治疗骶尾部藏毛窦的临床疗效。 方法应用袋形缝合术联合中药外敷治疗骶尾部藏毛窦13例。 结果13例患者全部治愈，随访1年，未见明显复发及并发症。 结论袋形缝合术联合中药外敷治疗骶尾部藏毛窦手术操作简单，治疗彻底，缩小了手术创面，愈合时间相对缩短，复发少，患者痛苦少，长期效果优良，治疗骶尾部藏毛窦安全、有效，值得临床推广应用。
ObjectivesTo systematically review the safety of traditional Chinese medicine injection based on clinical centralized monitoring studies that have been carried out and listed so far, to understand basic situation of adverse reactions and explore the risk factors of traditional Chinese medicine injections and to provide evidence for clinical rational use of drugs and optimizing centralized monitoring methods. MethodsCFDA, CNKI, VIP, WanFang Data, Sinomed, PubMed and The Cochrane Library databases were electronically searched to collect studies on safety monitoring of listed traditional Chinese medicine injections from inception to February, 2018. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Meta-analysis was then performed by using Excel software. ResultsA total of 14 studies involving 14 varieties of injections, 296 200 cases were included. The highest incidence rate of adverse reactions was found in the XueBiJing injection (2.54%). The related factors of ADR extraction were age, sex, drug combined usage, time from administration, allergic history, administration days, indication, dose and distribution of the tube. ConclusionsThe safety of traditional Chinese medicine injection is generally high. Middle and old age is an important factor in the occurrence of ADR. The incidence of ADR is relatively high in the first 6 days of drug use, and the incidence of ADR is more likely to be caused by irrational use of drugs in clinic, and the history of allergy may be related to the occurrence of ADR. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusion.
Objective To evaluate the efficacy and safety of Chinese herb compared with an analgesic drug in the treatment of cancer pain. Methods We electronically searched CBM (1990 to 2008), CNKI (1990 to 2008), VIP (1990 to 2008), The Cochrane Library (Issue 3, 2008), and MEDLINE (1990 to 2008). Relevant journals and conference proceedings were also handsearched. The quality of the included trials was assessed according to the criteria recommended by the Cochrane Handbook for systematic reviews of interventions and meta-analyses were performed for homogeneous studies using the Cochrane collaboration’s review manager 4.2.2 software. Results Five randomized controlled trails (RCTs), all published in Chinese, involving 590 participants, were included. The quality of all RCTs was graded C (low). Meta-analyses were not performed due to heterogeneity. Instead, descriptive analyses were conducted. The results showed that as for the total effective rate in pain-relieving, Zhentongsan (RR=1.11, 95%CI 1.00 to 1.24, P=0.05) and Xiaozhengzhitong paste (RR=1.35, 95%CI 1.02 to 1.78, P=0.04) were more effective than Indometacin, with significant differences. There were no significant differences between Duyiwei capsule and Indometacin, and so were between Huajianbadumo as well as Shebingzhitong paste and Tramado. In terms of early potency, there were significant differences between Zhentongsan (SMD= –?9.87, 95%CI –10.84 to –8.89, Plt;0.000 01) as well as Xiaozhengzhitong paste (SMD= –8.74, 95%CI –10.164 to –7.32, Plt;0.000?01) and Indometacin, and so were between Shebingzhitong paste and Tramadol (SMD= –2.24, 95%CI –3.00 to –1.49, Plt;0.000?01). There were no significant differences between Huajianbadumo and Tramodo. With regard to the durative effect on pain-relieving, there were significant differences between Xiaozhengzhitong paste and Indometacin (WMD=4.78, 95%CI 2.99 to 6.57, Plt;0.00001), but not between Shebingzhitong paste and Tramadol. Conclusion Because of low quality of the existing studies, the current evidence is insufficient to define the efficacy and safety of compound Chinese herb, and further large-scale and high-quality RCTs are needed.
【摘要】 目的 评价中药治疗贝尔（Bell’s）面瘫的有效性和安全性。 方法 以中药、中西医结合、Bell’s面瘫、特发性面瘫、面神经疾病和（或）麻痹、颅神经、颅神经疾病/麻痹为主题词，检索ECSCO数据库系列的ASP（Academic Source Premier）、 NSTL数据库系列的ACP美国医师协会电子期刊数据库及Medicines Complete英国医药出版社医药数据库、MEDLINE数据库、CNKI中国期刊全文数据库、VIP中文科技期刊全文数据库和万方数据库，并在因特网上检索相关学位论文和正在进行的研究。相关的学术会议论文和学位论文汇编也同时予以检索。鉴定相关文章附录的参考文献作为补充检索。 结果 所有以中药治疗Bell’s面瘫的随机对照试验均被纳入。 结论 对纳入的随机对照试验进行方法学质量的评估，数据提取和数据分析。【Abstract】 Objective To evaluate the efficacy and safety of Chinese herbs on Bell’s palsy. Methods With the searching terms including chinese herbs, integrated chinese and western medicine, Bell’s palsy, peripheral facial palsy,facial nerve disease/paralysis, cranial nerve,cranial nerve disease/paralysis were searched in the database of ASP, ACP, Medicines Complete, MEDLINE, CNKI,VIP and Wanfang. While to search the related academic dissertation and ongoing researches on internet. Relevant academic conference and dissertation proceedings have also been searched. Results All randomized trials about Chinese herbs for Bell’s palsy were included in this review. Conclusion Assessment of methodological quality, data extraction and syntheses were carried out.
ObjectivesTo systematically review the efficacy of traditional Chinese medicine for arrhythmia caused by anthracycline drugs.MethodsPubMed, EMbase, The Cochrane Library, CBM, CNKI, WanFang Data databases were electronically searched to collect randomized controlled trials (RCTs) on the efficacy of traditional Chinese medicine for arrhythmia caused by anthracycline drugs from inception to October 2017. Two reviewers independently screened literature, extracted data and evaluated risk of bias of included studies. Meta-analysis was then performed by Revman 5.3 software.ResultsA total of 4 RCTs involving 312 patients were included. The results of meta-analysis showed that: the incidence of tachycardia in the Wenxin granule treatment group was lower than that in the control group (RR=0.35, 95%CI 0.18 to 0.67, P=0.002). Baoxinkang was more effective than antioxidant western medicine in protecting myocardial SOD activity (RR=2.25, 95%CI 1.74 to 2.76, P<0.000 01). But there was no significant difference between two groups on the incidence of atrial premature beats (RR=0.40, 95%CI 0.15 to 1.08,P=0.07), premature ventricular contractions (RR=0.56, 95%CI 0.23 to 1.34, P=0.19) and atrial fibrillation (RR=0.41, 95%CI 0.11 to 1.53, P=0.18). In addition, there was no significant difference between Wenxin granules and amiodarone in treating arrhythmia induced by anthracycline. The addition of Wenxin granules on the basis of anthracycline antitumor chemotherapy regimens was not effective in delaying disease progression compared with anthracycline alone. Wenxin granules could not change the SOD level of breast cancer patients with cardiotoxicity caused by anthracycline chemotherapy, compared with chemotherapy and basic treatment.ConclusionsThe current evidence shows that Wenxin granules can prevent and reduce anthracycline-induced tachycardia, but its efficacy in improving the overall efficiency, preventing and reducing atrial premature beats, premature ventricular contractions, atrial fibrillation, and SOD levels are unclear. Baoxinkang can protect myocardial SOD activity. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusions.