雷公藤及其制剂临床不良反应分布特点随机对照试验的系统评价

Clinical Adverse Reaction Distribution Features of Tripterygium Wilfordii and Its Preparations:A Systematic Review of Randomized Controlled Trials

目的:本研究旨在尽量如实概括总结雷公藤及其制剂毒性引起的不良反应事件(Adverse Drug Reaction,ADR)情况,反映影响雷公藤毒性的各因素与报道出的ADR之间可能存在的关系。方法:系统检索Pubmed、中国知网、万方数据库、维普数据库和中国生物医学期刊数据库等5个数据库建库至2014年2月25日的雷公藤及其制剂毒性的所有相关文献,然后对其中的随机对照试验进行系统归纳、分析和总结。结果:纳入260篇随机对照试验,13 301例患者。分组分类统计结果显示,RCT1组和RCT2组的消化系统、生殖系统等的ADR发生率不同,RCT1和RCT2组的消化系统ADR发生率(每百人)为14.73和12.26,生殖系统为8.25和8.00,肝脏为6.50和5.66,肾脏为6.79和3.03,血液系统为6.73和6.50,心血管系统为2.35和0.67,皮肤粘膜系统为11.42和4.78。RCT1组和RCT2组治疗类风湿关节炎的文献都是最多,分别占22.17%和63.16%,ADR发生率为34.18和27.26。RCT1组RA、Ig A肾病、肾炎、肾病综合征、糖尿病肾病、银屑病、藓疹和子宫肌瘤等7类疾病对应的ADR发生率的标准差为8.69,RCT2组RA、Ig A肾病、银屑病和藓疹对应的ADR发生率的标准差为7.11。结论:临床使用雷公藤及其制剂可能引起的ADR分布为:消化系统、生殖系统和肝脏的ADR发生率最高,不同疾病(如类风湿关节炎、肾炎、肾病综合征等)对应的ADR发生率差异很大。因此,建议患者在使用雷公藤及其制剂时,选择合适的雷公藤制剂,做好护胃、护肝等措施;服用过程中注意患者的反应,适可而止,最大限度的避免可能产生的ADR。

This study was aimed to summarize the adverse drug reaction（ADR） caused by the toxicity of Tripterygium Wilfordii and its preparations, in order to explore possible relationship between Tripterygium Wilfordii factors and reported ADR. Relevant articles on toxicity of Tripterygium Wilfordii and its preparations were systematically searched in 5 databases, including the Pubmed, CNKI, Wanfang Data, VIP Data and Sinomed from the database was established until Feb 25 th, 2014. And then, the randomized controlled trials（RCTs） were systematically collected, analyzed and summarized. The results showed that there were 260 RCTs with 13301 patients included. The outcome of data analysis showed that ADR rates of digestive system and reproductive system of RCT1 and RCT2 were different. ADR rates（per hundred people） in RCT1 and RCT2 were as follows： digestive system were 14.73 and 12.26, reproductive system were 8.25 and 8.00, liver was 6.50 and 5.66, kidneys were 6.79 and 3.03, blood system were 6.73 and 6.50, cardiovascular system were 2.35 and 0.67, skin and mucous system were 11.42 and 4.78, respectively. Articles on rheumatoid arthritis（RA） of both RCT1 and RCT2 were the highest, which occupied 22.17% in RCT1 and 63.16% in RCT2. The corresponding ADR rates were 34.18 and 27.26. The standard deviation（SD） of 7 disease types, which were RA, Ig A nephropathy, nephritis, nephrotic syndrome（NS）, diabetic nephropathy, psoriasis, lichen and rashes, as well as uterine fibroids, was 8.69 in RCT1. The SD of RA, Ig A nephropathy, psoriasis, lichen and rashes was 7.11 in RCT2. It was concluded that the possible ADR distribution of Tripterygium Wilfordii and its preparations were the highest in the digestive system, reproductive system and liver. Besides, different diseases（i.e., RA, nephritis, NS, and etc.） had huge differences with their correspondent ADR rates. Therefore, it was suggested that specific measures should be taken to select the appropriate Tripterygium Wilfordii preparation, protect the stomach and liver during the application of Tripterygium Wilfordii and its preparations. During medication, attentions should be paid to the reaction of patients. Stop the medication when necessary to minimize ADR rates to the lowest.