附子理中汤及其加减方对溃疡性结肠炎疗效的系统评价

Efficacy of Fuzilizhong decoction and its modified decoction in treating ulcerative colitis: A systematic review

目的对附子理中汤及其加减方治疗溃疡性结肠炎的疗效进行系统评价,并总结其治疗溃疡性结肠炎的临床疗效及安全性。方法按照Cochrane系统评价的方法,在CNKI、VIP、万方数据以及Pub Med、EMBase、Medline、Cochrane Library等数据库中检索文献,查找应用附子理中汤及其加减方治疗溃疡性结肠炎的随机对照试验和半随机对照试验。经过筛选纳入符合条件的临床随机对照试验(randomized controlled trail,RCT),对所纳入的研究进行数据提取和质量评价后,应用Rev Man 5. 3软件进行Meta分析,应用GRADE系统对证据质量和等级推荐进行评分。结果一共纳入8项符合条件的RCT研究,共有688名患者参加符合条件的临床研究,但这8项研究方法学质量均较差。Meta分析结果显示:总有效率OR合并=4. 32 [OR=4. 32,95%CI (2. 55,7. 31),P <0. 000 01]。GRADE系统评价结果显示,证据水平均为B,推荐等级为弱推荐。结论采用附子理中汤及其加减方治疗溃疡性结肠炎有效率高于单纯西药治疗,且有较高的安全性,无明显的不良反应。由于纳入的临床对照研究质量有不足,所以附子理中汤及其加减方治疗溃疡性结肠炎的疗效尚不能做出最后的结论,仍然需要更多高质量的RCT才能得出肯定的结论。

Objective To evaluate Fuzilizhong decoction and its modified decoction systematically and summarize the clinical efficacy and safety of the treatment of ulcerative colitis. Methods According to the Cochrane system evaluation method, we searched the database of CNKI,VIP and Wanfang as well as in PubMed,EMBase,Medline,Cochrane Library database to search some randomized controlled trials and a semi randomized controlled trials of Fuzi Lizhong Decoction and its addition and subtraction in the treatment of ulcerative colitis. For eligible RCT, after data extraction and quality evaluation, RevMan 5.3 software was applied in Meta analysis, and GRADE system was used to score the quality and grade recommendation. Results A total of 8 eligible RCT studies were included, with a total of 688 patients participating in qualified clinical studies, but their methodological quality was poor. Meta analysis showed that the total effective rate was OR combined with OR=4.32[OR=4.32, 95%CI（2.55, 7.31）, P〈0.000 01]. Fuzilizhong decoction had no obvious adverse reactions in the treatment of ulcerative colitis, and had good safety. The results of GRADE system evaluation showed that the level of evidence was B, and the recommendation level was weak recommendation. Conclusion The effective rate of Fuzi Lizhong Decoction and its addition and subtraction therapy is higher than that of western medicine alone, and it had high safety and no obvious side effects. Due to the low quality of the clinical controlled studies, the curative effect of Fuzilizhong decoction and its addition and subtraction prescription on ulcerative colitis is still unable to make the final conclusion. More high-quality RCT is needed to get a positive conclusion.