中医外治法治疗便秘型肠易激综合征的Meta分析及试验序贯分析

Traditional Chinese medicine external therapy for constipation irritable bowel syndrome:a Meta-analysis and trial sequential analysis

[目的]运用循证医学的方法评价中医外治法治疗便秘型肠易激综合征(IBS-C)的临床疗效。[方法]计算机检索Pubmed、Embase、Cochranelibrary、万方、中国知网(CNKI)、维普(VIP)、中国生物医学数据库(CBM)等中文及英文数据库中所有关于中医外治法治疗便秘型肠易激综合征的随机对照试验,提取资料并运用RevMan5.3软件进行数据分析。[结果]最终纳入17篇文献,1246例患者。Meta分析结果提示:中医外治组有效率及治愈率均高于西药对照组[OR=2.76;95%CI:2.01,3.79;P<0.00001、OR=2.24;95%CI:1.63,3.08;P<0.00001]且复发率低[OR=0.14;95%CI:0.05,0.39;P=0.0002];中医外治组总体症状积分较西药组明显下降[MD=1.58;95%CI:1.46,1.69;P<0.00001],且排便及腹痛的改善也均优于西药组[MD=0.30;95%CI:0.12,0.47;P=0.0008、MD=0.43;95%CI:0.25,0.61;P<0.00001];但在粪便性状上,两组疗效无差异[MD=-0.02;95%CI:-0.71,0.67;P=0.96]。试验序贯分析表明,中医外治法治疗肠易激综合征疗效证据确切。[结论]中医外治法治疗IBS-C疗效可能优于常规西药,且安全性较高,不良反应少。但上述结论仍有待更多大样本、多中心、随访时间长的高质量RCT研究加以验证。

[Objective]To evaluate the clinical efficacy of traditional Chinese medicine(TCM)external treatment in the treatment of constipation-type irritable bowel syndrome(IBS-C)using evidence-based medicine.[Methods]Randomized controlled trials(RCTs)of Chinese medicine and Chinese literature were retrieved from the Chinese and English databases of Pubmed,Embase,Cochrane library,Wan Fang,CNKI,VIP,CBM,etc.for the treatment of constipation-type irritable bowel syndrome.The data were extracted and RevMan 5.3 was used for data analysis.[Results]A total of 17 articles and 1 246 patients were included.Meta-analysis results indicated that the effective rate and cure rate of TCM treatment group were higher than those of western medicine control group,[OR=2.76;95%CI:2.01,3.79;P<0.000 01,OR=2.24;95%CI:1.63,3.08;P<0.000 01],and the recurrence rate was low[OR=0.14;95%CI:0.05,0.39;P=0.000 2];the overall symptom score of TCM treatment group was significantly lower than that of western medicine group,[MD=1.58;95%CI:1.46,1.69;P<0.000 01],and the improvement of defecation and abdominal pain were also better than the western medicine group[MD=0.30;95%CI:0.12,0.47;P=0.000 8,MD=0.43;95%CI:0.25,0.61;P<0.000 01].However,there was no significant difference in the efficacy of the fecal traits between the two groups,[MD=-0.02;95%CI:-0.71,0.67;P=0.96].TSA suggested that there was definite therapeutic efficacy evidence for TCM external treatment in the treatment of IBS-C.[Conclusion]The treatment of IBS-C with TCM external treatment is better than conventional western medicine,and it has higher safety and less adverse reactions.However,the above conclusions are still to be verified by more large-scale,multi-center,long-term high-quality RCT studies.