痛泻要方加味治疗腹泻型肠易激综合征的疗效及安全性:随机、阳性药对照试验的荟萃分析

Efficacy and safety of Modified Tongxie Yaofang in diarrhea-predominant irritable bowel syndrome management: A meta-analysis of randomized, positive medicine-controlled trials.

作者信息

Dai Yun-Kai, Li Dan-Yan, Zhang Yun-Zhan, Huang Meng-Xin, Zhou Yi-le, Ye Jin-Tong, Wang Qi, Hu Ling

机构信息

Institute of Gastroenterology, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.

Institute of Clinical Pharmacology, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.

出版信息

PLoS One. 2018 Feb 6;13(2):e0192319. doi: 10.1371/journal.pone.0192319. eCollection 2018.

Abstract

OBJECTIVE

To systematically evaluate the efficacy and safety of Modified Tongxie Yaofang (M-TXYF) for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D).

METHOD

Electronic databases including PubMed, Springer Link, EMBASE, China National Knowledge Infrastructure (CNKI), Chinese Biomedical Literature (CBM), Wanfang, and Chinese Scientific Journals Database (VIP) were conducted from their inception through May 11, 2017 without language restrictions. Primary and secondary outcomes were estimated by 95% confidence intervals (CI). RevMan 5.3 and the Cochrane Collaboration's risk of bias tool were analyzed for this meta-analysis.

RESULTS

Twenty-three literatures with a total of 1972 patients were included for the meta-analysis. The overall risk of bias evaluation was low. The pooled odds ratio showed that M-TXYF was significantly superior to routine pharmacotherapies (RP) in clinical therapeutic efficacy (OR 4.04, 95% CI 3.09, 5.27, P < 0.00001, therapeutic gain = 17.6%, number needed to treat (NNT) = 5.7). Moreover, compared with RP, M-TXYF showed that it can significantly reduce the scores of abdominal pain (standardized mean difference (SMD) -1.27; 95% CI -1.99, -0.56; P = 0.0005), abdominal distention (SMD -0.37; 95% CI -0.73, -0.01; P = 0.09), diarrhea (SMD -1.10; 95% CI -1.95, -0.25; P = 0.01), and frequency of defecation (SMD -1.42; 95% CI -2.19, -0.65; P = 0.0003). The differences of the adverse events between experiment and control groups had no statistical significance.

CONCLUSION

This meta-analysis indicated that M-TXYF could be a promising Chinese herbal formula in treating IBS-D. However, considering the lack of higher quality of randomized controlled trials (RCTs), highly believable evidences should be required.

摘要

目的

系统评价痛泻要方加味治疗腹泻型肠易激综合征(IBS-D)的疗效及安全性。

方法

检索包括PubMed、Springer Link、EMBASE、中国知网(CNKI)、中国生物医学文献数据库(CBM)、万方数据库和维普中文科技期刊数据库(VIP)在内的电子数据库,检索时间从建库至2017年5月11日,无语言限制。主要和次要结局采用95%置信区间(CI)进行估计。本Meta分析使用RevMan 5.3和Cochrane协作网偏倚风险工具进行分析。

结果

纳入23篇文献,共1972例患者进行Meta分析。总体偏倚风险评估为低。合并比值比显示,痛泻要方加味在临床治疗效果上显著优于常规药物治疗(RP)(OR = 4.04,95% CI 3.09,5.27,P < 0.00001,治疗增益 = 17.6%,需治疗人数(NNT) = 5.7)。此外,与RP相比,痛泻要方加味可显著降低腹痛评分(标准化均数差(SMD) -1.27;95% CI -1.99,-0.56;P = 0.0005)、腹胀评分(SMD -0.37;95% CI -0.73,-0.01;P = 0.09)、腹泻评分(SMD -1.10;95% CI -1.95,-0.25;P = 0.01)及排便次数评分(SMD -1.42;95% CI -2.19,-0.65;P = 0.0003)。试验组与对照组不良事件差异无统计学意义。

结论

本Meta分析表明,痛泻要方加味可能是治疗IBS-D的一种有前景的中药方剂。然而,考虑到缺乏高质量的随机对照试验(RCT),仍需要高度可信的证据。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/70f9/5800650/4ea05f3ad095/pone.0192319.g001.jpg

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