济川煎加减联合针灸治疗功能性便秘临床疗效Meta分析

Meta Analysis of Therapeutic Effect of Jichuan Decoction Combined with Acupuncture and Moxibustion for Functional Constipation

目的:系统评价中药汤剂济川煎加减联合针灸治疗功能性便秘的临床疗效,为临床治疗提供必要的参考依据。方法:计算机全面检索维普数据库(VIP)、万方数据库(Wanfang)、中国学术期刊全文数据库(CNKI)、中国中医药数据库(TCMID)、中国生物医学文献数据库(CBM)、Embase、Pub Med、Clinicalkey,以功能性便秘患者为研究对象,纳入国内外有关中药汤剂济川煎加减联合针灸治疗功能性便秘疗效的临床随机对照试验(RCT)。检索时限从建库至2018年12月31日,由2位研究人员各自独立进行文献筛选、基本资料提取和偏倚风险评价,采用Jadad量表对研究文献进行文献质量评分(1~3分视为低质量,4~7分视为高质量),运用Review Manager 5.3软件进行数据分析。结果:最终共纳入8篇RCTs,共计574例患者。Meta分析发现,采用中药汤剂济川煎加减联合针灸治疗功能性便秘的有效率[OR=3.59,95%CI(1.37,9.39),P<0.01]、治愈率[OR=4.31,95%CI(2.92,6.37),P<0.01]均明显高于单纯采用其他药物(济川煎汤剂、麻仁类中药制剂、西沙比利片及乳果糖)治疗。其中2篇文献中提及不良反应,1篇文献中进行安全性指标检测,结果提示治疗组与对照组安全性指标均正常,且所有文献研究均未报道不良反应病例。纳入研究的文献均为低质量,Jadad量表评分为2~3分。以有效率为指标对纳入研究进行倒漏斗图分析,可见不完全对称,提示研究文献可能存在发表偏倚。结论:济川煎加减联合针灸能有效改善功能性便秘患者症候,效果优于单用其他药物(济川煎汤剂、麻仁类中药制剂、西沙比利片及乳果糖),该结论尚需更多大样本、高质量的研究加以验证。

Objective: To evaluate the efficacy of Jichuan decoction combined with acupuncture and moxibustion in the treatment of functional constipation, and provide necessary reference for clinical treatment. Methods: Two independent researchers electronically searched databases, including VIP Database(VIP), Wanfang Database, China Knowledge Network Database(CNKI), China’s Traditional Chinese Medicine Database, China Biomedical Literature Database(CBM), Embase, PubMed and Clinicalkey, to collect randomized controlled trials(RCTs) about functional constipation treated by acupuncture and moxibustion from the establishment time of the library to December 31, 2018. Then the two researchers independently conducted literature screening, basic data extraction and bias risk assessment. Jadad scale was used to evaluate the literature quality(score of 1-3 was considered as low quality, and score of4-7 was considered as high quality), and data was extracted and evaluated by RevMan 5.3 software, which was used for Meta-analysis.Results: A total of 8 RCTs were enrolled, including 574 cases. Meta-analysis showed that the effective rate of Jichuan decoction combined with acupuncture and moxibustion [OR=3.59, 95%CI(1.37,9.39), P<0.01] and the cure rate [OR=4.31, 95%CI(2.92,6.37), P<0.01] were significantly higher than those of other drugs only, including Jichuan decoction, Chinese medicine preparation of hemp kernel, Cisapride tablets. Among 8 RCTs, adverse reactions were mentioned in two literatures, and there was only one literature which detected safety indexes. The results indicated that both the treatment group and the control group had normal safety indexes, and no adverse reactions were reported in all literatures. The Jadad scale score was 2-3 points, and the quality of all of literatures included in the study was low. The inverted funnel plot analysis of the included studies with the effective rate as the index showed that there was incomplete symmetry, suggesting that there might be publication bias in the research literature. Conclusion: Jichuan decoction combined with acupuncture and moxibustion can improve effectively the TCM symptoms of patients with functional constipation, and the effect is better than using other drugs only, including Jichuan decoction, Chinese medicine preparation of hemp kernel, Cisapride tablets.However, it is still necessary to expand the sample size and improve the research quality, so as to design more rigorous randomized controlled trials to verify the above conclusions.