大柴胡汤联合西医常规治疗慢性胆囊炎临床疗效和安全性的Meta分析

Efficacy and safety of Dachaihu decoction combined with regular western medicine in the treatment of chronic cholecystitis:a Meta-analysis

[目的]对国内外已发表的有关大柴胡汤联合西医常规治疗慢性胆囊炎临床疗效和安全性的研究进行Meta分析。[方法]使用计算机检索CNKI、VIP、WangFang Data、CBM、Pubmed、Cochrane Library、SCI、PHMC数据库,检索时限为1994年1月~2017年12月,由2名评价员独立筛选文献、提取资料和评价纳入研究的偏倚风险后,采用RevMan 5.3软件进行Meta分析。[结果]最终纳入12项随机对照试验(RCT),总病例数1 034例。分析结果显示:与对照组比较,大柴胡汤联合常规西药治疗慢性胆囊炎的临床有效率更高[OR=4.94,95%CI(3.23~7.55),P<0.000 01];可明显缩短慢性胆囊炎围手术期肠道功能恢复时间,具体表现在肠鸣音恢复时间[MD=-14.71,95%CI(-15.92^-13.49),P<0.000 01]、排气时间[MD=-12.47,95%CI(-13.87^-11.07),P<0.000 01]和排便时间[MD=-23.89,95%CI(-25.47^-22.32),P<0.000 01];对临床有效率进行亚组分析,与对照组比较,大柴胡汤联合茴三硫临床有效率更高[OR=4.82,95%CI(1.85~12.55),P=0.001],大柴胡汤联合甲硝唑、熊去氧胆酸临床有效率更显著[OR=5.15,95%CI(2.69~9.84),P<0.000 01]。在安全性方面,与对照组比较,大柴胡汤联合西医常规治疗的不良反应发生率差异无统计学意义[OR=0.74,95%CI(0.28~1.94),P=0.54],且无严重不良反应报道。[结论]在常规应用西医治疗慢性胆囊炎的基础上联合应用大柴胡汤,临床疗效显著提高,能改善围手术期患者肠道功能的恢复,且用药安全,无明显不良反应。但纳入研究的文献质量偏低,另外由于符合纳入标准的文献数量较少,需更多高质量、大样本、随机对照双盲临床试验提供证据,以进一步验证研究结论。

[Objective]To evaluate the efficacy and safety of Dachaihu decoction combined with western medicine in the treatment of chronic cholecystitis by Meta-analysis.[Methods]A fully recursive literature search was conducted in CNKI,Wanfang Data,VIP,CBM,Pubmed,the Cochrane Library,SCI and PHMC database,the time limit for retrieval was set from January 1994 to December 2017.Two reviewers independently screened literature,extracted data and assessed the risk of bias of included studies.Then,meta-analysis was performed by RevMan 5.3 software.[Results]Twelve RCTs（1 034 cases）were included.Compared with the control group,Dachaihu decoction group was superior in the clinical effectiveness[OR=4.94,95%CI（3.23,7.55）,P0.000 01];shorten the time of the recovery of intestinal function including bowel sounds recovery time[MD=-14.71,95%CI（-15.92,-13.49）,P〈0.000 01],exhaust time[MD=-12.47,95%CI（-13.87,-11.07）,P〈0.000 01],defecation time[MD=-23.89,95%CI（-5.47,-22.32）,P〈0.000 01].Subgroup analysis was carried out on the clinical effective.Compared with the control group,Dachaihu decoction combined AnetholiTrithionum shows higher clinical efficiency[OR=4.82,95%CI（1.85,12.55）,P=0.001],and the same for Dachaihu decoction combined Metronidazole and Ursodeoxycholic Acid[OR=5.15,95%CI（2.69,9.84）,P0.000 01].Besides,there was no statistically significant difference incidence of adverse reactions observed in Dachaihu decoction group[OR=0.74,95%CI（0.28,1.94）,P=0.54].None of serious adverse reactions was reported.[Conclusion]Compared with the treatment of regular western medicine,Dachaihu decoction combined with regular western medicine can obviously improve the efficiency in the treatment of chronic cholecystitis,shorten the time of the recovery of intestinal function,and the treatment is safe.However,due to limited quantity and quality of the included studies,the conclusion above should be further verified by conducting more high quality RCTs.