益气养阴法治疗老年性便秘的系统评价与Meta分析

Systematic review and meta-analysis of elderly constipation treated with yiqi yangyin formula

目的系统地评价益气养阴法治疗老年性便秘的临床疗效及其安全性。方法计算机检索中国生物医学文献数据库(CBM)、中国知网(CNKI)、万方医学数据库、维普数据库、Pub Med、Cochrane Library、EMbase等数据库,检索时间均从建库至2018年3月1日。并且手工检索《世界华人消化杂志》《中国中西医结合消化杂志》《中华中医药杂志》《中医杂志》《中国中西医结合杂志》等近两年的相关文献,对有关采用益气养阴法治疗老年性便秘的临床随机对照试验(RCT)进行筛选,按照Cochrane Handbook 5. 1标准进行资料提取,文献质量的评价,运用Rev Man 5. 3软件对提取的数据进行Meta分析。结果共纳入44项研究,合计4173例老年便秘患者。纳入的研究质量普遍偏低。Meta分析结果显示:与导泻剂相比,益气养阴方能够降低老年便秘的复发率(RR=0. 35; 95%CI=[0. 17,0. 72]),提高临床愈显率(RR=1. 89; 95%CI=[1. 60,2. 23]);与促胃肠动力药相比,益气养阴方能够明显提高临床愈显率(RR=1. 48; 95%CI=[1. 23,1. 79]);与综合西药相比,益气养阴方能够降低老年便秘的复发率(RR=0. 16; 95%CI=[0. 09,0. 30]),但在临床愈显率方面二者疗效相当(RR=1. 35; 95%CI=[0. 99,1. 85]);与中成药相比,在复发率(RR=0. 42; 95%CI=[0. 07,2. 37])方面二者无明显差异,然而益气养阴方能够提高临床愈显率(RR=1. 39; 95%CI=[1. 23,1. 57])。不良反应发生率方面,益气养阴方较其他药物发生率低。结论益气养阴方能够提高老年便秘患者的临床愈显率,降低复发率,具有良好的临床安全性,但是鉴于纳入研究的质量普遍较低,尚需更多多中心、高质量的临床研究予以验证。

Objective To review systematically the clinical effects and safety of yiqi yangyin formula in treatment of elderly constipation.Methods From CBM,CNKI,Wanfang,VIP,PubMed,Cochrane Library and EMbase databases,the relevant articles were retrieved through to March 1,2018 since the database establishment.Additionally,the relevant articles in recent two years were retrieved manually from World Chinese Journal of Digestology,Chinese Journal of Integrated Traditional and Western Medicine on Digestion,Chinese Journal of Traditional Chinese Medicine and Pharmacy,Journal of Traditional Chinese Medicine,Chinese Journal of Integrated Traditional and Western Medicine.The randomized controlled trials(RCTs)of elderly constipation treated with yiqi yangyin formula were screened.According to the criteria of Cochrane Handbook 5.1,the data were extracted and literature quality was evaluated.Using RevMan 5.3 software,meta-analysis was performed on the extracted data.Results A total of 44 eligible RCTs were included,with 4173 cases of elderly constipation.The quality of RCTs was generally low.Meta-analysis results showed that compared with purgative prescription,yiqi yangyin formula reduced the recurrence rate( RR=0.35;95%CI =[0.17,0.72])and improved clinical curative rate( RR=1.89;95%CI =[1.60,2.23]).Compared with gastrointestinal excitomotor,yiqi yangyin formula obviously improved the clinical curative rate( RR=1.48;95%CI =[1.23,1.79]).Compared with comprehensive western medicine,yiqi yangyin formula reduced the recurrence rate( RR=0.16;95%CI =[0.09,0.30]),but the clinical curative rate was[LM]similar(RR=1.35;95%CI=[0.99,1.85]).Compared with Chinese patent medicine,the difference was not significant in the recurrence rate( RR=0.42;95%CI =[0.07,2.37]),but yiqi yangyin formula improves the clinical curative rate( RR=1.39;95%CI =[1.23,1.57]).Regarding the incidence.Conclusion Yiqi yangyin formula improves clinical curative rate on elderly constipation and reduces the recurrence rate in the patients.It is safe in clinical application.But,because of the low quality of the enrolled RCTs,more multi-central and high-quality RCTs are required for further verification.