蒲元和胃胶囊辅助治疗Hp相关性胃炎或消化性溃疡的Meta分析

Puyuan Hewei capsules as adjunctive therapy for Helicobacter pylori associated chronic gastritis or peptic ulcer:a Meta-analysis

目的:评价蒲元和胃胶囊联合三联方案治疗Hp相关性胃炎(HpAG)或消化性溃疡(PU)的疗效与安全性。方法:计算机检索PubMed、Embase、the Cochrane library、CNKI、Wanfang、SinoMed和VIP数据库,搜集蒲元和胃胶囊联合三联方案治疗HpAG和PU的随机对照研究(RCT),检索时间均从建库至2020年3月。采用RevMan 5.3软件进行Meta分析。结果:纳入15个RCT,共1584例患者(实验组803例,对照组781例)。Meta分析结果显示:(1)与三联方案相比,蒲元和胃胶囊联合三联方案在Hp的根除率(RR=1.25,95%CI 1.14~1.38,P<0.00001),临床总有效率(RR=1.29,95%CI1.20~1.39,P<0.00001),消化道症状缓解总有效率(RR=1.20,95%CI1.06~1.37,P=0.006),PU愈合率(RR=1.12,95%CI 1.01~1.24,P=0.02)方面均优于单纯三联方案组,差异有统计学意义;蒲元和胃胶囊联合三联方案的不良反应发生率低于三联方案组,差异有统计学意义(RR=0.37,95%CI 0.20~0.69,P=0.002)。(2)蒲元和胃胶囊联合三联方案在Hp根除率(RR=1.04,95%CI 0.77~1.42,P=0.78),消化道症状缓解总有效率(RR=1.18,95%CI 0.85~1.63,P=0.32),PU愈合率(RR=1.04,95%CI 0.94~1.14,P=0.4652)和不良反应发生率(RR=0.60,95%CI 0.15~2.40,P=0.47)方面与铋剂四联方案均差异无统计学意义。结论:现有临床证据显示,与三联方案相比,蒲元和胃胶囊联合三联方案可提高Hp根除率、临床总有效率,促进消化道症状缓解和PU的愈合,并能降低其不良反应的发生;但蒲元和胃胶囊联合三联方案在Hp根除率、消化道症状缓解总有效率、PU愈合率及不良反应发生率方面并不优于铋剂四联方案。

Objective:To systematically assess the efficacy and safety of Puyuan Hewei(PYHW)capsules in combination with triple regimen(TR)for in the treatment of Helicobacter pylori(Hp)associated chronic gastritis(HpAG)or peptic ulcer(PU).Methods:We electronically searched PubMed,Embase,the Cochrane library,CNKI,Wanfang,SinoMed and VIP database from inception to March 2020,to collect randomized controlled trials(RCT)of PYHW capsules in combination with TR for in the treatment of HpAG or PU.Revman 5.3 software was utilized to perform the Meta-analysis.Results:A total of 15 RCT containing 1584 patients(803 cases in the experimental group and 781 cases in the control group)were included in the final analysis.The results of meta-analysis showed that:(1)Compared with TR,the Hp eradication rate(RR=1.25,95%CI 1.14-1.38,P<0.00001),the total clinical effective rate(RR=1.29,95%CI1.20-1.39,P<0.00001),the total effective rate of gastrointestinal symptoms remission(RR=1.20,95%CI1.06-1.37,P=0.006),the healing rate of PU(RR=1.12,95%CI1.01-1.24,P=0.02)of PYHW combined with TR were superior to the TR group alone,with statistically significant differences;the incidence of adverse reactions of PYHW combined with TR group were lower than the TR group,with a statistically significant difference(RR=0.37,95%CI 0.20-0.69,P=0.002).(2)No significant differences between both groups in Hp eradication rate(RR=1.04,95%CI0.77-1.42,P=0.78),the total effective rate of gastrointestinal symptoms remission(RR=1.18,95%CI 0.85-1.63,P=0.32),the healing rate of PU(RR=1.04,95%CI 0.94-1.14,P=0.4652),and the incidence of adverse reactions(RR=0.60,95%CI 0.15-2.40,P=0.47).Conclusion:Current clinical evidence shows that PYHW combined with TR group could improve the Hp eradication rate,the total clinical effective rate,promote the relief of gastrointestinal symptoms and the healing of PU,and reduce the occurrence of adverse reactions compared with the TR.However,PYHW combined with TR is not superior to BQT in the Hp eradication rate,the total effective rate of gastrointestinal symptoms remission,the healing rate of PU and the incidence of adverse reactions.