蒲元和胃胶囊治疗功能性消化不良的系统评价与药物经济学评价OA

Objective To evaluate the efficacy,safety and economy of Puyuan Hewei capsule in the treatment of functional dyspepsia(FD).Methods A thorough search was performed across various databases including CNKI,SinoMed,WanFang,VIP,PubMed,Cochrane Library,Springer Link,and Embase.The search aimed to identify clinical randomized controlled trials(RCTs)on the combined use of Puyuan Hewei Capsule for treating functional dyspepsia.The search covered data until September 2023.Literature quality assessment and meta-analysis were conducted using the Cochrane Handbook's bias risk assessment tool and RevMan.Results A total of 503 patients were included in 5 RCTs.Meta-analysis results showed that,Puyuan Hewei capsule combined with domperidone is better than Domperidone[RR=1.20,95%CI(1.10～1.30),Z=4.28,P＜0.000 1),Puyuan Hewei capsule combined with Itopride hydrochloride tablets than itopride hydrochloride tablets[RR=1.19,95%CI(1.05～1.33),Z=2.83,P=0.005].Puyuan Hewei capsule combined with Itopride hydrochloride tablets were lower than Itopride hydrochloride tablets in upper abdominal distension score[MD=-0.44,95%CI(-0.70～-0.19),Z=3.39,P=0.000 7],belching score[MD=-0.72,95%CI(-0.80～-0.64),Z=18.07,P＜0.000 01],loss of appetite score[MD=-0.30,95%CI(-0.34～-0.25),Z=12.73,P＜0.000 01]and early satiety score[MD=-0.34,95%CI(-0.62～-0.05),Z=2.32,P=0.02],and the differences were statistically significant.The epigastric pain score of Puyuan Hewei capsule combined with Itopride hydrochloride tablets was lower than that of Itopride hydrochloride tablets in the treatment of FD[MD=-0.35,95%CI(-0.83,0.13),Z=1.41,P=0.16],and the difference was not statistically significant.There was no statistically significant difference in the incidence of adverse reactions in the treatment of FD between Puyuan and Wei capsule combined with Western medicine group and Western medicine group alone[RR=1.40,95%CI(0.46～4.22),Z=0.60,P=0.55].The results of pharmacoeconomic evaluation showed that the incremental cost-effectiveness ratio(ICER)of total effective rate in the treatment of FD in combination with Puyuan and Wei capsule was 18.78 compared with domperidone alone.Compared with Itopride hydrochloride tablets alone,the ICER of total effective rate,upper abdominal distension score,belching score,loss of appetite score,and early satiety score were 14.48,-507.28,-310,-744,and-656.47,respectively.Sensitivity analysis confirmed the stability of cost-effectiveness analysis results.Conclusion Puyuan Hewei Capsule has good efficacy,safety and economy in the treatment of FD.