消化酶制剂治疗消化不良的系统评价

目的系统评价不同消化酶制剂治疗消化不良的疗效、安全性及经济性。方法计算机检索PubMed、Cochrane图书馆临床对照试验资料库、CBM、VIP及CNKI等数据库,收集各种消化酶制剂治疗消化不良的随机对照试验(RCT),检索时限均从建库至2010年6月。按纳入标准选择文献、提取资料和进行方法学质量评价后,采用RevMan 5.0软件进行Meta分析。结果共纳入8个RCT,1 092例患者。文献质量为B级3个,C级5个。Meta分析结果显示:米曲菌胰酶片、复方消化酶胶囊、复方阿嗪米特肠溶片治疗各种原因引起的消化不良总症状有效率均优于安慰剂组或空白对照组[OR=49.70,95%CI(17.16,143.96),P<0.000 01;OR=7.71,95%CI(3.88,15.33),P<0.000 01;OR=16.27,95%CI(6.85,38.66),P<0.000 01],同时在治疗食欲不振、腹胀、腹痛、腹泻及嗳气等方面也优于安慰剂或空白对照组。米曲菌胰酶在治疗胆囊切除术后并发消化不良的总症状及各症状的疗效差于复方消化酶胶囊。复方阿嗪米特肠溶片与复方消化酶胶囊在治疗慢性胰腺炎化学性消化不良总症状的疗效方面无明显差异。此外,所有纳入研究均未报道与治疗药物相关的不良反应,也无相关经济学评价。结论各种消化酶制剂均可有效治疗各种原因引起的消化不良;与安慰剂或空白对照组的间接对照结果显示,米曲菌胰酶片的疗效优于其他消化酶制剂。

Digestive Enzyme for Dyspepsia:A Systematic Review

Objective To evaluate the efficacy,safety and economics of digestive enzyme for dyspepsia.Methods Electronic databases such as PubMed,Cochrane Central Register of Controlled Trials(CENTRAL),CBM,VIP and CNKI were searched from establishment dates of databases to June 2010 to identify the randomized controlled trials(RCTs) of digestive enzyme for dyspepsia.Then studies were identified according to predefined inclusion and exclusion criteria,and their quality was evaluated.The meta-analysis was performed using RevMan 5.0 software.Results Eight studies involving 1 092 patients were included,3 of which were Grade B while the rest were Grade C.The results of the meta-analysis showed that the total efficacy rate of oryz-aspergillus enzyme and pancreatin tablet,compound digestive enzymes capsule,and compound azintamide enteric-coated tablet for dyspepsia were better than either placebo or blank intervention,with the results as(OR=49.70,95%CI 17.16 to 143.96),(OR=7.71,95%CI 3.88 to 15.33) and(OR=16.27,95%CI 6.85 to 38.66),respectively.The efficacy for treating loss of appetite,abdominal distension,abdominal pain,diarrhea and belching was superior to either placebo or blank intervention.Oryz-aspergillus enzyme and pancreatin tablet was inferior to compound digestive enzyme capsule in treating dyspepsia following cholecystectomy.No significant difference was observed in treating dyspepsia following chronic pancreatitis between compound azintamide enteric-coated tablet and compound digestive enzymes capsule.Drug-related adverse reactions as well as economic evaluation were not reported in included studies.Conclusion Digestive enzyme is effective for dyspepsia caused by various diseases.The OR of digestive enzyme versus the placebo/blank-control group shows that oryz-aspergillus enzyme and pancreatin tablet is better than other digestive enzyme drugs.