消化酶制剂治疗消化不良的系统评价_唐惠林.pdf

Review Articles Chin J Evid-based Med 2012, 12(6): 714-721 消化酶制剂治疗消化不良的系统评价 唐惠林 栾 嵘 翟所迪* 北京大学第三医院药剂科（北京 100191） 摘要 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），P0.000?01；OR=7.71，95%CI（3.88， 15.33），P0.000?01；OR=16.27，95%CI（6.85，38.66），P0.000?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。 关键词 消化酶；消化不良；随机对照试验；Meta 分析；系统评价 Digestive Enzyme for Dyspepsia: A Systematic Review TANG Hui-lin, LUAN Rong, ZHAI Suo-di* Department of Pharmacy, Peking University Th ird Hospital, Beijing 100191, China Abstract Objective To evaluate the efficacy, safety and economics of digestive enzyme for dyspepsia. Meth- ods 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. Th en studies were identifi ed according to predefi ned inclusion and exclusion criteria, and their quality was evaluated. Th e meta-analysis was performed using RevMan 5.0 soft ware. Results Eight studies involving 1?092 patients were included, 3 of which were Grade B while the rest were Grade C. Th e results of the meta-analysis showed that the total effi cacy rate of oryz-aspergillus enzyme and pa