铁螯合剂治疗重型β-珠蛋白生成障碍性贫血安全性的Meta分析

Safety of iron chelator in the treatment of beta-thalassemia major:a systematic review with meta-analysis

目的:评价去铁胺和去铁酮联合治疗重型β-珠蛋白生成障碍性贫血(beta-thalassemia major,BTSM)的安全性。方法:检索1985-01-01至2012-09-30的Cochrane图书馆、PubMed、EMBASE、Springer、Ovid、中国期刊全文数据库、中国生物医学文献数据库和维普期刊数据库,收集有关去铁胺和去铁酮联合治疗BTSM安全性的随机对照试验。从胃肠道药物不良反应(ADRs)、关节ADRs、粒细胞减少症、皮肤ADRs四个指标分析药物治疗的安全性,采用RevMan 5.0软件进行Meta分析。结果:纳入10篇文献,共486名病人。各亚组均具有较好的同质性,采用固定效应模型。Meta分析结果:去铁胺和去铁酮联合治疗组胃肠道ADRs(P<0.000 01)、关节ADRs(P=0.009)和粒细胞减少症(P=0.02)发生率均高于单独治疗组;而单独治疗组的皮肤ADRs发生率高于联合治疗组(P=0.006)。合并分析结果显示,联合治疗组的ADRs发生率高于单独治疗组(P<0.000 01)。结论:去铁胺和去铁酮联合治疗的ADRs发生率总体上高于去铁胺或去铁酮单独治疗组,但皮肤ADRs的发生率低于单用组。受纳入文献质量的限制,此结论尚需进一步证实。

Objective： To evaluate the safety of deferoxamine combined with deferiprone in the treatment of beta- thalassemia major（BTSM） patients. Methods： The Cochrane library, PubMed, EMBASE, Springer, Ovid, the Chinese Journal Full-text Database,the Chinese Biomedical Literature and Vip Journals Database from 1985-01-01 to 2012-09-30 were retrieved. The randomized controlled trials （RCTs） on the safety of combined therapy with deferoxamine and deferiprone for the treat- ment of BTSM were collected. Gastrointestinal adverse drug reactions,joint adverse drug reactions,neutropenia and skin reac tions at the site of infusion were chosen to analyze medication safety. Meta analyses were conducted by using RevMan 5.0 soft- ware. Results.. Ten articles involving 486 patients in total were included. Tests for heterogeneity showed that all the four groups had good statistical homogeneity,which was analyzed by the fixed effect model. The results showed that the incidence rates of gastrointestinal disorders （P〈0. 000 01）, joint adverse drug reactions （P= 0. 009） and neutropenia （P= 0.02） were higher in the combined therapy group than those in the monotherapy group. However,the incidence of skin reactions at the site of infusion was higher in the monotherapy group （P=0. 006） than that in the combined therapy group. Incorporation analysis showed that the incidence of adverse reactions was higher in the combined therapy group（P〈0. 000 01） than that in the mono therapy group. Conclusion： Generally, the incidence rates of adverse drug reactions were higher in the combined therapy group than those in the monotherapy group, with the exception of the incidence of skin reactions at the infusion site. However, the conclusion demands further study due to the quality restrictions of the studies involved.