铁剂联合重组人促红细胞生成素治疗化疗诱导性贫血疗效与安全性的meta分析

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目的:系统比较和评价注射铁剂、口服铁剂与重组人促红细胞生成素(rHuEPO)联用以及rHuEPO单用治疗化疗诱导性贫血(CIA)的疗效与安全性。方法:以“贫血”、“化疗诱导性贫血”“硫酸亚铁、富马酸亚铁、葡萄糖铁钠注射液、蔗糖铁注射液、右旋糖酐铁注射液”及“重组人促红细胞生成素”、“达贝泊汀-α”或“阿法依泊汀”为关键词,分别检索PubMed(1966年至2011年4月)、EMbase(1974年至2011年4月)、中国生物医学文献光盘数据库(1978年至2011年4月)、中国期刊全文数据库(1979年至2011年4月)以及Cochrane图书馆系统评价和临床对照试验资料库(1960年至2011第1期)。收集口服或注射铁剂联合rHuEPO治疗CIA的随机对照试验(RCT)。根据纳入标准对文献进行筛选和评估,采用RevMan 5.0软件对数据进行meta分析。计算CIA患者应用3种不同治疗方案后血红蛋白(Hb)变化平均值、治疗有效率、输血率、不良反应发生率、生活质量评分变化均值。结果:共检索到相关文献106篇,经筛选最终纳入符合标准的文献6篇,共1294例患者。meta分析结果显示,注射铁剂相比于口服铁剂方案,在患者的Hb水平、治疗有效率、输血率、生活质量评分及不良事件发生率方面差异均无统计学意义(均P>0.05)。注射铁剂与不使用铁剂患者Hb水平的加权均数差值[95%可信区间(CI)]为0.54(0.16~0.91,P=0.005),治疗有效率和输血率的优势比(95%CI)分别为2.07(1.18~3.65,P=0.01)和0.66(0.46~0.93),2种方案比较差异有统计学意义。结论:在CIA的治疗中,注射铁剂和rHuEPO联用与rHuEPO单用比较,可明显提高患者Hb水平和治疗有效率,减少输血率,但是注射铁剂和rHuEPO联用与口服铁剂和rHuEPO联用比较,治疗效果未见明显差异。 OBJECTIVE: To systematically compare and evaluate the efficacy and safety of iron-injection, oral administration of iron with recombinant human erythropoietin (rHuEPO) and rHuEPO alone in the treatment of chemotherapy-induced anemia (CIA). Methods: The patients were treated with “Anemia”, “Chemotherapy-induced Anemia”, “Ferrous Sulfate, Ferrous Fumarate, Dextrose Sodium Injection, Sucrose Iron Injection, Dextran Injection” and “ PubMed (1966 to April 2011), EMbase (from 1974 to April 2011) were searched using the keywords ”human erythropoietin,“ ”darbepoetin-α“, and ” April 2011), China Biomedical Literature CD-ROM Database (1978 - April 2011), Chinese Journal Full-text Database (1979 - April 2011) and Cochrane Library System Evaluation and Clinical Control Trial Database (1960 Until 2011 first issue). Randomized controlled trials (RCTs) were conducted for the treatment of CIA with either oral or injectable iron plus rHuEPO. The literature was screened and assessed based on inclusion criteria and the data was meta-analyzed using RevMan 5.0 software. The average change of hemoglobin (Hb), treatment efficiency, blood transfusion rate, incidence of adverse reactions and quality of life score of CIA patients after applying the three different treatment regimens were calculated. Results: A total of 106 related articles were retrieved. Six of the 6 articles were finally screened and matched to the standard, a total of 1294 patients. The results of meta-analysis showed that there was no significant difference in Hb level, treatment efficiency, blood transfusion rate, quality of life score and the incidence of adverse events between the injection of iron and oral iron (P> 0.05) . The weighted mean difference [95% confidence interval (CI)] was 0.54 (0.16-0.91, P = 0.005) for Hb levels in patients with and without iron. The odds ratio (95 % CI) were 2.07 (1.18 ~ 3.65, P = 0.01) and 0.66 (0.46 ~ 0.93), respectively. There was significant difference between the two regimens. Conclusion: In the treatment of CIA, the injection of iron and rHuEPO combined with rHuEPO alone can significantly improve the patient’s Hb level and treatment efficiency, reduce blood transfusion rate, but the injection of iron and rHuEPO combined with oral iron and rHuEPO Combined use, no significant difference in treatment effect.
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