中小剂量丙种球蛋白治疗重症特发性血小板减少性紫癜疗效和安全性的系统评价  

Effectiveness and Safety of Middle and Low-dose Gamma Globulin for Severe Idiopathic Thrombocytopenic Purpura: A Systematic Review

作　　者：李治[1] 伊力达尔.阿布都外力 张晓光[2] 哈力达.亚森[1] 

机构地区：[1]新疆医科大学第一附属医院血液病中心,乌鲁木齐830054 [2]新疆医科大学第一附属医院超声医学中心,乌鲁木齐830054

出　　处：《中国循证医学杂志》2014年第3期312-319,共8页Chinese Journal of Evidence-based Medicine

摘　　要：目的系统评价中小剂量丙种球蛋白治疗重症特发性血小板减少性紫癜(ITP)的疗效和安全性。方法计算机检索h e Cochrane Library(2013年第2期)、PubMed、EMbase、CBM、CNKI和WanFang Data数据库,检索时限均为从建库至2013年7月,收集中小剂量丙种球蛋白与大剂量丙种球蛋白比较治疗ITP的随机对照试验(RCT)。由2名评价员按纳入与排除标准独立筛选文献、提取资料和评价质量后,采用RevMan 5.2软件进行Meta分析。结果共纳入11个RCT,548例患者。试验组(n=272)采用中小剂量丙种球蛋白治疗,对照组(n=276)采用大剂量丙种球蛋白治疗。Meta分析结果显示:两组对重症ITP的总有效率[RR=0.95,95%CI﹙0.87,1.04),P=0.30]、总反应率[RR=0.97,95%CI﹙0.85,1.10),P=0.60]以及显效率(完全反应率)[RR=0.94,95%CI﹙0.78,1.14),P=0.54]差异均无统计学意义。在血小板上升时间和止血时间上,两组差异均无统计学意义,但血小板达峰时间对照组优于试验组,且差异有统计学意义;治疗后3、7和14天的血小板计数、峰值血小板计数在两组间差异均无统计学意义。两组严重不良反应发生率均较低。结论中小剂量丙种球蛋白治疗ITP可取得与大剂量丙种球蛋白相似的疗效,且严重不良反应发生率低。受纳入研究质量和数量限制,上述结论尚需高质量、大样本的RCT加以验证。Objective To systematically review the clinical effectiveness and safety of middle and low-dose gamma globulin for severe idiopathic thrombocytopenic purpurar （ITP）. Methods Databases such as The Cochrane Library （Issue 2, 2013）, PubMed, EMbase, CBM, CNKI and WanFang Data were searched to collect randomized controlled tri- als （RCTs） involving the effectiveness and safety of middle and low-dose gamma globulin for severe ITP from the date of their establishment to luly 2013. Two reviewers independently screened studies according to the inclusion and exclusion criteria, extracted data and evaluated the methodological quality of included studies. Then meta-analysis was performed using RevMan 5.2 software. Results Eleven RCTs involving 548 patients were included. The trial group （n=272） were treated with middle and low dose of gamma globulin, while the control group （n=276） were treated with high dose of gamma globulin. The results of meta-analyses showed that there were no significant differences between the two groups in the total effective rate （RR=0.95, 95%CI 0.87 to 1.04, P=0.30）, overall response rate （RR=0.97, 95%CI 0.85 to 1.10, P=0.60） and excellence rate （RR=0.94, 95%CI 0.78 to 1.14, P=0.54）. The outcomes of time effect such as the time of platelet start- ing to rise and haemostasis time between the two groups was similar without significant differences. However, the control group was superior to the trial group in the peak time of platelet. The results of meta-analysis for platelet count of different periods showed that no significant differences were found in platelet count of 3, 7, and 14 days after starting the treatment, so do the peak of platelet count. No severe side effects were reported by both groups. Conclusion Middle and low-dose gamma globulin could achieve the similar effect with the high-dose gamma globulin in the treatment of ITP. However, more high-quality, large-scale, RCTs are required to validate these results.

关 键 词：丙种球蛋白 重症特发性血小板减少性紫癜 META分析 系统评价 随机对照试验 

分 类 号：R554.6[医药卫生—血液循环系统疾病]