Effectiveness and Safety of Middle and Low-dose Gamma Globulin for Severe Idiopathic Thrombocytopenic Purpura: A Systematic Review_Chinese Journal of Evidence-Based Medicine

Authors：

 LIZhi ¹ , YILIDAERAbuduwaili ¹ , ZHANGXiao-guang ² ,  HALIDAYasen ¹

1. Blood Disease Center, The First Affiliated Hospital of Xinjiang Medical University, Urumqi 830054, China;
2. Ultrasound Diagnosis Medicine Center, The First Affiliated Hospital of Xinjiang Medical University, Urumqi 830054, China;

Corresponding author：

HALIDAYasen, Email: halidayasen@hotmail.com

Keywords：

Gamma globulin; Severe idiopathic thrombocytopenic purpura; Meta-analysis; Systematic review; Randomized controlled trial

DOI：

10.7507/1672-2531.20140054

Video：

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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 trials (RCTs) involving the effectiveness and safety of middle and low-dose gamma globulin for severe ITP from the date of their establishment to July 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 starting 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.

Citation： LIZhi, YILIDAERAbuduwaili, ZHANGXiao-guang, HALIDAYasen. Effectiveness and Safety of Middle and Low-dose Gamma Globulin for Severe Idiopathic Thrombocytopenic Purpura: A Systematic Review. Chinese Journal of Evidence-Based Medicine, 2014, 14(3): 312-319. doi: 10.7507/1672-2531.20140054 Copy

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11.	曹红, 何秋连, 马春容, 等.激素联合小剂量静脉丙种球蛋白治疗重症血小板减少性紫癜疗效观察.西部医学, 2010, 22(12):2242-2244.
12.	孙士敏, 范红梅, 张玲, 等.小剂量丙种球蛋白治疗特发性血小板减少性紫癜.基层医学论坛, 2010, 14(22):722-723.
13.	张敬东, 谢明红, 谢鹏鸿, 等.小剂量静脉丙种球蛋白治疗急性和顽固性重症特发性血小板减少性紫癜临床分析.赣南医学院学报, 2010, 30(1):88-89.
14.	郑引索, 姚亚洲.不同剂量丙种球蛋白治疗重症ITP疗效观察.基层医学论坛, 2011, 15(7):220-222.
15.	黄玉梅, 邓足琴, 陈巧华, 等.组胺丙种球蛋白致过敏性休克1例.医药导报, 2005, 24(10):933.
16.	叶云才.肌注丙种球蛋白致一例过敏性休克.安徽预防医学杂志, 2003, 9(1):11.
17.	甄宇峰.静脉注射大剂量丙种球蛋白致颅内压增高三例报道.药学服务与研究, 2006, 6(1):16, 47.

1. 虞积仁.特发性血小板减少性紫癜.见:张之南, 沈悌, 主编.血液病诊断及疗效标准.第2版.北京:科学出版社, 1998:279-285.
2. Berchtold P, McMillan R. Therapy of chronic idiopathic thrombocytopenic Purpura in adults. Blood, 1989, 74(7):2309-2317.
3. Higpins JPT, Green S. Cochrane Handbook for Systematic Reviews of Intercentions Version 5.1.0. The Cochrane Collbration, 2011. Available at:www.cochrane-handbook.org.
4. 王军, 张茂飞, 钮建华, 等.不同剂量丙种球蛋白治疗儿童重症特发性血小板减少性紫癜临床观察.中国煤炭工业医学杂志, 2003, 6(1):80.
5. 王岩, 李彦玲, 刘世和, 等.不同剂量丙种球蛋白治疗重症特发性血小板减少性紫癜近期疗效观察.医师进修杂志, 2003, 26(2):17-18.
6. 章赛芜.非标准剂量静脉丙种球蛋白治疗重症特发性血小板减少性紫癜疗效观察.现代诊断与治疗, 2004, 15(4):248-249.
7. 王春森, 王晓冬, 张晋林, 等.不同剂量丙种球蛋白治疗老年人重症特发性血小板减少性紫癜的近期疗效观察.四川医学, 2006, 27(2):151-152.
8. 陈恕之.两种剂量丙种球蛋白联合地塞米松治疗36例重症特发性血小板减少性紫癜患者疗效观察.遵义医学院学报, 2008, 31(6):623-625.
9. 应敏洁, 徐进.两种剂量静注丙种球蛋白治疗特发性血小板减少性紫癜疗效分析.浙江临床医学, 2008, 10(1):60.
10. 杨朝荣.两种剂量丙种球蛋白治疗重症特发性血小板减少性紫癜临床观察.临床内科杂志, 2009, 26(8):569-570.
11. 曹红, 何秋连, 马春容, 等.激素联合小剂量静脉丙种球蛋白治疗重症血小板减少性紫癜疗效观察.西部医学, 2010, 22(12):2242-2244.
12. 孙士敏, 范红梅, 张玲, 等.小剂量丙种球蛋白治疗特发性血小板减少性紫癜.基层医学论坛, 2010, 14(22):722-723.
13. 张敬东, 谢明红, 谢鹏鸿, 等.小剂量静脉丙种球蛋白治疗急性和顽固性重症特发性血小板减少性紫癜临床分析.赣南医学院学报, 2010, 30(1):88-89.
14. 郑引索, 姚亚洲.不同剂量丙种球蛋白治疗重症ITP疗效观察.基层医学论坛, 2011, 15(7):220-222.
15. 黄玉梅, 邓足琴, 陈巧华, 等.组胺丙种球蛋白致过敏性休克1例.医药导报, 2005, 24(10):933.
16. 叶云才.肌注丙种球蛋白致一例过敏性休克.安徽预防医学杂志, 2003, 9(1):11.
17. 甄宇峰.静脉注射大剂量丙种球蛋白致颅内压增高三例报道.药学服务与研究, 2006, 6(1):16, 47.

Chinese Journal of Evidence-Based Medicine

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

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