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.	曹紅, 何秋連, 馬春容, 等.激素聯合小劑量靜脈丙種球蛋白治療重癥血小板減少性紫癜療效觀察.西部醫學, 2010, 22(12):2242-2244.
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13.	張敬東, 謝明紅, 謝鵬鴻, 等.小劑量靜脈丙種球蛋白治療急性和頑固性重癥特發性血小板減少性紫癜臨床分析.贛南醫學院學報, 2010, 30(1):88-89.
14.	鄭引索, 姚亞洲.不同劑量丙種球蛋白治療重癥ITP療效觀察.基層醫學論壇, 2011, 15(7):220-222.
15.	黃玉梅, 鄧足琴, 陳巧華, 等.組胺丙種球蛋白致過敏性休克1例.醫藥導報, 2005, 24(10):933.
16.	葉云才.肌注丙種球蛋白致一例過敏性休克.安徽預防醫學雜志, 2003, 9(1):11.
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1. ?虞積仁.特發性血小板減少性紫癜.見:張之南, 沈悌, 主編.血液病診斷及療效標準.第2版.北京:科學出版社, 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. 王軍, 張茂飛, 鈕建華, 等.不同劑量丙種球蛋白治療兒童重癥特發性血小板減少性紫癜臨床觀察.中國煤炭工業醫學雜志, 2003, 6(1):80.
5. 王巖, 李彥玲, 劉世和, 等.不同劑量丙種球蛋白治療重癥特發性血小板減少性紫癜近期療效觀察.醫師進修雜志, 2003, 26(2):17-18.
6. 章賽蕪.非標準劑量靜脈丙種球蛋白治療重癥特發性血小板減少性紫癜療效觀察.現代診斷與治療, 2004, 15(4):248-249.
7. 王春森, 王曉冬, 張晉林, 等.不同劑量丙種球蛋白治療老年人重癥特發性血小板減少性紫癜的近期療效觀察.四川醫學, 2006, 27(2):151-152.
8. 陳恕之.兩種劑量丙種球蛋白聯合地塞米松治療36例重癥特發性血小板減少性紫癜患者療效觀察.遵義醫學院學報, 2008, 31(6):623-625.
9. 應敏潔, 徐進.兩種劑量靜注丙種球蛋白治療特發性血小板減少性紫癜療效分析.浙江臨床醫學, 2008, 10(1):60.
10. 楊朝榮.兩種劑量丙種球蛋白治療重癥特發性血小板減少性紫癜臨床觀察.臨床內科雜志, 2009, 26(8):569-570.
11. 曹紅, 何秋連, 馬春容, 等.激素聯合小劑量靜脈丙種球蛋白治療重癥血小板減少性紫癜療效觀察.西部醫學, 2010, 22(12):2242-2244.
12. 孫士敏, 范紅梅, 張玲, 等.小劑量丙種球蛋白治療特發性血小板減少性紫癜.基層醫學論壇, 2010, 14(22):722-723.
13. 張敬東, 謝明紅, 謝鵬鴻, 等.小劑量靜脈丙種球蛋白治療急性和頑固性重癥特發性血小板減少性紫癜臨床分析.贛南醫學院學報, 2010, 30(1):88-89.
14. 鄭引索, 姚亞洲.不同劑量丙種球蛋白治療重癥ITP療效觀察.基層醫學論壇, 2011, 15(7):220-222.
15. 黃玉梅, 鄧足琴, 陳巧華, 等.組胺丙種球蛋白致過敏性休克1例.醫藥導報, 2005, 24(10):933.
16. 葉云才.肌注丙種球蛋白致一例過敏性休克.安徽預防醫學雜志, 2003, 9(1):11.
17. 甄宇峰.靜脈注射大劑量丙種球蛋白致顱內壓增高三例報道.藥學服務與研究, 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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