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目的：通过Meta 分析评价粒系或粒单系集落刺激因子（G-CSF 或GM-CSF）对接受免疫抑制治疗（IST）的重型再生障碍性贫血（SAA）患者的疗效和安全性。方法：使用相关检索词检索MEDLINE、Cochrane Library、EMBASE、CNKI 及CBM 数据库，检索时间1990 年1 月～2011 年12 月。纳入G-CSF 或GM-CSF 治疗SAA 的随机对照研究。用Review Manager4.2 统计软件对数据进行Meta 分析。结果：共纳入4 篇文献，共466 例SAA 患者。Meta 分析结果显示：①IST 疗效：G-CSF/GM-CSF 组与对照组的SAA 患者对比，近远期疗效与生存率均无显著差异：总体生存率［OR=1.15，95%CI（0.73，1.82），P=0.54］、完全缓解率［OR=1.20，95%CI （0.71，2.02），P=0.50］、早期总体有效率［OR=1.61，95%CI（0.85，3.03），P=0.14］、远期总体有效率［OR=1.17，95%CI（0.78，1.74）， P=0.45］；②IST 相关感染：IST 治疗早期感染发生率、严重感染发生率、感染相关死亡率方面均未优于对照组；③G-CSF/GM-CSF 组的复发率低于对照组，差异显著［OR=0.57，95%CI（0.35，0.93），P=0.02］；④G-CSF/GM-CSF 组远期随访发生克隆性病变的发生率与对照组无统计学差异，恶性肿瘤（MDS/AML）发生率［OR=0.90，95%CI（0.41，1.99），P=0.79］、PNH 发生率［OR=1.48，95%CI （0.65，3.33），P=0.35］。结论：G-CSF/GM-CSF 应用于接受IST 治疗的SAA 患者，尚不能证明具有提高总体生存率、完全缓解率、总体有效率、减少感染和感染相关死亡率等优势。虽然有可能降低复发率，也不增加远期克隆性病变发生率，但还需要更严格设计的大样本双盲随机对照试验，并进行更为长期的随访研究。

英文摘要:

Objective: Immunosuppressive therapy is the treatment for aplastic anemia patients ineligible for transplantation. The role of granulocyte colony stimulating factor (G-CSF) and granulocyte-monocyte colony stimulating factor (GM-CSF) as adjunct to treatment in these patients is unclear. Methods: All randomized controlled trials on the effect of G-CSF or GM-CSF on severe aplastic anemia obtained by searching MEDLINE, Cochrane Library, EMBASE, CNKI and CBM were included. Meta analysis was done by Review Manager 4.2 Software. Results: Four trials with totally 466 severe aplastic anemia patients were included. ① The addition of colony stimulating factor yielded no difference in overall survival [OR 1.15, 95%CI (0.73-1.82), P=0.54]. There was no difference in overall hematologic response, complete remission. ②There was no difference in the occurrence of infections. ③Colony stimulating factor significantly decreased the risk for relapse [OR 0.57,95%CI（0.35,0.93）,P=0.02］. ④Colony stimulating factor were not associated with higher occurrence of myelodysplastic syndrome and acute myeloid leukemia ［OR 0.90, 95% CI （0.41,1.99）, P=0.79］or paroxysmal nocturnal hemoglobinuria［OR 1.48, 95%CI（0.65,3.33）, P=0.35］. Conclusion: The addition of colony stimulating factor does not affect mortality, response rate or infections occurrence. Well designed double blind and randomized controlled trials with large sample size and long-term follow-up are needed for further evaluation of the efficacy and safety of the colony stimulating factor therapy.

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