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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%C(I0.73,1.82),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%C(I0.35,0.93),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。
PURPOSE: To evaluate the efficacy and safety of granulocytic or monocyte-derived colony stimulating factor (G-CSF or GM-CSF) in patients with severe aplastic anemia (ISA) undergoing immunosuppressive therapy (IST) by Meta-analysis. METHODS: MEDLINE, Cochrane Library, EMBASE, CNKI and CBM databases were searched using related search terms from January 1990 to December 2011. Randomized controlled study enrolling G-CSF or GM-CSF in the treatment of SAA. Use Review Manager 4.2 statistical software to conduct meta-analysis of the data. Results: A total of 4 articles were included, 466 cases of SAA were included. The results of Meta analysis showed that: ① Therapeutic effect of ANT: Compared with SAA patients in G-CSF / GM-CSF group and control group, there was no significant difference in short-term and long-term efficacy and survival rate: overall survival rate [OR = 1.15,95% C (I0. (OR = 1.61, 95% CI (0.85, 3.03), P = 0.54], complete remission rate [OR = 1.20,95% CI (OR = 1.17, 95% CI, 0.78, 1.74, P = 0.45); ②TIST-related infection: the incidence of early-stage infection, the incidence of severe infection and the infection-related mortality in IST The recurrence rate of G-CSF / GM-CSF group was significantly lower than that of control group (OR = 0.57,95% C (I0.35,0.93, P = 0.02] The incidence of clonal lesions in long-term follow-up in GM-CSF group was not significantly different from that in control group (OR = 0.90, 95% CI, 0.79, The incidence of PNH [OR = 1.48, 95% CI (0.65, 3.33), P = 0.35]. CONCLUSIONS: G-CSF / GM-CSF is not yet proven to have the advantage of improving overall survival, complete remission rate, overall response rate, and reduction of infection-related and infection-related mortality in patients with SAA treated with IST. Although it is possible to reduce the recurrence rate without increasing the incidence of long-term clonal lesions, a more rigorous design of a large double-blind, randomized, controlled trial is needed and a longer-term follow-up study is needed.