甘露聚糖肽对淋巴造血系统肿瘤支持治疗的临床荟萃研究

摘要

目的:系统评价甘露聚糖肽对恶性非实体瘤支持治疗的有效性及安全性.方法:电子检索Cochrane图书馆、MEDLINE,EMBASE,CNKI和CBM,纳入甘露聚糖肽治疗白血病、淋巴瘤、骨髓瘤的随机对照试验(RCT),检索日期至2011年10月.由两名研究者独立纳入试验、评价质量、提取数据并交叉核对.使用RevMan 5.0软件进行Meta分析.结果:纳入10项RCTs,共包括570例患者,其中治疗组300例,对照组270例.结果显示甘露聚糖肽可显著提高化疗的总有效率[OR =3.9,95％ CI:(2.45,6.20),Z=5.75,P＜0.01];显著提高T细胞免疫功能,分别为[SMD=1.05,95％ CI:(0.78,1.32);Z =7.55,P＜0.01],[SMD=1.38,95％ CI:(0.64,2.13),Z=3.63,P＜O.01],[SMD=0.79,95％ CI:(0.43,1.14),Z=4.35,P＜0.01];改善肿瘤患者体力状况[SMD=2.34,95％ CI:(1.96,2.72),Z=12.09,P＜0.01];同时能显著降低各种化疗引起的毒副反应,如白细胞下降[ SMD=0.84,95％ CI:(0.49,1.20),Z=4.63,P＜0.01],减少白细胞最低值持续时间[SMD=-1.19,95％ CI:(-1.56,-0.82),Z=6.30,P＜O.01]等.但治疗过程中可引起轻微发热和皮疹.结论:甘露聚糖肽可提高淋巴造血系统非实体瘤化疗的近期疗效,减轻不良反应,改善生活质量.但由于纳入研究的方法质量尚有待提高,上述结论还需进一步开展大样本、高质量、多中心的随机双盲对照试验来证实.%Objective; To evaluate the efficacy and safety of mannatide injection in the treatment of lym-phohaemopoietic tumors. Methods; Literature was retrieved from Medline, EMBASE, Cochrane Library, CBM, VIP, and CNKI databases by computer and from relevant Chinese medical journals manually. Trial selection, quality evaluation and information extraction were performed according to including and excluding criteria. Meta analysis was conducted using RevMan 5.0 software. Results; Totally 10 RCTs and 570 patients (treatment group; 300; placebo group; 270) were included in the Meta analysis. Mannatide improved the total effect of chemotherapy [OR =3.9, 95% CI; (2.45, 6.20) , Z =5.15 , P<0.01] , T cells immunologic function [ SMD = 1. 05 , 95% CI:(0.78, 1.32) , Z =1.55, P <0.01]; [SMD =1.38, 95% CI:(0. 64, 2. 13), Z =3. 63, P < 0. 01 ] ; [SMD =0.79, 95% CI:(0. 43, 1. 14) , Z =4. 35, P <0.01] and Karnofsky scale [SMD =2.34, 95% CI: (1. 96, 2.72) , Z = 12. 09, P <0. 01 ]. Mannatide also decreased toxicity of chemotherapy, such as leucopenia[SMD=0.84, 95% CI:(0.49, 1.20), Z=4. 63, P<0.01] , and hold time of lowest WBC [ SMD = -1. 19, 95% CI:( -1.56, -0.82), Z = 6.30, P<0.01]. The main adverse reactions of Mannatide were slight fever and skin eruption. Conclusion; Systematic review indicates that mannatide can improve the total effect of chemotherapy, immunologic function and Karnofsky scale. However, due to the limited quality of the included studies, the results suggest that further multi-centre and large-scale randomized double-blind control trials for mannatide injection are needed.