阿仑单抗治疗多发性硬化的系统评价

发布时间：2018-08-29 14:23

【摘要】：目的：系统评价阿仑单抗治疗多发性硬化的疗效及安全性。方法：计算机检索PubMed、Embase、Cochrane Library、CBM、CNKI、 VIP、万方等数据库,检索时间(2000-2014)。纳入关于阿仑单抗治疗多发性硬化的随机对照试验(RCT, randomized controlled trails)。由两名评论员按纳入标准独立筛选文献,采用Cochrane协作网的偏倚风险评估工具进行质量评价后,提取复发率、持续性残障率、脑部MRI钆强化病变数及不良反应发生率等观察指标数据,使用Cochrane协作网提供的专用软件RevMan5.2进行Meta分析,依据异质性的大小采用固定效应模型或者随机效应模型进行分析,评价和探索纳入研究的异质性、发表偏倚,并绘制森林图计算P值及合并效应量,以评价阿仑单抗治疗多发性硬化的疗效和安全性。结果：共纳入3个包括1755例患者的符合标准的RCT,异质性检验结果显示各纳入研究结果间不存在统计学异质性,采用固定效应模型进行Meta分析,结果显示：①与对照组相比,应用阿仑单抗治疗可明显降低多发性硬化复发率[OR=0.45,95%CI(0.36,0.57), P0.01]和持续性残障率[OR=0.55,95%CI(0.40,0.76), P0.01];②与对照组相比,应用阿仑单抗治疗可显著减少多发性硬化MRI脑部钆强化病变数[OR=0.33,95%CI(0.23,0.48), P0.01];③阿仑单抗的安全性与对照组比较无统计学差异[OR=1.03,95%CI(0.78,1.37), P=0.81]。结论：阿仑单抗治疗多发性硬化安全性好,可显著降低MS患者的复发率、持续性残障率和MRI脑部钆强化病变数,减少复发次数,其中,12mg和24mg之间的疗效比较无统计学差异。
[Abstract]:Objective: to evaluate the efficacy and safety of alendumab in the treatment of multiple sclerosis. Methods: PubMed,Embase,Cochrane Library,CBM,CNKI, VIP, Wanfang database was searched by computer and the retrieval time was (2000-2014). Include in randomized controlled trial (RCT, randomized controlled trails). For the treatment of multiple sclerosis with alendumab According to the inclusion criteria, two commentators independently sifted the literature. After using the bias risk assessment tool of Cochrane collaboration network to evaluate the quality, the recurrence rate and the persistent disability rate were extracted. The observed data of brain MRI gadolinium enhanced lesions and adverse reactions were analyzed by Meta with RevMan5.2, fixed effect model or random effect model according to the size of heterogeneity. To evaluate and explore heterogeneity, publication bias, and draw forest map to calculate P value and combined effect to evaluate the efficacy and safety of alendumab in the treatment of multiple sclerosis. Results: the results of three RCT, heterogeneity tests including 1755 patients showed that there was no statistical heterogeneity among the results of the study. The fixed effect model was used for Meta analysis. The rate of recurrence of multiple sclerosis [OR=0.45,95%CI (0.36 ~ 0.57), P0.01] and the rate of persistent disability [OR=0.55,95%CI (0.400.76), P0.01] were significantly decreased after treatment with alendumab, compared with the control group. The safety of Arenumab in MRI brain [OR=0.33,95%CI (0.230.48), P0.01] was not significantly different from that of control group [OR=1.03,95%CI (0.78 卤1.37), P _ (0.81)]. Conclusion: alendamab is safe in the treatment of multiple sclerosis, it can significantly reduce the recurrence rate, the rate of persistent disability and the number of brain gadolinium-enhanced lesions in patients with MS, and reduce the number of recurrent lesions. There is no significant difference in the curative effect between 12mg and 24mg in the treatment of multiple sclerosis.
【学位授予单位】：广西医科大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R744.51

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