甘露聚糖肽注射液配合放疗治疗鼻咽癌的系统评价

Systematic review of Mannatide Injection plus radiotherapy in the treatment of nasopharyngeal carcinoma

目的:系统评价甘露聚糖肽注射液配合放疗治疗鼻咽癌的有效性及安全性。方法:电子检索Cochrane图书馆、MEDLINE、EMBASE、CNKI、VIP、CBM,手工检索相关杂志、会议论文、学位论文,收集甘露聚糖肽治疗鼻咽癌的随机对照试验(RCT)。由两名研究者独立选择试验、评价质量、提取数据,并交叉核对。使用RevMan5.0软件进行Meta分析。结果:纳入9个RCT,结果显示,完全缓解率方面,鼻咽灶完全缓解率[OR=3.00,95%CI(1.82～4.97),P<0.01]及颈淋巴结病灶完全缓解率[OR=2.77,95%CI(1.64～4.70),P<0.01]均优于对照组;免疫功能方面,甘露聚糖肽能显著改善CD3+[OR=13.60,95%CI(4.43～22.76),P<0.01]、CD4+[OR=-11.71,95%CI(-12.65～-10.78),P<0.01]、CD8+[OR=-11.71,95%CI(-12.65～-10.78),P<0.01],CD4+/CD8+[OR=0.52,95%CI(0.29～0.75),P<0.01]、NK细胞[OR=8.52,95%CI(2.59～14.45),P<0.01]水平;不良反应方面,注射甘露聚糖肽可能会引起低、中度发热。结论:甘露聚糖肽可提高鼻咽癌放疗的近期疗效,同时改善患者的免疫状态,但应用过程中可引起轻微发热。由于纳入研究的方法质量问题和可能存在发表偏倚,因此,上述结论有待进一步开展大样本、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 plus radiotherapy in the treatment of nasopharyngeal carcinoma.Methods：Literatures were retrieved from MEDLINE,EMBASE,Cochrane Library,CBM,CNKI,VIP databases by computer and from relevant Chinese medical journals by hand.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：9 reports were included in the meta-analysis.CR,Nasopharynx CR [OR=3.00,95%CI（1.82-4.97）,P0.01] and lymphonodi cervicales CR [OR=2.77,95%CI（1.64-4.70）,P0.01] in the treatment group were both superior to those of the control group;Immunologic function,Mannatide Injection improved the level of CD3＋[OR=13.60,95%CI（4.43-22.76）,P0.01],CD4＋[OR=-11.71,95%CI（-12.65——10.78）,P0.01],CD4＋/CD8＋[OR=0.52,95%CI（0.29-0.75）,P0.01],NKcell[OR=8.52,95%CI（2.59-14.45）,P0.01] and reduce the level of CD8＋[OR=-11.71,95%CI（-12.65——10.78）,P0.01].The main adverse reaction of Mannatide was slight fever.Conclusion：Systematic review indicates that Mannatide is safe and effective for nasopharyngeal carcinoma.However,due to the limited quality of the included studies,the results suggest that further and multi-centre and large-scale randomized double-blind control trials using Mannatide Injection are needed.