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作 者:郭月芳[1] 张朕华[1] 盛雨辰[1] 谢伟[1] 吉蕊[1] 梅其炳[1]
出 处:《中国医药导报》2011年第15期36-40,共5页China Medical Herald
基 金:国家"重大新药创制"科技重大专项(2009ZX0901-007)
摘 要: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.
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