甘氨双唑钠对食管癌同步放化疗增敏疗效与安全性的Meta分析

Efficacy and safety of sodium glycididazole for esophageal carcinoma chemoradiotherapy：a Meta-anal-ysis

目的：系统评价甘氨双唑钠（CMNa）对食管癌同步放化疗增敏作用的临床疗效和安全性。方法检索中国生物医学文献数据库、中国期刊全文数据库（CNKI）、万方医药期刊全文数据库、维普中文科技期刊数据库、PubMed、Cochrane Library、EMBase，收集同步放化疗联合 CMNa 与不联合CMNa治疗食管癌的临床随机对照试验（RCT）。根据纳入排除标准筛选文献，对符合条件的 RCT 由两位研究者独立进行资料提取和质量评价后，采用 RevMan 5．3进行 Meta 分析。结果共有4篇 RCT、262例患者纳入研究。Meta 分析结果显示同步放化疗联合 CMNa 增敏组的完全缓解率（OR ＝2．09，95％CI 为1．24～3．54，Z ＝2．76，P ＝0．006）和总有效率（OR ＝2．75，95％CI 为1．39～5．44，Z ＝2．90，P ＝0．004）均优于非增敏组，差异有统计学意义；两组1年生存率差异无统计学意义（OR ＝1．85，95％CI 为0．94～3．64，Z ＝1．77，P ＝0．08）；两组消化道不良反应（OR ＝0．92，95％CI 为0．49～1．70，Z ＝0．28，P ＝0．78）、骨髓抑制（OR ＝0．69，95％CI 为0．39～1．19，Z ＝1．33，P ＝0．18）、肝功能损伤（OR ＝0．93，95％CI 为0．48～1．79，Z ＝0．23，P ＝0．82）、放射性食管炎（OR ＝1．07，95％CI 为0．58～2．00，Z ＝0．22，P ＝0．82）、放射性肺炎（OR ＝0．76，95％CI 为0．29～1．98，Z ＝0．56，P ＝0．57）、放射性皮肤损伤（OR ＝1．11，95％CI为0．51～2．43，Z ＝0．26，P ＝0．80）的发生率差异均无统计学意义。结论同步放化疗联合 CMNa 增敏治疗食管癌近期疗效好，且不增加不良反应的发生。

Objective To assess the efficacy and safety of chemoradiotherapy combined with sodium glycididazole （CMNa）for the patients with esophageal carcinoma by conducting a Meta-analysis.Methods By searching Chinese Biomedical Database,China National Knowledge Infrastructure （CNKI）,Wanfang Data-base,VIP Database,PubMed,Cochrane Library and EMBase,we collected randomized clinical controlled studies （RCTs）of chemoradiotherapy combined with CMNa and control group without CMNa in the treatment of esophageal carcinoma.According to the inclusion and exclusion criteria,data extraction and quality assessment were done by two researchers independently.Meta-analysis was performed by using Revman 5.3.Results A totle of 4 RCTs involving 262 patients were included.The Meta-analysis results showed that chemoradiotherapy combined with CMNa group had better complete remission rate （OR =2.09,95%CI：1 .24-3.54,Z =2.76, P =0.006）and overall response rate （OR =2.75,95%CI：1 .39-5.44,Z =2.90,P =0.004）than the con-trol group,with significant differences.The 1 -year survival rates of the two groups were similar,with no signifi-cant difference （OR =1 .85,95%CI：0.94-3.64,Z =1 .77,P =0.08）.There were no significant differences in the incidence rates of adverse reactions such as gastrointestinal adverse reaction （OR =0.92,95%CI：0.49-1 .70,Z =0.28,P =0.78）,bone marrow suppression （OR =0.69,95%CI：0.39-1 .1 9,Z =1 .33,P =0.1 8）,liver damage （OR =0.93,95%CI：0.48-1 .79,Z =0.23,P =0.82）,radioactive esophagitis （OR =1 .07,95%CI：0.58-2.00,Z =0.22,P =0.82 ）,radioactive pneumonia （OR =0.76,95%CI：0.29-1 .98, Z =0.56,P =0.57）and radioactive skin lesion （OR =1 .1 1 ,95%CI：0.51 -2.43,Z =0.26,P =0.80）. Conclusion In the treatment of esophageal carcinoma,chemoradiotherapy combined with CMNa has a good short-term effect,and does not increase the occurrence of adverse reactions.