复方苦参注射液联合放化疗治疗鼻咽癌疗效及安全性的Meta分析  

Meta Analysis of Effectiveness and Safety of Compound Kushen Injection Combined with Radiation Treatment and Chemotherapy Drugs in the Treatment of Esophageal Carcinoma

作　　者：杨青廷 熊文婧[2] 旷满华 李国峰[1] 刘也[1] 周平坤 让蔚清[1] 

机构地区：[1]南华大学公共卫生学院,湖南衡阳421001 [2]北京中医药大学基础医学院循证医学中心 [3]中国人民解放军军事医学科学院放射与辐射医学研究所

出　　处：《中南医学科学杂志》2016年第6期630-636,共7页Medical Science Journal of Central South China

基　　金：国家863项目(2012AA063501);疾病控制评价中心重点实验室建设经费(NHSYS04);公共卫生与预防医学湖南省重点学科建设经费

摘　　要：目的系统评价复方苦参注射液辅助放化疗治疗鼻咽癌的有效性和安全性，为临床治疗提供循证参考。方法计算机检索The Cochrane Library、Medline、EMbase、CBM、CNKI、VIP、万方数据库，收集复方苦参注射液联合放化疗（试验组）对照单纯放化疗（对照组）治疗鼻咽癌的随机对照试验（RCTs），提取资料并评价质量后，采用RevMan5．3统计软件对完全缓解率、Ⅲ～Ⅳ级口腔黏膜炎发生率、Ⅲ。Ⅳ级放射性皮炎发生率、Ⅲ-Ⅳ级白细胞减少发生率进行Meta分析。结果共纳入7项RCT，合计328例患者。Meta分析结果显示，观察组患者治疗完全缓解率[OR=2．00，95％CI（1．27，3．13），P〈0．05]、Ⅲ～Ⅳ级口腔黏膜炎发生率[OR=0．35，95％CI（0．24，0．51），P〈0．05]、Ⅲ～Ⅳ级放射性皮炎发生率[OR=0．39，95％CI（0．25，0．60），P〈0．05]、Ⅲ～Ⅳ级白细胞减少发生率[OR=0．41，95％CI（0．28，0．58），P〈0．05]显著优于对照组，两组比较差异均有统计学意义。结论复方苦参注射液辅助放化疗治疗鼻咽癌疗效与安全性均更好。受纳入研究方法学的局限性，该结论有待更多高质量、大样本、长期随访的RCTs进一步验证。Objective To systematically evaluate the efficacy and safety of Compound Kushen Injection combined with radiation treatment and chemotherapy drugs in the treatment of esophageal carcinoma and to provide evidence-based advice for clinical treatment by using Meta-Analysis. Methods The Cochrane Library （Issue 6,2015）, Medline, EMbase, CBM, CNKI, VIP, WanFang Data were retrieved to collect the randomized controlled trials （RCT）that compared Compound Kushen Injection combined with radiation treatment and chemotherapy drugs （test group）with only radiation treatment and chemotherapy drugs （control group）for esophageal carcinoma.After the data extraction and quality assessment, Meta-analysis was performed by using RevMan 5.3 software. Results 7 RCTs that included 328 patients were selected.Odds ratio（ 95% confidence interval [ CI] ;P value） was 2.00（ 1.27,3.13 ;P〈0.05 ） for remission rate, 0.35 （ 0.24,0.51 ;P〈0.05 ） for grade Ⅲ～Ⅳ oral mucositis rate, 0.39 （ 0.25,0.60; P 〈 0.05 ） for grade Ⅲ～Ⅳ radiation dermatitis rate, 0.41 （ 0.28,0.58 ; P 〈 0. 05 ） for grade Ⅲ～Ⅳleukocyte reduction rate,the outcome showed significant differences. Conclusions Compared with radiation treatment and chemotherapy drugs alone, compound Kushen Injection combined with radiation treatment and chemotherapy drugs might have better efficacy and safety for esophageal carcinoma.Due to the poor quality of included studies, it still needs more large-sample and high-quality RCTs with longer follow-up time to verify.

关 键 词：复方苦参注射液 鼻咽癌 META分析 系统评价 随机对照试验 

分 类 号：R739.6[医药卫生—肿瘤]