CAJ | 학술논문

目的：评价复方苦参注射液联合放疗治疗食管癌的有效性和临床研究质量。方法检索PubMed （1980～2012年）、Cochrane中心对照试验注册资料库（2012年第3期）、中国生物医学文献数据库（CBM,1980～2012年）、中国期刊全文数据库（CNKI,1980~2012年）、中文科技期刊数据库（VIP,1980~2012年）、万方数据库（1980～2012年），并根据文献中的参考文献进行文献追溯。手工检索新疆医科大学图书馆部分相关期刊，纳入随机对照试验。使用国际Cochrane中心推荐的方法进行文献质量评价，并用RevMan 4.2.2软件进行统计分析。结果共纳入5篇研究，合并分析显示：复方苦参注射液联合放疗在改善瘤体变化[RR=1.26,95％CI（1.10,1.45）, P=0.0009]、减少血液学反应[RR=0.39,95％CI（0.27,0.57）, P<0.0001]、减轻放射性食管炎发生[OR=0.28,95％CI（0.14,0.58）, P=0.0006]、改善生活质量[OR=3.34,95％CI（1.72,6.47）, P=0.0004]和增加体重[OR=3.77,95％CI（1.69,8.39）, P=0.001]方面的效果均优于单纯放疗；复方苦参注射液联合放化疗在改善瘤体变化[RR=1.42,95％CI（1.10,1.83）, P=0.008]、防治血液学反应[RR=0.27,95％CI（0.10,0.73）, P=0.010]和提高3年生存率[OR=2.73,95％CI（1.06,7.05）, P=0.04]方面均优于放化疗。结论复方苦参注射液联合放疗治疗食管癌具有一定的减毒增效作用，但不排除与纳入文献质量较低，样本量小和发表偏倚有关，尚需大样本多中心随机对照临床试验进一步证实其临床疗效。
목적：평개복방고삼주사액연합방료치료식관암적유효성화림상연구질량。방법검색PubMed （1980～2012년）、Cochrane중심대조시험주책자료고（2012년제3기）、중국생물의학문헌수거고（CBM,1980～2012년）、중국기간전문수거고（CNKI,1980~2012년）、중문과기기간수거고（VIP,1980~2012년）、만방수거고（1980～2012년），병근거문헌중적삼고문헌진행문헌추소。수공검색신강의과대학도서관부분상관기간，납입수궤대조시험。사용국제Cochrane중심추천적방법진행문헌질량평개，병용RevMan 4.2.2연건진행통계분석。결과공납입5편연구，합병분석현시：복방고삼주사액연합방료재개선류체변화[RR=1.26,95％CI（1.10,1.45）, P=0.0009]、감소혈액학반응[RR=0.39,95％CI（0.27,0.57）, P<0.0001]、감경방사성식관염발생[OR=0.28,95％CI（0.14,0.58）, P=0.0006]、개선생활질량[OR=3.34,95％CI（1.72,6.47）, P=0.0004]화증가체중[OR=3.77,95％CI（1.69,8.39）, P=0.001]방면적효과균우우단순방료；복방고삼주사액연합방화료재개선류체변화[RR=1.42,95％CI（1.10,1.83）, P=0.008]、방치혈액학반응[RR=0.27,95％CI（0.10,0.73）, P=0.010]화제고3년생존솔[OR=2.73,95％CI（1.06,7.05）, P=0.04]방면균우우방화료。결론복방고삼주사액연합방료치료식관암구유일정적감독증효작용，단불배제여납입문헌질량교저，양본량소화발표편의유관，상수대양본다중심수궤대조림상시험진일보증실기림상료효。
Objective To assess the methodological quality of clinical studies using Compound Kushen Injection com-bined with radiotherapy for esophageal carcinoma and evaluate the efficacy of Compound Kushen Injection. Methods PubMed (1980-2012), Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 3, 2012), CBM (1980-2012), CNKI (1980-2012), Wanfang data base (1980-2012), and VIP (1980-2012) were searched. The authors also hand-searched the po-tential related Chinese periodicals. All randomized controlled trials comparing Compound Kushen Injection with other treatment methods of esophageal carcinoma were included. Two reviewers selected studies, assessed the qualities of studies, and extracted the data independently. The included studies were appraised and analyzed by Cochrane Collaboration Review Manager 4.2. Results Five randomized controlled trials were included in the meta-analysis. Compound Kushen Injection combined with radiotherapy showed statistically significant differences improving the response rate[RR=1.26, 95%CI (1.10, 1.45), P=0.0009], decreasing the blood toxicity[RR=0.39, 95%CI (0.27, 0.57), P<0.0001], reducing the radioactive esophagitis[OR=0.28, 95%CI (0.14, 0.58), P=0.0006], improving the quality of life[OR=3.34, 95%CI (1.72, 6.47), P=0.0004]and increasing the weight[OR=3.77, 95%CI (1.69, 8.39), P=0.001], as compared with single use of radiotherapy, and the relative risk (RR or OR) and 95%con-fidence interval (CI) were 1.26 (1.10, 1.45), 0.39 (0.27, 0.57), 0.28 (0.14, 0.58), 3.34 (1.72, 6.47), 3.77 (1.69, 8.39), respectively. Compound Kushen Injection combined with radiotherapy and chemotherapy was superior to the chemoradiotherapy on im-proving the response rate[RR=1.42, 95%CI (1.10, 1.83), P=0.008], decreasing the blood toxicity[RR=0.27, 95%CI (0.10, 0.73), P=0.010], and increasing the three-year survival rate[OR=2.73, 95%CI (1.06, 7.05), P=0.04]. Conclusion The results of meta-analysis indicated that Compound Kushen Injection may have adjuvant therapeutic effects on the treatment of esophageal carcinoma patients. This results may be concerned with the few and poor quality of the included samples and publication bias. Yet the effects of Compound Kushen Injection still need to be confirmed by large multi-center randomized controlled trials.