CAJ | 학술논문

目的：系统评价复方苦参注射液联合化学治疗(简称化疗)药物胸腔内灌注治疗恶性胸腔积液的疗效和安全性，为临床治疗提供循证参考。方法计算机检索Cochrane图书馆、EMBase、PubMed、中国期刊全文数据库、中国生物医学文献数据库、中文科技期刊全文数据库，按纳入与排除标准，制订检索策略，全面收集复方苦参注射液联合化疗药物胸腔内灌注治疗恶性胸腔积液的随机对照试验（RCT），对纳入研究进行质量评价后，采用Rev Man 5.14统计软件进行Meta分析。结果共纳入11项RCT 899例患者。Meta分析结果显示，试验组患者有效率[ RR=1.43，95% CI（1.30，1.56），P﹤0.01]、生存质量改善率[ RR=1.60，95% CI（1.38，1.86），P﹤0.01]显著高于对照组，白细胞减少率、胸痛、胃肠道反应发生率显著低于对照组（ P﹤0.05）。结论复方苦参注射液联合化疗药物方案较单纯使用化疗药物疗效更好，可提高患者生存质量，降低部分不良反应，但尚需高质量的RCT予以证实。
목적：계통평개복방고삼주사액연합화학치료(간칭화료)약물흉강내관주치료악성흉강적액적료효화안전성，위림상치료제공순증삼고。방법계산궤검색Cochrane도서관、EMBase、PubMed、중국기간전문수거고、중국생물의학문헌수거고、중문과기기간전문수거고，안납입여배제표준，제정검색책략，전면수집복방고삼주사액연합화료약물흉강내관주치료악성흉강적액적수궤대조시험（RCT），대납입연구진행질량평개후，채용Rev Man 5.14통계연건진행Meta분석。결과공납입11항RCT 899례환자。Meta분석결과현시，시험조환자유효솔[ RR=1.43，95% CI（1.30，1.56），P﹤0.01]、생존질량개선솔[ RR=1.60，95% CI（1.38，1.86），P﹤0.01]현저고우대조조，백세포감소솔、흉통、위장도반응발생솔현저저우대조조（ P﹤0.05）。결론복방고삼주사액연합화료약물방안교단순사용화료약물료효경호，가제고환자생존질량，강저부분불량반응，단상수고질량적RCT여이증실。
Objective To evaluate the efficacy and safety of intrapleural injection of Compound Kushen Injection combined with chemotherapy in treating malignant pleural effusion,and to provide evidence-based reference for clinical use. Methods The data were retrieved from Cochrane library,EMbase,PubMed,CNKI,CBM,VIP,the RCT about intrapleural injection of Compound Kushen Injection combined with chemotherapy in treating malignant pleural effusion were collected according to the inclusion and exclusion criterion. The quality was evaluated and Meta-analysis was carried out by Rev Man 5. 14. Results 11 RCT were included,involving 899 patients in total. Meta-analysis indicated that the total effective rate of the experimental group was significantly higher than that of the control group [ RR=1. 43,95% CI(1. 30,1. 56),P ﹤ 0. 01 ] ,the quality of life [ RR=1. 60,95% CI(1. 38,1. 86),P ﹤ 0. 01 ] . The incidence of hypodynamia,chest pain and gastrointestinal reaction in the experimental group were significantly lower than those in the control group ( P ﹤ 0. 05). Conclusion Intrapleural injection of Compound Kushen Injection combined with chemotherapy can improve the efficacy and the quality of life in the treatment of malignant pleural effusion,decrease parts of adverse reactions. However,it still needs high-quality RCTs for further validation.