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机构地区:[1]咸宁市中心医院,湖北咸宁437100 [2]三峡大学医学院,湖北宜昌443002
出 处:《中国药房》2014年第20期1887-1891,共5页China Pharmacy
摘 要:目的:系统评价参一胶囊联合化疗对比单纯化疗治疗晚期非小细胞肺癌(NSCLC)的有效性和安全性。方法:计算机检索中国期刊全文数据库、维普中文科技期刊全文数据库、万方数据库、PubMed、Springer Link、Science Direct等,纳入参一胶囊联合化疗对比单纯化疗治疗晚期NSCLC的随机对照试验(RCT)。由两名评价者独立评价并交叉核对纳入研究质量,对纳入的同质研究采用Rev Man 5.0统计软件进行Meta分析。结果:共纳入12项研究,合计865例患者。Meta分析结果显示,与单纯化疗相比,参一胶囊联合化疗能够显著提高患者的有效率[RR=1.47,95%CI(1.25,1.72),P<0.000]、疾病控制率[RR=1.19,95%CI(1.05,1.35),P=0.006]、生存质量(KPS)评分[RR=1.58,95%CI(1.31,1.91),P<0.000]、1年生存率[RR=1.51,95%CI(1.20,1.89),P=0.004]和2年生存率[RR=3.45,95%CI(1.71,6.94)P=0.005]。对于化疗的毒副反应的改善方面,参一胶囊联合化疗与单纯化疗比较差异无统计学意义(P>0.05)。结论:参一胶囊联合化疗治疗晚期NSCLC比单纯化疗有效,主要体现在提高患者近期有效率、生存率、改善生存质量等方面;而安全性并无显著变化。由于纳入研究较少,质量不高,该结论尚待更大规模的多中心RCT进一步验证。OBJECTIVE: To evaluate the effectiveness and safety of Shenyi capsule combined with chemotherapy vs. chemotherapy alone for advanced non-small cell lung cancer (NSCLC). METHODS: Retrieved from CNKI, VIP, Wanfang database, PubMed, Springer Link, Science Direct, RCTs about Shenyi capsule combined with chemotherapy for advanced NSCLC were included. 2 reviewers evaluated the quality of included trials independently. Rev Man 5.0 software was used for Meta-analysis. RESULTS: 12 RCTs were included, involving 865 patients. Results of Meta-analysis showed that Shenyi capsule combined with chemotherapy significantly improved effective rate [RR= 1.47, 95 % CI (1.25,1.72), P〈 0.000], disease control rate [RR= 1.19, 95 % CI (1.05,1.35), P=0.006], KPS score [RR=l.58, 95%CI (1.31,1.91), P〈0.000] and one year survival rate [RR=1.51, 95%CI (1.20, 1.89), P=0.004] and two years survival rate [RR=3.45, 95%CI (1.71,6.94), P〈0.000], compared with chemotherapy alone. There was no statistical significance in the improvement of chemotherapy-induced side effect between Shenyi capsule combined with chemotherapy and chemotherapy alone (P〉0.05). CONCLUSIONS: Shenyi capsule combined with chemotherapy is bet ter than chemotherapy alone in the treatment of advanced NSCLC in respects of short-term efficacy, the quality of life and survival rate. The safeties of them are similar to each other. Considering about low quality of included studies, more large-scale multiple-center RCTs are required.
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