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目的:系统评价参芪扶正注射液联合GP方案治疗非小细胞肺癌的安全性和有效性。方法:计算机检索万方数字化期刊全文数据库、中国期刊全文数据库、中国生物医学文献数据库、维普中文科技期刊数据库及美国国立医学图书馆,检索时限为各数据库建库日起至2015年8月关于参芪扶正注射液联合GP方案治疗非小细胞肺癌的临床随机对照试验。根据纳入和排除标准筛选文献,对纳入的研究进行数据提取和质量评价,然后使用Revman 5.3软件进行Meta分析。结果:12个临床随机对照试验纳入系统评价,共928例患者,均为Jadad评分≤3的低质量研究。Meta结果显示:与单纯GP方案相比,参芪扶正注射液联合GP方案治疗非小细胞肺癌可显著提高有效率[OR=1.72,95%CI(1.32,2.25),P<0.000 1]和改善患者的生活质量[OR=3.35,95%CI(2.50,4.49),P<0.000 01],减少白细胞[OR=0.30,95%CI(0.21,0.42),P<0.000 01]和血红蛋白[OR=0.37,95%CI(0.22,0.62),P=0.000 2]下降,降低胃肠道反应[OR=0.47,95%CI(0.33,0.68),P<0.000 1],其差异具有统计学意义。结论:参芪扶正注射液联合GP方案治疗非小细胞肺癌可显著提高有效率和患者的生活质量,减少化疗毒副反应。然而,现有小样本的临床随机对照试验方法学和报告质量偏低,还需要进一步高质量、大样本严格设计的临床试验验证。
Objective: To systematically evaluate the safety and efficacy of Shenqi Fuzheng injection combined with GP regimen in the treatment of non-small cell lung cancer. Methods: The full-text databases of Wanfang Digitized Periodicals, Chinese Journal Full-text Database, Chinese Biomedical Literature Database, Vip Chinese Science and Technology Periodicals Database and the National Library of Medicine were searched by computer. The search time limit is from the date of establishment of each database to August 2015 Clinical Randomized Controlled Trial of Qifuzheng Injection Combined with GP Regimen in Treatment of Non-small Cell Lung Cancer. Data were screened based on inclusion and exclusion criteria, data extracted and quality assessed for the included studies, then Meta-Analyzed using Revman 5.3 software. RESULTS: Twelve randomized controlled trials were included in the systematic review, with a total of 928 patients, all of whom were low-quality studies with a Jadad score ≤3. Meta-analysis showed that Shenqi Fuzheng injection combined with GP regimen significantly improved the efficiency (OR = 1.72, 95% CI 1.32, 2.25, P <0.0001) and improvement compared with GP alone in the treatment of non-small cell lung cancer The patients’ quality of life [OR = 3.35, 95% CI (2.50, 4.49), P <0.000 01], leukopenia [OR = 0.30, 95% CI (0.21, 0.42), P <0.000 01] and hemoglobin [OR = 0.37, 95% CI (0.22,0.62), P = 0.0002], and decreased the gastrointestinal reaction [OR = 0.47,95% CI (0.33,0.68), P <0.0001]. The difference was statistically significant. Conclusion: Shenqi Fuzheng injection combined with GP regimen in the treatment of non-small cell lung cancer can significantly improve the efficiency and quality of life of patients, reduce the side effects of chemotherapy. However, the current small sample clinical trials of randomized controlled methods and reports of low quality, but also the need for further high-quality, large sample strictly designed clinical trial validation.