Wang Shanshan, Lian Xiaobo, Sun Miaomiao, Luo Lei, Guo Lizhong
Department of Internal Medicine of Traditional Chinese Medicine, First Clinical Medical College, Nanjing University of Traditional Chinese Medicine, Nanjing 210000, China.
Famous Doctor's Studio of Zhongying Zhou, First Clinical Medical College, Nanjing University of Traditional Chinese Medicine, Nanjing 210000, China.
J Cancer Res Ther. 2016 Oct-Dec;12(4):1298-1306. doi: 10.4103/0973-1482.199538.
To evaluate the benefits of compound Kushen injection (CKI) combined with radiotherapy for nonsmall cell lung cancer.
We searched nine electronic databases and six gray literature databases comprehensively until June 2015. Two reviewers independently selected and assessed the included trials according to the inclusion and exclusion criteria. The risk of bias tool from the Cochrane Handbook version 5.1.0, the Review Manager 5.3 software was employed for data analysis. Funnel plot and Egger's test were applied to evaluate the publication bias.
Thirteen studies including 1558 participants met the inclusion criteria, most of which were low quality. Compared with radiotherapy alone, CKI plus the same radiotherapy significantly improved the effective rate (odds ratio [OR] =1.92, 95% confidence interval [95% CI]: [1.42, 2.60] P < 0.0001) and quality of life (OR = 4.61, 95% CI: [3.28, 6.48], P < 0.00001). There was a significant decrement in the incidences of acute radiation pneumonia (OR = 0.48, 95% CI: [0.37, 0.61], P < 0.00001), radiation pneumonia 3 months after radiotherapy (OR = 0.29, 95% CI: [0.20, 0.41], P < 0.00001), radiation pneumonia 6 months after radiotherapy (OR = 0.24, 95% CI: [0.08, 0.69], P < 0.009), radiation esophagitis (OR = 0.29, 95% CI: [0.19, 0.45], P < 0.00001), and bone marrow suppression (OR = 0.35, 95% CI: [0.24, 0.51], P < 0.00001).
CKI combined with radiotherapy significantly improved the clinical effect and reduced the incidence of adverse events. Use of the CONSORT statement for randomized controlled trials is recommended for rigorous reporting.
评估复方苦参注射液(CKI)联合放疗治疗非小细胞肺癌的疗效。
全面检索9个电子数据库和6个灰色文献数据库至2015年6月。两名研究者根据纳入和排除标准独立选择并评估纳入的试验。采用Cochrane手册5.1.0版的偏倚风险工具,使用Review Manager 5.3软件进行数据分析。采用漏斗图和Egger检验评估发表偏倚。
13项研究共1558名参与者符合纳入标准,其中大多数研究质量较低。与单纯放疗相比,CKI联合相同放疗显著提高了有效率(比值比[OR]=1.92,95%置信区间[95%CI]:[1.42,2.60],P<0.0001)和生活质量(OR=4.61,95%CI:[3.28,6.48],P<0.00001)。急性放射性肺炎(OR=0.48,95%CI:[0.37,0.61],P<0.00001)、放疗后3个月放射性肺炎(OR=0.29,95%CI:[0.20,0.41],P<0.00001)、放疗后6个月放射性肺炎(OR=0.24,95%CI:[0.08,0.69],P<0.009)、放射性食管炎(OR=0.29,95%CI:[0.19,0.45],P<0.00001)和骨髓抑制(OR=0.35,95%CI:[0.24,0.51],P<0.00001)的发生率均显著降低。
CKI联合放疗显著提高了临床疗效,降低了不良事件的发生率。建议使用CONSORT声明对随机对照试验进行严格报告。