Institute of Basic Medical Science, Nanjing University of Traditional Chinese Medicine, Nanjing, P.R. China.
J Exp Clin Cancer Res. 2010 Oct 22;29(1):137. doi: 10.1186/1756-9966-29-137.
Platinum-based chemotherapy has been a standard therapy for advanced non-small cell lung cancer (NSCLC), but it has high toxicity. In China, Shenqi Fuzheng, a newly developed injection concocted from Chinese medicinal herbs has been reported that may increase efficacy and reduce toxicity when combined with platinum-based chemotherapy, but little is known about it outside of China. The aim of this study was to systematically review the existing clinical evidence on Shenqi Fuzheng Injection(SFI) combined with platinum-based chemotherapy for advanced NSCLC.
Pubmed, Cochrane Library, EMBASE, CNKI, and CBM search were organized for all documents published, in English and Chinese, until April 2010. The randomized controlled clinical trials were selected based on specific criteria, in which a SFI plus platinum-based chemotherapy treatment group was compared with a platinum-based chemotherapy control group for patients with advanced NSCLC. The quality of studies was assessed by modified Jadad's scale, and Revman 4.2 software was used for data syntheses and analyses.
Twenty nine studies were included in this review based on our selection criteria. Of them, ten studies were of high quality and the rest were of low quality, according to the modified Jadad scale. The meta-analysis showed there was a statistically significant higher tumor response (RR, 1.19; 95% CI, 1.07 to 1.32; P = 0.001) and performance status ((RR, 1.57; 95% CI, 1.45 to 1.70; P < 0.00001); but lower severe toxicity for WBC (RR, 0.37; 95% CI, 0.29 to 0.47; P < 0.00001), PLT (RR, 0.33; 95% CI, 0.21 to 0.52; P < 0.00001), HB (RR, 0.44; 95% CI, 0.30 to 0.66; P < 0.0001) and nausea and vomiting (RR, 0.32; 95% CI, 0.22 to 0.47; P < 0.00001), when the SFI plus platinum-based chemotherapy treatment group was compared with the platinum-based chemotherapy control group. Sensitivity analysis was restricted to studies with the high quality, and the result was similar when the studies with low quality were excluded. Asymmetry was observed in a funnel plot analysis, and Egger's test also indicated an evidence of publication bias (P = 0.016).
SFI intervention appears to be useful to increase efficacy and reduce toxicity when combined with platinum-based chemotherapy for advanced NSCLC, although this result needs to be further verified by more high-quality trials.
铂类化疗一直是晚期非小细胞肺癌（NSCLC）的标准治疗方法，但它具有很高的毒性。在中国，一种新开发的注射剂参芪扶正注射液（Shenqi Fuzheng Injection，SFI），由中草药制成，据报道与铂类化疗联合使用可能会提高疗效，降低毒性，但在国外知之甚少。本研究旨在系统评价 SFI 联合铂类化疗治疗晚期 NSCLC 的现有临床证据。
检索 Pubmed、Cochrane 图书馆、EMBASE、CNKI 和 CBM 数据库，检索截至 2010 年 4 月发表的所有英文和中文文献。根据具体标准选择随机对照临床试验，其中 SFI 联合铂类化疗治疗组与铂类化疗对照组比较晚期 NSCLC 患者。使用改良 Jadad 量表评估研究质量，并使用 Revman 4.2 软件进行数据综合分析。
根据我们的选择标准，本综述共纳入 29 项研究。其中，根据改良 Jadad 量表，10 项研究质量较高，其余研究质量较低。荟萃分析显示，肿瘤反应（RR，1.19；95%CI，1.07 至 1.32；P=0.001）和表现状态（RR，1.57；95%CI，1.45 至 1.70；P<0.00001）均有统计学意义更高;但白细胞（RR，0.37；95%CI，0.29 至 0.47；P<0.00001）、血小板（RR，0.33；95%CI，0.21 至 0.52；P<0.00001）、血红蛋白（RR，0.44；95%CI，0.30 至 0.66；P<0.0001）和恶心呕吐（RR，0.32；95%CI，0.22 至 0.47；P<0.00001）的严重毒性较低当 SFI 联合铂类化疗治疗组与铂类化疗对照组相比。敏感性分析仅限于高质量研究，当排除低质量研究时，结果相似。漏斗图分析显示存在不对称性，Egger 检验也表明存在发表偏倚的证据（P=0.016）。
SFI 干预似乎有助于提高疗效，降低毒性，与铂类化疗联合用于晚期 NSCLC，尽管这一结果需要更多高质量的试验进一步证实。
