Hao Teng-teng, Xie Yan-ming, Liao Xing, Wang Jing
Zhongguo Zhong Yao Za Zhi. 2015 Oct;40(20):4094-107.
The paper is to systematically evaluate the effect and safety of Shenqi Fuzheng injection (SFI) combined with first-line chemotherapy for non-small cell lung cancer (NSCLC). Randomized controlled trials (RCTs) on Shenqi Fuzheng injection (SFI) combined with first-line chemotherapy (experiment group) and chemotherapy alone group ( control group) were electronically retrieved from Medline, EMbase, Clinical Trials, Cochrane Library, CBM, CNKI, VIP, and Wanfang Data base. All trials were assessed for quality according to the Cochrane Reviewer's Handbook for Systematic Reviews of Intervention and then Meta-analysis was performed withRevMan5. 2 Software. A total of 43 RCTs (3433 patients) were included after screening and selecting. Results of Meta-analysis showed that: Objective remission rate (ORR): ORR of experimental group was about 20% higher than that of control group [RR = 1.23, 95% CI (1.11,1.35), P < 0.0001]. Disease control rate (DCR):DCR of SFI combined with first-line chemotherapy was 11% higher than that of first-line chemotherapy alone [RR = 1.11, 95% CI (1.07, 1.16), P < 0.000 01]. Life quality evaluated by Kosovan performance status (KPS) showed that: life quality improvement rate of experimental group was about twice of that in control group [RR = 2.02, 95% CI (1.81, 2.26), P < 0.000 01]. Toxic and side reaction analysis showed that: the incidence of side reactions in experimental group was about 50% lower than that in control group [RR = 0.59, 95% CI (0.53, 0.66), P < 0.000 01]. Immune function test showed that: the function of experimental group was 3.2 (standard deviations) times greater than that of control group [MD = 3.23, 95% CI (2.86, 3.60), P < 0.000 01]. We can see that SFI combined with first-line chemotherapy for NSCLC can increase objective efficacy, improve life quality, decrease toxic and side reactionsinduced by chemotherapy, and improve the immune functions. As most of the included studies in this systematic evaluation had poor quality, the evidence to support conclusion was weak, so it was necessary to conduct more multi-center clinical trials with high quality methods and rigorous design.
本文旨在系统评价参芪扶正注射液(SFI)联合一线化疗治疗非小细胞肺癌(NSCLC)的疗效及安全性。通过电子检索Medline、EMbase、Clinical Trials、Cochrane Library、中国生物医学文献数据库(CBM)、中国知网(CNKI)、维普资讯(VIP)和万方数据库,获取参芪扶正注射液联合一线化疗(试验组)与单纯化疗组(对照组)的随机对照试验(RCT)。根据《Cochrane干预系统评价手册》对所有试验进行质量评估,然后使用RevMan5.2软件进行Meta分析。经过筛选和选择,共纳入43项RCT(3433例患者)。Meta分析结果显示:客观缓解率(ORR):试验组的ORR比对照组高约20%[相对危险度(RR)=1.23,95%置信区间(CI)(1.11,1.35),P<0.0001]。疾病控制率(DCR):参芪扶正注射液联合一线化疗的DCR比单纯一线化疗高11%[RR = 1.11,95%CI(1.07,1.16),P<0.00001]。采用卡氏功能状态评分(KPS)评估生活质量,结果显示:试验组生活质量改善率约为对照组的两倍[RR = 2.02,95%CI(1.81,2.26),P<0.00001]。毒副反应分析显示:试验组不良反应发生率比对照组低约50%[RR = 0.59,95%CI(0.53,0.66),P<0.00001]。免疫功能检测显示:试验组的功能比对照组高3.2(标准差)倍[均数差(MD)= 3.23,95%CI(2.86,3.60),P<0.00001]。可见,参芪扶正注射液联合一线化疗治疗NSCLC可提高客观疗效,改善生活质量,降低化疗所致的毒副反应,并提高免疫功能。由于本系统评价纳入的大多数研究质量较差,支持结论的证据较弱,因此有必要采用高质量方法和严谨设计开展更多的多中心临床试验。