State Key Laboratory of Quality Research in Chinese Medicines, Macau University of Science and Technology, Macau, PR China; Faculty of Chinese Medicine, Macau University of Science and Technology, Macau, PR China.
School of Medicine and Life Science, Nanjing University of Chinese Medicine, Nanjing, PR China.
J Ethnopharmacol. 2018 Jul 15;221:137-150. doi: 10.1016/j.jep.2018.04.013. Epub 2018 Apr 12.
Aidi injection is one of the most commonly used Chinese patent medicines for advanced non-small cell lung cancer (NSCLC). It is made from an extraction of Mylabris Phalerata, Radix Astragalus, Radix Ginseng, and Acanthopanax Senticosus.
The objective of this study is to evaluate the efficacy and safety of Aidi injection in combination with platinum-based chemotherapy for stage IIIB/IV NSCLC.
A systematic review and meta-analysis were performed following the PRISMA (the Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Trials were combined using Review Manager 5.3 and Comprehensive Meta-Analysis(CMA) 2.0. Dichotomous data were expressed as risk ratio (RR) and continuous outcomes as weighted mean difference (WMD), with their 95% confidence intervals (CI) respectively. All randomized controlled trials (RCTs) comparing Aidi injection plus platinum-based chemotherapy versus platinum-based chemotherapy, with efficacy and safety outcomes were selected. Disease Control Rate (DCR) was the primary outcome, Objective Response Rate (ORR), survival rate, quality of life (QOL), and toxic effects were the secondary outcomes.
42 RCTs recruiting 4081 patients with stage IIIB/IV NSCLC were included, with overall low-moderate methodological quality. Compared with platinum-based chemotherapy alone, Aidi injection plus platinum-based chemotherapy can increase relative benefit of DCR (RR = 1.13, 95% CI 1.09-1.16, P < 0.00001), ORR (RR = 1.26, 95% CI 1.18-1.36, P < 0.00001), improve 1-, 2-, 3-year survival rates (RR = 1.14, 95% CI 1.02-1.28, P = 0.03; RR = 1.31, 95% CI 1.05-1.64, P = 0.02; and RR = 1.88, 95% CI 1.32-2.67, P = 0.0005, respectively), QOL (RR = 1.80, 95% CI 1.61-2.01, P < 0.00001), and reduce severe (grade 3 and 4) toxicities by 36% (RR = 0.64, 95% CI 0.58-0.70, P < 0.00001).
From the available evidence, compared with platinum-based chemotherapy alone, Aidi injection plus platinum-based chemotherapy improves the clinical efficacy and alleviates the toxicity of chemotherapy in patients with stage IIIB/IV NSCLC. However, considering the intrinsic limitations of the included RCTs, well-designed, rigorously performed, high-quality trials are still required to further assess and confirm the results.
艾迪注射液是一种常用于治疗晚期非小细胞肺癌（NSCLC）的中药制剂，主要成分包括斑蝥、黄芪、人参和刺五加。
本研究旨在评估艾迪注射液联合铂类化疗方案治疗 IIIB/IV 期 NSCLC 的疗效和安全性。
按照 PRISMA 指南进行系统评价和荟萃分析。使用 Review Manager 5.3 和 Comprehensive Meta-Analysis(CMA) 2.0 对试验数据进行合并。二分类数据表示为风险比（RR），连续数据表示为加权均数差（WMD），置信区间（CI）均为 95%。所有比较艾迪注射液联合铂类化疗与单纯铂类化疗的随机对照试验（RCT），均纳入疗效和安全性结局。疾病控制率（DCR）为主要结局，客观缓解率（ORR）、生存率、生活质量（QOL）和毒性反应为次要结局。
共纳入 42 项 RCT，涉及 4081 例 IIIB/IV 期 NSCLC 患者，整体方法学质量为中低水平。与单纯铂类化疗相比，艾迪注射液联合铂类化疗可提高 DCR（RR=1.13，95%CI 1.09-1.16，P<0.00001）、ORR（RR=1.26，95%CI 1.18-1.36，P<0.00001），改善 1、2、3 年生存率（RR=1.14，95%CI 1.02-1.28，P=0.03；RR=1.31，95%CI 1.05-1.64，P=0.02；RR=1.88，95%CI 1.32-2.67，P=0.0005），QOL（RR=1.80，95%CI 1.61-2.01，P<0.00001），降低严重（3 级和 4 级）毒性反应发生率 36%（RR=0.64，95%CI 0.58-0.70，P<0.00001）。
现有证据表明，与单纯铂类化疗相比，艾迪注射液联合铂类化疗可提高晚期 NSCLC 患者的临床疗效，减轻化疗毒性。但鉴于纳入 RCT 的固有局限性，仍需要设计严谨、高质量的临床试验进一步评估和验证这些结果。
