Department of Pharmacy, The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning, Guangxi, China.
Pharm Biol. 2021 Dec;59(1):1260-1275. doi: 10.1080/13880209.2021.1973038.
Aidi injection is one of the most commonly use antitumor Chinese medicine injections for advanced non-small cell lung cancer (NSCLC). It is made from the extraction of , and
To evaluate the efficacy and safety of Aidi injection in combination with gemcitabine-based chemotherapy (GBC) for advanced NSCLC.
PubMed, Embase, Cochrane Library, Chinese Biological Medicine, China National Knowledge Infrastructure, Wanfang, and VIP were searched for relevant randomised controlled trials (RCTs) comparing Aidi injection plus GBC treatment with GBC alone in NSCLC, from inception up to October 2020. The primary outcomes were objective response rate (ORR), and disease control rate (DCR). Secondary outcomes were quality of life (QOL) and adverse drug reactions (ADRs). The quality of evidence was rated using the GRADE approach. This study was registered with PROSPERO: CRD42021221225.
In total, 54 RCTs involving 4318 NSCLC patients were included in this meta-analysis. Compared with GBC alone, Aidi injection plus GBC significantly improve ORR (risk ratios [RR] = 1.38, 95% confidence interval [CI] 1.29-1.48), DCR (RR = 1.15, 95% CI 1.12-1.19), QOL (RR = 1.71, 95% CI 1.54-1.89), and reduced the risk of gastrointestinal toxicity, thrombocytopenia, neutropenia, liver injury, renal injury, and anaemia. The evaluation results of the evidence ranged from moderate to low.
Current moderate evidence revealed that Aidi injection as an adjunctive treatment to GBC was associated with superior benefits in patients with advanced NSCLC and alleviate toxicities. High-quality RCTs are needed to further confirm the results.
艾迪注射液是晚期非小细胞肺癌(NSCLC)最常用的抗肿瘤中药注射液之一。它是从 和 的提取物制成的。
评估艾迪注射液联合吉西他滨为基础的化疗(GBC)治疗晚期 NSCLC 的疗效和安全性。
检索了 PubMed、Embase、Cochrane 图书馆、中国生物医学文献数据库、中国国家知识基础设施、万方和 VIP,以获取比较艾迪注射液联合 GBC 治疗与单独 GBC 治疗 NSCLC 的相关随机对照试验(RCTs),检索时间截至 2020 年 10 月。主要结局指标是客观缓解率(ORR)和疾病控制率(DCR)。次要结局指标是生活质量(QOL)和不良反应(ADRs)。使用 GRADE 方法评价证据质量。本研究已在 PROSPERO 注册:CRD42021221225。
共纳入 54 项 RCT,涉及 4318 例 NSCLC 患者。与单独 GBC 相比,艾迪注射液联合 GBC 可显著提高 ORR(风险比 [RR] = 1.38,95%置信区间 [CI] 1.29-1.48)、DCR(RR = 1.15,95% CI 1.12-1.19)、QOL(RR = 1.71,95% CI 1.54-1.89),并降低胃肠道毒性、血小板减少症、中性粒细胞减少症、肝损伤、肾损伤和贫血的风险。证据评估结果为中等到低。
目前的中等证据表明,艾迪注射液作为 GBC 的辅助治疗,与晚期 NSCLC 患者的优势相关,并减轻毒性。需要高质量的 RCT 进一步证实这些结果。