Department of Respiratory Medicine, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, 210029, People's Republic of China.
Department of Respiratory Medicine, Jiangsu Province Hospital of Chinese Medicine, 155 Hanzhong Road, Nanjing, 210029, People's Republic of China.
BMC Complement Med Ther. 2020 Jan 13;20(1):3. doi: 10.1186/s12906-019-2795-y.
Xiao-ai-ping injection (XAPI), as patented Chinese medicine, has shown promising outcomes in non-small-cell lung cancer (NSCLC) patients. This meta-analysis investigated the efficacy and safety of XAPI in combination with platinum-based chemotherapy.
A comprehensive literature search was conducted to identify relevant studies in Pubmed, EMBASE, the Cochrane Library, Chinese National Knowledge Infrastructure, Wangfang Database, VIP Database, and Chinese Biology Medical Database from the date of their inception to September 2018. The RevMan 5.3 software was applied to calculate the risk ratio (RR) and mean difference (MD) with 95% confidence interval (CI).
We included and analyzed 24 randomized controlled trials. The meta-analysis showed that XAPI adjunctive to platinum-based chemotherapy had better outcomes in objective tumor response rate (ORR) (RR: 1.27, 95% CI, 1.14-1.40); improved Karnofsky performance scores (KPS) (RR: 1.70, 95% CI, 1.48-1.95); reduction in occurrence of grade 3/4 leukopenia (RR: 0.49, 95% CI, 0.38-0.64), anemia (RR: 0.63, 95% CI, 0.46-0.87) and thrombocytopenia (RR: 0.53, 95% CI, 0.38-0.73), nausea and vomiting (RR: 0.57, 95% CI, 0.36-0.90); and enhanced immune function (CD8 [MD: 4.96, 95% CI, 1.16-8.76] and CD4/CD8 [MD: 2.58, 95% CI, 1.69-3.47]). However, it did not increase dysregulated liver and kidney function, diarrhea, constipation, and fatigue. Subgroup analysis of ORR and KPS revealed that dosage, treatment duration, and methodological quality did not affect the outcome significantly.
Our meta-analyses demonstrated that XAPI in combination with platinum-based chemotherapy had a better tumor response, improved the quality of life, attenuated adverse side effects, and enhanced immune function, which suggests that it might be used for advanced NSCLC. Moreover, low dosage (< 60 ml/d) and long-term treatment of XAPI might be a choice for advanced NSCLC patients.
消癌平注射液（XAPI）作为专利中药，在非小细胞肺癌（NSCLC）患者中显示出良好的疗效。本荟萃分析研究了 XAPI 联合铂类化疗的疗效和安全性。
通过检索 Pubmed、EMBASE、Cochrane 图书馆、中国知网、万方数据库、维普数据库和中国生物医学文献数据库，从建库起至 2018 年 9 月，收集有关 XAPI 联合铂类化疗治疗 NSCLC 的随机对照试验（RCT）。采用 RevMan 5.3 软件进行荟萃分析，计算风险比（RR）和均数差（MD）及其 95%置信区间（CI）。
共纳入 24 项 RCT，荟萃分析结果显示，XAPI 联合铂类化疗可提高客观缓解率（ORR）（RR：1.27，95%CI，1.14-1.40）；提高卡氏功能状态评分（KPS）（RR：1.70，95%CI，1.48-1.95）；降低 III/IV 级白细胞减少（RR：0.49，95%CI，0.38-0.64）、贫血（RR：0.63，95%CI，0.46-0.87）和血小板减少（RR：0.53，95%CI，0.38-0.73）的发生率；降低恶心呕吐（RR：0.57，95%CI，0.36-0.90）的发生率；增强免疫功能（CD8 [MD：4.96，95%CI，1.16-8.76]和 CD4/CD8 [MD：2.58，95%CI，1.69-3.47]）。但不增加肝肾功能异常、腹泻、便秘和乏力的发生率。亚组分析结果显示，ORR 和 KPS 亚组中，XAPI 的剂量、用药时间和方法学质量对结果无显著影响。
XAPI 联合铂类化疗可提高 NSCLC 患者的肿瘤缓解率，改善生活质量，减轻不良反应，增强免疫功能，可能对晚期 NSCLC 有一定的治疗作用。此外，低剂量（<60ml/d）和长疗程的 XAPI 可能是晚期 NSCLC 患者的选择。
