Department of General Medicine, Affiliated Hospital of Zunyi Medical University, Guizhou, China; Evidence-Based Medicine Center, MOE Virtual Research Center of Evidence-based Medicine at Zunyi Medical University, Affiliated Hospital of Zunyi Medical University, Guizhou, China; School of Management, Zunyi Medical University, Guizhou, China.
Department of General Medicine, Affiliated Hospital of Zunyi Medical University, Guizhou, China; School of Management, Zunyi Medical University, Guizhou, China.
Clin Ther. 2020 Mar;42(3):515-543.e31. doi: 10.1016/j.clinthera.2020.01.011. Epub 2020 Feb 19.
Chemotherapy-induced hepatorenal toxicity often decreases tolerance for further therapies and results in poor quality of life and prognosis for patients with lung cancer. In this meta-analysis, all related studies were systematically re-evaluated to determine whether Aidi injection relieves hepatorenal toxicity and improves tumor response, and to determine its threshold and the optimal treatment regimen for obtaining the desired responses.
All studies regarding Aidi injection with chemotherapy were gathered from Chinese and English databases (from inception until January 2019). Their bias risk was evaluated and the data were synthesized using meta-analysis; the quality of evidence of all outcomes was rated by using the Grades of Recommendation Assessment, Development, and Evaluation approach.
Eighty randomized controlled trials containing 6279 patients were included in the study. Most of the trials showed unclear risk of bias. Aidi injection with chemotherapy increased the objective response rate (risk ratio [RR], 1.32; 95% CI, 1.25-1.40) and the disease control rate (RR, 1.15; 95% CI, 1.12-1.17) and resulted in a lower incidence of hepatotoxicity (RR, 0.61; 95% CI, 0.55-0.69) and nephrotoxicity (RR, 0.62; 95% CI, 0.53-0.72) than that of chemotherapy alone. Subgroup analyses showed that treatment with 50 mL per time, 10 to 14 days per cycle, and 2 to 3 cycles of Aidi injection with chemotherapy resulted in a low incidence of hepatorenal toxicity. All of the results were robust, and their quality was moderate.
The moderate evidence indicates that Aidi injection with chemotherapy may improve tumor response and result in a low incidence of hepatorenal toxicity in patients with lung cancer. Aidi injection may relieve hepatorenal toxicity and exhibit an important protective effect against chemotherapy-induced hepatorenal toxicity. Based on the subgroup analysis results, Aidi injection seems to lower the threshold for chemotherapy. Treatment with 50 mL per time, 10 to 14 days per cycle, and 2 to 3 cycles may be the optimal usage for attaining a decrease in hepatorenal toxicity.
化疗引起的肝肾功能毒性常降低患者对进一步治疗的耐受性,导致肺癌患者生活质量下降和预后不良。本研究通过系统评价所有相关研究,旨在明确艾迪注射液是否能减轻肝肾功能毒性、提高肿瘤缓解率,并确定其减轻肝肾功能毒性的阈值及最佳治疗方案。
检索中国和英文数据库(建库至 2019 年 1 月)中有关艾迪注射液联合化疗的研究,评估偏倚风险后采用 Meta 分析进行数据合成,并采用推荐意见的评估、制定与评价(Grades of Recommendation Assessment,Development,and Evaluation,GRADE)方法对所有结局的证据质量进行评价。
共纳入 80 项随机对照试验,包含 6279 例患者。多数研究存在偏倚风险不确定。与单纯化疗相比,艾迪注射液联合化疗可提高客观缓解率(RR=1.32,95%CI:1.251.40)和疾病控制率(RR=1.15,95%CI:1.121.17),降低肝毒性(RR=0.61,95%CI:0.550.69)和肾毒性(RR=0.62,95%CI:0.530.72)的发生率。亚组分析显示,每次 50 ml、每周期 1014 d、23 个周期的艾迪注射液联合化疗方案肝肾功能毒性发生率较低。结果均稳健,证据质量为中级。
中等质量证据表明,艾迪注射液联合化疗可能提高肺癌患者的肿瘤缓解率,降低肝肾功能毒性发生率。艾迪注射液可能缓解肝肾功能毒性,对化疗引起的肝肾功能毒性具有重要的保护作用。基于亚组分析结果,艾迪注射液似乎降低了化疗的门槛。每次 50 ml、每周期 1014 d、23 个周期的方案可能是降低肝肾功能毒性的最佳选择。