State Key Laboratory of Quality Research in Chinese Medicines, Macau University of Science and Technology, Macau, PR China.
State Key Laboratory of Quality Research in Chinese Medicines, Macau University of Science and Technology, Macau, PR China.
Phytomedicine. 2020 Feb;67:153154. doi: 10.1016/j.phymed.2019.153154. Epub 2019 Dec 19.
Kanglaite injection (KLT) is a broad-spectrum anti-tumor drug, which is extracted from the seeds of the Chinese medicinal herb Coix lacryma-jobi, and has been widely used for the treatment of advanced lung cancer.
To evaluate the combined effects of Kanglaite injection plus platinum-based chemotherapy (PBC) on patients with stage III/IV non-small cell lung cancer (NSCLC).
A systematic review and meta-analysis of randomized clinical trials (RCTs).
Twelve databases were searched from their inceptions until July 05, 2019. All the RCTs comparing the efficacy and safety of Kanglaite injection plus PBC versus PBC alone were selected. Analyses were performed using Review Manager 5.3, Comprehensive Meta-Analysis 3.0 and Trial Sequential Analysis (TSA). Disease control rate (DCR) was defined as the primary endpoint, objective response rate (ORR), survival rate, quality of life (QOL), cellular immunity function, and toxicities were defined as the secondary endpoints.
Twenty-seven RCTs recruiting 2,243 patients with stage III/IV NSCLC were included. The results showed that, compared with PBC alone, Kanglaite injection plus PBC improved DCR (RR = 1.20, 95% CI 1.15-1.26, p < 0.00001), ORR (RR = 1.45, 95% CI 1.31-1.60, p < 0.00001), 1-year survival rate (RR = 1.20, 95% CI 1.02-1.43, p = 0.03), QOL (RR = 1.32, 95% CI 1.25-1.40, p < 0.00001), CD4T cells (WMD = 4.86, 95% CI 4.00-5.73, p < 0.00001), CD4/CD8 ratio (WMD = 0.19, 95% CI 0.07-0.31, p < 0.002), and reduced severe toxicities by 59% (RR = 0.41, 95% CI 0.33-0.51, p < 0.00001). Most results were robust and the quality of evidence was from moderate to low.
Kanglaite injection in combination with PBC showed significantly higher efficacy than PBC alone in the treatment of stage III/IV NSCLC. Moreover, the combination therapy can improve cellular immunity and attenuate the severe toxicities caused by chemotherapy. However, high-quality RCTs are warranted to further assess the effects of the combined therapy.
康莱特注射液（KLT）是一种广谱抗肿瘤药物，从中药薏苡仁种子中提取，广泛用于治疗晚期肺癌。
评估康莱特注射液联合铂类化疗（PBC）对 III/IV 期非小细胞肺癌（NSCLC）患者的疗效。
系统评价和荟萃分析的随机临床试验（RCT）。
从各数据库建库至 2019 年 7 月 5 日检索 12 个数据库，纳入比较康莱特注射液联合 PBC 与 PBC 单独治疗 III/IV 期 NSCLC 的疗效和安全性的 RCT。采用 Review Manager 5.3、Comprehensive Meta-Analysis 3.0 和试验序贯分析（TSA）进行分析。疾病控制率（DCR）定义为主要终点，客观缓解率（ORR）、生存率、生活质量（QOL）、细胞免疫功能和毒性定义为次要终点。
共纳入 27 项 RCT，纳入 2243 例 III/IV 期 NSCLC 患者。结果显示，与 PBC 单独治疗相比，康莱特注射液联合 PBC 可提高 DCR（RR=1.20，95%CI 1.15-1.26，p<0.00001）、ORR（RR=1.45，95%CI 1.31-1.60，p<0.00001）、1 年生存率（RR=1.20，95%CI 1.02-1.43，p=0.03）、QOL（RR=1.32，95%CI 1.25-1.40，p<0.00001）、CD4T 细胞（WMD=4.86，95%CI 4.00-5.73，p<0.00001）、CD4/CD8 比值（WMD=0.19，95%CI 0.07-0.31，p<0.002），并降低严重毒性的发生率 59%（RR=0.41，95%CI 0.33-0.51，p<0.00001）。大多数结果稳健，证据质量从中等到低。
康莱特注射液联合 PBC 治疗 III/IV 期 NSCLC 比 PBC 单独治疗疗效显著更高，且联合治疗可改善细胞免疫功能，减轻化疗引起的严重毒性。然而，仍需要高质量的 RCT 来进一步评估联合治疗的效果。
