康艾注射液联合铂类双联化疗治疗晚期 NSCLC 的疗效与安全性：一项荟萃分析。
Therapeutic efficacy and safety of Kang-ai injection combined with platinum-based doublet chemotherapy in advanced NSCLC: A meta-analysis.
机构信息
Key Laboratory of Chinese Medicinal Resource from Lingnan, Ministry of Education, Research Center of Chinese Herbal Resource Science and Engineering, Guangzhou University of Chinese Medicine, Guangzhou 510006, PR China; Joint Laboratory of National Engineering Research Center for the Pharmaceutics of Traditional Chinese Medicines, Guangzhou University of Chinese Medicine, Guangzhou 510006, PR China.
Guangdong Provincial Key Laboratory of New Drug Development and Research of Chinese Medicine, Mathematical Engineering Academy of Chinese Medicine, Guangzhou University of Chinese Medicine, Guangzhou 510006, PR China.
出版信息
Life Sci. 2018 Oct 1;210:9-19. doi: 10.1016/j.lfs.2018.08.055. Epub 2018 Aug 24.
AIMS
Kang-ai injection (KA) is a famous Chinese patent medicine authorized by China Food and Drug Administration, which is widely used to treat advanced non-small cell lung cancer (NSCLC) in China. This meta-analysis is aimed to evaluate the therapeutic efficacy and safety of KA on advanced NSCLC.
METHODS
Seven databases were examined for related studies until January 15, 2018. Odds ratio (OR) was used to evaluate tumor response, Karnofsky Performance Scale (KPS) improvement and adverse reactions, and mean difference (MD) was used to estimate immune functions.
KEY FINDINGS
Thirty randomized controlled trials involving 1956 patients with advanced NSCLC were included. The results showed that compared with the platinum-based doublet chemotherapy (PBDC) alone, KA combined with PBDC could significantly enhance tumor response (OR = 1.69, 95% CI [1.40, 2.04], P < 0.00001), KPS improvement (OR = 3.01, 95% CI [2.36, 3.84], P < 0.00001) and immune functions including the percentages of CD (MD = 8.90, 95% CI [3.06, 14.73], P = 0.003), CD (MD = 9.43, 95% CI [6.32, 12.53], P < 0.00001) and NK (MD = 4.81, 95% CI [1.95, 7.68], P = 0.001) and the ratio of CD/CD (MD = 0.29, 95% CI [0.04, 0.53], P = 0.02). Moreover, KA combined with PBDC markedly decreased the incidences of adverse reactions including gastrointestinal reaction (OR = 0.38, 95% CI [0.30, 0.47], P < 0.00001), myelosuppression (OR = 0.32, 95% CI [0.23, 0.45], P < 0.00001) and hair loss (OR = 0.53, 95% CI [0.36, 0.76], P < 0.00001). However, there was no significant difference between the combination treatment group and the control group in the percentage of CD (MD = -2.93, 95% CI [-6.68, 0.82], P = 0.13).
SIGNIFICANCE
Despite the small sample size and study limitations, the results of this meta-analysis indicated that the combination therapy of KA and PBDC (especially NP regimen) might be a beneficial therapeutic method for advanced NSCLC patients.
目的
康艾注射液（KA）是中国食品药品监督管理局批准的一种著名的中药制剂，在中国被广泛用于治疗晚期非小细胞肺癌（NSCLC）。本荟萃分析旨在评估 KA 对晚期 NSCLC 的治疗效果和安全性。
方法
截至 2018 年 1 月 15 日，检索了 7 个数据库，以查找相关研究。采用比值比（OR）评估肿瘤反应、卡氏功能状态评分（KPS）改善和不良反应，采用均数差（MD）估计免疫功能。
主要发现
共纳入 30 项随机对照试验，涉及 1956 例晚期 NSCLC 患者。结果表明，与铂类双联化疗（PBDC）单独治疗相比，KA 联合 PBDC 可显著提高肿瘤反应（OR=1.69，95%CI[1.40, 2.04]，P<0.00001）、KPS 改善（OR=3.01，95%CI[2.36, 3.84]，P<0.00001）和免疫功能，包括 CD（MD=8.90，95%CI[3.06, 14.73]，P=0.003）、CD（MD=9.43，95%CI[6.32, 12.53]，P<0.00001）和 NK（MD=4.81，95%CI[1.95, 7.68]，P=0.001）的百分比以及 CD/CD（MD=0.29，95%CI[0.04, 0.53]，P=0.02）比值。此外，KA 联合 PBDC 可显著降低不良反应的发生率，包括胃肠道反应（OR=0.38，95%CI[0.30, 0.47]，P<0.00001）、骨髓抑制（OR=0.32，95%CI[0.23, 0.45]，P<0.00001）和脱发（OR=0.53，95%CI[0.36, 0.76]，P<0.00001）。然而，联合治疗组和对照组在 CD 百分比方面无显著差异（MD=-2.93，95%CI[-6.68, 0.82]，P=0.13）。
意义
尽管样本量较小且存在研究局限性，但本荟萃分析的结果表明，KA 联合 PBDC（尤其是 NP 方案）治疗晚期 NSCLC 患者可能是一种有益的治疗方法。
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