Zhu Guanghui, Wang Xinmiao, Li Jie, Zhang Ying, Gao Ruike, Zhang Xiaoxiao, Xu Bowen, Hu Jiaqi, Dai Minghao, Chen Jiayang
Guanganmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
Graduate school, Beijing University of Chinese Medicine, Beijing, China.
Front Pharmacol. 2021 Nov 3;12:694129. doi: 10.3389/fphar.2021.694129. eCollection 2021.
Kanglaite injection (KLTI) is a traditional Chinese medicine (TCM) preparation with anti-tumor activity, which has been used to treat malignant tumors in China. The purpose of this study was to evaluate the efficacy and safety of intrapleural infusion with KLTI in the treatment of malignant pleural effusion (MPE). Randomized controlled trials (RCTs) on the efficacy and safety of intrathoracic infusion with KLTI in the treatment of MPE were searched from the PubMed, EMBASE, the Cochrane Library, CNKI, VIP, Wanfang and CBM databases. The primary outcome was objective remission rate (ORR). Secondary outcomes included quality of life (QOL) and incidence of adverse events (AEs). The Stata15.1 software and RevMan5.3 software were used to calculate risk ratios (RR) at 95% confidence intervals (CI) and conduct the meta-analysis. This meta-analysis included 20 RCTs, involving 1,291 patients. The ORR of intrapleural infusion with KLTI + chemotherapy drugs in the treatment of MPE was higher than that of chemotherapy alone (RR) 1.23; 95%CI; 1.11-1.36, = 0%, = 3.876, = 0.000]. When KLTI is combined with cisplatin or KLTI 200 ml is used in every time, it is more advantageous to improve ORR. Moreover, compared with intrapleural infusion of chemotherapy drugs alone, KLTI combined with chemotherapy drugs significantly improved the QOL of patients with MPE (RR 1.28; 95%CI; 1.70-1.53, = 0%, = 2.70, = 0.007). In addition, the participation of KLTI reduced the gastrointestinal reaction (RR 0.79; 95% CI; 0.66-0.96; = 0%, = 2.37, = 0.018) and renal damage (RR 0.468; 95% CI; 0.23-0.945, = 0%, = 2.11, = 0.035) caused by chemotherapy drugs, but did not increase other adverse reactions ( > 0.05). The efficacy and safety of traditional chemotherapy drugs plus KLTI was superior to traditional chemotherapy drugs alone via intrapleural injection in controlling MPE, which suggested that KLTI can be used to treat MPE. However, a more rigorous RCT should be designed and completed before it is widely recommended.
康莱特注射液（KLTI）是一种具有抗肿瘤活性的中药制剂，在中国已被用于治疗恶性肿瘤。本研究的目的是评估胸腔内注入KLTI治疗恶性胸腔积液（MPE）的疗效和安全性。从PubMed、EMBASE、Cochrane图书馆、中国知网、维普、万方和中国生物医学文献数据库中检索关于胸腔内注入KLTI治疗MPE的疗效和安全性的随机对照试验（RCT）。主要结局是客观缓解率（ORR）。次要结局包括生活质量（QOL）和不良事件（AE）的发生率。使用Stata15.1软件和RevMan5.3软件计算95%置信区间（CI）的风险比（RR）并进行荟萃分析。该荟萃分析纳入了20项RCT，涉及1291例患者。KLTI联合化疗药物胸腔内注入治疗MPE的ORR高于单纯化疗（RR 1.23；95%CI：1.11 - 1.36，(P = 0%)，(Z = 3.876)，(P = 0.000)）。当KLTI与顺铂联合或每次使用200 ml KLTI时，对提高ORR更有利。此外，与单纯胸腔内注入化疗药物相比，KLTI联合化疗药物显著改善了MPE患者的QOL（RR 1.28；95%CI：1.70 - 1.53，(P = 0%)，(Z = 2.70)，(P = 0.007)）。此外，KLTI的加入降低了化疗药物引起的胃肠道反应（RR 0.79；95%CI：0.66 - 0.96；(P = 0%)，(Z = 2.37)，(P = 0.018)）和肾损伤（RR 0.468；95%CI：0.23 - 0.945，(P = 0%)，(Z = 2.11)，(P = 0.035)），但未增加其他不良反应（(P>0.05)）。传统化疗药物加KLTI通过胸腔内注射在控制MPE方面的疗效和安全性优于单纯传统化疗药物，这表明KLTI可用于治疗MPE。然而，在广泛推荐之前应设计并完成更严格的RCT。
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