Huang Jingyi, Wang Zhichao, Xue Han, Cao Ailing, Turner Cassidy, Wang Jing, Zhang Li, Wang Jinghai, Xiao Na, Xu Jie, Zhou Xianmei, He Hailang
Department of Respiratory Medicine, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.
Department of Respiratory Medicine, Jiangsu Province Hospital of Chinese Medicine, Nanjing, China.
Front Pharmacol. 2020 Sep 8;11:476165. doi: 10.3389/fphar.2020.476165. eCollection 2020.
Platinum-based chemotherapy is one of the first line therapies for the advanced non-small cell lung cancer (NSCLC), even though its high toxicity and limited clinical effects cannot be neglected. Huisheng oral solution (HSOS) has been widely used as an adjuvant chemotherapy drug for NSCLC in China. To systematically analyze the therapeutic effects of the combination of HSOS and platinum-based chemotherapy, a comprehensive meta-analysis was performed.
This systematic review and meta-analysis aimed to evaluate the effectiveness and safety of HSOS for NSCLC.
The randomized controlled trials (RCTs) were selected on seven medical databases up to June 2020, including advanced NSCLC treatment using HSOS plus platinum-based chemotherapy versus chemotherapy alone. We followed the PRISMA checklist in general, applying Cochrane handbook 5.1.0, GRADE Pro GDT, RevMan 5.3, Stata12.0, and TSA 0.9.5.10 Beta to evaluate the quality of the study and analyze the data.
Based on Cochrane handbook 5.1.0, 15 RCTs consisting 1165 patients met the criteria and were selected for further analysis. Compared to chemotherapy alone, the chemotherapy combined with HSOS significantly improved objective tumor response (ORR) [RR = 1.38, 95% CI (1.19, 1.59), < 0.0001], disease control rate (DCR) [RR = 1.10, 95% CI (1.04, 1.16), = 0.0006], and Karnofsky performance status (KPS) [RR = 1.79, 95% CI (1.41, 2.26), < 0.00001]. However, there was no evidence of improvement in the 1-year survival rate [RR = 1.37, 95% CI (0.98, 1.92), = 0.07]. In terms of the side effects, HSOS administered concurrently with chemotherapy resulted in a serial of substantial benefits: lower toxicity to white blood cell [RR = 0.30, 95% CI (0.20, 0.43), < 0.00001], lower platelet toxicity [RR = 0.56, 95% CI (0.34, 0.92), = 0.02], and reduced incidence of vomiting [RR = 0.52, 95% CI (0.29, 0.92), = 0.03].
The meta-analysis indicated that HSOS plus platinum-based chemotherapy was more beneficial for patients, as the therapy could synergize antitumor activity and could attenuate toxicity. The finding requires confirmation by further rigorously designed RCTs.
铂类化疗是晚期非小细胞肺癌（NSCLC）的一线治疗方法之一，尽管其高毒性和有限的临床效果不容忽视。慧生口服液（HSOS）在中国已被广泛用作NSCLC的辅助化疗药物。为了系统分析HSOS与铂类化疗联合应用的治疗效果，进行了一项综合荟萃分析。
本系统评价和荟萃分析旨在评估HSOS治疗NSCLC的有效性和安全性。
截至2020年6月，在七个医学数据库中选取随机对照试验（RCT），包括使用HSOS联合铂类化疗与单纯化疗治疗晚期NSCLC。我们总体遵循PRISMA清单，并应用Cochrane手册5.1.0、GRADE Pro GDT、RevMan 5.3、Stata12.0和TSA 0.9.5.10 Beta来评估研究质量并分析数据。
根据Cochrane手册5.1.0，15项包含1165例患者的RCT符合标准并被选作进一步分析。与单纯化疗相比，化疗联合HSOS显著提高了客观肿瘤缓解率（ORR）[RR = 1.38，95%CI（1.19，1.59），P < 0.0001]、疾病控制率（DCR）[RR = 1.10，95%CI（1.04，1.16），P = 0.0006]以及卡氏功能状态评分（KPS）[RR = 1.79，95%CI（1.41，2.26），P < 0.00001]。然而，没有证据表明1年生存率有所提高[RR = 1.37，95%CI（0.98，1.92），P = 0.07]。在副作用方面，HSOS与化疗同时使用带来了一系列显著益处：对白细胞的毒性更低[RR = 0.30，95%CI（0.20，0.43），P < 0.00001]、血小板毒性更低[RR = 0.56，95%CI（0.34，0.92），P = 0.02]以及呕吐发生率降低[RR = 0.52，95%CI（0.29，0.92），P = 0.03]。
荟萃分析表明，HSOS联合铂类化疗对患者更有益，因为该疗法可协同抗肿瘤活性并减轻毒性。这一发现需要通过进一步严格设计的RCT来证实。
