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Efficacy and Safety of Banxia XieXin Decoction, a Blended Traditional Chinese Medicine, as Monotherapy for Patients With Advanced Hepatocellular Carcinoma

机译:一种混合中医的BanxiaXiexin汤剂的疗效和安全性,作为先进肝细胞癌患者的单药治疗

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Purpose: To explore a new therapeutic option for patients with hepatocellular carcinoma (HCC), the efficacy and safety of a group of traditional Chinese medicines (Banxia XieXin recipe) as monotherapy for patients with advanced HCC was studied. Materials and Methods: The study included 68 patients with advanced HCC from August 16,2016 to August 15,2019 for analysis. These eligible patients received treatment with Banxia XieXin recipe for at least 1 month. The primary endpoints were progression-free survival (PFS) and overall survival (OS). The secondary efficacy endpoints included objective response rate (ORR) and disease control rate (DCR). In addition, safety was also assessed. Results: The median treatment duration of these 68 patients was 10.3 months (range = 1.6-33.5 months), and follow-up is still ongoing. The median PFS was 6.07 months (95% confidence interval [CI] = 3.748-8.392 months), and the median OS was 12.60 months (95% CI = 8.019-17.181 months). The ORR was 10.3% and the DCR was 41.2%. In the subgroup analysis, the median OS in the transcatheter arterial chemoembolization (TACE) group was not reached, and the median OS in the NO TACE group was 11.30 months (95% CI = 3.219-19.381 months). In addition, no drug-related serious adverse events were observed during the study. Conclusion: This is the first clinical analysis of traditional Chinese medicine as a single treatment for advanced HCC. The obtained results are encouraging as they suggest that this panel of Chinese herbs is safe and it may be effective for patients with advanced HCC in a real-world clinical setting.
机译:目的:研究了肝细胞癌(HCC)患者的新治疗选择,研究了一组中药(BanxiaXiexin Recipe)作为先进HCC患者的单药治疗的疗效和安全性。材料和方法:该研究包括68名高级HCC患者从8月16,2016年8月16日至8月15,2019进行分析。这些符合条件的患者接受了BanxiaXiexin配方的治疗至少1个月。主要终点是无进展的存活(PFS)和总存活(OS)。二次疗效终点包括客观反应率(ORR)和疾病控制率(DCR)。此外,还评估了安全性。结果:这68名患者的中位治疗持续时间为10.3个月(范围= 1.6-33.5个月),随访仍在继续。中位数PFS为6.07个月(95%置信区间[CI] = 3.748-8.392个月),中位数OS为12.60个月(95%CI = 8.019-17.181个月)。 ORR为10.3%,DCR为41.2%。在亚组分析中,未达到经截面动脉化疗栓塞(TACE)组中的中值OS,并且NO TACE组中的中位OS为11.30个月(95%CI = 3.219-19.381个月)。此外,在研究期间没有观察到毒品相关的严重不良事件。结论:这是中国中药首次临床分析,作为先进HCC的单一治疗方法。所获得的结果是令人鼓舞的,因为他们表明,这个中草药面板是安全的,并且在现实世界的临床环境中对HCC的患者有效。

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