Wang Cheng-Hsu, Lin Cheng-Yao, Chen Jen-Shi, Ho Ching-Liang, Rau Kun-Ming, Tsai Jo-Ting, Chang Cheng-Shyong, Yeh Su-Peng, Cheng Chieh-Fang, Lai Yuen-Liang
Division of Hematology/Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital, Chang Gung University, College of Medicine, Keelung 204, Taiwan.
Chi Mei Medical Center, Liouying, Tainan City 736, Taiwan.
Cancers (Basel). 2019 Jan 22;11(2):128. doi: 10.3390/cancers11020128.
Fatigue is a common and debilitating symptom in patients with advanced cancer, resulting in poor quality of life and reduced treatment efficacy. Phytotherapeutic agents have shown potential effects to relieve cancer-related fatigue in these patients. The aim of this study was to evaluate the efficacy and safety of Astragalus Polysaccharides injection and identify predictive factors associated with this treatment. Patients with advanced cancer receiving palliative care with moderate to severe cancer-related fatigue were enrolled in this study for two treatment cycles. Fatigue improvement response rates were analyzed as the primary endpoint at the end of the first cycle to determine treatment efficacy. The drug safety profile was evaluated by the reporting of adverse events. Three hundred and ten patients were enrolled in this study and 214 patients were included ITT population. Improvement in fatigue scores by at least 10% was observed in greater than 65% of subjects after one treatment cycle compared to scores at baseline. Patients with higher Karnofsky Performance Status (KPS) responded better to the Astragalus Polysaccharides injection. Drug-related adverse event rates were less than 9%. This study identified KPS as a promising predictive factor for the therapeutic efficacy of Astragalus Polysaccharides injection.
疲劳是晚期癌症患者常见且使人虚弱的症状，会导致生活质量下降和治疗效果降低。植物治疗剂已显示出缓解这些患者癌症相关疲劳的潜在作用。本研究的目的是评估黄芪多糖注射液的疗效和安全性，并确定与该治疗相关的预测因素。患有中重度癌症相关疲劳且接受姑息治疗的晚期癌症患者被纳入本研究进行两个治疗周期。在第一个周期结束时，将疲劳改善反应率作为主要终点进行分析以确定治疗效果。通过不良事件报告评估药物安全性。本研究共纳入310例患者，214例患者纳入意向性分析人群。与基线时的评分相比，超过65%的受试者在一个治疗周期后疲劳评分改善至少10%。卡氏功能状态（KPS）较高的患者对黄芪多糖注射液反应更好。药物相关不良事件发生率低于9%。本研究确定KPS是黄芪多糖注射液治疗效果的一个有前景的预测因素。
