Department of Oncology, Shanghai Municipal Clinical Medical, Centre for Traditional Chinese Oncology, China.
Am J Chin Med. 2010;38(1):15-25. doi: 10.1142/S0192415X10007646.
In order to pilot a study observing the feasibility of applying the Core Quality of Life Questionnaire (QLQ-C30) version 2.0 to assess the quality of life (QOL) of patients with NSCLC treated with Feiji Recipe, a randomized, parallel controlled clinical trial was conducted in the university-affiliated hospital. Seventy inpatients who met the inclusion criteria were randomized into the study, and 60 cases were available as subjects for QOL data analysis. The subjects were randomly assigned to one of three groups: the Feiji Recipe group (A); the Feiji Recipe combined with chemotherapy group (B); and the chemotherapy group (C) in which the patients were treated with vinorelbine plus cisplatin (NP) or gemcitabine plus cisplatin (GP). QOL was assessed with the Chinese version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30. Sixty cases that finished the questionnaires were analyzed, and we found that patients who received chemotherapy had low QOL, in terms of their global health, role, emotional, social, economic status and symptom burden including fatigue, nausea and vomiting, dyspnea, loss of appetite and abnormal bowel movements. Simultaneous treatment with Feiji Recipe and chemotherapy was able to prevent the worsening of function in terms of role, social, fatigue and global health. The Core Quality of Life Questionnaire (QLQ-C30) version 2.0 can be used to evaluate the QOL of patients with NSCLC treated by Chinese herbal medicine. Feiji Recipe might partially improve the QOL of NSCLC patients when administered alone or in combination with chemotherapy. No unexpected side effects were observed. However, further double-blinded placebo controlled studies are strongly recommended.
为了探索应用核心生活质量问卷(QLQ-C30)第 2.0 版评估非小细胞肺癌(NSCLC)患者接受肺积方治疗后的生活质量(QOL)的可行性,在一所大学附属医院开展了一项随机、平行对照临床试验。该研究纳入了 70 名符合纳入标准的住院患者,其中 60 例患者可用于 QOL 数据分析。这些患者被随机分为三组:肺积方组(A)、肺积方联合化疗组(B)和化疗组(C),其中化疗组患者接受长春瑞滨联合顺铂(NP)或吉西他滨联合顺铂(GP)治疗。采用欧洲癌症研究与治疗组织生活质量问卷核心模块 30 中文版(EORTC QLQ-C30)评估 QOL。共 60 例完成了问卷的患者被纳入分析,我们发现接受化疗的患者 QOL 较低,在总体健康状况、角色功能、情绪功能、社会功能、经济状况以及疲乏、恶心呕吐、呼吸困难、食欲丧失和腹泻等症状负担方面。肺积方联合化疗治疗可以预防角色功能、社会功能、疲乏和总体健康状况的恶化。核心生活质量问卷(QLQ-C30)第 2.0 版可用于评估中药治疗 NSCLC 患者的 QOL。肺积方单独或联合化疗可能会部分改善 NSCLC 患者的 QOL。未观察到意外的不良反应。但是,强烈建议开展进一步的双盲安慰剂对照研究。