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魏豪, 孙愚, 何军, 等. 紫黄精TM片缓解化疗期间癌因性疲乏的前瞻性单臂多中心临床研究[J]. 四川大学学报(医学版), 2023, 54(1): 148-154. DOI: 10.12182/20230160109
引用本文: 魏豪, 孙愚, 何军, 等. 紫黄精TM片缓解化疗期间癌因性疲乏的前瞻性单臂多中心临床研究[J]. 四川大学学报(医学版), 2023, 54(1): 148-154. DOI: 10.12182/20230160109
WEI Hao, SUN Yu, HE Jun, et al. Zi HuangjingTM Preparation Relieves Cancer-Related Fatigue During Chemotherapy: A Prospective Single-Arm Multicenter Clinical Trial[J]. Journal of Sichuan University (Medical Sciences), 2023, 54(1): 148-154. DOI: 10.12182/20230160109
Citation: WEI Hao, SUN Yu, HE Jun, et al. Zi HuangjingTM Preparation Relieves Cancer-Related Fatigue During Chemotherapy: A Prospective Single-Arm Multicenter Clinical Trial[J]. Journal of Sichuan University (Medical Sciences), 2023, 54(1): 148-154. DOI: 10.12182/20230160109

紫黄精TM片缓解化疗期间癌因性疲乏的前瞻性单臂多中心临床研究

Zi HuangjingTM Preparation Relieves Cancer-Related Fatigue During Chemotherapy: A Prospective Single-Arm Multicenter Clinical Trial

  • 摘要:
      目的  初步探究紫黄精TM片用于化疗期间癌因性疲乏患者的疗效。
      方法  本项临床研究设计为一项前瞻性、单臂、多中心临床研究,计划纳入至少接受过一个周期化疗,且存在中重度癌因性疲乏(Piper疲乏量表得分≥4分)的恶性肿瘤患者。所有入组患者将在接下来的两个化疗周期中每日按时口服紫黄精TM片(2.1 g,一天两次)并接受随访。期间入组患者分别于基线、第二周期化疗前(第21天)及第三周期化疗前(第42天)独立完成Piper疲乏量表、EORTC QLQ-C30量表的填写及部分生化免疫指标的测量。主要研究终点为从基线到第42天的Piper疲乏调查量表得分的变化情况。
      结果  最终47例患者完成研究。患者在第三周期化疗前(第42天)评估Piper疲乏量表平均得分为(3.21±1.67)分,较基线时〔(5.89±1.36)分〕下降(P=0.000),癌因性疲乏得到明显改善。在生活质量方面,患者的整体生活质量评分、躯体功能、角色功能、情感功能、认知功能、社会功能得到明显改善;在症状管理方面,患者的疲劳、恶心呕吐、失眠、食欲减退等症状也得到显著改善。实验过程中未出现3~4级不良反应,余轻微不良反应经评估后认为与化疗相关,与紫黄精TM片无关。
      结论  经初步研究,紫黄精TM片使用安全,具有可以改善肿瘤患者化疗期间癌因性疲乏的潜在治疗作用。但将来需开展更大规模的随机对照临床研究进一步证实紫黄精TM片的作用。

     

    Abstract:
      Objective  To primarily explore the efficacy of Zi HuangjingTM preparation in patients with cancer-related fatigue (CRF) during chemotherapy.
      Methods  This study was designed as a prospective, single-arm, multicenter clinical trial. According to the plan of the study, patients with malignant tumors who had received at least one cycle of chemotherapy and had moderate-to-severe CRF (Piper Fatigue Scale score≥4) were enrolled. All the enrolled patients took Zi HuangjingTM preparation (2.1 g, twice a day) every day during the two subsequent cycles of chemotherapy and were followed up. During the period, the enrolled patients independently completed the Piper Fatigue Scale and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scale, and part of their biochemical and immunological indicators were measured at the baseline, before the second cycle of chemotherapy (day 21), and before the third cycle of chemotherapy (day 42). The primary endpoint was the change in Piper Fatigue Scale scores between the baseline and day 42.
      Results  Eventually, 47 patients completed the entire study. After treatment, the mean score of the Piper Fatigue Scale assessed before the third cycle of chemotherapy (day 42) was 3.21±1.67, which was significantly lower than that at baseline (5.89±1.36) (P=0.000), and the patients’ CRF was significantly improved. In terms of quality of life, the patient's global quality of life, physical functions, role function, emotional function, cognitive function, and social function were significantly improved. In terms of symptom management, the patient's symptoms, such as fatigue, nausea and vomiting, insomnia, and appetite loss also significantly improved. No severe adverse reactions (grades 3 and 4) occurred during the observation period of this study. After evaluation, the adverse reactions that the patients actually had were considered to be related to chemotherapy, but unrelated to Zi HuangjingTM preparation.
      Conclusion  According to our preliminary investigation, Zi HuangjingTM preparation is safe and has the potential therapeutic effect of improving CRF in cancer patients during chemotherapy. However, further larger-scale randomized controlled clinical studies are needed to confirm the efficacy of Zi HuangjingTM in improving CRF.

     

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