小剂量短程泼尼松治疗晚期肿瘤患者癌性疲劳的临床研究

Clinical trial for small dose-short term of predinisone on advanced cancer patients with cancer related fatigue

目的癌性疲劳(cancer-related fatigue,CRF)是影响晚期肿瘤患者生活质量的主要原因,目前无确切有效的药物治疗。本研究旨在评价小剂量短程泼尼松治疗晚期肿瘤患者癌性疲劳的疗效及安全性。方法选取2013-09-01-2015-10-01绍兴市人民医院肿瘤内科放疗科住院并接受姑息性支持治疗的晚期肿瘤患者78例,分为泼尼松组(40例)和对照组(38例),泼尼松组予泼尼松片10mg早晚各1次,共14d;对照组给予最佳姑息支持治疗(不含激素类药物),在第0、8和15天进行埃德蒙顿症状评估系统(Edmonton Symptom Assessment System,ESAS)≥4分(0~10分)且肿瘤治疗中疲劳的相关功能评估量表评分(Functional Assessment of Cancer Therapy-Fatigue,FACT-F)≤36分及慢性病治疗中疲劳的相关功能评估量表(Functional Assessment of Chronic Illness Therapy-Fatigue,FACIT-F)评分,将FACT-F变化值作为主要研究终点。结果经过1~2周治疗后,泼尼松组和对照组第8天的FACT-F评分变化为11(4~25)和8(2~21),第15天的FACT-F评分变化为14(4~27)和10(3~23),泼尼松组在第8天及第15天均较对照组FACT-F评分变化显著,P值分别为0.004和0.024,同时总体生活质量FACIT-F评分增加值泼尼松组亦高于对照组,P=0.039,P=0.029;ESAS疲劳评分同样验证了泼尼松组CRF改善情况好于对照组。在常见症状中,泼尼松组ESAS食欲评分减少数值较对照组显著,泼尼松第8天ESAS食欲评分变化为-3.5(-5^-2),对照组为-3(-5~0),P=0.038;第15天泼尼松组和对照组ESAS食欲评分变化分别为-4(-5~2)和-3(-5^-1),P=0.017,而其他症状评分变化在两组间差异无统计学意义。不良事件均为轻、中度,两组间差异无统计学意义。结论小剂量短程泼尼松是临床上治疗癌性疲劳和厌食安全有效的药物。

OBJECTIVE Cancer related fatigue（CRF） has important impact on quality of life in patients with ad- vanced cancer,there is limited pharmacological interventions that effectively treat CRF. This study was to evaluate the ef fectiveness of small dose-short term of predinisone in advanced cancer patients with CRF. METHODS In-patients with ≥4 of 10 on the Edmonton Symptom Assessment Scale （ESAS） and ≤36 scores on Functional Assessment of Cancer Therapy-Fatigue （FACT-F） were eligible. Patients were assigned to predinisone 10 mg orally twice per day for 14 days in predinisone group, and in the controlled group patients were given the best support care （steroids drugs used）. The ES- AS, FACT-F and Functional Assessment of Chronic Illness Therapy-Fatigue（FACIT-F） were assessed at baseline, day 8 and day 15. The primary end point was the change in the FACT-F. RESULTS A total of 78 patients were evaluable （predinisone group 40; the controlled group 38）. The improvement in the FACT-F at day 8 and day 15 was significantly higher in the predinisone than in the controlled group, at day 8 the FACT-F score was 11 （4-25） in predinisone group, and8（2-21） in the controlled group（P=0.004）, and at day 15 the FACT-F score was 14（4-27） and 10（3-23）respectively（P= 0. 024）. The improvement in FACIT-F total quality-of-life scores was also significantly better for the predinisone group at day 8 and day 15（P=0. 039;P=0. 029）. The differences in the ESAS fatigue scores were signifi- cantly better for the predinisone group. Statistically improvement was found in ESAS appetite loss in the predinisone group,the ESAS score change for appetite loss was -3.5（--5--2） in the predinisone group,and --3（-5-0） in the controlled group at day 8（P=0. 038）. At day 15 the ESAS score change was -4（-5-2） and --3（-5--1） in the two groups（P=0. 017）, No differences were observed for other symptom. There were no differences in adverse effects be- tween the groups. CONCLUSION Small dose-short course of predinisone is effective in improving CRF and appetite loss in patients with advanced cancer.