【目的】评估扶正固本颗粒 （由补中益气汤化裁而成） 治疗癌因性疲乏 （cancer-related fatigue，CRF） 的临床疗效和安全性。 【方法】采用分层随机分组方法将84例患者随机分为试验组和对照组，每组各42例。2组患者均接受西医规范化治疗和常规对症治疗，在此基础上，试验组给予扶正固本颗粒治疗。4周为1个治疗周期，共治疗3个周期 （每周期连续服药 ≥ 3 d） 。观察2组患者治疗前后Piper疲乏量表评分、Karnofsky功能状态 （KPS） 评分和中医证候积分的变化情况，并评估2组患者的中医证候疗效和安全性。 【结果】（1） 疗效方面，治疗3个周期后，试验组的总有效率为57.14% （24/42） ，对照组为11.90% （5/42） ，组间比较，试验组的总体疗效 （秩和检验） 和总有效率 （χ2检验） 均明显优于对照组 （P＜0.05） 。 （2） 疲乏程度方面，治疗后，试验组的Piper疲乏量表总分和感官、情感、认知、行为等四个维度评分均较治疗前下降 （P＜0.05） ，而对照组的Piper疲乏量表总分和行为评分均较治疗前升高 （P＜0.05） ；组间比较，试验组对Piper疲乏量表总分和感官、行为评分的下降作用均明显优于对照组 （P＜0.05） 。 （3） 生活质量方面，治疗后，试验组的KPS评分较治疗前升高 （P＜0.05） ，对照组较治疗前下降 （P＜0.05） ；组间比较，试验组对KPS评分的升高作用明显优于对照组 （P＜0.05） 。 （4） 中医证候方面，治疗后，试验组的中医证候积分较治疗前下降 （P＜0.05） ，而对照组的中医证候积分与治疗前相仿 （P＞0.05） ；组间比较，试验组对中医证候积分的下降作用明显优于对照组 （P＜0.05） 。 （5） 安全性指标方面，治疗后，除对照组的谷草转氨酶 （AST） 、谷丙转氨酶 （ALT） 和试验组的血小板 （PLT） 有升高趋势 （P＜0.05） 外，2组患者的各项安全性指标均未见明显变化 （P＞0.05） 。在不良事件发生情况方面，试验组的骨髓抑制 （白细胞计数减少、血红蛋白含量减少） 发生率明显低于对照组，差异有统计学意义 （P＜0.05） 。 【结论】扶正固本颗粒能有效减轻患者疲乏程度，缓解患者不适症状，提高患者生活质量，且可一定程度降低抗肿瘤药物所导致的毒副反应，疗效显著且安全性高，对患者生存期起积极影响。

Objective To evaluate the clinical efficacy and safety of Fuzheng Guben Granules （derived from Buzhong Yiqi Decoction） for the treatment of cancer-related fatigue （CRF） . Methods Eighty-four patients were randomly divided into a trial group and a control group by stratified randomization method，with 42 cases in each group. Both groups were treated with standardized western medicine treatment and conventional symptomatic treatment. In addition，the trial group was treated with Fuzheng Guben Granules orally. Four weeks constituted a treatment cycle，and both groups were treated for a total of three cycles （≥ 3 days of continuous medication in each cycle） . The changes of Piper’ s Fatigue Scale （PFS） scores，Karnofsky Performance Status （KPS） scores and traditional Chinese medicine （TCM） syndrome scores in the two groups before and after treatment were observed. After treatment，the efficacy for TCM syndrome and clinical safety of the two groups were evaluated. Results （1） After three cycles of treatment，the total effective rate of the trial group was 57.14% （24/42） and that of the control group was 11.90% （5/42），and the intergroup comparison showed that the overall efficacy （by rank-sum test） and the total effective rate （by chi-square test） of the trial group were significantly superior to those of the control group （P＜0.05） . （2）After treatment，the scores of the four dimensions of sensory fatigue，emotional fatigue，cognitive fatigue and behavioral fatigue and the total score of PFS of the trial group were decreased when compared with those before treatment （P＜0.05） ，whereas the behavioral fatigue score and the total PFS score of the control group were increased when compared with those before treatment （P＜0.05） . The intergroup comparison showed that the decrease of total PFS score，sensory fatigue score and behavioral fatigue score in the trial group was significantly superior to that in the control group （P＜0.05） . （3） After treatment，KPS score for the quality of life in the trial group was increased （P＜0.05） while the KPS score in the control group was decreased when compared with that before treatment （P＜0.05） . The intergroup comparison showed that the increase of KPS score in the trial group was significantly superior to that of the control group （P＜0.05） . （4） After treatment，the TCM syndrome score of the trial group was decreased when compared with that before treatment （P＜0.05） ，while the TCM syndrome score of the control group showed no obvious change （P＞0.05） . The intergroup comparison showed that the decrease of TCM syndrome score in the trial group was significantly superior to that of the control group （P＜0.05） . （5） After treatment，no significant changes were founded in the safety indicators of the patients in the two groups （P＞0.05） except that the levels of aspartate transaminase （AST） and alanine transaminase （ALT） of the trial group，as well as the platelet （PLT） of the control group were increased （P＜0.05） . In terms of the adverse events， the incidence of myelosuppression （showing as the decrease of white blood cell count and hemoglobin content） in the trial group was significantly lower than that in the control group，and the difference was statistically significant （P＜0.05） . Conclusion Fuzheng Guben Granules can effectively reduce the degree of fatigue，relieve the discomforts of patients，improve their quality of life，and reduce the adverse reactions caused by anti-tumor drugs to a certain extent，with significant efficacy and high safety and exerting a positive impact on the survival of patients.

R273

佛山市卫生健康局医学科研课题 （编号：20230820A010274）