目的：探究益气活血汤对恶性肿瘤患者癌痛及癌因性疲乏（CRF）的疗效。方法: 选取2020 年1月至2022 年12 月间安徽省中医药大学第二附属医院收治的82 例确诊发生CRF的恶性肿瘤患者（气血亏虚证），采用随机数字表余数分组法将其分为对照组与观察组，每组各41例。对照组患者采用常规止痛、止吐、化痰等对症治疗及健康、心理指导，观察组患者在对照组干预的基础上联合益气活血汤治疗，4周为1个疗程。治疗前及治疗4周后，对两组患者进行中医证候积分评估，以积分变化评估中医临床疗效；采用修订版Piper 疲乏量表（RPFS）评估CRF的改善情况；采用数字疼痛分级法（NRS）评分比较癌痛情况；检测患者外周血纤维蛋白原（FIB）、D-二聚体（D-D）评价凝血功能差异，检测患者肝、肾功能指标以评估益气活血汤治疗的安全性。结果：治疗前，两组患者在中医证候积分、RPFS 评分、NRS评分及外周血FIB、D-D 方面的差异均无显著统计学意义（均P>0.05）。治疗4周后，两组患者在神疲乏力、面色淡白或萎黄、自汗、失眠健忘、手足麻木的证候评分及总积分均较治疗前明显降低（均P<0.05），且观察组各项评分均低于对照组（均P<0.05），中医临床疗效明显高于对照组（P<0.05）；两组患者RPFS各维度评分及总分均较治疗前降低（均P<0.05），观察组行为、情感、感觉维度RPFS评分及总分均低于对照组（均P<0.05），观察组CRF的改善明显优于对照组（P<0.05）；两组患者NRS评分及外周血FIB、D-D指标均较治疗前降低（均P<0.05），且观察组均低于对照组（均P<0.05）。两组患者治疗期间均未发生肝功能、肾功能等明显异常，说明益气活血汤安全性良好。结论：益气活血汤可纠正气血亏虚之证，改善机体凝血功能，促进恶性肿瘤患者CRF及癌痛的减轻，临床应用价值较高。

Objective: To analyze the improvement effects of Yiqi Huoxue decoction on cancer pain and cancer-related fatigue (CRF) in patients with malignant tumors. Methods: 82 patients with malignant tumors (qi and blood deficiency syndrome) who were admitted into the Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine and diagnosed with cancer-related fatigue (CRF) between January 2020 and December 2022 were selected and divided into the control group and the observation group by the remainder grouping method of the random number table, with 41 cases in each group. Patients in the control group received conventional symptomatic treatments such as pain relief, vomit stopping and phlegm reduction as well as health and psychological guidance while patients in the observation group was given the Yiqi Huoxue decoction treatment in addition to the intervention administered to the control group. Before and after 4 weeks of treatment (1 course of treatment), the clinical TCM efficacy of the two groups was evaluated by the changes of TCM syndromes scores.The clinical efficacy of CRF was assessed by Revised Piper Fatigue Scale (RPFS). The differences in cancer pain were compared by Numerical Rating Scale (NRS). Peripheral blood fibrinogen (FIB) and D-dimer (D-D) were detected to assess the differences in coagulation function,and the safety of Yiqi Huoxue decoction treatment was assessed by patients’ liver and kidney function indexes. Results: Before treatment,the differences between the TCM syndromes scores, RPFS scores, NRS score, peripheral blood FIB and D-D of the two groups were not statistically significant (all P>0.05). After 4 weeks of treatment, the scores of syndromes such as fatigue and tiredness, pale or sallow complexion, spontaneous sweating, insomnia and forgetfulness and hand and foot numbness well as total scores of both groups decreased compared with those before treatment (all P<0.05), and all the scores of the observation group were lower than those of the control group (all P<0.05), and the clinical TCM efficacy of the observation group was significantly higher than that of the control group (P<0.05). After 4 weeks of treatment the dimension scores and total scores of RPFS of the two groups were reduced compared to those before treatment (all P<0.05). The dimension scores of behaviors, emotion and feeling and total score of RPFS of the observation group were lower than those of the control group (all P<0.05) while the clinical efficacy of CRF was significantly higher than that of the control group (P<0.05). After 4 weeks of treatment, NRS score and peripheral blood FIB and D-D of both groups were reduced compared with those before treatment (all P<0.05), and the scores of the observation group were lower than those of the control group (all P<0.05). No obvious abnormal indicators of liver function and kidney function occurred in the two groups during treatment, suggesting that Yiqi Huoxue decoction was safe.Conclusion: Yiqi Huoxue decoction can correct the syndrome of qi and blood deficiency, improve the body’ s coagulation function, and promote the relief of CRF and cancer pain in patients with malignant tumors. Therefore, it has high clinical application value.

安徽省中医药传承创新项目（No.2020ccyb05）；曾永蕾安徽省名医工作室项目[No.（2020）10号]