[摘 要] 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。

Kunxian Capsule (KX) is a popular Chinese patent medicine for the treatment of rheumatoid arthritis, nephrotic syndrome, systemic lupus erythematosus, Henoch-Schönlein purpura, ankylosing spondylitis, psoriatic arthritis and eczema. However, there is scarcity of comprehensive information on the significance of KX in the clinical application and its side effects. Hence, it is aimed to provide a review of the significance of KX, with a focus on the pharmacological effects, clinical applications, and its adverse reactions. This review was based on the published literatures in PubMed, China National Knowledge Infrastructure and WanFang database. The articles were collected by two independent authors with no time limits applied until November 30, 2022. The search term includes Kunxian Capsule and/or clinical effect, pharmacology, disease, therapy, adverse effects and quality control. KX has been shown to be effective in the treatment of autoimmune arthritis by inhibiting inflammatory responses and inducing apoptosis. Many studies suggest that KX has anti-inflammatory and analgesic properties that aid in the improvement of joint functions. KX dispels wind, removes dampness, invigorates the kidneys, and promotes blood circulation, thereby curing various diseases. However, studies also suggest KX-related adverse reactions in multiple systems. Overall, this review highlights the scientific basis of KX in curing or preventing various diseases and provides novel insights for further research and clinical applications.