基于益气温阳理论应用中药沐足联合电艾灸治疗癌因性疲乏(CRF)临床疗效及安全性观察

目的:探究益气温阳理论指导下的中药沐足联合电艾灸治疗癌因性疲乏（CRF）的临床疗效及安全性。方法:研究纳入118例CRF患者，均由住院部2019年08月-2021年03月收治，采用随机数字表法将患者分为3组，对照组(40例)仅采用对症支持治疗，观察A组（39例）采用中药沐足+对症支持治疗，观察B组(39例)采用中药沐足+电艾灸+对症支持治疗。比较3组临床疗效、Piper疲乏量表积分、功能状态评分(KPS)、生活质量(QOL，食欲、精神、睡眠、疲乏、疼痛等)及T淋巴细胞亚群变化，并从临床症状体征及常规检查做安全性评价。结果:观察A组(82.1%，32/39)、B组(89.7%，35/39)患者总体有效率均高于对照组(57.5%，23/40)(P＜0.05)，观察B组优于观察A 组(P＜ 0.05)；治疗后KPS评分提高率对比，观察A组(79.5%，31/39)、B组(94.9%，37/39)患者均高于对照组(52.5%，31/39)，观察B组优于观察A组(P＜0.05)；治疗前3组QOL评分比较（P＞0.05），治疗后3组组内前后对比（P＜0.05），观察A、B组均优于对照组(P＜0.05），观察B组优于A组（P＜0.05)；在QOL量表条目中，治疗后患者在食欲、精神、睡眠、疲乏、对治疗态度、日常生活及面部表情7个方面，观察A组和B组均优于对照组（P＜0.05），其中在精神、睡眠、疲乏、治疗副作用方面，观察B组优于观察A组(P＜0.05）；治疗前3组免疫功能状况比较（P＞0.05），治疗后在CD3+T、CD3+CD4+T、CD3+CD4+T/CD3+CD8+T、NK细胞免疫指标中，观察A、B组均优于对照组（P＜0.05），在NK细胞状态观察B组优于A组（P＜0.05）。观察A组出现Ⅰ度皮肤瘙痒1例，治疗B组出现1例Ⅰ级血压升高，对照组出现1例治疗相关恶心呕吐，3组不良反应率比较(P＞0.05)。结论:益气温阳理论指导下联合应用中药沐足及电艾灸治疗CRF，有效改善了患者功能状态、生存质量及免疫功能状态，安全性好，值得进一步深入探索研究。

Observation on clinical efficacy and safety of foot massage combined with electric moxibustion in the treatment of cancer-related fatigue (CRF) based on invigorating Qi and warming Yang theory:A parallel controlled study

Objective:To evaluate the clinical efficacy and safety of foot massage with Chinese medicine(CM)combined with electric moxibustion in the treatment of cancer-related fatigue(CRF)based on invigorating Qi and warming Yang theory.Methods:A total of 118 patients with CRF were collected in inpatient department of our hospital from August 2019 to March 2021.By taking a random number table method,the patients were divided into observation group A,observation group B and control group.The control group (40 cases) was treated with only symptomatic support.Group A (39 cases) adopted CM decoction foot massage combined with symptomatic support treatment,and group B(39 cases)received electric moxibustion additionally.The clinical efficacy,Piper fatigue Scale score,functional status score(KPS),quality of life(QOL,appetite,spirit,sleep,fatigue,pain,etc.)and T lymphocyte subsets of the three groups were compared,and the safety was evaluated from clinical symptoms,signs and routine examination.Results:The total effective rate of group A(82.1%,32/39)and B(89.7%,35/39)was higher than that of control group(57.5%,23/40)(P＜ 0.05).Group B was better than group A(P＜0.05).The improvement rate of KPS score was compared after treatment.Group A(79.5%,31/39)and group B(94.9%,37/39)were higher than those in control group(52.5%,31/39),and group B was superior to group A(P＜0.05).There was difference in Comparison of QOL score among the 3 groups before treatment(P＞0.05),intra-group comparison of 3 groups after treatment(P＜0.05).Group A and B were improved and better than control group(P＜0.05),and group B was superior to group A(P＜0.05).In the details of QOL scale,observation group A and B were superior to control group in 7 aspects of appetite,spirit,sleep,fatigue,attitude to treatment,daily life and facial expression after treatment(P＜0.05),and group B was superior to group A in spirit,sleep,fatigue and treatment side effects(P＜ 0.05).There was no different in comparison of the immune function of the three groups before treatment(P＞0.05).After treatment,the immune indexes of CD3+T,CD3+CD4+T,CD3+CD4+T/CD3+CD8+T and NK cells in groups A and B were better than those in control group(P＜0.05).NK cell status in group B was better than that in group A(P＜0.05).There was 1 case of grade I skin pruritus in group A,1 case of grade 1 blood pressure elevation in group B,and 1 case of treatment-related nausea and vomiting in control group.The adverse reaction rates of the three groups were not significant(P＞0.05).Conclusion:Combined application of foot massage with CM and electric moxibustion under the guidance of the theory of invigorating Qi and warming Yang can effectively improve the KPS,QOL and immune function of CRF patients,with good safety and worthy of further exploration and research.