黄芪注射液联合补中益气针法治疗气虚质慢性疲劳综合征多中心随机对照临床试验  

Multi-center Randomized Controlled Clinical Trial of Huangqi Injection Combined with Buzhong Yiqi Acupuncture in Treatment of Chronic Fatigue Syndrome with Qi Deficiency

作　　者：王城城 唐兴 李春梅[2] 王中博[5] 附雁林 代敏[1] 杨敏[1] 余葱葱 WANG Chengcheng;TANG Xing;LI Chunmei;WANG Zhongbo;FU Yanlin;DAI Min;YANG Min;YU Congcong(Chengdu Medical College,Chengdu 610500,China;Sichuan Integrative Medicine Hospital,Chengdu 610041,China;Sichuan Institute for Translational Chinese Medicine(TCM),Chengdu 610041,China;Chengdu University of TCM,Chengdu 610075,China;Pengzhou People's Hospital,Pengzhou 611930,China;Jiange Hospital of TCM,Guangyuan 628300,China)

机构地区：[1]成都医学院,成都610500 [2]四川省中西医结合医院,成都610041 [3]四川省中医药转化医学中心,成都610041 [4]成都中医药大学,成都610075 [5]彭州市人民医院,四川彭州611930 [6]剑阁县中医医院,四川广元628300

出　　处：《中国实验方剂学杂志》2024年第7期163-169,共7页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家重点研发计划项目(2018YFC1704701);四川省中医药亚健康产业产品开发创新团队项目(2022C006)。

摘　　要：目的:探讨黄芪注射液联合补中益气针法治疗气虚质慢性疲劳综合征临床疗效及对中医证候、疲劳症状、血清超氧化物歧化酶(SOD)、丙二醛(MDA)、氧化低密度脂蛋白(ox-LDL)水平的影响。方法:200例气虚质慢性疲劳综合征患者随机分成对照组与观察组,各100例。对照组采用复方维生素B治疗,观察组采用黄芪注射液联合补中益气针法治疗,治疗2周,观察比较两组患者治疗前后中医证候积分、疲劳症状、血清SOD、MDA、ox-LDL水平变化及不良反应发生率。结果:治疗后,观察组总有效率为88.54%(85/96),对照组总有效率为54.34%(50/92),观察组患者总有效率高于对照组(χ^(2)=27.13,P<0.05)。与本组治疗前比较,治疗后两组患者疲劳自评量表(FSAS)评分、躯体疲劳、精神疲劳及疲劳对睡眠/休息的反应评分均明显降低(P<0.05);治疗后与对照组比较,观察组患者FSAS、躯体疲劳、精神疲劳及疲劳对睡眠/休息的反应评分改善更明显(P<0.05)。与本组治疗前比较,两组患者中医证候积分均明显降低(P<0.05);治疗后与对照组比较,观察组患者中医证候积分改善更明显(P<0.05)。与本组治疗前比较,治疗后两组患者MDA水平均明显降低(P<0.05),观察组ox-LDL水平明显降低,SOD水平明显升高(P<0.05);治疗后与对照组比较,观察组患者血清MDA、ox-LDL水平改善更明显(P<0.05),血清SOD有明显升高(P<0.05)。在本次临床试验期间未出现任何严重不良事件及严重不良反应。结论:黄芪注射液联合补中益气针法治疗气虚质慢性疲劳综合征具有较好的临床疗效,可有效改善患者疲劳症状,升高SOD水平,降低血清MDA、ox-LDL水平,其机制可能与促进抗氧化物的生成,抑制过氧化脂质的产生,提高机体的抗氧化应激能力有关。Objective:To investigate the clinical efficacy of Huangqi injection combined with Buzhong Yiqi acupuncture in the treatment of chronic fatigue syndrome(CFS) with Qi deficiency and its effects on TCM syndromes,fatigue symptoms,serum superoxide dismutase(SOD),malondialdehyde(MDA),and oxidized low-density lipoprotein(ox-LDL) levels.Method:A total of 200 patients with CFS of Qi deficiency were randomly divided into a control group(100 cases) and an observation group(100 cases).The control group was treated with vitamin B compounds,and the observation group was treated with Huangqi injection combined with Buzhong Yiqi acupuncture for two weeks.The scores of TCM syndromes,fatigue symptoms,levels of serum SOD,MDA,and ox-LDL and the incidence of adverse reactions were observed and compared before and after treatment in two groups.Result:After treatment,the total effective rate of the control group was 54.34%(50/92),while that of the observation group was 88.54%(85/96).The total effective rate of the observation group was higher than that of the control group (χ^(2)=27.13,P<0.05).Compared with those in the two groups before treatment,scores of fatigue self-assessment scale(FSAS),physical fatigue and mental fatigue,and sleep/rest response scores of fatigue in the two groups after treatment were significantly decreased(P<0.05).After treatment,scores of FSAS,physical fatigue and mental fatigue,and sleep/rest response scores of fatigue in the observation group were significantly decreased compared with those in the control group(P<0.05).Compared with those in the two groups before treatment,TCM syndrome scores in the two groups after treatment were significantly decreased(P<0.05).After treatment,TCM syndrome scores in the observation group were significantly decreased compared with those in the control group(P<0.05).Compared with those in the two groups before treatment,MDA levels in the two groups were significantly decreased(P<0.05),ox-LDL levels in the observation group were significantly decreased(P<0.05),and SOD levels

关 键 词：黄芪注射液 补中益气针法 慢性疲劳综合征 超氧化物歧化酶(SOD) 丙二醛(MDA) 氧化低密度脂蛋白(ox-LDL) 

分 类 号：R2-0[医药卫生—中医学] R22R242R2-031R287