四君子汤治疗脾虚型慢性疲劳综合征临床研究

Clinical Study on Sijunzi Decoction for Chronic Fatigue Syndrome of Spleen Deficiency Type

目的:观察四君子汤治疗脾虚型慢性疲劳综合征的临床疗效。方法:选取脾虚型慢性疲劳综合征患者72例作为研究对象,采用随机数字表法分为对照组和试验组各36例。2组均提供健康宣教,试验组采用四君子汤颗粒剂治疗,对照组给予安慰剂颗粒干预。比较2组临床疗效和安全性,以及治疗前后疲劳症状评分、中医证候评分、疲劳度[Chalder疲劳问卷评分表(Chalder)]评分、SF-36健康调查量表中文版(SF-36)评分、五水平五维健康量表(EQ-5D-5L)评分及血清氧化应激指标[皮质醇稳定蛋白(CORT)、丙二醛(MDA)、超氧化物歧化酶(SOD)及谷胱甘肽过氧化物酶(GSH-PX)]水平。结果:治疗后,试验组总有效率为94.44%,对照组为77.78%,2组比较,差异有统计学意义(P<0.05)。治疗1、2个月后,2组睡眠障碍、紧张焦虑和记忆力减退等疲劳症状评分均较治疗前降低(P<0.05),且试验组3项评分在相同时间点均低于对照组(P<0.05)。治疗1、2个月后,2组中医证候评分、Chalder评分均较治疗前降低(P<0.05),且试验组中医证候评分、Chalder评分在相同时间点均低于对照组(P<0.05)。治疗1、2个月后,2组SF-36、EQ-VAS评分评分均较治疗前升高(P<0.05);且试验组2项评分在相同时间点均高于对照组(P<0.05)。治疗1、2个月后,2组血清中CORT、SOD及GSH-PX水平均较治疗前升高(P<0.05),MDA水平均较治疗前降低(P<0.05),且试验组CORT、SOD及GSH-PX水平在相同时间点均高于对照组(P<0.05),MDA水平在相同时间点低于对照组(P<0.05)。结论:四君子汤治疗脾虚型慢性疲劳综合征疗效显著,可改善脾虚症状,提高患者生活质量,改善氧化应激反应,且安全性较好。

Objective:To observe the clinical effect of Sijunzi Decoction on chronic fatigue syndrome of spleen deficiency type.Methods:A total of 72 cases of patients with chronic fatigue syndrome of spleen deficiency type were selected as the research subjects,and were divided into the control group and the trial group according to the random number table method,with 36 cases in each group.Both groups received health education.The trial group was treated with granules of Sijunzi Decoction,and the control group was treated with placebo granules.The clinical effects and safety were compared between the two groups.The fatigue symptom scores,traditional Chinese medicine(TCM)syndrome scores,fatigue degree[Chalder Fatigue Scale(Chalder)scores],Chinese Version of Short Form Health Survey(SF-36)scores,EuroQol 5 Dimension 5 Level(EQ-5D-5L)scores and levels of serum oxidative stress indicators[cortisol,malondialdehyde(MDA),superoxide dismutase(SOD),and glutathione peroxidase(GSH-PX)]were compared before and after treatment.Results:After treatment,the total effective rate was 94.44%in the trial group,and 77.78%in the control group,the difference being significant(P<0.05).After 1 and 2 months of treatment,the scores of fatigue symptoms such as sleep disorders,tension and anxiety,and memory decline in the two groups were decreased when compared with those before treatment(P<0.05),and the three scores in the trial group were lower than those in the control group at the same time point(P<0.05).After 1 and 2 months of treatment,TCM syndrome scores and Chalder scores in the two groups were decreased when compared with those before treatment(P<0.05),and TCM syndrome scores and Chalder scores in the trial group were lower than those in the control group at the same time point(P<0.05).After 1 and 2 months of treatment,the scores of SF-36 and EQ-VAS in the two groups were increased when compared with those before treatment(P<0.05):the above two scores in the trial group were higher than those in the control group at the same time point(P<0.05).After 1 and 2 months of treatment,the serum levels of CORT,SOD,and GSH-PX in the two groups were increased when compared with those before treatment(P<0.05),and MDA levels were decreased when compared with those before treatment(P<O.05);the levels of CORT,SOD,and GSH-PX in the trial group were higher than those in the control group at the same time point(P<0.05),and MDA level was lower than that in the control group at the same time point(P<0.05).Conclusion:Sijunzi Decoction has a significant curative effect in treating chronic fatigue syndrome of spleen deficiency type.It can improve symptoms such as spleen deficiency,improve the quality of life of patients,improve oxidative stress reactions,and has good safety.