补肾抗衰片治疗慢性疲劳综合征脾肾亏虚证的疗效观察

目的:观察补肾抗衰片联合腹部按摩治疗慢性疲劳综合征(CFS)(脾肾亏虚证)的效果及抗氧化应激和免疫调节作用。方法:将160例患者采用SAS软件生成,随机按数字表法分为对照组和观察组各80例。对照组采用腹部按摩手法,1次/d,每周治疗5次,每个月治疗15次为1个疗程。共计3个疗程。观察组腹部按摩手法同对照组,并给予补肾抗衰片,6片/次,3次/d,温开水送服。两组疗程共治疗12周。进行治疗前后脾肾亏虚症状评分、疲劳量表-14 (SF-14)评分、焦虑自评量表(SAS),抑郁自评量表(SDS)和匹兹堡睡眠质量指数(PSQI)评分;检测治疗前后血清免疫球蛋白(Ig G,Ig A和Ig M),自然杀伤细胞(NK),T淋巴细胞亚群(CD3+,CD4+,CD8+,CD4+/CD8+),丙二醛(MDA),超氧化物歧化酶(SOD)和谷胱甘肽过氧化物酶(GSH-Px)水平。结果:经秩和检验,观察组临床疗效优于对照组(Z=1. 982,P 0. 05);治疗后观察组患者疲劳感、倦怠乏力、精神萎靡、腰膝酸软等主要症状评分、其他症状和脾肾亏虚证总积分均低于对照组(P 0. 01),躯体疲劳、精神疲劳评分和SF-14总分均低于对照组(P 0. 01),SAS,SDS和PSQI评分均低于对照组(P 0. 01);观察组患者Ig G,Ig A和Ig M水平均高于对照组(P 0. 01);观察组患者NK,CD3+,CD4+水平和CD4+/CD8+均高于对照组(P 0. 05),CD8+水平低于对照组(P 0. 05);观察组患者MDA低于对照组(P 0. 01),SOD和GSH-Px均高于对照组(P 0. 01)。结论:补肾抗衰片联合腹部按摩治疗CFS脾肾亏虚证患者,可明显的减轻疲劳程度,改善脾肾亏虚症状,并具有提高免疫功能和抗氧化应激作用,临床疗效优于单纯的腹部按摩疗法。

Effect of Bushen Kangshuai Tablets on Chronic Fatigue Syndrome with Syndrome of Spleen and Kidney Deficiency

Objective: To observe the effect of Bushen Kangshuai tablets combined with abdominal massage on chronic fatigue syndrome (CFS) with syndrome of spleen and kidney deficiency, and investigate its antioxidant stress and immune regulation effects. Method: One hundred and sixty patients were randomly divided into control group and observation group by random number table, 80 cases in each group. Patients in control group got abdominal massage, 1 time/day, 5 times/week, for a total of 3 treatment courses, 15 times in one course. Based on the treatment in control group, patients in observation group also received Bushen Kangshuai tablets, 6 tablets/time, 3 times/days, for a total of 12 weeks in treatment. Before and after treatment, symptom scores of spleen and kidney deficiency, fatigue scale-14 (SF-14), self-rating anxiety scale (SAS), self-rating depression scale (SDS) and Pittsburgh sleep quality index (PSQI) were graded; and levels of serum immunoglobulin (IgG, IgA and IgM), natural killer cells (NK), T lymphocyte subsets (CD3⁺, CD4⁺, CD8⁺ and CD4⁺/CD8⁺), malondialdehyde (MDA), superoxide dismutase (SOD) and glutathione peroxidase (GSH-Px) were detected. Result: In the rank sum test, the clinical efficacy in observation group was better than that in control group (Z=1.982, P<0.05). After treatment, scores of fatigue, listlessness, malaise, weakness of waist and knee, the total score of other symptoms and spleen and kidney deficiency syndrome in the observation groups were all lower than those in control group (P<0.01), and the scores of physical fatigue, mental fatigue and total score of SF-14, SAS, SDS and PSQI were also all lower than those in control group (P<0.01). Levels of IgG, IgA, and IgM in observation group were higher than those in control group (P<0.01). Levels of NK, CD3⁺, CD4⁺, CD4⁺/CD8⁺ were also higher then those in control group (P<0.05). SOD and GSH-Px were all higher than those in control group (P<0.01), while levels of CD8⁺ (P<0.05) and MDA (P<0.01) were all lower than those in control group. Conclusion: Bushen Kangshuai tablets combined with abdominal massage to CFS with syndrome of spleen and kidney deficiency can significantly relieve fatigue, improve spleen and kidney deficiency, and improve immune function and antioxidant stress, superior to abdominal massage therapy alone in the clinical Efficacy.