益胃汤加味方对原发性干燥综合征疲劳症状的影响

Effect of Modified Yiweitang on Fatigue Symptom of Primary Sjorgren′s Syndrome

目的:探讨益胃汤加味对改善原发性干燥综合征(primary sjorgren’s syndrome,pSS)气阴两虚、瘀血阻络证患者疲劳症状及免疫学指标的治疗效果。方法:将116例原发性干燥综合征患者按照随机、对照、单盲法分为治疗组与对照组,每组58例。治疗组给予益胃汤加味方,每日1剂,2次/d;对照组给予硫酸羟氯喹200 mg/次,2次/d,两组均连续治疗24周。比较治疗前后两组患者中医证候疗效、中医疲劳症状积分、疲劳症状视觉模拟评分(visual analogue scale,VAS)以及类风湿因子(rheumatoid factor,RF)与血清免疫球蛋白G(immunoglobulin G,IgG)水平。结果:治疗后治疗组患者中医证候疗效优于对照组(Z=3.712,P<0.05);治疗组中医疲劳积分与疲劳症状视觉模拟评分改善均优于对照组(P<0.05)。治疗6个月后,治疗组IgG水平较本组治疗前明显下降(P<0.05),与对照组组间比较差异无统计学意义。治疗后两组类风湿因子与本组治疗前比较均无明显下降。治疗组不良反应率1.75%(1/57),对照组不良反应发生率为25.49%(13/51)。结论:与硫酸羟氯喹相比,益胃汤加味方治疗pSS,可明显改善患者疲劳及总体症状,两者均可降低血清IgG,益胃汤加味方组疗效较硫酸羟氯喹更明显。两组药物对pSS患者RF水平均无明显影响。长期用药,益胃汤加味方治疗pSS较硫酸羟氯喹更为安全。

Objective:To observe the effect of modified Yiweitang on fatigue symptom and immunological indicators in primary Sjorgren′s Syndrome(pSS).Method:By random,control,single-blind method,116 cases of patients with pSS were divided into treatment group and control group,with 58 cases in each group.The treatment group was given modified Yiweitang,a dose a day,twice a day,and the control group was given hydroxychloroquine sulfate(HCQ)200 mg/time,twice a day.The treatment lasted for six months.Visual analogue scale(VAS)of fatigue symptoms,total traditional Chinese medicine(TCM)syndrome score,TCM fatigue score,rheumatoid factor(RF)and serum immunoglobulin G(IgG)were used to compare two groups before and after treatment.Result:After treatment,the treatment group had a better efficacy on TCM syndromes than control group(Z=3.712,P<0.05).After treatment,the treatment group were superior to control group in improvement of TCM fatigue score and VAS score of fatigue symptom(P<0.05).After 6 months of treatment,IgG level in treatment group decreased significantly compared with before treatment,with statistical differences(P<0.05),but no difference between treatment group and control group.After treatment,RF in two groups showed no significant decrease compared with before treatment.The incidence of adverse reactions in the treatment group and the control group were 1.75%(1/57)and 25.49%(13/51),respectively.Conclusion:Compared with HCQ,modified Yiweitang can significantly alleviate fatigue and overall symptoms of patients of pSS,both of which can reduce serum IgG,and the efficacy of modified Yiweitang is more obvious than hydroxychloroquine sulfate.Both drugs had no significant effect on RF level of pSS patients.After long-term administration,modified Yiweitang is safer than hydroxychloroquine sulfate in the treatment of pSS.