新风胶囊对32例干燥综合征患者的疗效及生活质量的影响

The Curative Effect of Xinfeng Capsule on 32 Cases with Sj gren Syndrome and its Effects on Their Quality of Life

目的:观察新风胶囊对干燥综合征患者的疗效及生活质量的影响。方法:将64例干燥综合征患者随机分为治疗组和对照组,每组32例。治疗组给予新风胶囊治疗,对照组给予羟氯喹治疗,两组均以3个月为1个疗程。观察患者临床疗效及两组治疗前后生活质量积分、抑郁自评量表积分(SDS)、焦虑自评量表(SAS)及中医症状积分等的变化。结果:①两组治疗后血、尿常规,红细胞沉降率,类风湿因子,抗核抗体谱,补体,免疫球蛋白,肝、肾功能,泪膜破碎时间均较前好转,且治疗组优于对照组(P<0.05);②干燥综合征患者双眼荧光素角膜评分,两组治疗后较治疗前评分明显下降,且治疗组优于对照组,差异有统计学意义(P<0.05);在3项加分的角膜改变中,以着染点融合最常见,其次为着染点出现在瞳孔区角膜,丝状角膜炎最少见。③两组治疗前后静态唾液流率比较,治疗后较治疗前唾液流率明显增加,差异均有统计学意义(P<0.05);治疗后两组间静态唾液流率比较,差异有统计学意义(P<0.05)。④两组治疗后各项中医证候积分均低于治疗前,差异有统计学意义(P<0.05);与对照组比较,治疗组治疗后各项中医证候积分均显著降低,差异有统计学意义(P<0.05)。⑤中医临床疗效评价发现,治疗组和对照组的有效率分别为90.62%和75.00%,两组疗效比较,差异有统计学意义(P<0.05);且治疗组显效率优于对照组(P<0.05)。⑥两组治疗前生活质量各维度积分(SF-36)、焦虑自评量表(SAS)、抑郁评分(SDS)比较,差异无统计学意义(P>0.05);治疗组治疗后的SF-36各维度评分高于对照组,SAS、SDS评分低于对照组,差异均有统计学意义(P<0.05)。结论:新风胶囊在对干燥综合征的临床疗效、患者总体生活质量、以及改善患者焦虑抑郁情绪、唾液流率、中医证候方面疗效优于羟氯喹。

Objective：To observe the curative effect of xinfeng capsule on sj6gren syndrome and its effects on patients＇ quality of life.Methods：64 cases with sj6gren syndrome were randomly and equally divided into the treatment group and the control group,with the former treated with xinfeng capsule and the latter with hydroxychloroquine for 3 months as a course,observing the clinical effect,and the changes of the life quality score,self-rating depression scale （ SDS ） ,self-rating anxiety scale （ SAS ） and TCM symptom score before and after treatment.Results： （1） The blood,urine routine,erythrocyte sedimentation rate,rheumatoid factor, antinuclear antibodies,complement,immunoglobulin, liver and kidney functions,lacrimal film broken time of the two groups after treatment were better, with the treatment group being better than the control group; （2） The fluorescein corneal scores of the two groups significantly decreased after treatment,the treatment group being better than the control group and the difference being statistically significant （ P 〈 0.05 ） ; （3） Salivary flow rates of the two groups after treatment significantly increased than those before treatment,the difference being statistically significant （ P 〈 0.05 ） ;the difference of static salivary flow rate between the two groups after treatment was statistically significant. （ P 〈 0.05 ） ; （4） The TCM symptom scores of the two groups after treatment were lower than those before treatment,the difference being statistically significant （ P 〈 0.05 ） ;compared with the control group,the TCM symptom scores of the treatment group after treatment were significantly lower, with statistical significance （ P 〈 0.05 ） ; （~） TCM clinical evaluation showed that the effective rate of the treatment group and the control group were respectively 90.62% and 75.00%,the difference between the two groups was statistically significant （ P 〈 0.05 ） ,the treatment group was more efficient than the control group （ P 〈 0.05 ） ; （5） The differences of SF-36,SAS and SDS of the two groups before treatment showed no significant difference （ P 〉 0.05 ） .Each dimensional score of SF-36 of the treatment group after treatment was higher than that of the control group,and its SAS and SDS scores were lower than those of the control group,the difference being statistically significant （ P 〈 0.05 ） .Conelusion：Xinfeng capsule could improve not only the curative effect but also the patients＇ overall quality of life,being better in improving anxiety and depression,salivary flow rate and TCM symptoms than hydroxychloroquine.