养阴生津解毒方治疗干燥综合征临床对照研究

Treatment of Sjgren syndrome with "Yangyin Shengjin Jiedu Decoction": A clinical controlled study

目的观察养阴生津解毒方治疗阴虚型干燥综合征的临床疗效。方法将160例干燥综合征患者随机分为治疗组和对照组(各80例),治疗组服用养阴生津解毒方,对照组服用养阴生津方。两组疗程均为24周,观察综合临床疗效、中医临床症状疗效及治疗后实验室指标、中医症状积分变化情况。结果治疗组、对照组综合临床疗效总有效率分别为71.25%、52.50%,组间综合临床疗效比较,差异有统计学意义(P<0.05)。治疗组、对照组中医临床症状疗效分别为68.75%、51.25%,组间中医临床症状疗效比较,差异有统计学意义(P<0.05)。治疗组及对照组治疗后中医临床症状积分、干眼症症状积分、含糖试验、Sch irm er试验(SIT)、泪膜破裂时间(BUT)及角膜荧光素染色(FL)均有改善(P<0.01),治疗组对干眼症症状、中医临床症状及含糖试验的改善较对照组更优(P<0.05)。两组治疗后ESR、CRP、血β2-MG均有下降(P<0.01),组间差异无统计学意义(P>0.05)。两组治疗后类风湿因子(RF)、B细胞均有下降(P<0.01),组间差异无统计学意义(P>0.05)。治疗组IgG、Th/Ts均有下降(P<0.05,P<0.01),对照组无明显变化(P<0.05);组间比较,差异无统计学意义(P>0.05)。结论养阴生津解毒方可抑制干燥综合征患者自身免疫性炎症,缓解临床症状,控制原发病进展;以养阴生津解毒方为代表的养阴生津解毒法与单纯养阴生津法疗效存在差异,养阴生津解毒方综合疗效优于养阴生津方。

Objective To observe the effects of ＂Yangyin Shengjin Jiedu Decoction＂ on Sjgren syndrome of yin deficiency.Methods One hundred and sixty subjects were divided randomly into two groups： treatment group in which 80 cases were treated with ＂Yangyin Shengjin Jiedu Decoction＂ and control group in which 80 cases were treated with ＂Yangyin Shengjin Decoction＂,with a course of 24 weeks.The overall clinical efficacy,clinical efficacy for symptoms,laboratory indexes and clinical symptoms scores were observed in the two groups.Results The overall effective rate was higher in the treatment group than in the control group（71.25% vs 52.50%,P〈0.05）;the effective rate for symptoms was higher in the treatment group than in the control group（68.75% vs 51.25%,P〈0.05）.After treatment,the clinical symptoms scores,dry eyes scores,sugar dissolve test,Schirmer test（SIT）,BUT and FL in the two groups were improved significantly（P〈0.01）.The improvement of clinical symptoms scores,dry eyes scores and sugar dissolve test was more significant in the treatment group than in the control group（P〈0.05）.The RF and B cell were reduced in both groups（P〈0.05）,with no difference between the two groups（P〉0.05）.The IgG and Th/Ts were decreased obviously in the treatment group（P〈0.05,P〈0.01）,and little in the control group,with no obvious difference between the two groups（P〉0.05）.Conclusion Both ＂Yangyin Shengjin Jiedu Decoction＂ and ＂Yangyin Shengjin Decoction＂ can suppress autoimmune inflammation,improve clinical symptoms and delay the progression in the treatment of Sjgren syndrome,with better results of the former Decoction.