解毒通络生津法治疗原发性干燥综合征的临床研究  

The Efficacy and Safety of the Therapeutic Method of Detoxicating, Relieving Meridian and Engendering Fluid in the Treatment of the Primary Sjogren Syndrome

作　　者：胡建东[1] 李国陵[1] 薛鸾[1] 王丹[1] 杨月[1] 吴香香[1] 朴雪梅[1] 关超[1] 吴丹巍[1] 王凌[1] 居庆浩[1] 

机构地区：[1]上海中医药大学附属岳阳中西医结合医院,上海200437

出　　处：《中国中医基础医学杂志》2013年第1期70-73,共4页JOURNAL OF BASIC CHINESE MEDICINE

基　　金：上海市科委中药现代化专项项目(09dZ1976400)

摘　　要：目的:评价解毒通络生津法分层干预原发性干燥综合征的疗效及安全性。方法:240例患者根据病情分为轻、中、重三层,三层患者分别随机分为治疗组和对照组。轻度层患者治疗组给予解毒通络生津方,对照组患者给予溴己新片和人工泪液治疗;中、重度患者治疗组给予解毒通络生津方和强的松、羟基氯喹联合治疗,对照组单纯给予强的松、羟基氯喹治疗。分别在治疗前、治疗3个月、治疗6个月观察患者的口干、眼干VAS评分、唾液流率、Schirmer’s试验、ESR、血清IgG、RF、CRP及生活量表SF-12,治疗过程中检查不良反应,治疗结束时评价总体疗效。结果:轻度层患者治疗组在改善口干VAS、增加唾液分泌、降低红细胞沉降率及CRP、降低血清IgG、改善SF-12方面优于对照组(P<0.05);2组均能改善眼干VAS评分,但Schirmer’s试验的改善均无统计学意义;治疗组有效率为60%,对照组为19%(P<0.05)。中度层患者2组均能有效改善口干VAS及提高唾液分泌,降低血沉、CRP,且治疗组优于对照组(P<0.05);2组均能有效改善眼干主观症状,降低RF及血清IgG,但2组比较差异无统计学意义;治疗组对Schirmer’s试验显示有效(P<0.05);6个月时2组均显示SF-12方面的显著变化,但治疗组在3个月时即显示SF-12方面的显著变化(P<0.05),治疗组疗效优于对照组(71%vs 49%)(P<0.05)。重度层患者治疗组口干VAS有显著变化(P<0.05),但较对照组无显著变化,2组在唾液流率、Schirmer’s试验、ESR、CRP、血清IgG、RF、SF-12、疗效对比等差异均无统计学意义,2组无药物相关严重不良反应。结论:解毒通络生津方有效改善患者的主观症状和客观指标,控制病情活动,从而提高患者生活质量和临床疗效,是轻中度原发性干燥综合征长期治疗安全、有效的优选方案。Objective To evaluate the efficacy and safety of ~he TCM therapeutic method of detoxicating , relieving meridian and engendering fluid in patients with primary Sjogren syndrome. Methods：In a 6 month, randomized, controlled clinical trial, 240 primary Sjogren syndrome patients were divided into three levels according to their state of illness. The three levels of patients were randomized to treatment group and control group respectively. In mild level, patients in treatment group receive Detoxicating , Relieving meridian and Engendering fluid Formula（DREF） , while receiving HCQ and artificial tears in control group; The treatment group of moderate and severe level receive DREF ＋ prednisone ＋ HCQ, while control group receive prednisone ＋ HCQ. VAS scale of xerostomia and xerophtalmia,saliva flow rates, Schirmer＇ s test, serum test（ESR,CRP,RF,IgG） and SF-12 were conducted before and after 3 and 6 months. The therapeutic effect was evaluated when the trials finished. Adverse reaction was monitored during the trail. Results： In the mild level： The treatment group show better effect in improving VAS scale of xerostomia and SF-12 increasing salvation, reducing ESR,CRP and IgG（P 〈0. 05; Both the two group showed significantly improving in VAS scale of xerophthalmia, but there was no significant difference between groups. The treatment group had better therapeutic effect than the control group （60% vsl 9, P 〈 0. 05）. In the moderate level： Though both the two groups improved significantly the VAS of xerostomia, decrease the ESR and CRP, the treatment group showed much superiority（ P 〈 O. 05 ）;There was no significant difference between group, though both the treatment groups and control group could improve the VAS of xerophtalmia, reduce RF and IgG;The change of SF-12 was earlier in treatment group than in the control group （ P 〈 0.05 ） ; The treatment group had better therapeutic effect than the control group （ 71% vs 49% , P 〈 0.05 ）. In severe level： VAS scale of xe

关 键 词：解毒通络生津法 原发性干燥综合征 分层干预 

分 类 号：R442.8[医药卫生—诊断学]