流津润燥浓煎剂治疗原发性干燥综合征的疗效及安全性评价  

Efficacy and Safety Evaluation of Liujin Runzao Concentrated Decoction in Treating Primary Sjgren's Syndrome

作　　者：胡伟[1] 徐蕾[1] 徐长松[1] 徐媚媚[1] 郭亮[1] 陈月月[1] 徐大可[1] 项承荣[1] 

机构地区：[1]江苏省南京市中医院南京中医药大学第三附属医院风湿科,南京210001

出　　处：《中国中西医结合杂志》2017年第2期179-183,共5页Chinese Journal of Integrated Traditional and Western Medicine

基　　金：江苏省南京市中医院课题(No.YJ201401)

摘　　要：目的评价流津润燥浓煎剂治疗原发性干燥综合征(primary Sjgren's syndrome,pSS)的疗效及安全性。方法将40例原发性干燥综合征津亏失布证患者按1∶1的比例随机分入试验组和对照组,两组均给予标准治疗:白芍总苷600 mg,每日2次。试验组在标准治疗基础上给予流津润燥浓煎剂,每次30 m L口服,每日2次。对照组只标准治疗,服药4周为1个疗程,连续观察2个疗程。综合评价两组口干眼干改善疗效;并进行Schirmer试验及唾液流率测定;观察中医证候评分,血沉、免疫球蛋白等指标及药物不良反应。结果在8周结束时口干眼干改善综合疗效试验组有效率为80%,对照组为35%,两组比较差异有统计学意义(χ~2=8.286,P<0.05)。两组口干眼干积分与治疗前比较均下降,试验组治疗8周时差值大于对照组,两组8周时差值(95%CI)为1.71分(-0.37~3.78),差异均有统计学意义(P<0.05);试验组唾液流率及Schirmer试验与治疗前比较有改善,但差异无统计学意义(P>0.05),试验组治疗8周时差值大于对照组[两组8周时差值(95%CI)分别为2.74 m L/15 min(0.49~4.98)、0.13 mm/5 min(-0.92~1.23)],差异有统计学意义(P<0.05)。两组中医证候积分与治疗前比较均下降,试验组治疗8周时差值优于对照组[两组8周时差值(95%CI)为1.71分(-1.40~4.81)],差异无统计学意义(P>0.05)。对照组有1例出现尿路感染,试验组未出现明显不良事件。结论标准治疗联合流津润燥浓煎剂对p SS津亏失布证患者的口干眼干综合疗效比单纯标准治疗更好。Objective To evaluate the efficacy and safety of Liujin Runzao Concentrated Decoction（ LRCD） for the treatment of primary Sjgren＇s syndrom e（ p SS）.Methods Forty pSS patients with fluid depletion and distribution obstacles syndrom e（ FDDOS） were randomly assigned to the experim ental group and the control group according to 1 ∶ 1 proportion.All patients received standard therapy ： Radix Paeoniae alba total glycosides 6 0 0 mg,twice per day.Patients in the experim ental group additionally took LRCD,3 0 mL each tim e,twice per day.The therapeutic course for all was 4 weeks,and two courses for all.The im provem ent of dry m outh and dry eyes were com prehensively evaluated.Each outcome of com posite index constitutions（ integrals of dry eyes and dry m outh, salivary flow rate,Schirm er test） was respectively reported.Schirmer test and salivary flow rate were determ ined as well.Score of TCM syndrom e,blood sedim entation,immunoglobulin,and adverse drug reactions were observed.Results The effective rate of comprehensive effect for dry eyes and dry mouth improvement at the end of 8 weeks was 80 % in the experimental group and 35 % in the control group,with statistical difference（χ^2= 8.2 8 6,P〈0.05）.As for the com position of com prehensive effect for dry eyes and drym outh im provem ent： The score for dry eyes and dry mouth decreased in the two groups m ore after treatm ent than before treatm ent.The difference in pre-post treatm ent score for dry eyes and dry m outh at week 8 was higher in the experim ental group than in the control group.The difference in pre-post treatm ent score at week 8 was 1.71（ 95 % CI：-0.3 7-3.7 8） between the two groups（P〈0.05）.The difference in pre-post treatm ent Schirm er test and salivary flow rate at week 8 was higher in the experim ental group than in the control group,but with on statistical difference（P〉0.05）.The difference in pre-post treatment Schirmer test and salivary flow rate at week 8 was 2.7 4 mL /1 5 m in（ 95 % CI：0.4

关 键 词：流津润燥浓煎剂 原发性干燥综合征 津亏失布证 随机对照试验 

分 类 号：R259[医药卫生—中西医结合]