生津润燥养血颗粒治疗干燥综合征的临床研究  

Clinical studies of Shengjinrunzaoyanyxue Granules on treating Sjogren syndrome

作　　者：钱先[1] 胡伟[2] 郭峰[1] 张缪佳[3] 陶娟[4] 高忠恩 周正球 

机构地区：[1]江苏省中医院,南京210029 [2]南京市中医院,南京210001 [3]江苏省人民医院,南京210029 [4]无锡市中医院,无锡214071 [5]苏州市中医院,苏州215009 [6]常州市中医院,常州213003

出　　处：《中华中医药杂志》2014年第11期3663-3666,共4页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：科技部"十一五"国家科技支撑计划项目(No.2007BAI20B055)~~

摘　　要：目的:观察生津润燥养血颗粒治疗干燥综合征(SS)阴虚津亏证口干眼干的疗效和安全性。方法:选取240例SS阴虚津亏证患者,按计算机生成的随机分组方案,以2∶1的比例予生津润燥养血颗粒剂或安慰剂颗粒,每日1剂,服药6周。主要观察终点为Schirmer试验、唾液流率、含糖时间的变化,次要观察终点为眼干及口干的评价积分。结果:6周时,意向性分析及符合方案分析:左眼Schirmer试验改善的差值分别为1.80mm/5min(95%置信区间0.37-3.22)和1.82mm/5min(95%置信区间0.32-3.31);右眼Schirmer试验改善的差值为2.77mm/5min(95%置信区间1.26-4.28)和2.81mm/5min(95%置信区间1.23-4.39),两组治疗后组间比较及组内前后配对比较,差异有统计学意义(P<0.05)。意向性分析及符合方案分析唾液流率改善的差值分别为0.04mL/15min(95%置信区间0.49-0.85)和0.04mL/15min(95%置信区间0.52-0.60),组间比较差异无统计学意义。含糖试验改善的差值意向性分析及符合方案分析分别为1.17min(95%置信区间0.11-3.44)和1.84min(95%置信区间0.12-3.55),组间比较差异无统计学意义。对于次要终点指标,眼干及口干的评价积分均有明显改善(P<0.05)。结论:生津润燥养血颗粒治疗SS阴虚津亏证6周后,能改善口干眼干的症状及泪流率,且安全性较高。Objective： To observe the efficacy and safety evaluation of Shengjinrunzaoyangxue Granules on relieving symptoms of dry eye and dry mouth in primary Sjogren syndrome patients with yin-deficiency and depletion of fluid syndrome. Methods： Two hundreds and forty patients with yin-deficiency and depletion of fluid syndrome were grouped by a computer- generated randomized grouping design. The dosage regimen was devised as Shengjinrunzaoyangxue Granules or placebo granules （in ratio of 2：1） were given 1 dose per day for 6 weeks. The primary end point was change of the Schirmer test, salivary flow rate, speed of sugar test. The secondary end point was the score of dry eyes and dry mouths. Results： After 6 weeks： The results of intention-to-treat analysis and per-protocol analysis showed that the difference value of Schirmer test for the left eyes were 1.8mm/5min（95% confidence interval： 0.37-3.22） and 1.82mm/5min （95% confidence interval： 0.32-3.31）, and the value of Schirmer test for the fight eyes were 2.77mm/5min （95% confidence interval： 1.26-4.28） and 2.81mm/5min （95% confidence interval： 1.23-4.39）. The difference has statistical significance in post-treatment intergroup comparison and intragroup comparison （P〈0.05）. The results of intention-to-treat analysis and per-protocol analysis showed the difference value of salivary flow rate were 0.04mL/15min（95% confidence interval： 0.49-0.85） and 0.04mL/15min（95% confidence interval： 0.52-0.60）. There was no statistical significance in post-treatment intergroup comparison （P〈0.05）. The results of intention-to-treat analysis and per-protocol analysis showed the difference value of speed of sugar test were 1.17min （95% confidence interval： 0.11-3.44） and 1.84rain （95% confidence interval： 0.12-3.55）. And there was no statistical significance in post-treatment intergroup comparison （P〈0.05）. There was a significant improvement of the scores of dry eyes and dry mouths. And the difference has sta

关 键 词：生津润燥养血颗粒 干燥综合征 阴虚津亏证 随机对照试验 

分 类 号：R259[医药卫生—中西医结合]