摘要
【目的】探讨加味逍遥散治疗肝郁脾虚型原发性干燥综合征的疗效和安全性。【方法】采用随机平行对照方法,将60例患者随机分为对照组和观察组,每组各30例。对照组给予口服硫酸羟氯喹治疗,观察组在对照组的基础上给予加味逍遥散治疗,疗程3个月。观察2组患者治疗前后口干及眼干视觉模拟法(VAS)评分、唾液流率、泪液流率、泪膜破碎时间、C-反应蛋白(CRP)、生活质量量表(SF-36)评分、肝肾功能指标的变化情况,评价2组疗效和安全性。【结果】(1)经治疗3个月后,观察组的总有效率为96.67%,对照组为62.07%,观察组的疗效明显优于对照组(χ2=10.89,P=0.001)。(2)治疗后,2组患者口干、眼干VAS评分均显著下降(P<0.01),SF-36量表评分均显著升高(P<0.01),且观察组在降低口干、眼干VAS评分和提高SF-36量表评分方面均优于对照组(P<0.05)。(3)治疗后,2组患者唾液流率、泪液流率、泪膜破碎时间均显著升高(P<0.01),CRP水平均显著下降(P<0.01),且观察组在提高唾液流率、泪液流率、泪膜破碎时间和降低CRP水平方面均明显优于对照组(P<0.05)。(4)治疗期间,2组患者均无明显不良反应事件发生,肝肾功能指标均无异常改变(P>0.05)。【结论】加味逍遥散联合硫酸羟氯喹治疗肝郁脾虚型原发性干燥综合征疗效确切,且无不良反应。
Objective To observe the clinical efficacy of Jiawei Xiaoyao Powder (JXP)for the treatment of primary Sjogren syndrome with liver depression and spleen deficiency.Methods A randomized,parallel-controlled trial was carried out in 60 primary Sjogren syndrome patients with liver depression and spleen deficiency.The patients were evenly divided into control group and observation group.Patients in the control group were treated by Hydroxychloroquine Sulfate Tablets (HST)orally,and the patients in the observation group were treated by HST combined with JXP orally.Both groups received the treatment for 3 months.Before and after treatment,the visual analogue scale (VAS)scores of dryness in the mouth and eyes,salivary flow rate (SFR),tear flow rate (TFR), tear break-up time (TBUT),serum C-reactive protein (CRP)level,scores of life quality of Short-form 36-item Health Survey (SF-36)and hepatic-renal function indexes were recorded.After treatment,the clinical efficacy and adverse reaction were recorded.Results (1)After treatment for 3 months,the total effective rate in the observation group was 96.67%,which was superior to 62.07%in the control group (x^2=10.89:P =0.001).(2) The VAS scores of dryness in the mouth and eyes of the two groups after treatment were decreased (P <0.01),SF-36 scores were increased (P <0.01),and effects on decreasing VAS scores and on increasing SF-36 scores in the observation group were superior to those in the control group (P<0.05).(3)SFR,TFR and TBUT in the two groups after treatment were increased (P <0.01),serum CRP level was decreased (P <0.01),and the effects on increasing SFR,TFR and TBUT and on decreasing CRP level in the observation group were superior to those in the control group (P <0.05).(4)During treatment,the two groups showed no adverse events or abnormal changes in the hepatic-renal function indexes.Conclusion HST combined with JXP is effective and safe for the treatment of primary Sjogren syndrome patients with liver depression and spleen deficiency.
作者
何清华
张露鹤
陈纪藩
黄广文
刘清平
HE Qing-Hua;ZHANG Lu-He;CHEN Ji-Fan;HUANG Guang-Wen;LIU Qing-Ping(Guangzhou University of Chinese Medicine,Guangzhou 510405 Guangdong,China;The First Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510405 Guangdong,China)
出处
《广州中医药大学学报》
CAS
2019年第2期160-164,共5页
Journal of Guangzhou University of Traditional Chinese Medicine
基金
广东省科技计划项目(编号:2012B031800211)
关键词
加味逍遥散
原发性干燥综合征
肝郁脾虚
口干眼干VAS评分
生活质量评分
Jiawei Xiaoyao Powder
primary Sjogren syndrome
liver depression and spleen deficiency
VAS scores of dryness in mouth and eyes
scores of quality of life
