平目颗粒治疗非活动期Graves眼病阳气亏虚、痰瘀阻滞证的临床观察

Clinical Observation on Treatment of Non-active Graves' Ophthalmopathy with Syndrome of Yang-Qi Deficiency and Phlegm-Blood Stagnation by Pingmu Granule

目的:观察平目颗粒治疗非活动期Graves眼病患者阳气亏虚、痰瘀阻滞证的临床疗效。方法:将来自三个分中心90例非活动期Graves眼病患者,按照区组随机、双盲、对照原则分为试验组和对照组,试验组予平目颗粒,对照组予平目颗粒模拟剂,疗程24周,分别观察两组治疗前后突眼度,中医证候改善情况(中医证候积分)及有效率,游离三碘甲状腺原氨酸(FT3)、游离甲状腺素(FT4)、促甲状腺激素(TSH)的变化情况,安全性指标血常规、尿常规、大便常规、肝肾功能及心电图,观察可能出现的不良反应。结果:治疗后两组突眼度总有效率比较,试验组为81.4%,对照组17.1%,试验组较对照组明显降低患者的突眼度(P<0.01)。试验组中医证侯疗效总有效率为88.37%,对照组总有效率为31.71%,试验组中医证侯改善明显优于对照组(P<0.01)。治疗前后两组甲状腺功能比较,差异无统计学意义。治疗后两组安全性指标检查均正常。结论:与对照组比较,平目颗粒可有效降低非活动期Graves眼病阳气亏虚、痰瘀阻滞证患者的突眼度,改善其临床中医证候,具有良好的临床疗效和安全性。

Objective：To observe the clinical efficacy of Pingmu Granule in treating non -active Graves Ophthalmopathy with syndrome of yang- qi deficiency and phlegm- blood stagnation. Methods ：90 cases of patients with non- active Graves Ophthalmopathy were collected and divided into treatment group and control group according to the methods of a multi -center, block randomization, double -blind, contras methodt. The treatment group was treated with Pingmu Granule and the control one was treated with the simulation drug and the course of treatment was 24 weeks. The clinical curative effect and Chinese medicine symptom complex score were evaluated. The degrees of exophthalmus, the level of free triiodothyronine （ FT3 ）, free thyroxine （ PlOd ）, and thyroid strmulating hormone （TSH） were detected. Blood routine, urine routine, stool routine, the function of liver and kindney, and electrocardiograph were monitored, and the adverse reactions were examined. Results ：The total effective rate of the treatment group and control group was 81.4% and 17.1% respectively, and the Chinese medicine symptom complex score of treatment group and control group was 88.37 % and 31.71% , respectively. Compared to control group, the treatment group significantly reduced the degree of exophthalmus and improved Chinese medicine symptom of patients with non -active Graves Ophthalmopathy （P 〈0.01 ）. There was no differ- ence in the thyroid function test such as FT3, FF4 and TSH between before and after treatment. The security indicators are also normal after treatment. Conclusions ： Pingmu Granule is an effective and safe drug to treat the non - active Graves disease with syndrome of yang- qi deficiency and phlegm- blood stagnation.