养阴消甲方联合甲巯咪唑治疗甲状腺功能亢进症急性期随机平行对照研究

Yangyin Xiaojia Fang(养阴消甲方) with Methimazole in the Treatment of Hyperthyroidism Randomized Controlled Study

[目的]观察养阴消甲方联合甲巯咪唑治疗甲状腺功能亢进症急性期疗效。[方法]使用随机平行对照方法,将80例住院及门诊患者按随机数字表法简单随机分为两组。对照组40例甲巯咪唑,10mg/次,3次/d,餐饭后30min口服,甲状腺激素水平恢复正常后逐渐减量,5~10mg/次。治疗组40例养阴消甲方:生地25g,玄参、麦冬各20g,龟板、牡蛎各15g,栀子10g,浙贝、猫爪草各15g,香附10g,水煎300m L,1剂/d,早晚分服;甲巯咪唑治疗同对照组。连续治疗8周为1疗程。观察临床症状、中医症候积分(心悸不宁、烦躁易怒、消瘦、眠差、颈前肿大)、生活质量评分、SF-36、TT4、FT4、TT3、FT3、TSH、不良反应。治疗1疗程(8周),判定疗效。[结果]治疗组临床控制1例,显效22例,有效17例,无效0例,愈显率57.50%;对照组临床控制2例,显效20例,有效19例,无效0例,愈显率55.00%;临床疗效两组无显著性差异(P>0.05)。心悸不宁、烦躁易怒、消瘦、眠差、颈前肿大两组均有明显改善(P<0.01,P<0.05),治疗组改善优于对照组(P<0.01);颈前肿大改善两组间无明显差异(P>0.05)。生活质量评分治疗组明显改善(P<0.01),对照组无明显变化(P>0.05)。[结论]养阴消甲方联合甲巯咪唑治疗甲状腺功能亢进症急性期,疗效满意,无严重不良反应,值得推广。

[Objective] To observe the clinical efficacy of Yangyin Xiaojia Fang with methimazole in the treatment of hyperthyroidism in acute phase. [Methods] 80 patients were randomly divided into the observation group and the control group, 40 cases in each. 40 patients in the control group received methimazole 10 mg tid, 30 minutes after a meal, reduced after the thyroid hormone level gradually returning to normal, 5-10 mg. 40 patients in the observation group received TCM therapy of Yangyin Xiaojia Fang： Shengdi 25 g, Xuanshen and Maidong each 20 g, Guiban and Muli each 15 g, Zhizi 10 g, Zhebeimu and Maozhaocao each 15 g, Xiangfu 10 g, fried with water to 300 m L, 1 day 1 agent,oraled in the morning and evening. Treatment of the observation group was the same with the control group in methimazole. Continuous treatment of 8 weeks for one course.Observed the clinical symptoms、traditional Chinese medicine symptom integral（hear palpitations, irritable, weight loss, poor sleep, swelling of the anterior portion）﹑score of living quality﹑SF-36﹑TT4﹑FT4﹑TT3﹑FT3﹑TSH﹑untoward effect. Treatment as a course（8 weeks）, judged curative effect. [Results] The observation group achieved clinical control in 1 case, 22 cases had marked effect, 17 cases effective, 0 noeffect, the markedly effective rate was 57.50%. The control group achieved clinical control in 12 case, 20 cases had marked effect, 179 cases effective, 0 no effect, the markedly effective rate was 55.00%. The total efficiency of the two groups showed no significant difference（P〉0.05）. Hear palpitations, irritable, weight loss, poor sleep had improved significantly after the treatment（P〈0.01, P〈0.05）, the observation group were better than the control group, the difference was statistically significant（P〈0.01）. The improving of swelling of the anterior portion has no significant differences between the two groups（P〉0.05）. The observation group had a significant improving in living quality（P〈0.01）, in which the control group had no change（P〉0.05）.[Conclusion] The Yangyin Xiaojia Fang with methimazole was effective in the treatment of hyperthyroidism in acute phase, which had no serious untoward effect and worthy of clinical application.