甲巯咪唑片治疗甲状腺功能亢进患者的临床研究

Clinical trial of thiamazole tablets in the treatment of patients with hyperthyroidism

目的比较甲巯咪唑片和丙硫氧嘧啶片治疗甲状腺功能亢进患者的临床疗效及安全性。方法将100例甲状腺功能亢进患者随机分为对照组和试验组,每组50例。对照组给予丙硫氧嘧啶片初始剂量每次300~450 mg,qd,口服,2周后根据具体情况可酌情加减;试验组给予甲巯咪唑片初始剂量每次30~45 mg,qd,口服,2周后根据具体情况可酌情加减。2组患者均治疗6个月。比较2组患者的临床疗效,甲状腺功能,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为96.00%(48例/50例)和82.00%(41例/50例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的游离三碘甲状腺原氨酸分别为(3.95±0.81)和(4.80±1.16)pg·mL^-1,游离甲状腺素分别为(2.33±0.85)和(3.02±0.90)ng·mL^-1,促甲状腺激素分别为(1.95±0.48)和(1.56±0.55)mU·L^-1,差异均有统计学意义(均P<0.05)。试验组发生的药物不良反应有失眠、心悸和胃肠道不适,对照组发生的药物不良反应有胃肠道不适和失眠。试验组和对照组的总药物不良反应发生率分别为14.00%和6.00%,差异无统计学意义(P>0.05)。结论甲巯咪唑片治疗甲状腺功能亢进患者的临床疗效优于丙硫氧嘧啶片,其能显著地改善患者的甲状腺功能,且不增加药物不良反应的发生率。

Objective To compare the clinical efficacy and safety of thiamazole tablets and propylthiouracil tablets in the treatment of patients with hyperthyroidism. Methods One hundred patients with hyperthyroidism were randomly divided into control and treatment groups with 50 cases per group. Control group was given the initial dose of propylthiouracil tablets 300-450 mg per time, qd, orally, and it can be added or subtracted according to the specific situation after 2 weeks. Treatment group received the initial dose of thiamazole tablets 30-45 mg per time, qd, orally, and it can be added or subtracted according to the specific situation after 2 weeks. Two groups were treated for 6 months. The clinical efficacy, thyroid function and adverse drug reactions were compared between two groups. Results After treatment, the total effective rates of treatment and control groups were 96.00%(48 cases/50 cases) and 82.00%(41 cases/50 cases) with significant difference(P<0.05). After treatment, the main indexes of treatment and control groups were compared: free three-point thyrosine were ( 3. 95 ± 0. 81) and( 4. 80 ± 1. 16) pg·mL^-1,free thyroxine were( 2. 33 ± 0. 85) and( 3. 02 ± 0. 90) ng·mL^-1,thyrotrophin were( 1. 95 ± 0. 48) and( 1. 56 ± 0. 55) mU · L^-1,the differences were statistically significant( all P < 0. 05). The adverse drug reactions of treatment group were insomnia,palpitation and gastrointestinal discomfort,while those in the control group were gastrointestinal discomfort and insomnia. The incidences of total adverse drug reactions in the treatment and control groups were 14. 00% and 6. 00% without significant difference( P > 0. 05).Conclusion The clinical efficacy of thiamazole tablets in the treatment of patients with hyperthyroidism is better than that of propylthiouracil tablets,which can significantly improve the thyroid function of patients without increasing the incidence of adverse drug reactions.