探讨甲巯咪唑联合左旋甲状腺素( L-T4)治疗Graves病的疗效及预后。初诊Graves病患者入组治疗且随访1年者共540例(男性179例,女性361例),随机分成联合治疗组和单药治疗组,疗程12个月,联合治疗组给予甲巯咪唑和L-T4,入组治疗且最终完成1年随访者共263例(男性83例,女性180例);单药治疗组只给予甲巯咪唑,入组治疗且随访完毕者共277例(男性96例,女性181例)。治疗过程中每2个月随诊1次,复查甲状腺功能、肝酶及白细胞,停药时外加复查甲状腺自身抗体,行甲状腺超声检查并测定甲状腺体积。分别在甲状腺恢复正常且停药后的2、4、6、8、10、12个月监测甲状腺功能,比较2组的疗效,包括:Graves病缓解率、促甲状腺素受体抗体( TRAb)变化、甲状腺体积变化及复发情况。联合治疗组较单药治疗组在治疗1年后TRAb水平显著降低,甲状腺体积显著缩小,差异均有统计学意义(均P<0.05)。治疗过程中联合治疗组发生药物性甲状腺功能减退有3例,单药治疗组有23例。联合治疗组在停药的2、4、6、8、10、12个月内Graves病的复发率分别是5.7%、6.1%、4.9%、3.8%、3.8%、2.7%,总复发率为27.0%;单药治疗组为6.5%、5.8%、5.4%、5.1%、4.3%,4.3%,总复发率为31.4%,治疗后各阶段及1年内总复发率在两治疗组间差异无统计学意义(P>0.05)。甲巯咪唑联合L-T4治疗有助于降低TRAb的水平,使甲状腺体积明显缩小,并能减少治疗过程中药物性甲状腺功能减退的发生率,但并没有降低治疗后1年内Graves病的复发率。
[Summary] To assess and compare the curative effect and replase rates of methimazole alone vs in combination with levo-thyroxine for the treatment of Graves′ disease. 540 patients with newly diagnosed, and previously untreated Graves′ disease, were randomly divided into combined therapy group and monotherapy group. Combined therapy group were given methimazole and levo-thyroxine;on the contrary, monotherapy group only methimazole was given. Then thyroid stimulating hormone receptor (TRAb), thyroid volume, and thyroid function were measured to evaluate curative effect and prognosis. Compared with monotherapy group, levels of TRAb and the sizes of thyroid glands in combined therapy group were significantly decreased. In 2, 4, 6, 8, 10, 12 months after discontinuation of combined drugs, hyperthyroidism recurrence rates, were 5. 7%, 6. 1%, 4. 9%, 3. 8%, 3. 8%, and 2. 7% respectively, the overall recurrence rate of 12 months was 27. 0%, while in monotherapy group, the recurrence rates were 6. 5%, 5. 8%, 5. 4%, 5. 1%, 4. 3%, and 4. 3% respectively, the total recurrence rate was 31.4%, and the difference between combined group and monotherapy group was not significant (P>0.05). The conclusion is: comparing with monotherapy group, methimazole combined with levo-thyroxine in the treatment of hyperthyroidism reduces the levels of TRAb and thyroid volumes, decreases the incidence of drug-induced hypothyroidism, but does not decrease recurrence rate within one year.