丙硫氧嘧啶治疗Graves病减量期方案比较

Comparison of Graves disease by PTU in the reduction period

目的探讨丙硫氧嘧啶治疗Graves病减量期合理方案,为临床治疗提供参考.方法采用多中心随机实验研究,将初次确诊的1 440例Graves病患者,按照随机区组设计原则分配至A组、B组、C组、D组各360例,每组再分为亚1组、亚2组、亚3组各120例;治疗期均口服丙硫氧嘧啶治疗,减量期方案为A组、B组、C组、D组分别在第1周、第2周、第3周、第4周减少药物剂量1次;亚1组、亚2组、亚3组各组每次减少1/12、1/8、1/6基础剂量;维持治疗6个月.统计各组有效率、甲状腺功能亢进复发率、甲状腺功能减退发生率、不良反应发生率、治疗变异率、疗程,并以积分法综合评价各治疗方案.结果 A组、B组、C组、D组及各对应亚组(1组、2组、3组)的总有效率、甲亢复发率、治疗变异率、疗程比较差异均有统计学意义(P<0.05或0.01).两两比较显示:总有效率B组>C组>D组>A组,亚1组>亚2组>亚3组;甲亢复发率A组>D组>C组>B组,亚3组>亚1组>亚2组;甲减发生率D组>C组>A组>B组,亚1组>亚2组、亚3组;不良反应发生率D组>A组>B组>C组,亚1组>亚2组>亚3组;治疗变异率A组>D组>C组>B组,亚3组>亚2组>亚1组;疗程D组>A组>C组>B组,亚3组>亚2组>亚1组.各组治疗效果积分依次为B组>C组>A组>D组,各亚组治疗效果积分依次为亚1组、亚2组均>亚3组,B组亚1组、亚2组合积分最高,即B组亚1组、亚2口服丙硫氧嘧啶治疗Graves病患者具有较好疗效,减量期以每2周减量1次,每次减少1/12或组为最佳治疗方案.结论 1/8为较合理的治疗方案.

Objective To investigate the reasonable reduction plan for oral anti-thyroid drug therapy for Graves disease. Methods A multicenter randomized trial was used to assign 1440 patients with Graves’ disease, initially diagnosed, to Group A, Group B, Group C, and Group D according to randomized block design principles, 360 cases in each group. Each group was subdivided into subgroup 1, subgroup 2, and subgroup 3,120 cases each. During the treatment period,propylthiouracil (PTU) was given orally,and in the reduction period, the doses of A, B,C,and D were reduced once in the first, second, third,and fourth weeks, respectively. Subgroup 1,subgroup 2,and subgroup 3 reduced the base dose by 1/12,1/8, and 1/6 each time. Maintenance treatment for 6 months. The efficiency of each group, the recurrence rate of hyperthyroidism, the incidence of hypothyroidism, the incidence of adverse reactions, the treatment mutation rate, and the course of treatment were analyzed. The integral method was used to comprehensively evaluate each treatment plan. Results The total effective rate, recurrence rate, treatment mutation rate and course of treatment of group A, group B, group C,group D and corresponding subgroups (group 1, group 2, group 3) were statistically sig-nificant ( P< 0. 05 or 0. 01 ). Pairwise comparison shows: total effective group B〉C group〉D group〉A group,subgroup 1〉subgroup 2〉subgroup 3. Recurrence rate of hyperthyroidism group A〉group D〉group C〉group B,subgroup 3〉subgroup 1〉subgroup 2. The incidence of hypothyroidism group D〉group C〉group A〉group B,subgroup 3〉subgroup 1〉subgroup 2. The incidence of adverse re-actions group D> group A> group B> group C, subgroup 1 > subgroup 2 > subgroup 3. Treatment mutation rate group A〉group D> group C〉group B,subgroup 3〉subgroup 2〉subgroup 1. Course of treatment group D〉group A〉group C〉group B,subgroup 3〉subgroup 2〉subgroup 1. The treatment effect scores of each group were respectively group B> group C> group A> group D,the treatment effect scores of each subgroup were respectively subgroup 1 and subgroup 2 all > subgroup 3, subgroup 1 and subgroup 2 in group B had the highest scores. That is,subgroup 1 and subgroup 2 in group B were the best treatment options. Conclusions Oral propylthiouracil is effective in the treatment of patients with Graves disease. The reduction period is reduced by 1 time every 2 weeks,and the reduction of 1/12 or 1/8 is a reasonable treatment plan. It is reduced every time by 2 weeks in the reduction period. The reduction of 1\12 or 1< each time is a reasonable treatment plan.