亚甲方治疗血热夹瘀型亚急性甲状腺炎临床随机对照研究

“Yajia Formula”for the treatment of subacute thyroiditis of the blood heat with blood stasis pattern: a randomized controlled clinical trial

目的观察亚甲方治疗血热夹瘀型亚急性甲状腺炎的临床疗效。方法将70例亚急性甲状腺炎患者随机分为治疗组与对照组,每组35例。对照组予醋酸泼尼松片口服,治疗组予中药亚甲方口服。两组疗程均为2个月,观察临床疗效、不良反应及复发情况,比较单项症状疗效以及血液相关生化指标(白细胞、中性粒细胞、C反应蛋白、血沉)、甲状腺相关指标(FT3、FT4、TSH)的变化情况。结果 1疗程结束时,最终完成试验者60例,治疗组30例,对照组30例。2治疗组、对照组总有效率分别为90.00%、73.33%;组间临床疗效比较,差异有统计学意义(P<0.05)。3治疗前后组内比较,两组各单项症状均有所改善,差异有统计学意义(P<0.05)。组间治疗后比较,甲状腺肿、乏力、多汗、肢体酸痛、食欲不佳的改善差异有统计学意义,治疗组优于对照组(P<0.05);发热、甲状腺痛、震颤、咽痛的改善差异无统计学意义(P>0.05)。4治疗前后组内比较,两组白细胞、中性粒细胞、CRP、ESR水平差异均有统计学意义(P<0.05);组间治疗前后差值比较,白细胞、中性粒细胞、CRP、ESR水平差异有统计学意义(P<0.05)。5治疗前后组内比较,两组FT3、FT4、TSH水平差异均有统计学意义(P<0.05);组间治疗前后差值比较,FT3、FT4、TSH水平差异无统计学意义(P>0.05)。6两组不良反应发生率比较,治疗组低于对照组(P<0.05)。7两组复发率差异有统计学意义,治疗组低于对照组(P<0.05)。结论亚甲方治疗血热夹瘀型亚急性甲状腺炎,可显著缓解患者临床症状,减轻炎症反应,且不良反应较少,不易复发。

Objective To observe the clinical efficacy of ＂Yajia Formula＂ for the treatment of subacute thyroiditis of the blood heat with blood stasis pattern. Methods Sevnety cases with subacute thyroiditis were randomized into treatment group and control group, with 35 cases in each group. Control group was treated with Prednisone Acetate Tablets orally, and treatment group was treated with ＂Yajia Formula＂ orally, with the course of 2 months. The clinical efficacy, adverse reactions, recurrence rate were observed, and the effect of individual symptoms, changes of related blood biochemical indexes （ including leukocyte, neutrophil, C- reactive protein, erythrocyte sedimentation rate） , and related thyroid gland indicators （FT3, FT4, TSH） were compared and analyzed. Results （1） Sixty patients finished the experiment at the end of treatment, 30 cases in the treatment group and 30 cases in the control group. （2） The total effective rate was 90.00% in the treatment group and 73.33% in the control group, with a difference between the two groups （P 〈 0.05 ）. （3） In both groups, the individual symptoms were improved, with significant difference between before and after treatment （P 〈 0.05 ）. After treatment, there were significant differences in goiter, weakness, hidrosis, pain limbs, poor appetite between the two groups, and the improvement in the treatment group was superior to that of the control grup （ P 〈0.05 ） ; no significant difference was found in fever, thyroid pain, tremble, pharyngalgia between the two groups （P 〉0.05 ）. （4） In both groups, there were significant differences in leukocyte, neutrophil, C- reactive protein and erythrocyte sedimentation rate between before and after treatment （ P 〈0.05 ）. After treatment, there were significant differences in the value of leukocyte, neutrophil, C-reactive protein and erythrocyte sedimentation rate between the two groups （P 〈0.05 ）. （5） In both groups, there were significant difference in the levels of FT3, FT4 and TSH between before and after treatment （ P 〈0.05 ） ; After treatment, no significantdifference was found in the levels of FT3, FT4 and TSH between the two groups （ P 〉0.05 ）. （6） The adverse effective rate of tile treatment group was superior to that of the control group （ P 〈 0. 05 ）. （7） The recurrence rate in the treatment group was superior to that of the control group （ P 〈0.05 ）. Conclusion ＂Yajia Formula＂ can relieve the clinical symptoms and reduce inflammation reaction in treating subaeute thyroiditis of the blood heat with blood stasis pattern with less adverse reactions and recurrence rates.