[关键词]
[摘要]
【目的】 观察甲一方(由鳖甲、猫爪草、法半夏、瓜蒌皮、茯苓、郁金、浙贝母、合欢皮组成)对甲状腺功能亢进症 (简称甲亢)患者焦虑状态的临床疗效。【方法】 选取 2024年 2月到 2024年 12月期间在广州中医药大学附属广州中医医院(广 州市中医医院)内分泌科门诊及住院部就诊的84例阴虚内热、痰瘀互结型甲亢伴焦虑状态患者为研究对象,采用随机数字表 法将患者随机分为治疗组和对照组,每组各 42例。2 组患者均接受基础治疗,对照组在基础治疗的同时给予口服甲巯咪唑 治疗,治疗组在对照组的基础上给予甲一方治疗,2 组疗程均为12周。观察2 组患者治疗前后汉密尔顿焦虑量表(HAMA)评 分、中医证候积分及血清甲状腺激素[游离三碘甲状腺原氨酸(FT3)、游离甲状腺素(FT4)、促甲状腺激素(TSH)]水平的变化 情况,并评价 2 组患者的焦虑状态改善疗效、中医证候改善疗效和用药安全性。【结果】(1)中医证候改善疗效方面,治疗 12 周后,治疗组的总有效率为 92.86%(39/42),对照组为 71.43%(30/42);组间比较(Mann-Whitney U非参数检验),治疗组 的中医证候改善疗效明显优于对照组(P<0.05)。(2)焦虑状态改善疗效方面,治疗 12 周后,治疗组的总有效率为 83.33% (38/42),对照组 69.05%(29/42);组间比较(Mann-Whitney U 非参数检验),治疗组的焦虑状态改善疗效明显优于对照组 (P<0.01)。(3)相关量表评分方面,治疗后,2 组患者的中医证候积分和HAMA评分均较治疗前明显下降(P<0.01),且治疗 组对中医证候积分和 HAMA 评分的下降幅度均明显优于对照组(P<0.01)。(4)甲状腺激素方面,治疗后,2 组患者的 FT3、 FT4、TSH 水平均较治疗前明显改善(P<0.01),且治疗组对 FT3、TSH 的改善幅度均明显优于对照组(P<0.05或 P<0.01); 而2 组对FT4的改善作用比较,差异无统计学意义(P>0.05)。(5)安全性方面,治疗组的不良反应发生率为4.76%(2/42),对 照组为7.14%(3/42),组间比较(Fisher精确检验),差异无统计学意义(P>0.05),提示2 组的用药安全性相当。【结论】 甲一 方对阴虚内热、痰瘀互结型甲亢伴焦虑状态患者有确切的疗效,甲一方联合甲巯咪唑比单纯使用甲巯咪唑能更显著地改善 患者的焦虑状态、临床症状和甲状腺功能。
[Key word]
[Abstract]
Objective To investigate the clinical efficacy of Jia Yi Formula (composed of Trionycis Carapax, Ranunculi Ternati Radix,Pinelliae Rhizoma Praeparatum,Trichosanthis Pericarpium,Poria,Curcumae Radix, Fritillariae Thunbergii Bulbus,and Albiziae Cortex) in improving anxiety symptoms of patients with hyperthyroidism (HT). Methods A total of 84 HT patients with yin deficiency with internal heat and phlegm blended with stasis syndrome accompanied by anxiety were enrolled from the Endocrinology Outpatient and Inpatient Departments of The Affiliated Guangzhou Traditional Chinese Medicine Hospital of Guangzhou University of Chinese Medicine between February and December of 2024. Patients were randomly divided into treatment group and control group (n=42 each) using a random number table. Both groups received conventional therapy,while the control group additionally received oral methimazole,and the treatment group received Jia Yi Formula and methimazole. The treatment duration was 12 weeks for both groups. Changes in Hamilton Anxiety Scale (HAMA) scores,traditional Chinese medicine (TCM) syndrome scores,and serum thyroid hormone levels [free triiodothyronine (FT3),free thyroxine (FT4),and thyroid-stimulating hormone (TSH)] were observed. The improvement in anxiety status, TCM syndrome efficacy,and drug safety were evaluated. Results (1) In terms of TCM syndrome improvement, the total effective rate was 92.86% (39/42) in the treatment group versus 71.43% (30/42) in the control group. Intergroup comparison (by Mann-Whitney U test) showed that the TCM syndrome improvement in the treatment group was superior to the control group (P<0.05).(2) For anxiety improvement, the total effective rate was 83.33% (38/42) in the treatment group versus 69.05% (29/42) in the control group. Intergroup comparison (by Mann-Whitney U test) showed that the anxiety improvement in the treatment group was superior to the control group (P<0.01).(3) After treatment, both groups showed significant reductions in HAMA scores and TCM syndrome scores (P<0.01), with greater reductions observed in the treatment group (P<0.01).(4) Thyroid hormone levels (FT3,FT4,TSH) were significantly improved in both groups (P<0.01),with FT3 and TSH showing greater improvement in the treatment group (P<0.05 or P<0.01),while FT4 improvement did not differ significantly between groups (P>0.05).(5) The incidence of adverse reactions was 4.76% (2/42) in the treatment group and 7.14% (3/42) in the control group. Intergroup comparison (by Fisher’s exact test) showed that the difference was not statistically significant (P>0.05). Conclusion Jia Yi Formula demonstrates significant efficacy in improving anxiety,clinical symptoms,and thyroid function in HT patients with yin deficiency with internal heat and phlegm blended with stasis syndrome,showing superior benefits when used together with methimazole compared to methimazole alone.
[中图分类号]
R259.811
[基金项目]
广东省自然科学基金项目(编号:2021A1515012547);广州市科学技术局科技计划项目(编号:2023A03J0783)