The Effect of Yinjia Pellet on the Short Term Efficacy and Long Term Recurrence Rate of Treating Graves' Hyperthyroidism
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摘要: 目的 探讨银甲丹治疗弥漫性甲状腺肿(Graves病)甲状腺功能亢进(简称甲亢)的近期疗效及对远期复发率的影响。方法 选取江苏省中医院Graves病甲亢痰火郁结证患者80例利用SAS系统随机分为2组，治疗组使用银甲丹联合西药治疗，对照组单用西药治疗，疗程6个月，观察近期疗效；停药后继续观察2年，评估复发率。结果 治疗后2组甲亢突眼分级及中医证候积分均有改善(P < 0.01)，治疗组优于对照组(P < 0.05, P < 0.01)；2组促甲状腺素(TSH)、游离三碘甲腺原氨酸(FT3)、游离甲状腺素(FT4)、总三碘甲状腺原氨酸(TT3)、总甲状腺素(TT4)、促甲状腺素受体抗体(TRAb)水平均有改善(P < 0.05, P < 0.01)，治疗组优于对照组(P < 0.05, P < 0.01)，且甲状腺相关指标恢复正常时间更短(P < 0.01)。治疗组总有效率高于对照组(P < 0.01)。停药后随访2年，治疗组复发率低于对照组(P < 0.05)。结论 银甲丹联合西药治疗Graves病甲亢疗效显著，甲状腺功能恢复正常时间短，且能减少甲亢复发。Abstract: OBJECTIVE To discuss the effect of Yinjia pellet on the short term efficacy and long term recurrence rate of treating hyperthyroidism in diffuse goiter (Graves' disease).METHODS 80 patients with Graves' disease and hyperthyroidism in Jiangsu Hospital of traditional Chinese medicine were randomly divided into two groups by SAS system. The treatment group was given Yinjia pellet combined with western medicine while the control group was only given western medicine. After six-month course, the short term efficacy was observed. We followed up the patients for two years after the treatment and estimated the recurrence rate.RESULTS After treatment, the degree of proptosis and traditional Chinese medicine syndrome scores in the two groups were improved (P < 0.01), and the treatment group was better than the control group (P < 0.05, P < 0.01). The levels of total triiodothyronine (TT3), total thyroxine (TT4), free triiodothyronine (FT3), free thyroxine (FT4), thyroid stimulating hormone (TSH), and thyrotrophin receptor antibody (TRAb) were improved (P < 0.05, P < 0.01), which in the treatment group were better than those in the control group (P < 0.05, P < 0.01) and took less time to recover than those in the control group (P < 0.01). The total efficacy rate in the treatment group was higher than that of the control group (P < 0.01). With the two-year follow-up, it was found that the recurrence rate in the treatment group was lower than that in the control group (P < 0.05).CONCLUSION Yinjia pellet combined with Western medicine has more significant effect on treating hyperthyroidism of Graves' disease, which can reduce the recovery duration of thyroid function and the recurrence rate of hyperthyroidism.
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Key words:
- hyperthyroidism /
- Graves' disease /
- traditional Chinese medicine /
- recrudescence
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表 1 2组患者基线资料比较(x±s，n=40)
组别 性别 年龄/岁 TSH/ (μU·mL-1) FT3/ (pg·mL-1) FT4/ (ng·mL-1) TT3/ (ng·mL-1) TT4/ (ng·mL-1) TRAb/ (U·L-1) 男 女 治疗组 11 29 34.80±11.76 0.03±0.02 7.17±5.20 2.27±1.56 2.34±1.26 140.72±55.67 12.42±11.70 对照组 18 22 37.58±11.47 0.03±0.03 9.17±6.44 2.80±1.38 2.56±1.68 150.75±64.87 11.74±10.99 
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表 2 2组患者治疗前后突眼及中医证候积分变化情况比较(x±s，n=40)
组别 时间 突眼 甲状腺肿 烦躁 震颤 治疗组 治疗前 4.50±1.85 4.80±1.56 5.25±1.26 4.50±1.74 治疗后 1.75±1.82**# 1.90±1.35**# 0.15±0.70**# 0.15±0.53**## 对照组 治疗前 4.35±1.86 4.50±1.85 5.40±1.13 4.25±1.98 治疗后 2.75±1.96** 2.65±1.99** 0.75±1.26** 1.05±1.69** 组别 时间 口黏 心悸 多汗 恶热 治疗组 治疗前 5.05±1.43 5.35±0.95 5.15±1.27 5.10±1.35 治疗后 0.35±0.89**## 0.15±0.53**## 0.83±1.34**# 1.35±1.23**# 对照组 治疗前 4.80±1.34 5.25±1.17 5.15±1.35 4.95±1.36 治疗后 2.00±1.92** 1.35±1.99** 1.65±2.12** 2.15±1.99** 注：与治疗前比较，**P < 0.01；与对照组比较，#P < 0.05，##P < 0.01。
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表 3 2组患者治疗前后甲状腺相关指标及恢复正常时间比较(x±s，n=40)
组别 时间 TSH/(μU·mL-1) FT3/(pg·mL-1) FT4/(ng·dL-1) TT3/(ng·mL-1) 治疗组 治疗前 0.03±0.02 7.17±5.20 2.27±1.56 2.34±1.26 治疗后 1.89±1.88**## 3.15±0.54**# 0.89±0.28**## 1.12±0.24**## 对照组 治疗前 0.03±0.03 9.17±6.44 2.80±1.38 2.56±1.68 治疗后 0.77±1.33** 3.58±0.81** 1.27±0.60** 1.79±1.14* 组别 时间 TT4/(ng·mL-1) TRAb/(U·L-1) 恢复正常时间/月 治疗组 治疗前 140.72±55.67 12.42±11.70 3.23±1.56## 治疗后 74.25±17.75*# 2.73±3.15**# 对照组 治疗前 150.75±64.87 11.74±10.99 5.10±1.35 治疗后 84.28±23.62** 4.27±4.05** 注：与治疗前比较，*P < 0.05，**P < 0.01；与对照组比较，#P < 0.05，##P < 0.01。
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表 4 2组患者临床疗效比较(n=40)
组别 临床控制 显效 有效 无效 总有效率/% 治疗组 13 13 12 2 95.00## 对照组 5 14 10 11 72.50 注：与对照组比较，χ2=7.44，##P < 0.01。
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表 5 2组患者不良反应比较
组别 例数 不良反应 发生率/% 治疗组 40 6 15.00# 对照组 40 15 37.50 注：与对照组比较，χ2=5.23，#P < 0.05。
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