消瘿散结方联合左甲状腺素治疗痰结血瘀型甲状腺结节的临床疗效与安全性分析

Clinical efficacy and safety analysis of Xiaoying Sanjie Formula combined with levothyroxine on thyroid nodule with phlegm retention and blood stasis type

目的观察消瘿散结方联合左甲状腺素治疗痰结血瘀型甲状腺结节的疗效和安全性。方法将100例痰结血瘀型甲状腺结节患者按照随机数字表法分为2组,对照组50例予左甲状腺素钠片治疗,治疗组50例在对照组治疗基础上予消瘿散结方治疗。2组均治疗3个月。比较2组治疗前后最大结节最大直径,血清中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)水平及中医证候积分变化。结果2组治疗后最大结节最大直径均较本组治疗前减小(P<0.05),且治疗组治疗前后差值大于对照组(P<0.05)。2组治疗后FT3、FT4、TSH与本组治疗前比较差异无统计学意义(P>0.05),且2组治疗前后各项差值比较差异无统计学意义(P>0.05)。治疗组治疗后中医证候评分较本组治疗前降低(P<0.05),且治疗组治疗前后差值高于对照组(P<0.05)。治疗组总有效率76.0%(38/50),对照组总有效率56.0%(28/50),治疗组疗效优于对照组(P<0.05)。2组治疗期间均无不良反应。结论消瘿散结方联合左甲状腺素治疗痰结血瘀型甲状腺结节能够提高治疗效果,安全性好,有较高的临床应用价值。

Objective To analyze the efficacy and safety of Xiaoying Sanjie Formula combined with levothyroxine in the treatment of thyroid nodule(phlegm retention and blood stasis type).Methods A total of 100 patients with thyroid nodule(phlegm retention and blood stasis type)were randomized 1∶1 to receive levothyroxine sodium tablet(the control group)or Xiaoying Sanjie Formula+levothyroxine(the treatment group)for 3 months.The maximum diameter of nodules,the serum levels of free triiodothyronine(FT3),free thyroxine(FT4),thyroid stimulating hormone(TSH)and traditional Chinese medicine(TCM)syndrome scores were compared between the two groups before and after treatment.Results After treatment,the maximum diameter of nodules in both groups were significantly smaller than those before treatment(P<0.05),which were significantly smaller in the treatment group than in the control group(P<0.05).There were no statistically significant differences in FT3,FT4 and TSH between the two groups before and after treatments(P<0.05).After treatments,the TCM syndrome scores in the treatment group were significantly reduced compared with those before treatment(P<0.05),while the control group had no significant change(P<0.05).The total effective rate in the treatment group was significantly higher than that in the control group(76.0%[38/50]vs 56.0%[28/50],P<0.05).Conclusion For thyroid nodule patients(phlegm retention and blood stasis type),the combined application of levothyroxine and Xiaoying Sanjie Formula can improve the therapeutic effect,with good safety and high clinical application value.