散结片联合耳穴压豆治疗良性甲状腺结节的临床观察

Clinical observation on the treatment of benign thyroid nodules with Sanjie Tablet combined with ear acupoint pressing beans

目的:观察散结片联合耳穴压豆治疗良性甲状腺结节的临床疗效。方法:将良性甲状腺结节患者90例,按随机对照原则分为空白对照组、中成药组、试验组,每组各30例。治疗过程共3个月,嘱患者调畅情志,放松身心,避免紧张焦虑。空白对照组仅随诊观察,中成药组给予小金丸口服1.2g/次,每日2次口服,试验组给予散结片3.0g/次,每日3次口服联合耳穴压豆(肝、脾、内分泌、皮质下、神门)治疗。观察治疗前后各组中医症状积分、证候总积分、证候疗效、结节最大横径、超声疗效、高危因素积分、安全性评价等指标,以评估临床疗效。结果:治疗后空白对照组各项观察指标较前均无明显改善。与中成药组比较,试验组除乳房胀痛症状改善无差异外,余各症状积分、证候总积分改善均明显优于中成药组(P<0.05,P<0.01);试验组证候疗效显效率、总有效率明显高于中成药组(P<0.05,P<0.01)。试验组可明显缩小结节最大横径,降低高危因素积分,较中成药组显著提高超声总有效率及显效率(P<0.05,P<0.01)。除空白对照组1例出现TSH轻度降低外,安全性评价为2级;余两组均无不良反应发生,安全性较高。结论:散结片联合耳穴压豆治疗良性甲状腺结节,临床疗效显著确切,值得进一步推广应用。

Objective:To observe the clinical effect of Sanjie Tablets combined with ear acupoint pressing beans in the treatment of benign thyroid nodules.Methods:Ninety patients with benign thyroid nodules were divided into control group,Chinese patent medicine group and experimental group according to the principle of randomized control,with 30 cases in each group.The treatment process lasted for 3 months.The patients were instructed to relax,relax and avoid tension and anxiety.The control group was only followed up for observation,while the Chinese patent medicine group was given Xiaojin Pill orally(1.2g Bid),and the experimental group was given Sanjie tablet orally(3.0g Tid)combined with ear acupoint pressing beans(liver,spleen,endocrine,subcortical,Shenmen)for treatment.Before and after treatment,the TCM symptom score,syndrome total score,syndrome efficacy,maximum transverse diameter of nodules,ultrasound efficacy,high-risk factor score,safety evaluation and other indicators were observed to evaluate the clinical efficacy.Results:After treatment,the observation indexes of control group had no significant improvement.Compared with the traditional Chinese medicine group,except for the improvement of breast swelling and pain symptoms,the improvement of other symptoms and syndromes in the experimental group were significantly better than those in the traditional Chinese medicine group(P<0.05,P<0.01).The marked and total effective rates of the experimental group were significantly higher than those in the traditional Chinese medicine group(P<0.05,P<0.01).Compared with the traditional Chinese medicine group,the experimental group could significantly reduce the maximum transverse diameter of nodules and the score of high-risk factors(P<0.05,P<0.01).Except for one case in control group with slight decrease of TSH,the safety evaluation was grade 2.There were no adverse reactions in the other two groups,and the safety was higher.Conclusion:Sanjie tablet combined with ear point pressing beans is effective in the treatment of benign thyroid nodules,which is worthy of further promotion and application.