散结外敷方贴敷治疗气郁痰阻型良性甲状腺结节40例临床观察

Clinical Observation on 40 Cases of Benign Thyroid Nodules with Qi Constraint and Phlegm Obstruction Syndrome by External Application of Sanjie Waifu Formula (散结外敷方)

目的观察散结外敷方贴敷治疗气郁痰阻型良性甲状腺结节患者的临床疗效及安全性。方法将80例气郁痰阻型良性甲状腺结节患者随机分为治疗组和对照组各40例。对照组予健康教育及随访观察,治疗组在对照组基础上加用散结外敷方贴敷治疗,每次6~8 h,每天1次。两组均以30天为1个周期,连续观察3个周期。比较两组治疗前后主要疗效指标,包括甲状腺结节体积、最大结节的最大直径、中医证候积分,以及次要疗效指标血清甲状腺功能指标[游离三碘甲状腺原氨酸(FT_(3))、游离甲状腺素(FT_(4))、促甲状腺素(TSH)];治疗后比较两组中医证候疗效。同时观察安全性指标,于治疗前后检测两组血常规、肝肾功能指标,并记录研究过程中不良反应发生情况。结果与本组治疗前比较,两组治疗后甲状腺结节体积、最大结节的最大直径、中医证候积分均降低(P<0.05或P<0.01)。治疗后组间比较,治疗组最大结节的最大直径、中医证候积分均低于对照组(P<0.01),但两组甲状腺结节体积比较差异无统计学意义(P>0.05)。治疗组中医证候疗效总有效率为77.50%(31/40),明显高于对照组的总有效率52.50%(21/40,P<0.01)。两组患者治疗前后甲状腺功能、血常规、肝肾功能指标组间和组内比较,差异均无统计学意义(P>0.05),且均在正常范围内。研究过程中治疗组未出现皮肤瘙痒、红疹、水疱等过敏反应情况。结论散结外敷方贴敷治疗可以改善气郁痰阻型良性甲状腺结节患者的临床症状,减小结节的最大直径,且对甲状腺功能无明显影响,具有较好的安全性。

Objective To observe the clinical effectiveness and safety of Sanjie Waifu Formula(散结外敷方)application therapy for benign thyroid nodules of qi constraint and phlegm obstruction syndrome.Methods Eighty patients with benign thyroid nodules of qi constraint and phlegm obstruction syndrome were randomly divided into 40 cases each in a treatment group and a control group.The control group was given health education and follow-up observation,while the treatment group applied Sanjie Waifu Formula externally on the basis of the control group,6~8 h each time,once a day.Both groups took 30 days as a course,and were observed for 3 consecutive courses.The main effectiveness indexes of both groups were compared before and after treatment,including the volume of thyroid nodules,the maximum diameter of the largest nodule,the scores of traditional Chinese medicine(TCM)syndrome,and the secondary effectiveness indexes of serum thyroid function including free triiodothyronine(FT_(3)),free thyroxine(FT_(4)),thyrotropin(TSH)levels were also observed.The effectiveness of the TCM syndrome of both groups was compared after treatment.Meanwhile,the safety indexes were observed before and after treatment,such as the blood routine,liver and kidney function indexes,and the occurrence of adverse reactions during the study was recorded.Results Compared with in group before treatment,the volume of thyroid nodules,the maximum diameter of the largest nodule,and the TCM symptom scores were lowered in both groups after treatment(P<0.05 or P<0.01).Comparing between groups after treatment,the difference in thyroid nodule volume was not statistically significant(P>0.05),but the maximum diameter of the largest nodule and the TCM symptom scores of the treatment group were lower than those of the control group(P<0.01).The total effective rate of TCM syndrome in the treatment group was 77.50%(31/40),which was significantly higher than that of the control group with 52.5%(21/40,P<0.01).Thyroid function,blood routine and liver and kidney function indexes of both groups before and after treatment were compared between and within groups,and the differences were not statistically significant(P>0.05),and they were all within the normal range.During the treatment period,no allergic reactions such as skin itching,red rash and blisters occurred in the treatment group.Conclusion The external application of Sanjie Waifu Formula can improve the clinical symptoms of patients with benign thyroid nodules,reduce volume and the maximum diameter of nodules,and has no significant effects on thyroid function and show good safety.