Objective To observe the clinical therapeutic effect of Xiaozhong Sanjie prescription combined with Huayu powder external application for treatment of patients with nodular goiter (NG) and approach its mechanism. Methods A prospective randomized controlled study was conducted, including 128 patients who were definitely diagnosed as NG and admitted into Affiliated Hospital of Qinghai University from September 2014 to December 2016, and they were divided into a control group and a traditional Chinese medicine (TCM) treatment group by random number table method, 64 cases in each group. The control group received follow up observation; the TCM group was treated by Xiaozhong Sanjie prescription (the ingredients: rhizoma sparganii 15 g, zedoary 10 g, fritillary bulb 15 g, prunella vulgaris 20 g, bupleurum 6 g, dried tangerine 10 g, oyster 20 g, fructus aurantii 10 g, radix glycyrrhizae 5 g) in the mean time combined with Huayu powder (the ingredients: borneol 10 g, prunella vulgaris 20 g, pinellia ternata 15 g, oyster 15 g, radix curcumae 15 g, rhubarb 15 g); the ingredients of the prescription were immersed in water and decocted to form a decoction, a dose 400 mL daily, 200 mL taken orally in the morning and 200 mL in the evening after meal; the powder ingredients were mixed and stirred thoroughly with Chinese rice wine or vinegar (10 mL) to form a paste which was put uniformly flat onto a gauze about 15 cm in length and 1 cm in thickness, roasted by infrared lamp, as the paste temperature was lowered to body temperature, it was attached on the goiter skin of neck, then fixed by bandage before sleep to the next morning, afterwards the paste was removed and nodular skin washed, the length of external application being guaranteed to be over 4 hours a day; in the event when skin red swelling or pruritus occurred, promethazine should be used or the duration of application was shortened. Fifteen days constituted one therapeutic course, and after consecutive 3 courses of treatment, the therapeutic effects in the two groups were observed. Before and after treatment in the two groups, the changes of thyroid nodular size and TCM syndrome score were observed, meanwhile the thyroid functional index levels of serum vascular endothelial growth factor (VEGF), insulin-like growth factor Ⅰ(IGF-Ⅰ) and transforming growth factor-β1 (TGF-β1) were detected by enzyme-linked immunosorbent assay (ELISA). Results After treatment for 45 days, compared with control group, the thyroid nodule in TCM treatment group was significantly shrunken (mm: 8.75±3.41 vs. 15.89±4.51, P < 0.05) , and TCM syndrome score in TCM treatment group was significantly lowered (20.35±4.83 vs. 35.53±6.71, P < 0.05); before and after admission in the two groups, the thyroid function indexes of thyrotropic-stimulating hormone (TSH), free triiodothyronine (FT3), free thyroxine (FT4) were in the normal range, and there were no statistical significant differences between the two groups (all P > 0.05); the levels of serum VEGF, IGF-I were reduced in the TCM treatment group [VEGF (ng/L): 27.52±8.35 vs. 33.08±9.57, IGF-Ⅰ (μg/L): 24.12±6.74 vs. 35.57±11.39], TGF-β1 was increased in the TCM treatment group (ng/L: 363.67±97.83 vs. 225.87±47.71), and the differences were statistically significant (all P < 0.05). Conclusions Xiaozhong Sanjie decoction combined with Huayu powder external application can inhibit the levels of VEGF, IGF-Ⅰ and elevate the TGF-β1 level that possibly the mechanism of the combined therapy to shrink the thyroid nodule size.%目的 观察消肿散结方联合化瘀散外敷对结节性甲状腺肿(NG)患者临床疗效的影响,并探讨其作用机制.方法 采用前瞻性随机对照研究方法,选择2014月9月至2016年12月青海大学附属医院确诊为NG的患者128例,将患者按随机数字表法分为对照组和中药治疗组,每组64例.对照组为随诊观察;中药治疗组口服消肿散结方(三棱15 g、莪术10 g、浙贝母15 g、夏枯草20 g、柴胡6 g、陈皮10 g、牡蛎20 g、枳壳10 g、炙甘草5 g),水煎后取400 mL药液,每日1剂,早晚饭后分服,同时将化瘀散(冰片10 g、夏枯草20 g、半夏15 g、牡蛎15 g、郁金15 g、大黄15 g)研成粉末兑入黄酒或醋10 mL,搅拌均匀成糊状平摊于纱布上,制成长约15 cm、厚度为1 cm左右的膏药状,用红外线烤灯烘热,降温至与体温一致时贴敷于患者颈部,并用绷带将其固定.可于睡前局部外敷至次日清晨洗掉,保证用药时间4 h以上,局部皮肤出现红肿、瘙痒者可加入盐酸异丙嗪或缩短用药时间.15 d为1疗程,3个疗程后观察临床疗效.观察两组入组前后甲状腺结节大小、中医症状评分和甲状腺功能指标的变化,同时采用酶联免疫吸附试验(ELISA)检测血清血管内皮生长因子(VEGF)、胰岛素样生长因子Ⅰ(IGF-Ⅰ)、转化生长因子-β1(TGF-β1)水平.结果 与对照组比较,中药治疗组治疗后甲状腺结节明显缩小(mm:8.75±3.41比15.89±4.51,P<0.05),中医症状评分明显降低(分:20.35±4.83比35.53±6.71,P<0.05),入组前后两组甲状腺功能指标〔促甲状腺激素(TSH)、游离三碘甲状腺原氨酸(FT3)、游离甲状腺素(FT4)〕均在正常值范围,差异无统计学意义(均P>0.05);血清VEGF和IGF-Ⅰ水平均降低〔VEGF(ng/L):27.52±8.35比33.08±9.57,IGF-Ⅰ(μg/L):24.12±6.74比35.57±11.39〕,TGF-β1明显升高(ng/L:363.67±97.83比225.87±47.71),差异均有统计学意义(均P<0.05).结论 消肿散结方联合化瘀散外敷可能通过降低VEGF、IGF-Ⅰ、升高TGF-β1水平,进而起到缩小NG的作用.
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