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目的观察回康灵片(墓头回提取物)治疗分化型甲状腺癌(differentiated thyroid carcinoma,DTC)外周血微转移的临床效果。方法将DTC微转移阳性患者87例随机分两组,两组均执行DTC内分泌抑制治疗标准,口服左甲状腺素钠片(50μg/片),从低剂量开始,25μg/次,每日1次,早餐前0.5 h口服,1周后逐渐增加剂量,根据促甲状腺激素(TSH)检测结果结合患者复发危险分层及内分泌抑制治疗不良反应作用风险分层调整剂量。对照组42例单纯采用内分泌抑制治疗。治疗组45例,采用口服回康灵片(每片0.4 g,每次3片,每日3次,全部完成口服12周)配合内分泌抑制治疗。两组在第4周及12周时采用流式细胞术(FCM)检测DTC外周血微转移状况细胞角蛋白19(CK19)及多态性上皮黏蛋白1(MUC1)水平,并进行分析,同时观察远处转移及不良反应。结果服用回康灵片4周时,治疗组微转移阳性18例(40%)、对照组29例(69%),两组比较,差异有统计学意义(χ~2=5.68,P<0.05)。服药12周时,治疗组微转移阳性7例(15.6%)、对照组17例(44.7%),差异亦有统计学意义(φ~2=8.49,P<0.01)。随访中对照组出现肺转移2例、骨转移1例;治疗组1例出现不伴甲状腺癌复发的颈淋巴结复发,无明显肝、肾功能异常。结论回康灵片对DTC外周血微转移有抑制作用,其机制尚需进一步研究。
Objective To observe the clinical effect of Hui-Kang-Ling tablet (extract of the tomb head back to the body) in the treatment of differentiated thyroid carcinoma (DTC) peripheral blood micrometastasis. Methods 87 patients with positive micrometastasis in DTC were randomly divided into two groups. DTC group (50 μg / tablet) was administered with DTC endocrine inhibition. Dose of 25 μg / Oral 0.5 h before breakfast, gradually increase the dose after 1 week, according to the thyroid stimulating hormone (TSH) test results combined with the risk of relapse risk stratification and endocrine inhibition of adverse reactions stratified adjustment risk dose. The control group of 42 patients were treated with endocrine inhibition alone. In the treatment group, 45 cases were treated with oral ketamine (0.4 g per tablet, 3 tablets each time, 3 times daily, all for 12 weeks) with endocrine inhibition. The levels of cytokeratin 19 (CK19) and polymorphonuclear mucin 1 (MUC1) in peripheral blood micrometastasis of DTC were detected by flow cytometry (FCM) at the 4th and 12th week in both groups, and analyzed at the same time Observation of distant metastasis and adverse reactions. Results After 4 weeks of treatment, the micrometastases in the treatment group were 18 (40%) positive and 29 (69%) in the control group. The differences between the two groups were statistically significant (χ ~ 2 = 5.68, P <0.05 ). At 12 weeks after treatment, micrometastasis in the treatment group was positive in 7 cases (15.6%) and in the control group in 17 cases (44.7%). The difference was also statistically significant (φ ~ 2 = 8.49, P <0.01). In the follow-up, 2 cases of lung metastasis and 1 case of bone metastasis occurred in the control group. One case of recurrence of cervical lymph node without recurrence of thyroid cancer in the treatment group showed no obvious liver and kidney dysfunction. Conclusion Huikangling tablet can inhibit the micrometastasis in peripheral blood of DTC, and its mechanism needs further study.