回康灵片治疗分化型甲状腺癌外周血微转移的临床研究

Huikangling Tablet Intervened Peripheral Blood Micrometastasis of Differentiated Thyroid Carcinoma

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 Huikangling Tablet（HT,extracted from Scabrous Patrinia root） on peripheral blood micrometastasis of differentiated thyroid carcinoma（DTC）patients.Methods Totally 87 DTC patients with positive micrometastasis were randomly assigned to the treatment group（45 cases） and the control group（42 cases）.DTC endocrine inhibition treatment standards were executed in all patients.They all took levothyroxine sodium（50 μg/tablet,from low dose,25 μg each time,once per day,0.5 h before breakfast）,and its dosage was gradually added one week later.The dosage was adjusted according to tested results of TSH combined recurrence risk stratification and endocrine suppression induced adverse reactions risk stratification.Patients in the treatment group took HT（0.4 g per tablet,3 tablets each time,three times per day for a total of 12 weeks） combined TSH suppression therapy,while those in the control group only received TSH suppression therapy.Peripheral micrometastatic cytokeratin 19（CK19） and polymorphic epithelial mucinl（MUC1） were detected by FCM at week 4 and 12.Meanwhile,distant metastasis and adverse reactions were observed.Results After 4-week treatment positive micrometastasis was shown in 18 cases（40%） of the treatment group and 29 cases（69%） in the control group with statistical difference（χ~2=5.68,P 0.05）.After 12-week treatment positive micrometastasis was shown in 7 cases（15.6%） of the treatment group and 17 cases（44.7%） in the control group with statistical difference（χ~2=8.49,P 0.01）.Pulmonary metastasis occurred in 2 cases and bone metastasis in 1 case of the control group at follow-ups.Cervical lymph node metastasis without accompanied recurrence of thyroid cancer occurred in one case of the treatment group.No obvious liver or renal abnormalities occurred.Conclusion HT inhibited peripheral blood micrometastasis of DTC patients and its mechanism needed to be further studied.