中文摘要：

目的对13一顺式．维甲酸（13．cisretinoidacid，13-CRA）和全反式维甲酸（Alltransretinoidacid，ATRA）诱导再分化治疗低分化甲状腺癌的疗效和安全性进行评价。方法采用单中心、随机、双盲、平行对照的临床试验。分为3组，试验组A用13-CRA诱导，试验组B用ATRA诱导，对照组用安慰剂。所有受试者均进行200mCi的131I治疗。疗效评价以维甲酸诱导效果和诱导后131I治疗效果作为主要指标。结果诱导再分化治疗后，试验组A诱导的有效率为59．72％，试验组B为52．86％，对照组为7．69％，3组的诱导效果差异有统计学意义（P〈0．05）。两两比较分析显示，试验组A、试验组B分别与对照组相比较诱导效果明显增高（均P〈0．017），而试验组A与试验组B的诱导效果差异无统计学意义。131I治疗后，试验组A、试验组B、对照组的治疗有效率分别为70．83％、64．29％和28．2l％．3组间差异有统计学意义（P〈0．05）。两两比较分析显示，试验组A、试验组B分别与对照组相比较的治疗效果明显增高（均P〈0．017），而试验组A与试验组B间差异无统计学意义。在维甲酸类药物的不良反应方面，试验组A主要表现为脱皮、皮肤干燥、嘴唇干燥、眼干等皮肤黏膜的损害，试验组B主要表现为头痛、头晕等神经系统症状。结论13一CRA和ATRA诱导再分化是治疗失分化／低分化甲状腺癌的一种有效方法。

英文摘要：

Objective Toevaluate the efficacy and safety of 13-cis retinoid acid （13-CRA） and all trans retinoid acid （ ATAR ） redifferentiation therapy in patients with poorly differentiated thyroid cancer. Methods A single-center, randomized, double-blind, parallel controlled clinical trial was preformed. All patients were randomized into three groups. 78 cases were enrolled in each group. The patients were treated by 13-CRA in A group, by ATRA in B group, and by placebo in control group. The induced effects of retinoid acid （RA） and 131I treatment efficacies were defined as primary outcome of efficacy. Results After RA induction therapy, the effective rates in A, B, and control groups were 59.72% , 52.86% and 7.69% , respectively, with statistically significant difference among 3 groups （ P〈0.05 ）. Compared with control group, A and B groups revealed significant induced efficacies （ P〈 0.017 ） , but there was no significant difference between A group and B group. After 131I treatment, the effective rates in A, B, and control group were 70. 83%, 64. 29%, and 28. 21% respectively, with statistically significant difference （P〈0.05）. Compared with control group, the effective rates of 1311 treatment in A and B groups were significantly raised （P〈0. 017 ） , but there was no significant difference between A group and B group. The damage of skins and mucous membranes such as desquamation, dry skin, dry＂ lips, dry eyes, etc occurred mostly in A group. The symptoms of nervous system such as headache, dizziness, ete occurred mostly in B group. Conclusions The induced differentiation of 13-CRA or ATRA is an effective method for the treatment of poorly differentiated thyroid carcinoma.