研究疾病:
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分化型甲状腺癌
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研究疾病代码:
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Target disease:
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Differentiated Thyroid Carcinoma
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Target disease code:
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研究类型:
Study type:
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干预性研究
Interventional study
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研究设计:
Study design:
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随机平行对照
randomized controlled trial(parallel group design)
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研究所处阶段:
Study phase:
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其它
Others
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研究目的:
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本研究拟设计单中心、优效对照临床研究,以 DTC 术后患者为研究对象, 将 306 例患者随机分为对照组与治疗组,对照组给予标准化优甲乐治疗,治疗组 予优甲乐+甲癌术后方治疗,通过为期 6 月的治疗、随访,观察患者生活质量量 表(QLQ-C-30)、甲状腺超声、甲功、甲状腺球蛋白、中医证候指标积分、疗效 反应分级、肝肾功的变化,评价患者 DTC 术后应用“甲癌术后方”的临床疗效 和安全性,为“甲癌术后方”应用于 DTC 术后临床管理提供循证医学证据
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Objectives of Study:
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This study intends to design a single-center, superiority-controlled clinical trial, targeting postoperative patients of differentiated thyroid carcinoma (DTC). 306 patients will be randomly divided into the control group and the treatment group. Patients in the control group will receive standardized levothyroxine (LT4) treatment, while those in the treatment group will be treated with LT4 combined with the "Postoperative thyroid Cancer Chinese medicine decoction "
. Through a 6-month treatment and follow-up period, the quality of life scale (QLQ-C-30), thyroid ultrasound, thyroid function tests, thyroid globulin, the integral of TCM syndrome indicators, therapeutic response grading, and changes in liver and kidney functions will be observed. The clinical efficacy and safety of applying the "Postoperative thyroid Cancer Chinese medicine decoction " to postoperative clinical management of DTC patients will be evaluated, providing evidence-based medical evidence for the application of the "Postoperative thyroid Cancer Chinese medicine decoction " in the clinical management of DTC postoperative patients.
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药物成份或治疗方案详述:
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甲癌术后方药物组成:党参、麦冬、五味子、夏枯草、丹参、白芍、香附、姜黄、玄参、法半夏、女贞子、甘草等
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Description for medicine or protocol of treatment in detail:
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The composition of the Thyroid Carcinoma postoperative prescription: Codonopsis, Ophiopogon japonicum, Schisandrae fructus, Prunella vulgaris, Salvia miltiorrhiza, Radix paeoniae alba, Rhizoma fragrans, turmeric, scrophularia, Pinellia, Ligustrum, licorice, etc
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纳入标准:
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①年龄在25-70岁,经手术后病理确诊为DTC;②甲状腺癌术后(或术后碘131治疗后)常规给予优甲乐治疗,TSH抑制值达到指南标准者;③中医辨证属气阴两虚兼肝郁者;④签署知情同意书的患者。
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Inclusion criteria
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① Patients aged from 25 to 70 years old were diagnosed as DTC by postoperative pathology; ② patients with thyroid cancer after surgery (or after postoperative iodine-131 therapy) routinely treated with Euthyrox, TSH suppression value reached the guideline standard; ③ qi and Yin deficiency combined with liver depression in TCM syndrome differentiation; ④ patients who signed informed consent.
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排除标准:
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①严重的心、肝、肾等全身性疾病和精神疾病患者;
②对药物所含成分过敏者;
③发现远处转移癌灶;
④妊娠、哺乳期妇女;
⑤正在参加其他临床药物试验者
⑥不签署知情同意书的患者;符合上述任何一项者,均予以排除。
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Exclusion criteria:
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① patients with serious systemic diseases such as heart, liver, kidney and mental diseases;
② Allergic to the ingredients contained in the drug;
③ the presence of distant metastasis;
④ pregnant and lactating women;
⑤ those who were participating in other clinical drug trials
⑥ patients who did not sign the informed consent;
Those fulfilling any of the above criteria were excluded.
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研究实施时间:
Study execute time:
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从From
2022-05-01
至To
2025-05-31
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征募观察对象时间:
Recruiting time:
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从From
2022-07-01
至To
2025-05-31
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