ChiCTR2100052572Active, not recruitingPhase 4
分析优甲乐和联合甲硫咪唑治疗良性甲状腺结节的临床效果
自筹经费1 site in 1 country900 target enrollmentStarted: December 1, 2020Last updated:
Trial Snapshot
- Phase
- Phase 4
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 900
- Locations
- 1
- Primary Endpoint
- 甲状腺功能
Study Overview
Brief Summary
分析优甲乐和联合甲硫咪唑治疗良性甲状腺结节的临床效果。
Study Design
- Study Type
- 干预性研究
- Primary Purpose
- 随机平行对照
- Masking
- 未说明
Eligibility Criteria
- Ages
- 20 to 60 (—)
- Sex
- All
Inclusion Criteria
- •1.症状:结节可随吞咽上下活动,结节无红肿热痛;
- •2.体征:甲状腺查体时可触及单侧或双侧单个或多个甲状腺结节,结节边界清楚,无压痛,可随吞咽上下活动;
- •3.影像学检查:甲状腺 B 超检查发现甲状腺有 1 个或以上结节,结节回声均匀,无形态和边缘不规则晕圈缺如,结节内血供不丰富,结节无微小钙化,针尖样弥散分布或簇状分布的钙化,颈部淋巴结超声无异常。B 超显示三类结节。无可疑超声表现;
- •4.年龄为 20 到 60 岁;
- •5.结节小于 2.5cm;
Exclusion Criteria
- •实性低回声或囊实性结节中的实性成分为低回声的结节。结节内血供丰富;
- •同时具有以下一项或多项超声特征:
- •(1)低回声或极低回声;
- •(2)边缘分叶或模糊;
- •甲状腺结节过大,有压迫症状明显,呼吸困难者;
- •血 ALT,AST 超过正常者 1.5 倍;
Arms & Interventions
试验组 A
一天一次,一次 50ug 剂量的优甲乐
试验组 B
一天一次,一次 50ug 剂量的优甲乐,加 10mg 剂量的甲巯咪唑
对照组 C
一天一次,一次 10mg 剂量的维生素 B1
Outcomes
Primary Outcomes
甲状腺功能
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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