评估线索嵌入针的安全性:临床实践中多中心,前性,观察性研究的协议
Seojung Ha1, Changwoo Seon1, Jinyeong Hong1
1Department of Acupuncture and Moxibustion Medicine, College of Korean Medicine, Sangji University, Wonju-si 26339, Republic of Korea.
Healthcare (Basel, Switzerland)
|January 25, 2025
概括
这项研究评估了线程嵌入针 (TEA) 的安全性,这是一种使用可吸收线程的疗法. 结果将为临床实践和TEA不良事件的未来研究提供信息.
科学领域:
- 综合医学是一个整体的医学.
- 针研究 针研究
- 生物降解材料在治疗中的作用
背景情况:
- 线程嵌入针 (TEA) 使用可吸收的聚二松线进行持续的治疗效果.
- TEA 越来越多地用于各种疾病,但其安全性需要彻底调查.
- 目前的研究缺乏关于在临床实践中与TEA相关的不良事件的全面数据.
研究的目的:
- 为了前性地评估线程嵌入针 (TEA) 的安全性.
- 在现实环境中收集和分析TEA患者不良事件的数据.
- 为临床决策和未来的大规模研究提供必要的安全数据.
主要方法:
- 一个前性观察性试验,涉及350名接受TEA的参与者.
- 治疗后对1周,1个月,3个月的不良反应进行系统监测.
- 评估3个月期间不良事件发生率和治疗中止率.
主要成果:
- 在接受TEA的350名参与者中收集关于不良事件的数据.
- 在多次随访间隔 (1周,1个月,3个月) 监测患者的安全性.
- 评估因不良事件而导致的治疗中止率.
结论:
- 这项研究将确定线程嵌入针 (TEA) 的安全概况.
- 结果将指导临床应用,并为患者管理策略提供信息.
- 为未来关于TEA安全性和有效性的广泛研究提供基础数据.
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