Not just real world evidence, indispensable clinical trial: clinical trial
Not just real world evidence, indispensable clinical trial: clinical trial
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不仅仅是真实世界的证据，不可或缺的临床试验：临床试验
DOI：
10.11487/oukan.2019.0_a-3-2
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发表时间：
2019
期刊：
影响因子：
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通讯作者：
中島孝 丹野清美 渡辺美智子
中科院分区：
文献类型：
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作者：
Misawa F;Okumura Y;Takeuchi Y;Fujii Y;中島孝 丹野清美 渡辺美智子
以HAL（混合辅助肢体）为例，我们将讨论如何为新医疗器械建立证据。HAL的使用和评价方法是通过医生主导的HAL医用下肢类型（CYBERDYNE Inc.）临床试验（NCY 3001）构建的。由于HAL在NCY 3001中已被证明对8种神经肌肉疾病有效和安全，因此HAL治疗已被纳入一般健康保险。目前，我们正在探索如何在真实的世界中根据其他治疗方法的组合、HAL的使用频率和数量、疾病状态等获得最佳的长期效果。
With HAL (Hybrid Assistive Limb) as an example, we will discuss how to establish evidence for new medical devices. The use and evaluation method of HAL was constructed through a physician led clinical trial (NCY 3001) of the HAL medical lower limb type (CYBERDYNE Inc.). Since HAL has been shown to be effective and safe in 8 neuromuscular diseases in NCY 3001, the treatment with HAL has been covered by general health insurance Currently, we are exploring how the best long term effect can be obtained dependin g on the combination of other therapies, frequency and number of use of HAL, disease state, etc in the real world.