Investigation of risk management and validity about clinical tests in the field of neurological medicine

神经医学领域临床试验的风险管理及有效性研究

• 批准号: 15590461
• 负责人: KONDO Masaki
• 金额: $ 2.18万
• 依托单位: Kyoto Prefectural University of Medicine
• 依托单位国家: 日本
• 项目类别: Grant-in-Aid for Scientific Research (C)
• 财政年份: 2003
• 资助国家: 日本
• 起止时间: 2003 至 2005
• 项目状态: 已结题
• 来源: https://kaken.nii.ac.jp/en/grant/KAKENHI-PROJECT-15590461/
• 关键词: CSF examination; needle EMG; nerve and muscle biopsy

A total of 3291 patients were admitted between 1991 and 2005. Admission records confirmed that these patients underwent the following examinations : CSF examination, n=824 (25%) ; needle EMG, n=306 (9.3%) ; muscle biopsy, n=64 (1.9%) ; and nerve biopsy, n=19 (0.6%).<Usefulness of examinations>1)CSF examination : In the infection group, pathogen tests were useful in 28.8% of cases, and either general tests or pathogen tests was useful in 81.8% of cases. Comparison between viruses and bacteria, etc. (bacteria, tuberculosis, fungi, syphilis, etc.) showed that CSF examination was more useful for bacteria, etc. than for viruses (100% vs. 76.2%), and pathogen tests alone were also more useful for bacteria, etc. than for viruses (50% vs. 19%). In the immunological and inflammatory disease group, either general tests or specific tests was useful in 53.5% of cases. In addition, specific tests were more useful for MS than for other immunological and inflammatory diseases (43.8% vs. 7-16%).2)Need … More le EMG : This examination was useful in 67.1% of cases, specifically in 68.3% of cases of muscle disease and 66.7% of cases of other diseases, and was particularly useful for motor neuron disease (92.3%).3)Muscle biopsy : This examination was useful in 59.7% of cases, and was more useful for inflammatory muscle disease than for other muscle diseases (89.5% vs. 48.6%).4)Nerve biopsy : This examination was useful in 66.7% of cases, and tended to be useful for inflammatory neuropathy.<Complications of examinations>1)CSF examination : Headache was reported in 20.1% of cases, and was more frequently reported in cases of muscle disease (44.4%), motor neuron disease (33.3%), and neuropathy (28.3%), with an occurrence of 10-20% in most other diseases. Other complications comprised 7 cases of back pain.2)Needle EMG : No clear complications were reported other than pain and discomfort during examination.3)Muscle biopsy : Although poor wound healing was observed in 3 cases (5.1 %), no sequelae were reported.4)Nerve biopsy : Complications were observed in 3 cases (16.7%), including 2 cases of poor wound healing and 1 case of numbness around the wound. Less

1991年至2005年间，共有3291名患者入院。入院记录证实这些患者接受了以下检查：脑脊液检查，n=824（25%）；针肌电图，n=306 (9.3%)；肌肉活检，n=64 (1.9%)；和神经活检，n=19（0.6%）。 <检查的有用性>1）脑脊液检查：在感染组中，病原体检查对28.8％的病例有用，而一般检查或病原体检查对81.8％的病例有用。病毒与细菌等（细菌、结核、真菌、梅毒等）的比较表明，脑脊液检查对细菌等比对病毒更有用（100%对76.2%），单独进行病原检查对细菌等也比对病毒更有用（50%对19%）。在免疫和炎症性疾病组中，一般测试或特异性测试对 53.5% 的病例有用。此外，与其他免疫和炎症性疾病相比，特定测试对多发性硬化症更有用（43.8% vs. 7-16%）。2）需要…更多肌电图：这项检查对 67.1% 的病例有用，特别是对 68.3% 的肌肉疾病病例和 66.7% 的其他疾病病例有用，对运动神经元疾病特别有用 (92.3%)。3) 肌肉活检：这项检查有用在 59.7% 的病例，对炎性肌肉疾病比其他肌肉疾病更有用（89.5% vs. 48.6%）。4) 神经活检 : 该检查对 66.7% 的病例有用，并且往往对炎性神经病变有用。<检查的并发症>1) 脑脊液检查 : 20.1% 的病例报告头痛，在肌肉疾病病例中报告频率更高 (44.4%)、运动神经元疾病(33.3%)和神经病(28.3%)，在大多数其他疾病中发生率为10-20%。其他并发症包括背痛 7 例。2) 针肌电图：除检查时疼痛和不适外，未报告明显并发症。3) 肌肉活检：3 例（5.1%）伤口愈合不良，但未报告后遗症。4) 神经活检：3 例（16.7%）出现并发症，其中 2 例伤口愈合不良，1 例伤口周围麻木。较少的