2013年7月2日
;81 (1)
文章
测定灵敏度和神经性疼痛研究特性试验
一个ACTTION荟萃分析
罗伯特·h·德沃金,丹尼斯·c·特克,莎拉Peirce-Sandner,花他,迈克尔·p·麦克德莫特,约翰·t·法勒,纳撒尼尔·p·卡茨,艾莉森·h·林,鲍勃·a·拉帕波特,Michael c . Rowbotham
第一次出版2013年5月22日
DOI: https://doi.org/10.1212/WNL.0b013e318297ee69
罗伯特·h·德沃金
部门的麻醉学(R.H.D.,S.P.-S.), Biostatistics and Computational Biology (H.H., M.P.M.), and Neurology (R.H.D., M.P.M), University of Rochester School of Medicine and Dentistry, Rochester, NY; Department of Anesthesiology and Pain Medicine (D.C.T.), University of Washington, Seattle; Department of Clinical Epidemiology and Biostatistics (J.T.F.), University of Pennsylvania, Philadelphia; Analgesic Solutions, Natick, and Tufts University, Boston (N.P.K.), MA; Division of Anesthesia, Analgesia, and Addiction Products (A.H.L., B.A.R.), Food and Drug Administration, Silver Spring, MD; and California Pacific Medical Center Research Institute (M.C.R.), San Francisco, CA.
丹尼斯·c·特克
部门的麻醉学(R.H.D.,S.P.-S.), Biostatistics and Computational Biology (H.H., M.P.M.), and Neurology (R.H.D., M.P.M), University of Rochester School of Medicine and Dentistry, Rochester, NY; Department of Anesthesiology and Pain Medicine (D.C.T.), University of Washington, Seattle; Department of Clinical Epidemiology and Biostatistics (J.T.F.), University of Pennsylvania, Philadelphia; Analgesic Solutions, Natick, and Tufts University, Boston (N.P.K.), MA; Division of Anesthesia, Analgesia, and Addiction Products (A.H.L., B.A.R.), Food and Drug Administration, Silver Spring, MD; and California Pacific Medical Center Research Institute (M.C.R.), San Francisco, CA.
莎拉Peirce-Sandner
部门的麻醉学(R.H.D.,S.P.-S.), Biostatistics and Computational Biology (H.H., M.P.M.), and Neurology (R.H.D., M.P.M), University of Rochester School of Medicine and Dentistry, Rochester, NY; Department of Anesthesiology and Pain Medicine (D.C.T.), University of Washington, Seattle; Department of Clinical Epidemiology and Biostatistics (J.T.F.), University of Pennsylvania, Philadelphia; Analgesic Solutions, Natick, and Tufts University, Boston (N.P.K.), MA; Division of Anesthesia, Analgesia, and Addiction Products (A.H.L., B.A.R.), Food and Drug Administration, Silver Spring, MD; and California Pacific Medical Center Research Institute (M.C.R.), San Francisco, CA.
花他
部门的麻醉学(R.H.D.,S.P.-S.), Biostatistics and Computational Biology (H.H., M.P.M.), and Neurology (R.H.D., M.P.M), University of Rochester School of Medicine and Dentistry, Rochester, NY; Department of Anesthesiology and Pain Medicine (D.C.T.), University of Washington, Seattle; Department of Clinical Epidemiology and Biostatistics (J.T.F.), University of Pennsylvania, Philadelphia; Analgesic Solutions, Natick, and Tufts University, Boston (N.P.K.), MA; Division of Anesthesia, Analgesia, and Addiction Products (A.H.L., B.A.R.), Food and Drug Administration, Silver Spring, MD; and California Pacific Medical Center Research Institute (M.C.R.), San Francisco, CA.
迈克尔·p·麦克德莫特
部门的麻醉学(R.H.D.,S.P.-S.), Biostatistics and Computational Biology (H.H., M.P.M.), and Neurology (R.H.D., M.P.M), University of Rochester School of Medicine and Dentistry, Rochester, NY; Department of Anesthesiology and Pain Medicine (D.C.T.), University of Washington, Seattle; Department of Clinical Epidemiology and Biostatistics (J.T.F.), University of Pennsylvania, Philadelphia; Analgesic Solutions, Natick, and Tufts University, Boston (N.P.K.), MA; Division of Anesthesia, Analgesia, and Addiction Products (A.H.L., B.A.R.), Food and Drug Administration, Silver Spring, MD; and California Pacific Medical Center Research Institute (M.C.R.), San Francisco, CA.
约翰·t·法勒
部门的麻醉学(R.H.D.,S.P.-S.), Biostatistics and Computational Biology (H.H., M.P.M.), and Neurology (R.H.D., M.P.M), University of Rochester School of Medicine and Dentistry, Rochester, NY; Department of Anesthesiology and Pain Medicine (D.C.T.), University of Washington, Seattle; Department of Clinical Epidemiology and Biostatistics (J.T.F.), University of Pennsylvania, Philadelphia; Analgesic Solutions, Natick, and Tufts University, Boston (N.P.K.), MA; Division of Anesthesia, Analgesia, and Addiction Products (A.H.L., B.A.R.), Food and Drug Administration, Silver Spring, MD; and California Pacific Medical Center Research Institute (M.C.R.), San Francisco, CA.
纳撒尼尔·p·卡茨
部门的麻醉学(R.H.D.,S.P.-S.), Biostatistics and Computational Biology (H.H., M.P.M.), and Neurology (R.H.D., M.P.M), University of Rochester School of Medicine and Dentistry, Rochester, NY; Department of Anesthesiology and Pain Medicine (D.C.T.), University of Washington, Seattle; Department of Clinical Epidemiology and Biostatistics (J.T.F.), University of Pennsylvania, Philadelphia; Analgesic Solutions, Natick, and Tufts University, Boston (N.P.K.), MA; Division of Anesthesia, Analgesia, and Addiction Products (A.H.L., B.A.R.), Food and Drug Administration, Silver Spring, MD; and California Pacific Medical Center Research Institute (M.C.R.), San Francisco, CA.
艾莉森·h·林
部门的麻醉学(R.H.D.,S.P.-S.), Biostatistics and Computational Biology (H.H., M.P.M.), and Neurology (R.H.D., M.P.M), University of Rochester School of Medicine and Dentistry, Rochester, NY; Department of Anesthesiology and Pain Medicine (D.C.T.), University of Washington, Seattle; Department of Clinical Epidemiology and Biostatistics (J.T.F.), University of Pennsylvania, Philadelphia; Analgesic Solutions, Natick, and Tufts University, Boston (N.P.K.), MA; Division of Anesthesia, Analgesia, and Addiction Products (A.H.L., B.A.R.), Food and Drug Administration, Silver Spring, MD; and California Pacific Medical Center Research Institute (M.C.R.), San Francisco, CA.
鲍勃·a·拉帕波特
部门的麻醉学(R.H.D.,S.P.-S.), Biostatistics and Computational Biology (H.H., M.P.M.), and Neurology (R.H.D., M.P.M), University of Rochester School of Medicine and Dentistry, Rochester, NY; Department of Anesthesiology and Pain Medicine (D.C.T.), University of Washington, Seattle; Department of Clinical Epidemiology and Biostatistics (J.T.F.), University of Pennsylvania, Philadelphia; Analgesic Solutions, Natick, and Tufts University, Boston (N.P.K.), MA; Division of Anesthesia, Analgesia, and Addiction Products (A.H.L., B.A.R.), Food and Drug Administration, Silver Spring, MD; and California Pacific Medical Center Research Institute (M.C.R.), San Francisco, CA.
Michael c . Rowbotham
部门的麻醉学(R.H.D.,S.P.-S.), Biostatistics and Computational Biology (H.H., M.P.M.), and Neurology (R.H.D., M.P.M), University of Rochester School of Medicine and Dentistry, Rochester, NY; Department of Anesthesiology and Pain Medicine (D.C.T.), University of Washington, Seattle; Department of Clinical Epidemiology and Biostatistics (J.T.F.), University of Pennsylvania, Philadelphia; Analgesic Solutions, Natick, and Tufts University, Boston (N.P.K.), MA; Division of Anesthesia, Analgesia, and Addiction Products (A.H.L., B.A.R.), Food and Drug Administration, Silver Spring, MD; and California Pacific Medical Center Research Institute (M.C.R.), San Francisco, CA.
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文摘
摘要目的:我们的目标是识别患者,研究,和站点与试验相关的因素在安慰剂对照神经性疼痛敏感性试验。
方法:我们检查之间的关联研究特点和标准化的效果(SES)在数据库中200年公开的随机临床试验的药物治疗神经性疼痛。
结果:有相当大的异质性之间的税进行试验。单变量多元回归分析表明,大税明显与试验,1)更大的最低基准疼痛入选标准,2)更大的意思是时代主题,3)一个更大比例的白种人,和4)一个更小的对象的总数。多重多元回归分析,SES和最低基准疼痛包含标准之间的关系和年龄仍然显著。
结论:我们分析了潜在的修改的相关研究SES和显示最低疼痛包含标准40以上在0到100的范围内与一个更大的SES相关联。这些数据提供了一个基础调查策略来提高检测灵敏度,从而减少错误的消极结果的可能性有效治疗神经性疼痛的临床试验。
术语表
- ACTTION=
- 镇痛、麻醉和成瘾临床试验翻译,创新,机会,和网络;
- CI=
- 置信区间;
- DPN=
- 糖尿病周围神经病变;
- 食品及药物管理局=
- 美国食品和药物管理局;
- 关系,=
- 数值评定量表;
- PHN=
- postherpetic神经痛;
- 棱镜=
- 首选项报告系统评价和荟萃分析;
- 个随机对照试验=
- 随机临床试验;
- SES=
- 标准化的效果;
- 血管=
- 视觉模拟评分
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