科学家们应该持怀疑态度的调查“不管他们的赞助。”Industry bias is self-evident, and it is actually more likely that "subtle biases ... may be invisible" for other types of research.
Drs。查德威克Privitera不问题的科学完整性,但责难的动机和必要性布卢姆等[1]调查,称其为“营销研究”。It is naïve to think that any post-marketing study (unless FDA required) does not have a marketing component, and it is unfair to leave the impression that this study is unique in this regard.
相关的随机对照试验“不应该用来证明明显。”We all knew that carbamazepine had less cognitive effects than phenytoin, until they were rigorously compared. [2] When the Blum et al study was designed, generalization of healthy human results to epilepsy was questioned, and lamotrigine data in epilepsy patients with formal neuropsychological testing was inadequate due to inconsistent results, limited neuropsychological batteries, and small sample sizes. Further, modest cognitive effects for topiramate had been reported in two post-marketing studies.
“为什么研究不充分的可靠检测的差异发作的结果?”This was not the purpose of the study. An RCT cannot address all issues within a single study (e.g., teratogenesis, bone loss, drug interactions, rare serious events). A design for efficacy or even effectiveness would not be optimal for examining antiepileptic drug (AED) cognitive effects. [3]
”是不寻常的试验主要结果是一个负面影响。”To be balanced, the editorial should have pointed out that multiple companies have conducted studies, including RCTs, with primary outcomes examining adverse effects of AEDs.
“(这项研究)应该改变我们的临床实践吗?…大多数临床医生只会减少药物剂量的临床重要的认知影响。”Cognitive effects are assessed clinically by patient perception. However, subjective AED cognitive effects are more related to mood than objective performance. [4-5] Unrecognized AED cognitive effects can be clinically significant. Information on relative AED cognitive effects contributes to AED choice, helps separate deficits due to underlying disease and should be a component of the informed consent process for treatment.
科学家们应该持怀疑态度的调查“不管他们的赞助。”Industry bias is self-evident, and it is actually more likely that "subtle biases ... may be invisible" for other types of research.
Drs。查德威克Privitera不问题的科学完整性,但责难的动机和必要性布卢姆等[1]调查,称其为“营销研究”。It is naïve to think that any post-marketing study (unless FDA required) does not have a marketing component, and it is unfair to leave the impression that this study is unique in this regard.
相关的随机对照试验“不应该用来证明明显。”We all knew that carbamazepine had less cognitive effects than phenytoin, until they were rigorously compared. [2] When the Blum et al study was designed, generalization of healthy human results to epilepsy was questioned, and lamotrigine data in epilepsy patients with formal neuropsychological testing was inadequate due to inconsistent results, limited neuropsychological batteries, and small sample sizes. Further, modest cognitive effects for topiramate had been reported in two post-marketing studies.
“为什么研究不充分的可靠检测的差异发作的结果?”This was not the purpose of the study. An RCT cannot address all issues within a single study (e.g., teratogenesis, bone loss, drug interactions, rare serious events). A design for efficacy or even effectiveness would not be optimal for examining antiepileptic drug (AED) cognitive effects. [3]
”是不寻常的试验主要结果是一个负面影响。”To be balanced, the editorial should have pointed out that multiple companies have conducted studies, including RCTs, with primary outcomes examining adverse effects of AEDs.
“(这项研究)应该改变我们的临床实践吗?…大多数临床医生只会减少药物剂量的临床重要的认知影响。”Cognitive effects are assessed clinically by patient perception. However, subjective AED cognitive effects are more related to mood than objective performance. [4-5] Unrecognized AED cognitive effects can be clinically significant. Information on relative AED cognitive effects contributes to AED choice, helps separate deficits due to underlying disease and should be a component of the informed consent process for treatment.
我同意这是一个关键需要crt势均力敌,但责任不应仅仅放在行业。当前的监管部门的批准和标签激励不鼓励这样的试验,和其它资金来源不足需要解决这个。
引用
1。布卢姆D, tommeador一路KJ, Biton V, et al .认知影响的拉莫三嗪与托吡酯癫痫患者。首页神经病学2006:67:400 - 406。
2。tommeador一路KJ。癫痫和抗癫痫药物的认知的影响。:建于E,艾德,癫痫的治疗。原则和实践,第四版。费城:Lippincott Williams &威尔金斯,2005:1185 - 1195。
3所示。tommeador一路KJ。认知和行为评估AED试验。抗癫痫药物的发展。神经学的进步1998;2首页3:231 - 237。
4所示。Perrine K,赫尔曼BP tommeador一路KJ, et al。神经心理功能的关系在癫痫患者的生活质量。拱神经52:997 1995;1003年。
5。阿尔玛盟,梁郭P, P,他C,陈j .主观记忆和情绪的香港中国成人癫痫患者。癫痫Behav 9:68 2006; 72年。
披露的相关文章,这对应是指:Cyberonics tommeador一路博士担任顾问,葛兰素史克,Neuropace,诺华,邻位的McNeil, UCB制药公司。他收到葛兰素史克谢礼,邻位的。麦克内尔,UCB制药。tommeador一路博士研究经费来自国家卫生研究院/研究所(2 ro1-ns38455 *, R01——NSO31966-11A2 n01 - ns - 5 - 2364), Neuropace,山姆技术,联合制药公司葛兰素史克。他还收到工资的支持梅尔文格里尔赋予椅子,佛罗里达大学*和脑电图程序和护理神经病人。*星号项涉及工资超过去年的10000美元。