The safety of flavocoxid, a medical food, in the dietary management of knee osteoarthritis.
The safety of flavocoxid, a medical food, in the dietary management of knee osteoarthritis.
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DOI：
10.1089/jmf.2008.0244
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发表时间：
2009-10
影响因子：
2.4
通讯作者：
Kendrach AC
中科院分区：
文献类型：
--
作者：
Morgan SL;Baggott JE;Moreland L;Desmond R;Kendrach AC
本研究旨在确定黄酮类药用食品的安全性。黄酮类是由黄芩和相思树树皮中的游离B环黄酮类和黄酮类化合物组成的专利混合物，用于膝关节骨关节炎的饮食管理。这项为期12周的随机、双盲、安慰剂对照试验在一个学术医学中心进行，纳入了59名患有至少一侧膝关节的中度骨性关节炎的患者，他们被纳入使用基于弗雷明翰的评分工具，被归类为具有“低于平均水平”到“略高于平均水平”的心血管风险。受试者随机服用黄曲霉毒素250毫克，每天两次，与相同的安慰剂对照。比较两组的安全措施，包括不良事件的记录、严重不良事件的发生率和常规化验值结果。安慰剂组和黄曲霉素组的基线人口学特征没有重大差异。除了一个例外，两组之间在身体系统、血压或化验值方面的不良事件没有发现显著差异。安慰剂组上呼吸道不良事件的发生率显著高于安慰剂组(35.4%比5.8%，P=.0003)。从研究基线到研究完成，组内或组间的任何实验室参数都没有差异。因此，在心血管风险低于平均水平到略高于平均水平的人群中使用黄曲霉毒素时，与安慰剂相比是安全的。
This study was designed to determine the safety of a medical food, flavocoxid, a proprietary blend of free-B ring flavonoids and flavans from the root of Scutellaria baicalensis (Chinese skullcap) and the bark of Acacia catechu in the dietary management of knee osteoarthritis. The 12-week, randomized, double-blind, placebo-controlled trial in an academic medical center enrolled 59 patients with moderate osteoarthritis of at least one knee who were recruited who were classified as having “below average” to “a moderately above average cardiovascular risk” with a Framingham-based scoring tool. Subjects were randomized to flavocoxid 250 mg twice a day versus identical placebo. Safety measures, including recording of adverse events, incidence of serious adverse events, and results of routine laboratory values, were compared between the two groups. There were no major differences in the baseline demographic characteristics of the placebo and flavocoxid groups. With one exception no significant differences were found between the two groups with respect to adverse events by body system, blood pressure, or laboratory values. There was a significantly higher incidence of upper respiratory adverse events in the placebo group (35.4% vs. 5.8%, P = .0003). There were no intra- or inter-group differences in any of the laboratory parameters from study baseline to completion. Thus, flavocoxid is safe when used in a population with “below average” to “moderately above average cardiovascular risk” compared to placebo.
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影响因子：
2.4
作者：
Burnett, B. P.;Jia, Q.;Levy, R. M.
通讯作者：
Levy, R. M.
影响因子：
3.4
作者：
Beck, AT;Steer, RA;Ranieri, WF
通讯作者：
Ranieri, WF
影响因子：
2.7
作者：
Lai, MY;Hsiu, SL;Chao, PDL
通讯作者：
Chao, PDL
影响因子：
4.3
作者：
Chung, Ho-Lam;Yue, Grace Gar-Lee;Ko, Wing-Hung
通讯作者：
Ko, Wing-Hung
DOI：
10.1111/j.2044-8341.1959.tb00467.x
发表时间：
1959-01-01
期刊：
BRITISH JOURNAL OF MEDICAL PSYCHOLOGY
影响因子：
--
作者：
HAMILTON, M
通讯作者：
HAMILTON, M