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首页> 外文期刊>The journal of clinical psychiatry >Bioavailability of S-adenosyl methionine and impact on response in a randomized, double-blind, placebo-controlled trial in major depressive disorder
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Bioavailability of S-adenosyl methionine and impact on response in a randomized, double-blind, placebo-controlled trial in major depressive disorder

机译：在严重抑郁症的一项随机，双盲，安慰剂对照试验中，S-腺苷甲硫氨酸的生物利用度及其对反应的影响

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Objective: To characterize the impact of S-adenosyl methionine (SAMe) on homocysteine and potential risk of adverse cardiovascular effects by examining plasma levels of SAMe, S-adenosyl homocysteine (SAH), total homocysteine (tHCY), methionine (MET), and 5-methyltetrahydrofolate (5-MTHF) in 35 of 73 patients from a 6-week randomized double-blind, placebo-controlled trial of SAMe augmentation in serotonin reuptake inhibitor partial responders with DSM-IV major depressive disorder (MDD), published in 2010. Method: Subjects were randomized from June 4, 2004, until August 8, 2008, to adjunctive placebo or SAMe 800-1600 mg/d for 6 weeks. Primary outcome measures included changes in one-carbon cycle intermediates within each treatment arm (by paired t test) and between treatment arms (by independent samples t test). Univariate analysis of variance and Fisher Protected Least Significant Difference were carried out to compare posttreatment levels of each one-carbon cycle intermediate. Secondary outcome measures included associations between clinical improvement and change in plasma intermediate levels, examined by linear regression (for change in Hamilton Depression Rating Scale scores) and logistic regression (for response or remission). Results: We found significant differences in pretreatment plasma levels of tHCY (P = .03) between the SAMe and placebo arms. Following 6 weeks of treatment, plasma SAMe (P = .002) and SAH (P < .0001) levels increased significantly in the SAMe arm; no intermediates in the placebo group changed significantly. Posttreatment plasma SAMe (P = .0035), SAH (P < .0001), and tHCY (P = .0016) levels differed significantly between the SAMe and placebo groups. No significant associations were found between plasma intermediate levels and clinical improvement, response, or remission. Conclusions: Despite concerns about the impact that SAMe therapy may have on homocysteine levels and risk of adverse cardiovascular effects, the lack of significant increase in tHCY levels after treatment suggests that no toxic effects from SAMe should be expected. Our findings, however, have some significant limitations and should be interpreted with caution. Trial Registration: ClinicalTrials.gov identifier: NCT00093847
机译：目的：通过检查血浆SAMe，S-腺苷高半胱氨酸（SAH），总高半胱氨酸（tHCY），甲硫氨酸（MET）和血浆中的半胱氨酸水平，来表征S-腺苷甲硫氨酸（SAMe）对同型半胱氨酸的影响以及潜在的不良心血管影响风险。来自73位患者中的35位患者中的5-甲基四氢叶酸（5-MTHF），该患者为期6周，通过SAME增强治疗对5-羟色胺再摄取抑制剂的部分缓解与DSM-IV重度抑郁症（MDD）进行了SAMe增强试验，于2010年发表方法：从2004年6月4日至2008年8月8日，将受试者随机分为辅助安慰剂或SAMe 800-1600 mg / d，共6周。主要结果指标包括每个治疗组内（通过配对t检验）和治疗组间（通过独立样本t检验）一碳循环中间体的变化。进行了方差和Fisher保护的最小显着差异的单变量分析，以比较每个一个碳循环中间体的后处理水平。次要结果指标包括临床改善与血浆中间水平变化之间的关联，通过线性回归（汉密尔顿抑郁量表评分的变化）和逻辑回归（对于缓解或缓解）进行检查。结果：我们发现SAMe和安慰剂组之间的tHCY预处理血浆水平存在显着差异（P = .03）。治疗6周后，SAMe组的血浆SAMe（P = .002）和SAH（P <.0001）水平显着增加;安慰剂组中没有中间体发生明显变化。在SAMe组和安慰剂组之间，治疗后血浆SAMe（P = .0035），SAH（P <.0001）和tHCY（P = .0016）水平显着不同。在血浆中间水平与临床改善，反应或缓解之间未发现显着关联。结论：尽管担心SAMe疗法可能对同型半胱氨酸水平产生影响，并具有不良心血管效应的风险，但治疗后tHCY水平缺乏显着增加表明，不应预期SAMe会产生毒性作用。但是，我们的发现有一些明显的局限性，应谨慎解释。试验注册：ClinicalTrials.gov标识符：NCT00093847

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