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首页> 外文期刊>The journal of clinical psychiatry >The safety and early efficacy of oral-loaded divalproex versus standard-titration divalproex, lithium, olanzapine, and placebo in the treatment of acute mania associated with bipolar disorder.
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The safety and early efficacy of oral-loaded divalproex versus standard-titration divalproex, lithium, olanzapine, and placebo in the treatment of acute mania associated with bipolar disorder.

机译：口服双丙戊酸钠与标准滴定双丙戊酸钠，锂，奥氮平和安慰剂相比，治疗双相情感障碍急性躁狂症的安全性和早期疗效。

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BACKGROUND: Previous studies have examined the safety and tolerability of oral-loaded divalproex sodium in the treatment of acute mania, but not the early efficacy of this dosing strategy. The purpose of this study was to evaluate the early efficacy of oral-loaded divalproex. METHOD: In this pooled analysis, 348 subjects from 3 randomized, double-blind, parallel-group, active- or placebo-controlled studies were used to compare the efficacy, safety, and tolerability of oral-loaded divalproex with standard-titration divalproex, lithium, olanzapine, or placebo. Subjects were inpatients diagnosed with acute mania associated with bipolar I disorder (DSM-III-R or -IV and SADS-Change Version). Patients were administered oral-loaded divalproex (20 or 30 mg/kg/day on days 1 and 2 followed by 20 mg/kg/day, and increased at physician's discretion), standard-titration divalproex initiated at 250 mg t.i.d. and titrated to 40-150 microg/mL, lithium (300 mg t.i.d. initial dose) titrated to 0.4 to 1.5 mEq/L, olanzapine (10 mg q.d. initial dose) up to 20 mg/day, or placebo. RESULTS: The results demonstrate an early efficacy advantage for oral-loaded divalproex compared to standard-titration divalproex at days 5, 7/8, and 10. Efficacy was improved over lithium on day 7/8. There were no efficacy differences between divalproex loading and olanzapine. Divalproex loading showed greater efficacy than placebo at all time points. Divalproex loading was as well tolerated or better tolerated than the other active treatments as measured by adverse events and changes in laboratory parameters. CONCLUSION: These results suggest the oral loading of divalproex leads to a more rapid antimanic effect when compared with standard-titration divalproex, lithium, or placebo and is better tolerated than olanzapine and as well tolerated as lithium or standard-titration divalproex.
机译：背景：以前的研究已经检查了口服二氯丙戊酸钠口服液治疗急性躁狂的安全性和耐受性，但没有研究这种给药策略的早期疗效。这项研究的目的是评估口服divalproex的早期疗效。方法：在这项汇总分析中，来自3个随机，双盲，平行组，活性或安慰剂对照研究的348名受试者被用于比较口服负荷的divalproex与标准滴定divalproex的疗效，安全性和耐受性，锂，奥氮平或安慰剂。受试者为被诊断患有双相性I型躁狂症（DSM-III-R或-IV和SADS-Change版本）的急性躁狂症的住院患者。患者口服divalproex（第1天和第2天每天20或30 mg / kg /天，然后每天20 mg / kg /天，并由医生酌情增加剂量），标准滴定divalproex于250 mg t.i.d开始。并滴定至40-150 microg / mL，锂（300 mg t.i.d.初始剂量）滴定至0.4至1.5 mEq / L，奥氮平（10 mg q.d.初始剂量）至20 mg / day，或安慰剂。结果：结果表明，与标准滴定双丙戊酸钠相比，口服双丙戊酸钠在第5、7 / 8和10天有较早的疗效，在第7/8天与锂相比，疗效得到改善。 Divalproex负荷量与奥氮平之间没有疗效差异。在所有时间点，Divalproex加载量均显示出比安慰剂更高的功效。通过不良事件和实验室参数的变化来衡量，Divalproex的负荷耐受性比其他主动治疗好或更好。结论：这些结果表明，与标准滴定的divalproex，锂或安慰剂相比，口服divalproex的抗躁作用更快，并且比奥氮平更好，并且与锂或标准滴定的divalproex一样耐受。

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