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首页> 外文期刊>The journal of clinical psychiatry >Risperidone in acutely exacerbated schizophrenia: dosing strategies and plasma levels.
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Risperidone in acutely exacerbated schizophrenia: dosing strategies and plasma levels.

机译：利培酮在急性加重性精神分裂症中的作用：给药策略和血浆水平。

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BACKGROUND: The optimal risperidone dosing strategy for acute schizophrenia requires elucidation. Furthermore, plasma levels of risperidone and its active metabolite (9-hydroxyrisperidone) at a given dose vary greatly among different individuals. For patients who metabolize risperidone slowly, a medium dose results in excessively high plasma levels, which might be related to adverse events and perhaps poor response. We thus investigated whether dose reduction to diminish adverse reactions associated with ordinary risperidone doses could still yield efficacy for acutely exacerbated schizophrenia. METHOD: Thirty-one newly hospitalized Chinese patients with acute exacerbation of schizophrenia (DSM-IV) entered this prospective, 6-week open trial. Risperidone doses were titrated to 6 mg/day (if tolerable) over 3 days, but were lowered thereafter if side effects appeared. Efficacy and side effect assessments were conducted on days 0, 4, 14, 28, and 42. Endpoint steady-state plasma levels of risperidone and 9-hydroxyrisperidone were analyzed by high performance liquid chromatography with ultraviolet detection. RESULTS: Thirty patients completed the trial. Of them, 17 tolerated the 6-mg target dose well, while the other 13 received lower final doses (mean +/- SD = 3.6 +/- 0.9 mg, p = .0001) for curtailing treatment-emergent side effects. At endpoint, 92.3% of the 13 low-dose individuals responded to treatment (20% or more reduction in the total Positive and Negative Syndrome Scale score), compared with 52.9% of the 17 high-dose subjects (p < .05). No significant between-group differences were revealed in other minor efficacy measures. Of note, endpoint plasma levels of the active moiety (risperidone plus 9-hydroxyrisperidone) were similar between the low- and high-dose groups (40.4 +/- 31.1 ng/mL vs. 49.7 +/- 13.4 ng/mL, NS). CONCLUSION: The results of this preliminary trial suggest that up to 6 mg of risperidone is efficacious in treating patients with acute exacerbation of schizophrenia. Nearly 60% of the patients could tolerate a 6-mg dose. For the other 40%, reducing dosages to 3.6 +/- 0.9 mg for relieving side effects still yielded efficacy. The 2 dose groups were comparable in the endpoint steady-state plasma drug concentrations.
机译：背景：急性精神分裂症的最佳利培酮给药策略需要阐明。此外，在给定剂量下，利培酮及其活性代谢物（9-羟基利培酮）的血浆水平在不同个体之间差异很大。对于缓慢代谢利培酮的患者，中等剂量会导致血浆水平过高，这可能与不良事件和不良反应有关。因此，我们研究了降低剂量以减少与普通利培酮剂量相关的不良反应是否仍能产生急性加重性精神分裂症的疗效。方法：31位新住院的中国精神分裂症急性加重患者（DSM-IV）参加了这项为期6周的前瞻性试验。在3天内将利培酮的剂量滴定至6 mg / day（如果可以忍受），但如果出现副作用，则将其降低。在第0、4、14、28和42天进行了功效和副作用评估。利培酮和9-羟基利培酮的稳态血浆血浆水平通过高效液相色谱-紫外检测法进行分析。结果：30名患者完成了该试验。其中17例耐受6 mg的目标剂量，而其他13例接受较低的最终剂量（平均+/- SD = 3.6 +/- 0.9 mg，p = .0001），以减少治疗中出现的副作用。到终点时，在13位低剂量个体中有92.3％对治疗有反应（阳性和阴性综合症状量表总分降低20％或更多），而在17位高剂量受试者中，这一比例为52.9％（p <.05）。其他次要疗效指标中未发现明显的组间差异。值得注意的是，低剂量组和高剂量组的活性成分（利培酮加9-羟基利培酮）的终点血浆水平相似（40.4 +/- 31.1 ng / mL与49.7 +/- 13.4 ng / mL，NS） 。结论：该初步试验的结果表明，高达6 mg的利培酮可有效治疗精神分裂症急性加重患者。将近60％的患者可以耐受6毫克的剂量。对于其他40％的患者，将剂量减少至3.6 +/- 0.9 mg以缓解副作用仍可产生疗效。 2个剂量组在终点稳态血浆药物浓度方面具有可比性。

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