Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.
CNS Drugs. 2012 Oct 1;26(10):883-92. doi: 10.2165/11635850-000000000-00000.
Several small studies have shown beneficial effects of ondansetron, a serotonin 5-HT(3) receptor antagonist, in the treatment of obsessive-compulsive disorder (OCD). The efficacy of other 5-HT(3) receptor antagonists in patients with OCD is still unclear. Granisetron does not alter cytochrome P450 activity and might have a lower risk of drug interactions, a longer duration of action and a better tolerability profile than other 5-HT(3) receptor antagonists.
The objective of this study was to assess the efficacy and tolerability of granisetron augmentation of fluvoxamine in patients with OCD.
This was a two-centre, randomized, double-blind, placebo-controlled, parallel-group study conducted from November 2011 to March 2012.
The study setting was outpatient clinics of two large referral centres.
Study participants were men and women, aged 18-60 years, who met the diagnostic criteria of OCD based on the DSM-IV-TR and who had a Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score of at least 21.
Participants were randomly assigned to granisetron (Kytril(®); SmithKline Beecham, Philadelphia, PA, USA) 1 mg every 12 hours or placebo every 12 hours in addition to fluvoxamine for 8 weeks.
Patients were assessed using the Y-BOCS at baseline, second, fourth, sixth and eighth weeks. The primary outcome measure was the difference in the score change of Y-BOCS total score from baseline to week 8 between the two groups. We also compared changes in the obsession and compulsion subscales of the Y-BOCS, and frequencies of partial response (≥25% reduction in Y-BOCS score), complete response (≥35% reduction in Y-BOCS score) and remission (Y-BOCS score ≤16) between the two groups.
Of the 42 included patients, 39 (20 in the placebo group, 19 in the granisetron group) completed the study. Significant time X treatment interaction was observed for total Y-BOCS (F [2.097, 79.678] = 4.941, p = 0.009), obsession (F [2.337, 88.799] = 4.938, p = 0.006) and compulsion (F [2.050, 77.899] = 4.674, p = 0.012) subscales. By week 8, complete response and remission were achieved by 20 (100%) and 18 (90%) patients in the granisetron group and by 7 (35%) patients in the placebo group (p-value of Fisher's exact test <0.001, risk ratio (RR) [95% CI] = 3.857 [2.039, 7.297]). There was no significant difference in the tolerability between the two regimens.
Granisetron is an efficacious adjunct for the short-term treatment of patients with moderate to severe OCD and is well tolerated.
IRCT201202041556N32.
几项小型研究表明，5-羟色胺 5-HT(3)受体拮抗剂昂丹司琼对治疗强迫症（OCD）有有益的作用。其他 5-HT(3)受体拮抗剂在 OCD 患者中的疗效仍不清楚。格拉司琼不会改变细胞色素 P450 的活性，与其他 5-HT(3)受体拮抗剂相比，它可能具有更低的药物相互作用风险、更长的作用持续时间和更好的耐受性。
本研究旨在评估格拉司琼增强氟伏沙明治疗 OCD 的疗效和耐受性。
这是一项为期 8 周的、在 2011 年 11 月至 2012 年 3 月进行的、在两个大型转诊中心进行的、双盲、安慰剂对照、平行组研究。
研究地点为两个大型转诊中心的门诊。
研究参与者为年龄在 18-60 岁之间的男性和女性，符合 DSM-IV-TR 中 OCD 的诊断标准，且耶鲁-布朗强迫症量表（Y-BOCS）评分至少为 21。
参与者被随机分配到格拉司琼（Kytril(®)；SmithKline Beecham，费城，宾夕法尼亚州，美国）组，每 12 小时服用 1 毫克，或安慰剂组，每 12 小时服用 1 毫克，同时服用氟伏沙明 8 周。
患者在基线、第二、第四、第六和第八周时使用 Y-BOCS 进行评估。主要观察指标是两组患者从基线到第 8 周时 Y-BOCS 总分评分变化的差异。我们还比较了 Y-BOCS 的强迫观念和强迫行为子量表的变化，以及两组之间部分反应（Y-BOCS 评分减少≥25%）、完全反应（Y-BOCS 评分减少≥35%）和缓解（Y-BOCS 评分≤16）的频率。
在纳入的 42 名患者中，有 39 名（安慰剂组 20 名，格拉司琼组 19 名）完成了研究。总 Y-BOCS（F [2.097，79.678] = 4.941，p = 0.009）、强迫观念（F [2.337，88.799] = 4.938，p = 0.006）和强迫行为（F [2.050，77.899] = 4.674，p = 0.012）亚量表均观察到显著的时间 X 治疗交互作用。到第 8 周时，格拉司琼组有 20 名（100%）和 18 名（90%）患者达到完全反应和缓解，而安慰剂组只有 7 名（35%）患者达到完全反应和缓解（Fisher 精确检验 p 值 <0.001，RR [95%CI] = 3.857 [2.039，7.297]）。两种方案的耐受性无显著差异。
格拉司琼是治疗中重度 OCD 患者的有效辅助药物，且耐受性良好。
IRCT201202041556N32。
