氟伏沙明与氯米帕明治疗强迫症:确定药物安全性和有效性的比较研究

Anirudh Atul Salunke
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引用次数: 0

摘要

研究目的这项为期12周的盲法随机对照比较研究旨在确定uvoxamine和氯米帕明对成年门诊强迫症(OCD)患者的安全性和有效性。研究方法:156名患有DSM-IV强迫症的成年门诊患者被随机分为两组,分别接受100至300毫克的uvoxamine CR(78人)或氯米帕明(78人),每天一次,睡前服用,为期12周。采用耶鲁-布朗强迫症量表(YBOCS)、临床总体印象-疾病严重程度量表(CGI-S)进行意向性治疗、疗cacy评估分析。结果显示通过LOCF分析,研究结束时两组应答者(YBOCS总分改善>35%)的比例相似(62% FLV vs 65% CMI)。氟伏沙明(CR)和氯米帕明(Clomipramine)从第2周开始显示出YBOCS总分显著下降(>35%)。这种早期反应在随后的所有检查中都得到了维持。终点时,与基线相比,uvoxamine CR治疗组的YBOCS总分平均下降了11.65 ± 0.7(44.89%),而氯米帕明治疗组的YBOCS总分平均下降了12.3 ± 0.7(46.32%)(p = .001)。据观察,受试者对FLV的耐受性优于CMI;而接受CMI治疗的患者出现更多的抗胆碱能副作用(口干、便秘和震颤),并因不良反应而过早退出治疗。CGI-S评分也显示,FLV组和CMI组分别有59.25%和55.14%的显著改善。结论:研究表明,uvoxamine和氯米帕明具有同等的疗效,两种药物都能显著降低主要cacy参数:YBOCS和CSI-S评分。氯米帕明组(24%)的治疗退出率高于 uvoxamine 组(17%)。我们的结论是,鉴于强迫症患者需要长期甚至终身治疗,氟伏沙明与氯米帕明相比具有耐受性和安全性优势,因此似乎是治疗的首选。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
FLUVOXAMINE VERSUS CLOMIPRAMINE FOR OBSESSIVE COMPULSIVE DISORDER: A COMPARATIVE STUDY TO DETERMINE SAFETY AND EFFICACY OF THE DRUGS
Objective: The aim of this 12-week, blind randomized control comparative study was to determine the safety and efcacy of uvoxamine and clomipramine in adult outpatients with obsessive-compulsive disorder (OCD). Method: 156 adult outpatients with DSM-IV OCD were randomly assigned into two groups to receive 100 to 300 mg of uvoxamine CR (N=78) or Clomipramine (N = 78) once daily at bedtime for 12 weeks. Intentto-treat, analysis of efcacy assessments with the Yale- Brown Obsessive Compulsive Scale (YBOCS), Clinical Global Impressions-Severity of Illness scale (CGI-S) was done. Results: The percentage of responders (response >35% improvement in the YBOCS total score) at the end of the study was similar in both groups (62% FLV vs 65% CMI) by LOCF analysis. Fluvoxamine CR and Clomipramine showed a signicant (>35%) decrease in YBOCS total score beginning at week 2. This early response was sustained at all subsequent visits. At endpoint, there was a mean decrease of 11.65 ± 0.7 (44.89%) in the YBOCS total score compared with baseline in the uvoxamine CR treatment group versus a mean decrease of 12.3 ± 0.7 (46.32%) in the clomipramine treatment group (p = .001). It was observed that FLV was better tolerated than CMI among subjects; patients treated with CMI had more anticholinergic side effects (dry mouth, constipation, and tremor) and premature withdrawals due to adverse events. CGI-S scores also showed a statistically signicant improvement of 59.25% in FLV group and 55.14% in CMI group. Conclusion: The study show that both uvoxamine and clomipramine has equivalent efcacy, wherein both the drugs start showing signicant reduction in primary efcacy parameters: YBOCS and CSI-S scores since the end of second week. Treatment dropout rate was higher in the Clomipramine (24%) group than the uvoxamine (17%) group. We concluded that with long-term or even life- long treatment appearing necessary for people with OCD, Fluvoxamine would appear to be the treatment of choice in view of their tolerability and safety advantages compared with clomipramine.
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