Bergeron Richard, Ravindran Arun V, Chaput Yves, Goldner Elliot, Swinson Richard, van Ameringen Michael A, Austin Carol, Hadrava Vratislav
McGill University, Montreal, Quebec, Canada.
J Clin Psychopharmacol. 2002 Apr;22(2):148-54. doi: 10.1097/00004714-200204000-00007.
The purpose of this study was to evaluate the comparative efficacy and tolerability of sertraline and fluoxetine in the treatment of obsessive-compulsive disorder (OCD). Outpatients meeting DSM-IV criteria for OCD, with a Yale-Brown Obsessive-Compulsive (Y-BOCS) total score >or= 17, an NIMH Global Obsessive-Compulsive (NIMH-OC) scale score >or= 7, and a CGI-Severity score >or= 4 were randomized to 24 weeks of double-blind treatment with sertraline (N = 77) or fluoxetine (N = 73). Primary efficacy measures consisted of the Y-BOCS, the NIMH-OC scale, and the CGI-Severity (CGI-S) and Improvement (CGI-I) scales. Equivalent and significant (p < 0.001) improvement was found at week 24 in Y-BOCS and NIMH-OC scale scores for sertraline and fluoxetine. After 12 weeks, 49.2% of patients on sertraline were rated on the CGI-S scale as being mildly ill or not ill compared to 24.6% on fluoxetine (p < 0.01). A Cox analysis found patients on sertraline to have a statistically nonsignificant 42% greater likelihood of achieving a response by week 12 (CGI-I, much or very much improved; 95% CI, 0.85, 2.38; p = 0.18). Sertraline treatment also resulted in a higher proportion of remissions than fluoxetine (defined as a CGI-I <or= 2 and a Y-BOCS score <or= 11), both at week 12 (20% vs. 8%; chi2, 3.95; df 1; p = 0.047) and week 24 (36% vs. 22%; chi2, 3.18; df, 1; p = 0.075). Both medications were well-tolerated and demonstrated significant efficacy in the treatment of outpatients with moderate to severe OCD with the subjects treated with sertraline showing a greater likelihood of remission as well as an earlier improvement on some but not all efficacy measures
本研究的目的是评估舍曲林和氟西汀治疗强迫症（OCD）的相对疗效和耐受性。符合DSM-IV强迫症标准的门诊患者，耶鲁-布朗强迫症量表（Y-BOCS）总分≥17，美国国立精神卫生研究所全球强迫症量表（NIMH-OC）评分≥7，临床总体印象严重程度量表（CGI-S）评分≥4，被随机分为接受24周舍曲林（N = 77）或氟西汀（N = 73）双盲治疗。主要疗效指标包括Y-BOCS量表、NIMH-OC量表、CGI严重程度量表（CGI-S）和CGI改善量表（CGI-I）。在第24周时，舍曲林和氟西汀的Y-BOCS量表和NIMH-OC量表评分均有同等显著的改善（p < 0.001）。12周后，接受舍曲林治疗的患者中有49.2%在CGI-S量表上被评为轻度疾病或无疾病，而接受氟西汀治疗的患者中这一比例为24.6%（p < 0.01）。一项Cox分析发现，接受舍曲林治疗的患者在第12周达到缓解的可能性在统计学上虽无显著差异，但比接受氟西汀治疗的患者高42%（CGI-I，显著或非常显著改善；95%置信区间，0.85，2.38；p = 0.18）。舍曲林治疗导致缓解的比例也高于氟西汀（定义为CGI-I≤2且Y-BOCS评分≤11），在第12周时（20%对8%；χ2，3.95；自由度1；p = 0.047）和第24周时（36%对22%；χ2，3.18；自由度，1；p = 0.075）均如此。两种药物耐受性良好，在治疗中度至重度强迫症门诊患者方面均显示出显著疗效，接受舍曲林治疗的患者缓解的可能性更大，并且在一些但并非所有疗效指标上改善更早。
