Mundo E, Bareggi S R, Pirola R, Bellodi L, Smeraldi E
Department of Neuropsychiatric Sciences, San Raffaele Hospital, University of Milan, Italy.
J Clin Psychopharmacol. 1997 Feb;17(1):4-10. doi: 10.1097/00004714-199702000-00002.
The aim of this study was to investigate whether obsessive-compulsive patients previously treated successfully with clomipramine or fluvoxamine could tolerate reduction of the daily dosage without worsening of the clinical condition. Thirty informed obsessive-compulsive patients, given a diagnosis according to DSM-III-R criteria, were recruited consecutively into the study. Patients were blindly assigned to one of the groups of treatment with different rates of reduction of the previously effective daily drug dosage: group 1 (control group, no reduction), group 2 (reduction of 33-40%), and group 3 (reduction of 60-66%). The entire study lasted 102 days. From baseline to the end of the study, the clinical condition was evaluated by the administration of standardized tests (Yale-Brown Obsessive-Compulsive Scale, Hamilton Rating Scale for Depression, Clinical Global Impression [CGI] scale), and blood samples were collected for plasma drug level determinations. The criterion for discontinuation of the study was the worsening of obsessive-compulsive symptoms, arbitrarily defined by an increase of > 5% from the baseline total Yale-Brown Obsessive-Compulsive Scale score, as measured in two successive assessments, and a worsening of global clinical condition as measured by the CGI scale. The main result of the study was borne out from the survival analysis. There were no significant differences in the cumulative proportion of patients from each group of treatment who did not worsen during the 102 days of observation. This preliminary result, which needs to be confirmed in larger samples, suggests that long-term maintenance therapy for obsessive-compulsive disorder might be provided with lower dosages of the antiobsessional drug, with clear advantages for tolerability and compliance.
本研究的目的是调查先前用氯米帕明或氟伏沙明成功治疗的强迫症患者是否能够耐受每日剂量的减少而不使临床状况恶化。根据DSM-III-R标准确诊的30名知情强迫症患者被连续纳入研究。患者被随机分配到以不同速率减少先前有效每日药物剂量的治疗组之一:第1组(对照组,不减少),第2组(减少33 - 40%),第3组(减少60 - 66%)。整个研究持续102天。从基线到研究结束,通过标准化测试(耶鲁-布朗强迫症量表、汉密尔顿抑郁评定量表、临床总体印象[CGI]量表)评估临床状况,并采集血样测定血浆药物水平。研究终止的标准是强迫症症状恶化,任意定义为连续两次评估中耶鲁-布朗强迫症量表总分较基线增加>5%,以及CGI量表测量的整体临床状况恶化。研究的主要结果来自生存分析。在102天的观察期内,各治疗组中未恶化的患者累积比例没有显著差异。这一初步结果需要在更大样本中得到证实,表明强迫症的长期维持治疗可能可以用较低剂量的抗强迫药物进行,在耐受性和依从性方面具有明显优势。