CAJ | 학술논문

目的探讨重复经颅磁刺激( repetitive transcranial magnetic stimulation,rTMS)联合帕罗西汀对重性抑郁障碍( major depressive disorder,MDD)的疗效。方法本研究是一项为期6周的随机、双盲、伪刺激对照临床试验。48例MDD患者采用数字表法随机分为2组接受rTMS真(real)或伪(sham)刺激治疗2周,基线起同时合并固定剂量的帕罗西汀(20 mg/d),rTMS治疗结束后随访至6周末,随访期间帕罗西汀治疗剂量保持不变。设置7个访视点进行疗效评定和不良事件记录。结果研究结束时,两组患者的蒙哥马利抑郁量表、汉密尔顿抑郁量表17项、汉密尔顿焦虑量表评分较基线均显著降低,但两组对比总体疗效相当。 Real组平均起效时间比Sham组早3天,但差异不具有统计学意义。符合方案人群分析显示Real组对汉密尔顿抑郁量表“焦虑/躯体化”因子分的改善,在第10、14、28天显著优于Sham组；对汉密尔顿焦虑量表评分的改善在第10天显著优于Sham组。2组患者的不良事件发生率差异无统计学意义。结论 rTMS联合帕罗西汀是一种较好的抑郁症治疗方法,显示出较快起效的趋势,rTMS对焦虑症状、躯体化症状可能具有较快的改善作用。
목적탐토중복경로자자격( repetitive transcranial magnetic stimulation,rTMS)연합파라서정대중성억욱장애( major depressive disorder,MDD)적료효。방법본연구시일항위기6주적수궤、쌍맹、위자격대조림상시험。48례MDD환자채용수자표법수궤분위2조접수rTMS진(real)혹위(sham)자격치료2주,기선기동시합병고정제량적파라서정(20 mg/d),rTMS치료결속후수방지6주말,수방기간파라서정치료제량보지불변。설치7개방시점진행료효평정화불량사건기록。결과연구결속시,량조환자적몽가마리억욱량표、한밀이돈억욱량표17항、한밀이돈초필량표평분교기선균현저강저,단량조대비총체료효상당。 Real조평균기효시간비Sham조조3천,단차이불구유통계학의의。부합방안인군분석현시Real조대한밀이돈억욱량표“초필/구체화”인자분적개선,재제10、14、28천현저우우Sham조；대한밀이돈초필량표평분적개선재제10천현저우우Sham조。2조환자적불량사건발생솔차이무통계학의의。결론 rTMS연합파라서정시일충교호적억욱증치료방법,현시출교쾌기효적추세,rTMS대초필증상、구체화증상가능구유교쾌적개선작용。
Objective To investigate the efficacy of repetitive transcranial magnetic stimulation( rTMS) in combination with paroxetine for major depressive disorder. Methods In a 6-week, randomized, double-blind, sham-controlled trial, 48 patients with major depressive disorder were randomly assigned to receive real or sham rTMS for 2 weeks. During the 6 weeks, paroxetine was used at a fixed dose of 20 mg per day for all participants. Seven sites were set to conduct assessment of efficacy and adverse events in this study. ResultsThe Montgomery-Asberg Depression Rating(MADRS), the 17-item Hamilton Depression Rating Scale(HAMD-17) and Hamilton Anxiety Rating Scale( HAMA) scores significantly decreased from baseline to the endpoint in both groups. No meaningful difference was observed between the two groups in general clinical effect. The mean time-to-onset was earlier by 3 days in Real group, but the difference was not significant. In the Real group, the scores of HAMD anxiety/somatic symptom factor significantly decreased on day10, 14 and 28; the scores of HAMA significantly decreased on day 10. The incidence of adverse events in both groups had no significant difference. Conclusion The combination of rTMS and paroxetine was effective and safe in treatment of MDD. The tendency of fast onset of effect was observed in the comprehensive intervention, which probably is beneficial to the patients with anxiety and somatic symptoms.