重复经颅磁刺激联合艾司西酞普兰治疗广泛性焦虑障碍的随机对照研究

A randomized controlled trial of repetitive transcranial magnetic stimulation combined with escitalopram in the treatment of generalized anxiety disorder

目的研究重复经颅磁刺激(r TMS)联合艾司西酞普兰治疗广泛性焦虑障碍(GAD)的疗效及安全性。方法招募符合诊断标准的GAD患者65例,随机分组为研究组32例,对照组33例,两组均使用艾司西酞普兰片固定剂量10mg/d治疗。研究组采用1Hz低频、90%运动阈值的r TMS进行右背外侧前额叶皮层刺激治疗,共20次(5次/周,4周,24000总刺激量)。对照组治疗部位、强度、频率、次数同治疗组,采用假性刺激。以汉密尔顿焦虑量表(HAMA)和汉密尔顿抑郁量表(HAMD-17)评定疗效。使用药物不良反应量表(TESS)及患者报告的不良反应评价安全性。结果治疗4周后两组患者HAMA总分及分量表分和HAMD-17评分均显著下降,与基线值相比差异有统计学意义(P均<0.05);与对照组相比,研究组在第2周,第4周的HAMA总分及分量表分和HAMD-17评分减分更为明显,差异有统计学意义(P均<0.05);两组均未发生严重不良反应,不良反应发生率的差异无统计学意义(P>0.05)。结论 r TMS可能是治疗GAD安全、有效的辅助手段。

Objective To study the efficacy and safety of repetitive transcranial magnetic stimulation (rTMS) combined with escitalopram in the treatment of generalized anxiety disorder (GAD). Methods 65 GAD patients who met the diagnostic criteria were recruited and randomly assigned to 32 cases in the study group and 33 cases in the control group. Both groups were treated with escitalopram at a fixed dose of 10mg/d for 4 weeks.In the study group,1HZ low-frequency rTMS with 90% motion threshold was used for right dorsolateral prefrontal cortex(DLPFC) stimulation therapy,for 20 sessions(5 days/week for 4 weeks;24000 total pulses). The site,intensity,frequency and number of treatment in the control group were the same as those in the treatment group,receiving sham rTMS. The Hamilton anxiety scale (HAMA) and Hamilton depression scale (HAMD-17) were used to evaluate the efficacy. TESS and self-reported adverse reactions were used to evaluate safety. Results After 4 weeks of treatment,the HAMA total score,subscale score and HAMD-17 score of the two groups were significantly decreased,with statistically significant differences from the baseline values(all P<0.05). Compared with the control group,the HAMA total score and subscale score and HAMD-17 score in the study group at week 2 and week 4 were significantly lower than those in the control group (all P<0.05). No serious adverse reactions occurred in the two groups,and there was no statistically significant difference in the incidence of adverse reactions (P=>0.05). Conclusion rTMS may be a safe and effectivity djunct treatment for GAD.