度洛西汀合并重复经颅磁刺激治疗广泛性焦虑障碍患者的对照研究

Clinical controlled study of repetitive transcranial magnetic stimulation combined with duloxetine versus duloxetine in the treatment of generalized anxiety disorder

目的:比较度洛西汀单用或联合重复经颅磁刺激(r TMS)治疗广泛性焦虑障碍(GAD)的临床疗效和安全性。方法:113例GAD患者随机分为研究组(r TMS联合度洛西汀治疗)56例和对照组(单用度洛西汀治疗)57例,疗程4周。采用汉密尔顿焦虑量表(HAMA)、临床疗效总评量表(CGI)、治疗中出现的症状量表(TESS)分别在治疗前后评估疗效和不良反应。结果:研究组显效率76.7%,对照组显效率71.9%(F=1.441,P>0.05)。两组HAMA评分时间主效应存在统计学意义(F=163.12,P<0.05),组间主效应(F=1.44)及交互效应(F=1.62)均无统计学意义(P>0.05)。两组CGI评分组间主效应(F=49.29,P<0.05)、时间主效应(F=1043.00,P<0.001)以及交互效应(F=49.29,P<0.05)均有统计学意义。两组TESS评分差异有统计学意义(t=4.983,P<0.05)。结论:度洛西汀单用或联合r TMS治疗GAD疗效相当,但后者起效更快,不良反应更小。

Objective：To observe the clinical efficacy and safety of repetitive transcranial magnetic stimu-lation（ rTMS）combined with duloxetine in the treatment of generalized anxiety disorder（ GAD）patients. Method：One hundred and thirteen patients diagnosed as GAD were randomly divided into experimental group （ rTMS plus duloxetine,57 patients）and control group（ only duloxetine treatment,56 patients）. At the begin-ning of the experiment and at the end of first,second,and fourth week of the trail,the symptom severity,clinical effect and side effects were evaluated by Hamilton anxiety scale（ HAMA）,the clinical global impression scale （CGI）and the treatment emergent symptom scale（TESS）respectively. Resuits：The marked effective rate （76. 7%） of experimental group was not significantly different from that （ 71. 9%） of control group （F=1. 441,P〉0. 05）. On HAMA,time main effect（F=163. 12,P〈0. 05）was statistically significant,while group main effect（ F = 1. 44 ） and interaction effect（ F = 1. 62 ） were not statistically significant（ all P〉0. 05）. There were significant group main effect（F=49. 29,P〈0. 05）,time main effect（F=1043. 00, P〈0. 001）and interaction effect（F=49. 29,P〈0. 05）on CGI. The two groups showed significant differences on TESS（t=4. 983,P〈0. 05）. Conciusion：Both two-treatment paradigms have similar clinical outcome. But patients from rTMS plus duloxetine group showed more quickly clinical remission,rare side effect and a bet-ter treatment adherence.