米氮平及曲唑酮辅助治疗镇静催眠药常规治疗无效失眠的对照研究

目的:了解米氮平对失眠的疗效和安全性。方法:对符合CCMD-3失眠症并使用镇静催眠药无效的30例门诊病人加用米氮平治疗,剂量10～30 mg·d~(-1),与曲唑酮对照,曲唑酮剂量25～200 mg·d~(-1),共观察8 wk。疗效在治疗后1,2,4,8 wk用阿森失眠量表评定;不良反应用TESS评定。结果:至wk 8,米氮平组减分值为(8±s 5)分,治愈14例(54％),曲唑酮组减分值为(6±3)分,治愈11例(41％),疗效与曲唑酮组无明显差异(P＞0．05),主要不良反应为头昏、瞌睡、乏力和体重增加等,不良反应除食欲减退较曲唑酮少外(P＜0．01),2组无显著差异:米氮平剂量(22±11)mg·d~(-1),曲唑酮剂量(62±38)mg·d~(-1)。米氮平组4例和曲唑酮组3例脱落。结论:米氮平可辅助治疗镇静催眠药无效的失眠病人,疗效与安全性与加用曲唑酮相似。

Comparison study of efficacy and safety of mirtazapine and trazodone added to hypnotics-resistant insomnia

AIM:To observe the efficacy and safety of mirtazapine in treating refractory insomnia resistant to hypnotics.METHODS:Thirty outpatients diagnosed insomnia with CCMD-3 criteria resistant to hypnotics were furthermore treated by adding mirtazapine,10-30 mg·d~(-1)and compared with those of adding trazodone,25-200mg·d~(-1)altogether for 8 wk.Efficacy and adverse reactions were assessed by Athens insomnia scale and TESS.RESULTS:The scores of Athens insomnia scale decreased significantly at 1,2,4, 6 and 8 wk after treatment in both mirtazapine and trazodone groups.Fourteen patients in mirtazapine group and 11 patients in trazodone group were clinically remitted(P＞0.05).Four patients in mirtazapine group and 3 pa- tients in trazodone group were dropped out because of adverse reactions or lack of effectiveness.Adverse reactions showed no significant difference between two groups except more frequency of losing appetite in trazodne group. The dose of mirtazapine ranged from 10 to 30 mg·d~(-1)with a mean dose of(22±s 11)mg·d~(-1)and that of trazodone from 25 to 200 mg·d~(-1)with a mean dose of(62±38)mg·d~(-1),were commonly utilized.CONCLUSION: Mirtazapine is effective and safe as trazodone in treating hypnotic resistant insomnia as an additional hypnotics but the optimal dosage should be extensively studied.