丙戊酸镁缓释片单用与和喹硫平伍用治疗老年躁狂发作的对照研究

Efficiency of magnesium valproate sustained release tablets alone vs combined with quetiapine in treatment of manic episode in elderly patients with bipolar disorder

摘要:

目的 探讨喹硫平合并丙戊酸镁缓释片治疗老年双相情感障碍躁狂发作的临床疗效和安全性。方法 选择2013年5月至2014年5月在解放军第261医院，住院符合国际疾病分类-10（ICD-10）双相情感障碍躁狂发作诊断的46例患者，年龄60～78岁。46例符合ICD-10躁狂发作的老年患者随机分为喹硫平合并丙戊酸镁缓释片组（研究组）和单用丙戊酸镁缓释片组（对照组）。治疗6周，应用贝克?拉范森躁狂量表（BRMS）评定疗效，治疗意外症状量表（副反应量表，TESS）评定不良反应。结果 治疗过程中每组BRMS总分都有显著下降（P＜0.05），治疗2周后研究组总分及因子分言语/吵闹、睡眠与对照组比较，差异存在统计学意义（P＜0.05）。治疗6周后，研究组与对照组临床总有效率差异无统计学意义（P＞0.05）。两组均无严重的药物不良反应，两组TESS评分差异无统计学意义（P＞0.05）。结论 喹硫平和丙戊酸镁缓释片伍用治疗老年躁狂发作疗效较好，安全性较好，特别是在治疗初期（2周末）能更好的控制兴奋症状和改善睡眠。

Abstract:

Objective To determine the clinical efficacy and safety of magnesium valproate sustained release tablets and combination with quetiapine in treatment of manic episode in the elderly with bipolar disorder. Methods A total of 46 elderly patients (aged 60 to 78 years) who met the criteria of the International Classification of Diseases (ICD-10) for manic episode of bipolar disorder admitted in our hospital from May 2013 to May 2014 were enrolled in this study. They were randomly assigned to 2 groups, and treated with magnesium valproate sustained release tablets (control group) or combined with quetiapine (study group). In 6 weeks after treatment, Bech-Rafaelsen Mania Rating Scale (BRMS) and Treatment Emergent Symptoms Scale (TESS) were employed to evaluate the clinical efficacy and adverse effects respectively. Results BRMS scores were dropped significantly in both groups (P＜0.05). At the end of the second weeks, there were significant differences in the total score of BRMS and the factor points (noisy/speech, sleep) between the study and control groups (P＜0.05). At the end of 6 weeks’ treatment, there was no significant difference in the total score of BRMS between the 2 groups (P＞0.05). No severe adverse effect was seen in the both groups, and there was no significant difference in TESS score between them. Conclusion Magnesium valproate sustained release tablets combined with quetiapine show better efficacy and sound safety in the treatment of maniac episode in the elderly patients, especially in controlling excitement symptoms and improving sleep at the early stage of treatment (the end of 2 weeks).