齐拉西酮治疗双相障碍抑郁发作的临床观察  

Clinical Observation of Ziprasidone in the Treatment of Bipolar Disorder Depression

作　　者：于浚玫[1] 王立娜[1] 王永军[1] 

机构地区：[1]天津市安定医院,天津300222

出　　处：《中国药房》2014年第40期3761-3764,共4页China Pharmacy

基　　金：天津市卫生局科技基金资助项目(No.2012KR01)

摘　　要：目的：观察齐拉西酮治疗双相障碍抑郁发作的临床疗效和安全性。方法：将符合标准的77例双相障碍抑郁发作患者，按随机数字表法分为齐拉西酮组（37例）和丙戊酸钠组（40例）。齐拉西酮组患者给予齐拉西酮胶囊起始剂量为20mg，每2d增加1次剂量，每次增加20mg，剂量范围为60～120mg，口服，bid；丙戊酸钠组患者给予丙戊酸钠片起始剂量为400mg，每2d增加1次剂量，每次增加200mg，剂量范围为4001200mg，口服，tid。两组患者疗程均为8周。所有患者失眠症状严重时，给予佐匹克隆3．75～7．5mg，治疗期间不得服用其他镇静药、抗焦虑药、抗抑郁药。观察两组患者的临床疗效，平均使用佐匹克隆例数及平均使用天数，汉密尔顿抑郁量表（HAMD-17）评分随时间变化趋势，治疗后双相障碍专用量表（CGI-BP）评分减分值、体质量和代谢指标减分值，记录治疗前后不良反应量表（TESS）评分以评价药物的安全性。结果：两组患者总有效率、HAMD-17评分、实际随访时间、实际服用药物时间、不良反应发生率比较，差异均无统计学意义（P〉0．05）。齐拉西酮组患者平均使用佐匹克隆例数及平均使用天数均显著低于丙戊酸钠组，两组比较差异有统计学意义（P〈O．05）。治疗后齐拉西酮组抑郁cGI-BP评分减分值、体质量、代谢各指标减分值均显著优于丙戊酸钠组，差异有统计学意义（P〈0．05），但躁狂、双相CGI—BP减分值、葡萄糖减分值两组间比较，差异无统计学意义（P〉0．05）。治疗后两组患者TESS评分显著低于同组治疗前，差异有统计学意义（P〈0．05），但两组间比较差异无统计学意义（P〉0．05）。结论：齐拉西酮治疗双相障碍抑郁发作疗效和安全性与丙戊酸钠相当，但齐拉西酮在改善患者失眠、转躁方面显著优于丙戊酸钠。OBJECTIVE： To observe clinical efficacy and safety of ziprasidone in the treatment of bipolar disorder depression. METHODS： 77 patients with bipolar disorder depression were randomly divided into ziprasidone group （37 cases） and sodium val- proate group （40 cases）. Ziprasidone group was given Ziprasidone capsule with initial dose of 20 mg, increasing by 20 mg every 2 days, ranging from 60 to 120 mg, p.o., twice a day. Sodium valproate group was given Sodium valproate tablet with initial dose of 400 mg, increasing by 200 mg every 2 days, ranging from 400 mg to 1 200 mg, p.o., 3 times a day. The patients were given zopi- clone 3.75-7.5 mg if suffering from severe insomnia; other sedative, antianxiety agent and antidepressant were avoided during treat- ment. Treatment course of 2 groups lasted for 8 weeks. Clinical efficacy, average case number and duration of zopiclone use, HAMD-17 score were observed in 2 groups. The decrease of CGI-BP, body weight, metabolic indicator and TESS score were ob- served after treatment, and the safety of drug use were evaluated. RESULTS： Total effective rate, HAMD-17 score, actual fol- low-up duration, actual medication duration and the incidence of ADR has no statistical significance between 2 groups （P〉0.05）. Average case number and duration of zopiclone use in ziprasidone group were significantly lower than in sodium valproate group; there was statistical significance （P〈0.05）. The decrease of CGI-BP and metabolic indicator in ziprasidone group were significantly lower than in sodium valproate group; there was statistical significance （P〈0.05）. There was no statistical significance in mania, the decrease of bipolar CGI-BP and glucose between 2 groups （P〉0.05）. There was no significant difference in TESS score be- tween 2 groups before treatment （P〉0.05） ; TESS score of 2 groups after treatment was significantly lower than before; there was statistical significance （P〈0.05）. There was no statistical significance between 2 groups （P

关 键 词：齐拉西酮 丙戊酸钠 双相障碍抑郁发作 随机对照研究 疗效 安全性 

分 类 号：R749.4[医药卫生—神经病学与精神病学] R971.41[医药卫生—临床医学]