【摘要】 目的 观察阿立哌唑片联合丙戊酸镁片治疗双相情感障碍（BD）的临床疗效和安全性。方法 将BD患者根据用药方案分为对照组和试验组。对照组口服丙戊酸镁缓释片,首次剂量每次0.25 g,bid,1～2 w后根据病情调整剂量至0.75～1.5 g·d^-1。试验组在对照组的基础上口服阿立哌唑片,每次5 mg,bid,用药2 w后根据患者耐受情况适当调整剂量至每次10 mg,bid。2组均治疗8 w。比较2组的疗效、症状量表评分、认知功能、睡眠质量、5-羟色胺（5-HT）水平、生存质量,并进行安全性评价。结果 共纳入92例,对照组44例、试验组48例。治疗后,对照组和试验组的临床疗效分别为72.73%（32例/44例）和91.67%（44例/48例）,汉密尔顿抑郁量表评分（HAMD）分别为（7.07±1.38）和（6.38±1.35）分,双相情感障碍情绪状态评定量表评分（BRMS）分别为（8.68±2.01）和（7.65±1.16）分,阳性和阴性综合征量表评分（PANSS）分别为（52.07±8.97）和（45.27±8.12）分,威斯康星卡片分类测验评分（WCST）分别为（51.57±5.66）和（54.13±5.43）分,霍普金斯言语学习测验-修订版评分（HVLT-R）分别为（26.27±3.64）和（28.02±3.50）分,持续性操作测验评分（CPT）分别为（1.86±0.63）和（2.13±0.57）分,睡眠效率分别为（85.45±2.48）%和（89.17±1.17）%,觉醒次数分别为（3.39±0.81）和（2.92±0.77）次,5-羟色胺水平分别为（52.29±8.23）和（58.09±8.06）ng·L^-1,上述指标在2组间比较,在统计学上差异均有统计学意义（P <0.05,P <0.01,P<0.001）。对照组的主要药物不良反应为嗜睡、恶心呕吐、腹泻和头晕头痛;试验组为嗜睡、恶心呕吐、腹泻、便秘和头晕头痛。对照组与试验组总药物不良反应发生率分别为11.36%（5例/44例）和14.58%（7例/48例）（P>0.05）。结论 阿立哌唑片与丙戊酸镁片的联合治疗方案可以有效缓解BD患者的临床症状,改善认知功能和睡眠状况,在整体上提高生活质量,且安全性良好。更多还原

【Abstract】 Objective To observe the clinical efficacy and safety of aripiprazole tablets combined with magnesium valproate sustained-release tablets in the treatment of patients with bipolar disorder（BD）.Methods BD patients were divided into control group and treatment group according to treatment regimen.The control group was given oral magnesium valproate sustained-release tablets with an initial dose of0.25 g per time,bid.After 1-2 weeks,the dose was adjusted to0.75-1.5 g·d^-1 according to the patient’s condition.On the basis of the treatment for the control group,the treatment group was additionally given oral aripiprazole tablets,5 mg per time,bid.After 2 weeks of medication,the dose was appropriately adjusted to10 mg per time,bid,according to the patient’s tolerance.Both groups received treatment for 8 weeks.The efficacy,clinical symptom scores,cognitive function,sleep quality,5-hydroxytryptamine（5-HT）,quality of life and adverse drug reactions were compared between the two groups.Results A total of 92 cases were enrolled,including 44 in the control group and 48 in the treatment group.After treatment,the clinical efficacy rates in the control group and treatment group were 72.73%（32 cases/44 cases） and 91.67%（44 cases/48 cases）,respectively;the Hamilton depression rating scale（HAMD） scores were（7.07±1.38） and（6.38±1.35） points,respectively;the Bipolar disorder rating scale（BRMS） scores were（8.68±2.01） and（7.65±1.16） points,respectively;the positive and negative syndrome scale（PANSS） scores were（52.07±8.97） and（45.27±8.12） points,respectively;the Wisconsin card sorting test（WCST） scores were（51.57±5.66） and（54.13±5.43） points,respectively;the Hopkins Verbal learning test-revised（HVLT-R） scores were（26.27±3.64） and（28.02±3.50） points,respectively;the continuous performance test（CPT） scores were（1.86±0.63） and（2.13±0.57） points,respectively;sleep efficiency rates were（85.45±2.48） % and（89.17±1.17）%,respectively;wakefulness frequency were（3.39±0.81） and（2.92±0.77） times,respectively;5-HT levels were（52.29±8.23） and（58.09±8.06） ng · L^-1,respectively.Comparisons between the two groups for all the aforementioned indicators showed statistically significant differences（P <0.05,P <0.01,P <0.001）.The overall adverse drug reaction rates in the control group and treatment group were 11.36%（5 cases/44 cases） and 14.58%（7 cases/48 cases）,respectively（P> 0.05）.Conclusion The combination therapy regimen of aripiprazole tablets and magnesium valproate sustained-release tablets can effectively alleviate clinical symptoms in patients with BD,improve cognitive function and sleep quality,enhance overall quality of life and demonstrate good safety profiles.更多还原