CAJ | 학술논문

目的：比较阿立哌唑与联合碳酸锂治疗双相Ⅰ型躁狂发作患者的疗效和安全性。方法将89例双相Ⅰ型躁狂发作患者按随机数字表法分为3组。阿立哌唑组28例，给予阿立哌唑起始剂量10 mg·d－1，最大剂量30 mg· d－1，平均剂量（28．5±4．50）mg·d－1；碳酸锂组31例，碳酸锂起始剂量0．5 g·d－1，最大剂量1．5 g·d－1，平均剂量（1．18±0．21）g·d－1；阿立哌唑联合碳酸锂组30例，给予阿立哌唑起始剂量、最大剂量及平均剂量同阿立哌唑组，碳酸锂起始剂量、最大剂量及平均剂量为同碳酸锂组。3组均6周为1个疗程。于治疗前和治疗第1、2、4、6周末分别采用躁狂状态评定量表（BRMS）、临床疗效总评量表（CGI）及副反应量表（TESS）评定3组患者的疗效及不良反应。于治疗前及治疗6周末各检测1次血、尿常规，肝、肾功能，血糖、血锂浓度、血脂及脑电图等，以评价其安全性。结果阿立哌唑组、碳酸锂组、阿立哌唑联合碳酸锂组治疗后各时间段（1、2、4及6周末）的 BRMS、CGI 评分均明显低于治疗前（均 P ＜0．01）；阿立哌唑联合碳酸锂组治疗2、4及6周末的 BRMS、CGI 评分均低于阿立哌唑组和碳酸锂组（均 P ＜0．05）。阿立哌唑组总有效率为75．0％，碳酸锂组总有效率为77．4％，阿立哌唑联合碳酸锂组总有效率为90．0％。阿立哌唑联合碳酸锂组总有效率均明显高于阿立哌唑组和碳酸锂组（均 P ＜0．05）。3组均未出现严重的不良事件。治疗前后3组血、尿常规，肝、肾功能，血糖、血脂及脑电图均无明显异常改变。结论阿立哌唑单药治疗双相障碍Ⅰ型躁狂发作患者是安全、有效的，但阿立哌唑联合碳酸锂治疗双相障碍Ⅰ型患者总有效率均优于阿立哌唑和碳酸锂单药治疗。
목적：비교아립고서여연합탄산리치료쌍상Ⅰ형조광발작환자적료효화안전성。방법장89례쌍상Ⅰ형조광발작환자안수궤수자표법분위3조。아립고서조28례，급여아립고서기시제량10 mg·d－1，최대제량30 mg· d－1，평균제량（28．5±4．50）mg·d－1；탄산리조31례，탄산리기시제량0．5 g·d－1，최대제량1．5 g·d－1，평균제량（1．18±0．21）g·d－1；아립고서연합탄산리조30례，급여아립고서기시제량、최대제량급평균제량동아립고서조，탄산리기시제량、최대제량급평균제량위동탄산리조。3조균6주위1개료정。우치료전화치료제1、2、4、6주말분별채용조광상태평정량표（BRMS）、림상료효총평량표（CGI）급부반응량표（TESS）평정3조환자적료효급불량반응。우치료전급치료6주말각검측1차혈、뇨상규，간、신공능，혈당、혈리농도、혈지급뇌전도등，이평개기안전성。결과아립고서조、탄산리조、아립고서연합탄산리조치료후각시간단（1、2、4급6주말）적 BRMS、CGI 평분균명현저우치료전（균 P ＜0．01）；아립고서연합탄산리조치료2、4급6주말적 BRMS、CGI 평분균저우아립고서조화탄산리조（균 P ＜0．05）。아립고서조총유효솔위75．0％，탄산리조총유효솔위77．4％，아립고서연합탄산리조총유효솔위90．0％。아립고서연합탄산리조총유효솔균명현고우아립고서조화탄산리조（균 P ＜0．05）。3조균미출현엄중적불량사건。치료전후3조혈、뇨상규，간、신공능，혈당、혈지급뇌전도균무명현이상개변。결론아립고서단약치료쌍상장애Ⅰ형조광발작환자시안전、유효적，단아립고서연합탄산리치료쌍상장애Ⅰ형환자총유효솔균우우아립고서화탄산리단약치료。
Objective To compare the efficacy and safety of aripiprazole and aripiprazole com-bined with neurolithium in the treatment of mania in bipolar I disorder.Methods A total of 89 patients with mania in bipolar I disorder were randomly treated with aripiprazole(aripiprazole group,n = 28 ),neurolithium (neurolithium group,n = 31 )or their combination (combination group,n = 30)for 6 weeks.In aripiprazole group,the initial,maximum and average dosages of aripiprazole were 10,30 and(28.5±4.50)mg·d-1 ,respectively.In neurolithium group,the ini-tial,maximum and average dosages of neurolithium were 0.5,1.5 and(1.18±0.21)g·d-1 ,re-spectively.In combination group,the initial,maximum and average dosages of aripiprazole were the same as aripiprazole group and the initial,maximum and average dosages of neurolithium were the same as neurolithium group.The curative efficacies were evaluated by Bech-Rafaelsen Mania Scale(BRMS)and Clinical Global Impression Scale(CGI)and adverse reactions by Treatment E-mergent Symptom Scale(TESS)before and after treatment for 1,2,4 and 6 weeks.Routine blood and urine parameters,hepatic and renal function,blood glucose,blood lithium,blood lipids and e-lectroencephalogram were determined before and after treatment for 6 weeks to assess the safety of treatment.Results After treatment,BRMS and CGI scores significantly decreased in all the three groups(P <0.01).Compared with aripiprazole group or neurolithium group,BRMS and CGI scores significantly decreased in combination group after treatment for 2,4 and 6 weeks(P <0.05).Moreover,the total effective rate in combination group(90.0%)was significantly higher than that in aripiprazole group(75.0%)or neurolithium group(77.4%)(P <0.05).No serious adverse events occurred in all patients.In addition,no abnormal changes in routine blood and urine parameters,hepatic and renal function,blood glucose,blood lipids and electroencephalogram were found before and after treatment.Conclusion The treatment with aripiprazole is safe and effec-tive for mania in bipolar I disorder.However,the combined treatment with aripiprazole and aripi-prazole results in a higher total effective rate than treatment with aripiprazole or aripiprazole a-lone.