CAJ | 학술논문

目的探讨不同剂量阿立哌唑治疗氨磺必利和利培酮所致高催乳素血症的疗效及安全性.方法采用随机数字表法将87例氨磺必利所致高催乳素血症患者随机分为氨磺必利联用5、10、15 mg阿立哌唑(Ami+5 mg、Ami+10 mg、Ami+15 mg)组,每组29例;将106例利培酮所致高催乳素血症患者随机分为利培酮联用5、10、15 mg阿立哌唑(Ris+5 mg、Ris+10 mg、Ris+15 mg)组,每组分别为36例、35例、35例.维持原有氨磺必利或利培酮剂量不变,联用相应剂量阿立哌唑进行12周对照研究.于治疗前、治疗后第4周、第8周及第12周检测患者催乳素水平,观察高催乳素血症患者的相关临床变化;以PANSS和治疗中需处理的不良反应症状量表评定联用不同剂量阿立哌唑对疗效和不良反应的影响.结果在第4、8、12周末氨磺必利合并阿立哌唑不同剂量组催乳素水平在组内及组间差异无统计学意义.利培酮合并阿立哌唑不同剂量组在第4周起催乳素水平均有显著下降并持续到12周,与基线时相比,Ris+5 mg组[(38.9±19.0) nmol/L与(11.0±8.1) nmol/L]、Ris+ 10 mg组[(36.2±16.5)nmol/L与(8.8±7.3)nmol/L]、Ris+15 mg组[(35.6±14.8) nmol/L与(9.2±7.6)nmol/L]第12周催乳素水平差异有统计学意义(t=4.129、4.798、4.506,均P＜0.01).Ris+5 mg组、Ris+10 mg组、Ris+15 mg组高催乳素血症相关临床症状消失比率分别为66.67％(24/36)、62.86％ (22/35)、51.43％(18/35),3组间高催乳素血症相关临床症状消失比率的差异无统计学意义.PANSS评分第12周末除Ami+15 mg组、Ris+10mg组、Ris+15 mg组较基线有明显下降外(t=2.419、2.406、2.631,均P＜0.05),其余差异均无统计学意义.Ami+ 15 mg组不良反应率[52％(15/29)]高于Ami+5 mg组[17％(5/29),t=3.521,P＜0.01]和Ami+10mg组[24％ (7/290),t=2.348,P＜0.05],Ris+ 15 mg组不良反应率[34％(12/35)]高于Ris+5 mg组[11％(4/36),t=2.203,P＜0.05]和Ris+10 mg组[11％(4/35),t=2.314,P＜0.05].结论合并不同剂量阿立哌唑对氨磺必利所致高催乳素血症无改善作用,但可以降低由利培酮引起的高催乳素血症,且5 mg/d为合适的联用剂量. 目的探討不同劑量阿立哌唑治療氨磺必利和利培酮所緻高催乳素血癥的療效及安全性.方法採用隨機數字錶法將87例氨磺必利所緻高催乳素血癥患者隨機分為氨磺必利聯用5、10、15 mg阿立哌唑(Ami+5 mg、Ami+10 mg、Ami+15 mg)組,每組29例;將106例利培酮所緻高催乳素血癥患者隨機分為利培酮聯用5、10、15 mg阿立哌唑(Ris+5 mg、Ris+10 mg、Ris+15 mg)組,每組分彆為36例、35例、35例.維持原有氨磺必利或利培酮劑量不變,聯用相應劑量阿立哌唑進行12週對照研究.于治療前、治療後第4週、第8週及第12週檢測患者催乳素水平,觀察高催乳素血癥患者的相關臨床變化;以PANSS和治療中需處理的不良反應癥狀量錶評定聯用不同劑量阿立哌唑對療效和不良反應的影響.結果在第4、8、12週末氨磺必利閤併阿立哌唑不同劑量組催乳素水平在組內及組間差異無統計學意義.利培酮閤併阿立哌唑不同劑量組在第4週起催乳素水平均有顯著下降併持續到12週,與基線時相比,Ris+5 mg組[(38.9±19.0) nmol/L與(11.0±8.1) nmol/L]、Ris+ 10 mg組[(36.2±16.5)nmol/L與(8.8±7.3)nmol/L]、Ris+15 mg組[(35.6±14.8) nmol/L與(9.2±7.6)nmol/L]第12週催乳素水平差異有統計學意義(t=4.129、4.798、4.506,均P＜0.01).Ris+5 mg組、Ris+10 mg組、Ris+15 mg組高催乳素血癥相關臨床癥狀消失比率分彆為66.67％(24/36)、62.86％ (22/35)、51.43％(18/35),3組間高催乳素血癥相關臨床癥狀消失比率的差異無統計學意義.PANSS評分第12週末除Ami+15 mg組、Ris+10mg組、Ris+15 mg組較基線有明顯下降外(t=2.419、2.406、2.631,均P＜0.05),其餘差異均無統計學意義.Ami+ 15 mg組不良反應率[52％(15/29)]高于Ami+5 mg組[17％(5/29),t=3.521,P＜0.01]和Ami+10mg組[24％ (7/290),t=2.348,P＜0.05],Ris+ 15 mg組不良反應率[34％(12/35)]高于Ris+5 mg組[11％(4/36),t=2.203,P＜0.05]和Ris+10 mg組[11％(4/35),t=2.314,P＜0.05].結論閤併不同劑量阿立哌唑對氨磺必利所緻高催乳素血癥無改善作用,但可以降低由利培酮引起的高催乳素血癥,且5 mg/d為閤適的聯用劑量.
목적 탐토불동제량아립고서치료안광필리화리배동소치고최유소혈증적료효급안전성.방법 채용수궤수자표법장87례안광필리소치고최유소혈증환자수궤분위안광필리련용5、10、15 mg아립고서(Ami+5 mg、Ami+10 mg、Ami+15 mg)조,매조29례;장106례리배동소치고최유소혈증환자수궤분위리배동련용5、10、15 mg아립고서(Ris+5 mg、Ris+10 mg、Ris+15 mg)조,매조분별위36례、35례、35례.유지원유안광필리혹리배동제량불변,련용상응제량아립고서진행12주대조연구.우치료전、치료후제4주、제8주급제12주검측환자최유소수평,관찰고최유소혈증환자적상관림상변화;이PANSS화치료중수처리적불량반응증상량표평정련용불동제량아립고서대료효화불량반응적영향.결과 재제4、8、12주말안광필리합병아립고서불동제량조최유소수평재조내급조간차이무통계학의의.리배동합병아립고서불동제량조재제4주기최유소수평균유현저하강병지속도12주,여기선시상비,Ris+5 mg조[(38.9±19.0) nmol/L여(11.0±8.1) nmol/L]、Ris+ 10 mg조[(36.2±16.5)nmol/L여(8.8±7.3)nmol/L]、Ris+15 mg조[(35.6±14.8) nmol/L여(9.2±7.6)nmol/L]제12주최유소수평차이유통계학의의(t=4.129、4.798、4.506,균P＜0.01).Ris+5 mg조、Ris+10 mg조、Ris+15 mg조고최유소혈증상관림상증상소실비솔분별위66.67％(24/36)、62.86％ (22/35)、51.43％(18/35),3조간고최유소혈증상관림상증상소실비솔적차이무통계학의의.PANSS평분제12주말제Ami+15 mg조、Ris+10mg조、Ris+15 mg조교기선유명현하강외(t=2.419、2.406、2.631,균P＜0.05),기여차이균무통계학의의.Ami+ 15 mg조불량반응솔[52％(15/29)]고우Ami+5 mg조[17％(5/29),t=3.521,P＜0.01]화Ami+10mg조[24％ (7/290),t=2.348,P＜0.05],Ris+ 15 mg조불량반응솔[34％(12/35)]고우Ris+5 mg조[11％(4/36),t=2.203,P＜0.05]화Ris+10 mg조[11％(4/35),t=2.314,P＜0.05].결론 합병불동제량아립고서대안광필리소치고최유소혈증무개선작용,단가이강저유리배동인기적고최유소혈증,차5 mg/d위합괄적련용제량.
Objective To investigate the efficacy and safety of different doses of aripirazole on hyperlactinemia induced by amisulpride and risperidone.Methods 87 patients with hyperlactinemia induced by amisulpride were randomly assigned to three groups on the basis of original medication combined with aripiprazole 5 mg/d,10 mg/d and 15 mg/d (Ami+5 mg,Ami+10 mg,Ami+15 mg) with 29 cases in each group.106 patients with hyperlactinemia induced by risperidone were randomly assigned to three groups on the basis of original medication combined with aripiprazole 5 mg/d (36 cases),10 mg/d (35 cases) and 15 mg/d (35 cases).The plasma prolactin (PRL) level was measured before and after 4th,8th and 12th week treatment.The Positive and Negative Syndrome Scale (PANSS) and Treatment Emergent Symptom Scale (TESS) were assessed for psychotic symptoms and adverse effects.Results The level of PRL of Ami+5 mg,Ami+ 10 mg and Ami+ 15 mg group had no statistical difference within and between groups at 4th,8th and 12th week.The level of PRL of Ris+5 mg,Ris+ 10 mg and Ris+ 15 mg group were significantly lower than that of baseline at each visit after baseline.The level of PRL of Ris+ 5 mg group ((38.9± 19.0) nmol/L vs.(11.0±8.1) nmol/L),Ris+ 10 mg group ((36.2± 16.5) nmol/L vs.(8.8±7.3) nmol/L) and Ris+ 15 mg group((35.6± 14.8) nmol/L vs.(9.2±7.6) nmol/L) at baseline were significantly different from which at the 12th week (t=4.129,4.798,4.506;all P＜0.01).The remission rates of symptoms relevant with hyperlactinemia in Ris+5 mg group,Ris+10 mg group and Ris+15 mg group were 66.67％ (24/36),62.86％ (22/35),51.43％ (18/35) respectively.There were no difference of the remission rate of symptoms relevant with hyperlactinemia among those three groups.There were no difference of PANSS score within groups at 12th week except Ami+ 15 mg group,Ris+ 10 mg group and Ris+ 15 mg group(t=2.419,2.406,2.631,all P＜0.05).The adverse effect rate of Ami+ 15 mg group (52％(15/29)) was significantly higher than that of Ami+5 mg group(17％(5/29),t=3.521,P＜0.01) and Ami+ 10 mg group (24％ (7/29),t=2.348,P＜0.05).The adverse effect rate of Ris+ 15 mg group (34％(12/35))was significantly higher than that of Ris+5 mg group (11％(4/36),t=2.203,P＜0.05) and Ris+ 10 mg group (11％ (4/35),t=2.314,P＜0.05).Conclusion Various dose of aripiprazole did not show improvement in hyperprolactinemia induced by amisulpride,However that could significantly decrease PRL level in hyperprolactinemia induced by risperidone,and considering efficacy and safety,5 mg/d aripirazole may be the best combination dose.