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机构地区:[1]天津市安定医院药剂科,天津300222 [2]天津市安定医院老年科,天津300222
出 处:《中国临床药理学杂志》2016年第12期1078-1080,1084,共4页The Chinese Journal of Clinical Pharmacology
基 金:国家"重大新药创制"科技重大专项基金资助项目(2011ZX09303-001)
摘 要:目的 观察喹硫平联合丙戊酸镁治疗双相情感障碍的临床疗效及安全性。方法 将94例双相情感障碍患者随机分为对照组47例和试验组47例。对照组予以口服丙戊酸镁500 mg,qd,按照患者耐受程度,一周后增加剂量为750mg,qd;试验组在对照组的基础上,予以口服喹硫平初始剂量100 mg,qd,第1~4天每日增加剂量100 mg,qd,第5~7天增加至600 mg,qd,第8~28天增加至800mg,qd。2组患者均治疗28 d。比较2组患者的临床疗效、血清总胆红素、白蛋白、炎症因子水平、生活质量评分、狂躁量表(BRMS)和汉密尔顿抑郁量表(HAMD)评分及安全性。结果 治疗后,2组患者的临床疗效比较差异无统计学意义(P〉0.05)。治疗后,试验组的血清总胆红素和白蛋白水平均显著高于对照组(P〈0.05),试验组的白细胞介素-1β和白细胞介素-4水平均明显低于对照组(P〈0.05)。治疗后,试验组的BRMS和HAMD评分均显著低于对照组(P〈0.05)。2组患者不良反应发生率比较差异无统计学意义(P〉0.05)。结论 喹硫平联合丙戊酸镁治疗双向情感障碍的临床疗效确切,可改善患者的生活质量,减轻狂躁和抑郁症状,且安全性较高。Objective To evaluate the clinical efficacy and safety of quetiapine combined with valproate in the treatment of bipolar disorder Methods Ninety -four patients of bipolar disorder were randomly divi- ded into control group ( n = 47 ) and treatment group ( n = 47 ). Control group was given oral valproate 500 mg, qd, and according to the tole- rance of the patients increased the dose of 750 mg, qd after one week. Treatment group was based on the treatment of control group, and re- ceived oral quetiapine 100 rag, qd for starting dose, then increased the dosage 100 mg daily in day 1 -4, to 600 mg in day 5 -7, to 800 mg, qd in day 8 -28. Two groups were treated for 28 d. The clinical efficacy, serum total bilirubin (TBIL), albumin, levels of inflammatory factors, quality of living evaluation, Bech - Rafaelsen mania scale (BRMS), Hamilton depression scare(HAMD) scores and the safety were compared between two groups. Results After treatment, there were no significant difference in clinical efficacy between two groups (P 〉 0. 05 ). After treatment, the levels of TBIL and albumin were significantly higher than those of control group (P 〈 0. 05 ), the levels of interleukin - 113 and interleukin-4 in treatment group were significantly lower than those in control group (P 〈 0. 05 ). The BRMS and HAMD scores in treatment group were significantly lower than those in control group ( P 〈 0. 05 ).There was no significant difference in the incidence of adverse drug reactions between two groups ( P 〉 0.05 ). Cortelttsion Quetiapine combined with valproate have a definite clinical efficacy and safety in the treatment of bipolar disorder, which can significantly improve the quality of life and reduce the manic and depressive symptoms.
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