【摘要】 目的 探讨盐酸度洛西汀肠溶片不同滴定剂量、给药次数对抑郁症疗效和安全性的影响。方法 共纳入抑郁症患者226例。分为3组:A组,起始剂量40 mg/d,3 d后加量至60 mg/d;B组,起始剂量40mg/d,7d后加量至60mg/d;C组,起始剂量20mg/d,3 d后加量至40mg/d,7d后加至60mg/d;给药次数分1次/d和2次/d。以HAMD-17和HAMA以及临床总体印象量表(CGI)作为主要疗效评价指标;以10分制满意度调查表评价患者对治疗的满意度;记录不良反应以评价安全性。结果 基线与治疗6周后,患者的HAMD-17评分分别为(25.2±4.9)分和(5.4±3.8)分;HAMA评分分别为(21.4±7.2)分和(4.0±3.5)分;抑郁和焦虑的痊愈率分别为64.8%和71.4%;CGI-I为非常明显进步的患者占66.1%;满意度>5分的患者占78.0%;不同剂量滴定和给药次数不影响该药对抑郁、焦虑症状的疗效;滴定方法 B可更快缓解患者的抑郁、焦虑症状,且每天2次给药的疗效更为显著;治疗过程中常见的不良反应为恶心(14.9%)、头晕(4.4%);其中滴定方法 A、B、C恶心的发生率分别为17.1%,7.1%,17.8%,差异趋于统计学水平(P=0.053)。结论 盐酸度洛西汀肠溶片能有效治疗抑郁症患者的抑郁、焦虑症状,安全性良好;40 mg/d起始,7 d滴定至60 mg/d可能对患者症状的缓解更为有益。更多还原

【Abstract】 Objective To investigate the efficacy and safety of different dosage titration and treatment frequency of duloxetine hydrochloride enteric-coated tablets in treatment of depression.Methods Totals of 226 patients with depression were enrolled,and were divided into group A(initial dose was 40 mg/d,and increased to 60 mg/d after 3 d),group B(initial dose was 40 mg/d,and increased to 60 mg/d after 7 d) and group C(initial dose was 40 mg/d,increased to 40 mg/d after 3 d and to 60 mg/d after 7 d) according to the clinical status;the frequencies were divided into once or twice a day.The Hamilton Depression Scale(HAMD),Hamilton Anxiety Scale(HAMA),and the Clinical Global Impression Scale(CGI) were used to assess the therapeutic effect;10 points system satisfaction questionnaire was used to evaluate the satisfaction of patients;the incidence of adverse event was used to evaluate the safety.Results As compared to baseline,the symptoms of depression[baseline vs endpoint:(25.2±4.9) vs(5.4±3.8)]and anxiety[baseline vs endpoint:(21.4±7.2) vs(4.0±3.5)]were relieved significantly after 6 weeks medication.The remission rate of depression and anxietywas64.8%and 71.4%;the rate of obvious progress in CGI-I was 66.1%;the rate of the degree of satisfaction(over 5) was 78.0%.The three methods of dosage titration and administration frequency did not affect the efficacy on depression and anxiety;method B could relieve depression and anxiety symptoms faster,moreover,the efficacy was more obvious by medication of twice a day administration.During the treatment,the most common adverse events were nausea(14.9%),dizziness(4.4%);and the incidence of nausea for group A,B,and C was 17.1%,7.l%and 17.8%respectively.The difference was potentially significant(P = 0.053).Conclusions Duloxetine enteric-coated tablet is effective and safe in the treatment of depression and anxiety symptoms in patients with depression;the method that initial dose is40 mg/d,and increases to 60 mg/d after 7 d may be more useful to alleviate the symptoms of patients.更多还原