CAJ | 학술논문

背景：本研究是经国家食品药品监督管理总局批准的仿制度洛西汀注册前试验（批准号：2006L01603）。目的：比较仿制度洛西汀和帕罗西汀治疗抑郁症患者的疗效和安全性。方法：这是一项双盲双安慰剂(double dummy)、多中心、有效药物（帕罗西汀）平行随机对照临床试验。将纳入的299例抑郁症患者随机分组，使用度洛西汀(n=149；40-60 mg/d)或帕罗西汀(n=150；20 mg/d)连续治疗8周。在基线和开始治疗后的第1、2、4、6和8周使用汉密尔顿抑郁量表(Hamilton Depression rating scale, HAMD-17)评估。缓解的定义为研究终点HAMD-17评分低于8分，治疗有效的定义为研究终点HAMD-17得分较基线至少降低了50%。根据报告的不良反应的发生率、严重程度以及实验室检查结果、心电图结果的变化来评估安全性。度洛西汀组中有三例患者在开始用药前退出，采用修正的意向治疗分析(intention-to-treat, ITT)方法以比较研究组146例患者和对照组150例患者的研究结果。结果：在8周的研究期间两组有均29例患者脱落。与基线比，两组HAMD-17评分在整个试验过程中均显著降低。根据ITT分析，研究终点时度洛西汀组和帕罗西汀组在疗效方面差异无统计学意义(67.1% v.71.3%, X2=0.62,p=0.433)，缓解率(41.1% v.51.3%,X2=3.12, p=0.077)及不良作用发生率56.8% v.54.7%,X2=0.14, p=0.705)等方面的差异也无统计学意义。结论：对于在国内精神科门诊就医的抑郁症患者而言，急性期使用仿制度洛西汀与使用帕罗西汀同样安全有效。
배경：본연구시경국가식품약품감독관리총국비준적방제도락서정주책전시험（비준호：2006L01603）。목적：비교방제도락서정화파라서정치료억욱증환자적료효화안전성。방법：저시일항쌍맹쌍안위제(double dummy)、다중심、유효약물（파라서정）평행수궤대조림상시험。장납입적299례억욱증환자수궤분조，사용도락서정(n=149；40-60 mg/d)혹파라서정(n=150；20 mg/d)련속치료8주。재기선화개시치료후적제1、2、4、6화8주사용한밀이돈억욱량표(Hamilton Depression rating scale, HAMD-17)평고。완해적정의위연구종점HAMD-17평분저우8분，치료유효적정의위연구종점HAMD-17득분교기선지소강저료50%。근거보고적불량반응적발생솔、엄중정도이급실험실검사결과、심전도결과적변화래평고안전성。도락서정조중유삼례환자재개시용약전퇴출，채용수정적의향치료분석(intention-to-treat, ITT)방법이비교연구조146례환자화대조조150례환자적연구결과。결과：재8주적연구기간량조유균29례환자탈락。여기선비，량조HAMD-17평분재정개시험과정중균현저강저。근거ITT분석，연구종점시도락서정조화파라서정조재료효방면차이무통계학의의(67.1% v.71.3%, X2=0.62,p=0.433)，완해솔(41.1% v.51.3%,X2=3.12, p=0.077)급불량작용발생솔56.8% v.54.7%,X2=0.14, p=0.705)등방면적차이야무통계학의의。결론：대우재국내정신과문진취의적억욱증환자이언，급성기사용방제도락서정여사용파라서정동양안전유효。
Background:This study is a pre-registraiton trial of generic duloxeitne that was approved by the China Food and Drug Administraiton (approval number: 2006L01603). Aim:Compare the treatment effcacy and safety of generic duloxeitne to that of paroxeitne in paitents with major depressive disorders (MDD). Methods:This was a double-dummy, double-blind, multicenter, positive drug (paroxetine), parallel randomized controlled clinical trial. The 299 patients with MDD recruited for the study were randomly assigned to use duloxeitne (n=149; 40–60 mg/d) or paroxeitne (n=150; 20 mg/d) for 8 weeks. The Hamilton Depression raitng scale (HAMD-17) was administered at baseline and 1, 2, 4, 6, and 8 weeks atfer staritng treatment. Remission was defined as a HAMD-17 score below 8 at the end of the trial, and treatment effecitveness was deifned as a decrease in baseline HAMD-17 score of at least 50% by the end of the trial. Safety was assessed based on the reported prevalence and severity of side effects and changes in laboratory and electrocardiographic findings. Three patients in the duloxetine group dropped out before starting medication, so results were analyzed using a modified intention-to-treat (ITT) method with 146 in the experimental group and 150 in the control group. Results:Both groups experienced 29 dropouts during the 8-week trial. HAMD-17 scores decreased signiifcantly from baseline throughout the trial in both groups. Based on the ITT analysis, at the end of the trial there was no signiifcant difference between the duloxeitne group and the paroxeitne group in effecitveness (67.1% v. 71.3%, X2=0.62 p=0.433), remission rate (41.1% v. 51.3%, X2=3.12, p=0.077), or in the incidence of side effects (56.8% v. 54.7%,X2=0.14,p=0.705). Conclusion: Generic duloxeitne is as effecitve and safe as paroxeitne in the acute treatment of paitents with MDD who seek care at psychiatric outpaitent departments in China.