文拉法辛缓释剂治疗抑郁症的开放性研究

The efficacy and safety of venlafaxine XR in treating patients with major depression in a multicenter,open-label,16 week study

目的 观察文拉法辛缓释剂（商品名：怡诺思）治疗抑郁症16周的疗效和不良反应。方法 采用开放性多中心研究方法，对350例符合国际疾病分类第10版抑郁障碍诊断标准的住院或门诊患者，进行可变剂量文拉法辛缓释剂治疗，共16周。分别于治疗前和治疗后第2，4，8，12和16周末评定17项汉密尔顿抑郁量表（HAMD17）、14项汉密尔顿焦虑量表（HAMA14）和临床疗效总评量表（CGI）及药物疗效，记录治疗中出现的不良反应。结果 321例完成16周治疗。（1）从治疗第2周末至第16周末，HAMD17总分和各因子分均低于治疗前[基线和第16周末的HAMD17总分分别为（28．04±7．9）分和（4．2±3．9）分；P〈0．001]。治疗第16周末，HAMD17总分减分率达85％，216例（67．3％）患者达到临床治愈（HAMD17总分≤7分），315例达到治疗有效，有效率（HAMD17减分率≥50％的例数占所完成研究例数的比例）为98．1％。（2）反复发作者的药物剂量自第2-16周均明显高于单次发作者（P〈0．05），病程〈1年的患者其疗效[抑郁因子分为（1．72±1．91）分]优于病程≥1年的患者[（2．004±2．26）分；P〈0．05]。（3）73例（20．8％）患者出现不良反应，多为中枢神经系统和消化系统反应，如头晕，多汗和恶心等。治疗前后患者的血压无明显改变。结论 文拉法辛缓释剂是一种较为安全有效的抗抑郁药，适合长期治疗以预防抑郁症的复发。

Objective The aim of this naturalistic open-label study was to contribute further information on the long-term efficacy and tolerability of venlafaxine extended releasing form in Chinese patients with major depression. Methods A multi-center, open-label study was specifically designed to prospectively understand the efficacy and safety of flexible dose of venlafaxine in treating major depression for 16 weeks. All patients met the ICD-10 criteria for depressive disorders and were assessed with the Hamilton Depression Rating Scale （ HAMD）, Hamilton Anxiety Rating Scale （ HAMA）, Clinical Global Impression （CGI） and side effects, including the lab test and blood pressure, at baseline and on weeks 2, 4, 8 12 and 16. Results Altogether 350 patients were enrolled in the study, with 144 males and the mean age of 37 years old. In 321 patients who completed 16 week treatment, significant reductions in HAMD and HAMA, and subscale of HAMD scores were seen from baseline on week 2 and continuing to week 16, and 67.3% of patients were clinical remission （total score of HAMD ≤7）. The dosage in patients with recurrent episodes was higher than that with first episode, and the efficacy in acute patients was better than in chronic patients. The common side effects were temporal dizziness, vomit and hyperhidrosis. There were not significant changes for the blood pressure after treatment. Conclusion The extended releasing venlafaxine is an efficient antidepressant with better tolerability, it is suitable for long-term preventive treatment.