西酞普兰与氯米帕明治疗抑郁症对照研究
【摘要】 目的 探讨西酞普兰与氯米帕明治疗抑郁症的临床疗效及安全性。 方法 将68例抑郁症患者随机分为两组各34例，研究组口服西酞普兰治疗，对照组口服氯米帕明治疗，观察6 w。于治疗前及治疗1 w、2 w、4 w、6 w末采用汉密顿抑郁量表和副反应量表评定临床疗效和不良反应。 结果 治疗6 w末，研究组显效率73.5%、有效率85.3%；对照组分别为70.6%和82.4%，两组间比较差异无显著性（P均＞0.05）。两组治疗1 w末起汉密顿抑郁量表评分较治疗前均下降明显，研究组治疗1 w、2 w末较对照组下降显著（P＜0.01），其他时点差异无显著性（P＞0.05）。研究组治疗6 w末副反应量表评分显著低于对照组（t=2.935，P＜0.01），不良反应较轻微。 结论 西酞普兰治疗抑郁症疗效与氯米帕明相当，但起效较氯米帕明更快，安全性更高，依从性更好。
A control study of citalopram vs clomipramine in the treatment of depression。
【Abstract】 Objective To explore the efficacy and safety of citalopram vs. clomipramine in the treatment of patients with depression. Methods 68 depression patients were randomly divided into research group(n=34) orally took citalopram and control group(n=34) clomipramine for 6 weeks. Clinical efficacy and adverse effects were assessed with the Hamilton Depression Rating Scale(HAMD) and the Treatment Emergent Symptom Scale(TESS) before treatment and at the ends of the 1st, 2nd,4th and 6th week treatment, respectively. Results At the end of the 6th week, excellence and effectiveness rates were respectively 73.5% and 85.35 in the research group and 70.6% and 82.4% in the control group, which had no significant differences(both P0.05). Since the end of the 1st week, the HAMD score lowered very significantly in the research group and significantly in the control group compared with pretreatment; at the ends of the 1st and 2nd week, the HAMD score lowered more significantly in the research than in the control group(P0.01) and there was no significant difference in the other timepoints (P0.05). At the end of the 6th week, the TESS score was significantly lower in the research than in the control group(P0.01) and adverse effects of the former were mild. Conclusion Citalopram has equivalent efficacy to clomipramine but takes effects faster and has higher safety and better compliance.
【Keywords】 Depression; citalopram；clomipramine； efficacy；safety 西酞普兰是一种高选择性5羟色胺再摄取抑制剂（SSRIs），对去甲肾上腺素和多巴胺的作用微弱。研究表明［1］，西酞普兰治疗抑郁症疗效显著，不良反应少。为进一步探讨其临床疗效及安全性，我们与氯米帕明进行了对照研究，现将结果报告如下。
1 对象与方法。
1.1 对象 选取2004年6月～2005年12月在我院住院治疗的抑郁症患者为研究对象。入组标准：（1）符合《中国精神障碍分类与诊断标准》第3版（CCMD3）抑郁症诊断标准。（2）汉密顿抑郁量表（HAMD）评分≥18分。（3）入组前2 w内未应用抗抑郁药物。（4）排除脑器质性病变，严重躯体疾病，酒精及药物依赖，妊娠及哺乳期妇女，既往有药物过敏史者。共入组68例，随机分为两组各34例，研究组男18例，女16例；年龄19 a～58 a，平均（27.5±8.7） a；病程1 mo～24 mo，平均（6.6±5.4） mo。对照组男19例，女15例；年龄17 a～58 a，平均（27.6±8.5） a；病程1 mo～20 mo，平均（6.3±5.1） mo。两组一般资料经统计学分析均无显著性差异（P＞0.05）。
1.2 方法。
1.2.1 给药方法 研究组口服西酞普兰20 mg～60 mg·d—1，对照组口服氯米帕明200 mg～300 mg·d—1。观察6 w。治疗期间均不联合其他抗抑郁剂及抗精神病药物。
1.2.2 疗效评定 于治疗前及治疗1 w、2 w、4 w、6 w末采用HAMD评定临床疗效，副反应量表（TESS）评定不良反应。一致性测定Kappa=0.89。以HAMD减分率判定临床疗效，减分率≥75%为痊愈，≥50%为显著进步，≥25%为进步，＜25%为无效。治疗前后进行血常规、肝功能及心电图检查。
1.2.3 统计方法 所有数据应用SPSS10.0统计软件处理，并进行χ2检验和t检验。