文拉法辛和氟西汀对绝经后抑郁症患者躯体疼痛症状8周疗效的对照研究

Comparison of the effects between venlafaxine and fluoxetine in relieving somatic pain symptoms of postmenopausal depression patients

目的探讨文拉法辛与氟西汀治疗绝经后抑郁症患者躯体疼痛症状的有效性及安全性。方法本研究为随机对照研究。采用随机数字表法将纳入的184例绝经后抑郁症患者分为文拉法辛组(90例)和氟西汀组(94例),172例进入全分析数据集,184例进入安全性数据集。分别在基线、治疗1、2、4、6、8周末,采用视觉模拟量表(Visual Analogue Scale,VAS)、临床总体印象-严重度量表(Clinical Global Impression-Severity,CGI-S)、HAMD24量表评定疗效。采用混合效应模型重复测量、配对t检验及独立样本t检验比较2组治疗效果差异。结果(1)VAS得分组间主效应有统计学意义,文拉法辛组较氟西汀组降低明显(F=6.89,P=0.001)。(2)2组在治疗1、2、4、6、8周末,HAMD24焦虑/躯体化、CGI-S评分均较治疗前下降(均P<0.05)。文拉法辛组在治疗1、2、4、6、8周末HAMD24焦虑/躯体化评分均低于氟西汀组(t=-2.66、-2.21、-3.52、-4.10、-3.14,均P<0.05),文拉法辛组在治疗4、6、8周末CGI-S评分均低于氟西汀组(t=-2.73、-2.08、-2.17,均P<0.05)。(3)2组不良反应发生率差异无统计学意义(χ^2=0.61,P=0.434)。结论与氟西汀相比,文拉法辛更有利于改善绝经后抑郁症患者躯体疼痛症状。

Objective To investigate the efficacy and safety of venlafaxine and fluoxetine for somatic pain symptoms in postmenopausal depression patients.Methods In an 8-week randomized controlled study,184 postmenopausal depression patients who met the study criteria were randomly assigned into the venlafaxine group(90 cases)and the fluoxetine group(94 cases).172 patients were divided into full analysis set(FAS)and 184 patients were divided into safety set(SS).The efficacy was assessed by the Visual Analogue Scale(VAS),Clinical Global Impression-Severity(CGI-S),and HAMD24 at baseline,1-week,2-week,4-week,6-week and 8 weeks treatment.Mixed-effect model repeated measure(MMRM),paired sample t test and independent sample t test were used to compare the efficacy between the two groups.Results(1)MMRM analysis showed that the main effect of VAS scores between groups was statistically significant,venlafaxine group was significantly lower than the fluoxetine group(F=6.89,P=0.001).(2)The anxiety/somatization scores and CGI-S scores at 1-week,2-week,4-week,6-week and 8 weeks treatment were significantly lower than baseline(all P<0.05)in both groups.The anxiety/somatization scores of the venlafaxine group were statistically lower than the fluoxetine group at 1-week,2-week,4-week,6-week and 8 weeks treatment(t=-2.66,2.21,-3.52,-4.10,-3.14,all P<0.05).The CGI-S scores of venlafaxine group were lower than fluoxetine group at 4-week,6-week and 8 weeks treatment(t=-2.73,-2.08,-2.17,all P<0.05).(3)There was no significant difference in the incidence of adverse reaction between the two groups(χ^2=0.61,P=0.434).Conclusion Venlafaxine is more effective in the treatment of somatic pain symptoms in postmenopausal depression than fluoxetine.