帕罗西汀单独或联合加巴喷丁治疗躯体形式障碍的疗效比较

Paroxetine alone versus paroxetine combined with gabapentin in patients with somatoform disorders

目的比较帕罗西汀单独与联合加巴喷丁治疗躯体形式障碍(SFD)的有效性和安全性。方法前瞻性选取2018年7月至2020年12月在济宁市第一人民医院心理门诊就诊的108例SFD成人患者,所有患者按照随机数字表法分为对照组(52例)和观察组(56例)。对照组仅接受帕罗西汀治疗,观察组接受帕罗西汀联合加巴喷丁治疗,共12周。在治疗前、治疗结束时和治疗后3个月随访时采用症状自查量表(SCL-90)、汉密顿焦虑量表(HAMA)、汉密顿抑郁量表(HAMD)、健康状况调查问卷简表(SF-36)评估两组SFD患者的焦虑抑郁情绪和生活质量;采用副反应量表(TESS)记录治疗期间的不良事件。在治疗结束时和治疗后3个月随访时采用整体印象改变量表(GIC)评价治疗效果。结果对照组和观察组治疗结束时GIC评分分别为3(2-4)分和2(1.25-3)分(Z=2.081,P=0.037),治疗有效率(GIC评分≤3分)分别为65.4%(34/52)和83.9%(47/56),差异有统计学意义(χ^(2)=4.945,P=0.026)。与治疗前相比较,两组治疗结束时及治疗后3个月随访时的SCL-90、HAMA和HAMD评分均显著降低(均P<0.05),且观察组SCL-90躯体化、焦虑因子评分低于对照组(均P<0.05),观察组治疗结束时HAMA躯体性焦虑评分低于对照组(P<0.05)。与治疗前比较,两组治疗结束时及治疗后3个月随访时SF-36躯体健康和精神健康评分均显著增加(均P<0.05),但两组间比较差异无统计学意义(均P>0.05)。两组不良事件的总发生率差异无统计学意义(P=0.085),但观察组眩晕的发生率显著高于对照组(χ^(2)=4.405,P=0.036)。结论帕罗西汀联合加巴喷丁可进一步增加帕罗西汀治疗的有效率,改善SFD患者的焦虑情绪,但对生活质量无明显影响,且有导致眩晕、嗜睡等不良反应增加的潜在风险。

Objective To compare the efficacy and safety of paroxetine alone and paroxetine combined with gabapentin in patients with somatoform disorder(SFD).Methods From July 2018 to December 2020,108 adult patients with SFD were prospectively selected from the psychological clinic of Jining First People′s Hospital.All patients were divided into the control group(52 cases)and the observation group(56 cases)according to the random number table method.The control group only received paroxetine,and the observation group received paroxetine combined with gabapentin for 12 weeks.Before treatment,at the end of treatment and at the 3-month follow-up after treatment,the levels of anxiety,depression and quality of life in the two groups of SFD patients were assessed by Symptom Checklist 90(SCL-90),Hamilton Anxiety Scale(HAMA),Hamilton Depression Scale(HAMD)and the Short Form-36 Health Survey(SF-36),respectively.Adverse event during treatment was recorded with Treatment Emergent Symptom Scale(TESS).At the end of treatment and at the 3-month follow-up after treatment,the therapeutic efficacy was evaluated with the patient′s Global Impression of Change(GIC).Results At the end of treatment,GIC scores of the control group and the observation group were 3(2-4)and 2(1.25-3)respectively(Z=2.081,P=0.037),and the treatment efficiency(GIC score≤3)was 65.4%(34/52)and 83.9%(47/56),respectively,with a statistically significant difference(χ^(2)=4.945,P=0.026).Compared with that before treatment,the SCL-90,HAMA and HAMD scores of the two groups at the end of treatment were significantly reduced(all P<0.05);the SCL-90 somatization and anxiety factor scores of the observation group were lower than those of the control group(all P<0.05),and the HAMA somatization anxiety score of the observation group at the end of treatment was lower than that of the control group(P<0.05).Compared with that before treatment,the scores of physical health and mental health in the two groups at the end of treatment and 3 months follow-up after treatment were significantly increased(both P<0.05),but there was no significant difference between the two groups(both P<0.05).There was no statistical difference in the total incidence of adverse events between the two groups(P=0.085),but the incidence of vertigo in the observation group was significantly higher than that in the control group(χ^(2)=4.405,P=0.036).Conclusions Paroxetine combined with gabapentin can further increase the effective rate of paroxetine treatment and improve the anxiety of SFD patients,but it has no significant impact on the quality of life,and has the potential risk of increasing dizziness,lethargy and other adverse reactions.