目的 观察小剂量富马酸喹硫平联合丙戊酸镁治疗双相情感障碍伴重度抑郁发作的临床疗效及安全性.方法 选取2022年1月—2023年6月湖南省脑科医院收治的180例双相情感障碍伴重度抑郁发作患者,采用随机抽签法分为对照组(n=90)和观察组(n=90).对照组患者采取丙戊酸镁持续治疗8周,观察组患者在对照组基础上采取小剂量富马酸喹硫平片持续治疗8周.比较2组临床疗效,治疗前及治疗8周后实验室指标[血清催乳素(PRL)、促甲状腺激素(TSH)、游离甲状腺素(FT4)和游离三碘甲状腺原氨酸(FT3)]、汉密尔顿抑郁量表(HAMD)评分及不良反应.结果 观察组治疗总有效率高于对照组(83.33%vs.64.44%,x2=8.322,P=0.004).治疗前及治疗8周后,2组血清PRL、TSH、FT4、FT3水平比较无统计学差异(P>0.05);治疗8周后,2组血清PRL、TSH水平高于治疗前,血清FT4、FT3水平低于治疗前(P<0.01).治疗8周后,2组HAMD评分低于治疗前,且观察组低于对照组(P<0.01).对照组与观察组治疗期间均发生不良反应,但总发生率比较无统计学差异(8.89%vs.12.22%,x2=0.530,P=0.467).结论 小剂量富马酸喹硫平联合丙戊酸镁治疗双相情感障碍伴重度抑郁发作可更有效地减轻患者抑郁症状,可更好地控制患者临床症状,对内分泌激素的影响较小,且具有较高的用药安全性.
Objective To observe the clinical efficacy and safety of low-dose quetiapine fumarate combined with magnesium valproate in the treatment of bipolar disorder accompanied by severe depressive episodes.Methods A total of 180 patients with bipolar disorder accompanied by severe depressive episodes admitted to Hunan Brain Hospital from January 2022 to June 2023 were selected,and they were randomly divided into the control group(n =90)and the observation group(n =90).The control group of patients were treated with magnesium valproate for 8 weeks,while the observation group of patients were treated with low-dose quetiapine fumarate tablets for 8 weeks in addition to the control group.Clinical efficacy,laboratory indicators(serum level of PRL,TSH,FT4,FT3),HAMD score before and after 8 weeks of treatment,and adverse reactions were compared between the two groups.Results The observation group of total effective rate was higher than that of the control group(83.33%vs.64.44%,x2 =8.322,P =0.004).Before and at 8 weeks after treatment,there was no difference in serum PRL,TSH,FT4 or FT3 levels between the two groups(P>0.05);Compared with before treatment,serum PRL and TSH levels after 8 weeks of treatment in the two groups were higher,while the serum FT4 and FT3 levels were lower(P<0.01).Compared with before treatment,HAMD score after8 weeks of treatment in the two groups was lower,and score of HAMD in the observation group was lower than that of the control group(P<0.01).The control group and the observation group experienced adverse reactions during treatment,but there was no difference in the overall incidence rate(8.89%vs.12.22%,x2 =0.530,P =0.467).Conclusion The combination of low-dose quetiapine fumarate and magnesium valproate in the treatment of bipolar disorder accompanied by severe depressive episodes can more effectively alleviate depressive symptom of patients,it can control clinical symptoms more effectively,and have less impact on endocrine hormones,and with higher medication safety.