帕利哌酮缓释片联合碳酸锂治疗双相抑郁障碍的临床疗效分析

Analysis of clinical efficacy of paliperidone extended-release tablets combined with lithium carbonate in treatment of bipolar depressive disorder

目的:探讨帕利哌酮缓释片联合碳酸锂对双相抑郁障碍患者的临床疗效和安全性。方法:选取60例双相抑郁障碍患者,随机分为帕利哌酮缓释片+碳酸锂联合治疗组(研究组)和碳酸锂单药治疗组(对照组),每组各30例,治疗期均为8周。采用17项汉密尔顿抑郁量表(Hamilton Depression Scale,HAMD-17)、治疗副反应量表(Treatment Emergent Symptom Scale,TESS)对比分析治疗2周、4周及8周后两组的临床疗效。结果:两组患者对比:基线期HAMD-17评分差异无统计学意义(P>0.05)。治疗2周及4周后研究组较对照组HAMD-17评分下降更明显,差异有统计学意义(P<0.05)。治疗8周后,研究组和对照组HAMD-17评分比较差异无统计学意义(P>0.05)。两组不良反应比较,第2周末差异有统计学意义(P<0.05),第4周末和第8周末差异无统计学意义(P>0.05)。结论:帕利哌酮缓释片联合碳酸锂治疗双相抑郁障碍较单用碳酸锂起效更快,不良反应相当。

Objective：To explore efficacy and safety of paliperidone extended-release tablets combined lithium carbonate intreatment of bipolar depressive disorder. Methods：Sixty patients with bipolar depressive disorder were randomly divided into researchgroup （30 cases, took orally paliperidone extended-release tablets combined lithium carbonate for 8 weeks） and control group （30 ca-ses, took only lithium carbonate for 8 weeks）. The clinical efficacies were assessed with Hamilton depression scale （HAMD-17） andtreatment emergent symptom scale （TESS） before and 2, 4 and 8 weeks after the treatment. Results： There was no difference in thebaseline HAMD-17 score between the two groups （P〉0. 05）. The HAMD-17 score of study group decreased significantly than controlgroup 2 and 4 weeks after the treatment, and the difference between the two groups was significant （P〈0. 05）. 8 weeks after the treat-ment, there was no difference in the HAMD-17 score between the two groups （P〉0. 05）. For the adverse reactions, there were signif-icant differences between the two groups 2 weeks after the treatment （P〈0. 05） but no statistical differences 4 and 8 weeks after thetreatment （P〉0. 05）. Conclusions： Paliperidone extended-release tablets combined with lithium carbonate is rapid in the curativeeffects, and has less adverse reactions and higher security in the treatment of bipolar depressive disorder.