| 赵媛媛,吴倩,刘波,郭飞,刘聪,谢艳利,杨世昌.氟西汀联合舒肝解郁胶囊治疗抑郁症的效果及对患者心率变异性的影响[J].四川精神卫生杂志,2023,36(5):433-439.Zhao Yuanyuan,Wu Qian,Liu Bo,Guo Fei,Liu Cong,Xie Yanli,Yang Shichang,Effect of fluoxetine combined with Shugan Jieyu capsule in the treatment of patients with depression and its impact on heart rate variability[J].SICHUAN MENTAL HEALTH,2023,36(5):433-439 |
| 氟西汀联合舒肝解郁胶囊治疗抑郁症的效果及对患者心率变异性的影响 |
| Effect of fluoxetine combined with Shugan Jieyu capsule in the treatment of patients with depression and its impact on heart rate variability |
| 投稿时间：2023-04-29 |
| DOI：10.11886/scjsws20230429001 |
| 中文关键词: 抑郁症 氟西汀 舒肝解郁胶囊 心率变异性 临床疗效 |
| 英文关键词:Depression Fluoxetine Shugan Jieyu capsule Heart rate variability Clinical efficacy |
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| 中文摘要: |
| 背景 抑郁症可能导致患者存在较高的自杀风险，严重影响患者和家属的生活质量，给社会带来较大负担。虽然西药中的抗抑郁药疗效确切，但单一使用对抑郁症状改善相对局限，且联用两种抗抑郁药可能增加不良反应。中成药与西药合理配伍使用可能起到相辅相成的效果，且中成药安全性较高。目的 探讨氟西汀联合舒肝解郁胶囊治疗抑郁症的效果，比较氟西汀联合舒肝解郁胶囊与单用氟西汀的疗效、安全性以及对患者心率变异性影响的差异，为抑郁症患者的临床用药提供参考。方法 收集2015年12月-2016年6月在新乡医学院第二附属医院门诊就诊和住院治疗的、符合《精神障碍诊断与统计手册（第5版）》（DSM-5）抑郁症诊断标准的64例患者为研究对象，采用随机数字表法分为联合用药组和氟西汀组各32例。两组均接受氟西汀治疗，联合用药组在此基础上联用舒肝解郁胶囊。治疗前，两组均接受汉密尔顿抑郁量表24项版（HAMD-24）和汉密尔顿焦虑量表（HAMA）评定以及心率变异性（HRV）分析，并于治疗第2、4、6周末接受HAMD-24和副反应量表（TESS）评定，治疗第6周末再次进行HRV分析。结果 最终共60例抑郁症患者完成研究，联合用药组和氟西汀组各30例。治疗第2、4、6周末，联合用药组HAMD-24评分均低于氟西汀组，差异均有统计学意义（t=-2.677、-3.960、-4.432，P<0.05或0.01）。与治疗前相比，联合用药组在治疗第6周末24小时平均正常RR间期标准差（SDNN）、标化低频功率（nLF）以及标化高频功率（nHF）均较高（t=-73.970、-31.878、-38.721，P均<0.01），而低频功率与高频功率之比（LF/HF）较低（t=3.525，P<0.01）。治疗第6周末，联合治疗组总有效率高于氟西汀组，差异有统计学意义（86.67% vs. 70.00%，χ2=18.764，P<0.01）。治疗第2、4、6周末，两组不良反应发生例数差异均无统计学意义（P均>0.05）。结论 与单用氟西汀相比，舒肝解郁胶囊联合氟西汀对抑郁症的临床疗效和改善患者心率变异性方面可能更好，且不增加不良反应。 |
| 英文摘要: |
| Background Depression is a kind of disease with relatively high suicide risk， which seriously affects the quality of life of patients and their families， and brings a great burden to society. Antidepressants in western medicine are effective， but the improvement of depressive symptoms is relatively limited by single use， and the combination of two antidepressants may increase the risk of adverse reactions in patients. The rational use of Chinese patent medicine and western medicine may play a complementary role， and the safety of Chinese patent medicine is high.Objective To explore the early clinical efficacy of fluoxetine combined with Shugan Jieyu capsule in the treatment of depression， and to compare the differences in efficacy， safety and influence on heart rate variability between fluoxetine combined with Shugan Jieyu capsule and fluoxetine alone， so as to provide references for clinical medication of depression patients.Methods From December 2015 to June 2016， 64 patients who met the diagnostic criteria of depression in the Diagnostic and Statistical Manual of Mental Disorders， fifth edition （DSM-5） who were hospitalized in the Second Affiliated Hospital of Xinxiang Medical University were selected as the research objects， and were randomly divided into the combined medication group and the fluoxetine group with 32 patients in each group. Patients in both groups were treated with fluoxetine， while patients in the combined medication group were treated with Shugan Jieyu capsule on this basis. Patients in both groups were assessed with Hamilton Depression Scale-24 item （HAMD-24）， Hamilton Anxiety Scale （HAMA） and Heart Rate Variability （HRV） before treatment， and were assessed with HAMD-24 and Treatment Emergent Symptom Scale （TESS） at the end of the 2nd， 4th and 6th week of treatment， and HRV was analyzed again at the end of the 6th week of treatment.Results The study ultimately included 60 patients with depression， with 30 cases in the combination therapy group and 30 cases in the fluoxetine group. At the end of the 2nd， 4th and 6th week of treatment， the HAMD-24 score of the combined drug group was lower than that of the fluoxetine group （t=-2.677， -3.960， -4.432， P<0.05 or 0.01）. Compared with before treatment， the 24-hour mean standard deviation of normal RR intervals （SDNN）， normal low frequency （nLF） and normal high frequency （nHF） in the combined treatment group were higher at the end of the 6th week （t=-73.970， -31.878， -38.721， P<0.01）， but significant lower in LF/HF （t=3.525， P<0.01）. At the end of the 6th week of treatment， the total effective rate of the combined treatment group was higher than that of fluoxetine group， and the difference was statistically significant （86.67% vs. 70.00%， χ2=18.764， P<0.01）. At the 2nd， 4th and 6th week of treatment， there was no significant difference in the number of adverse reactions between the two groups （P>0.05）.Conclusion Compared with fluoxetine alone， Shugan Jieyu capsule combined with fluoxetine may be better in clinical efficacy and improvement of heart rate variability in patients with depression， without increasing adverse reactions. |
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