蒙药匝迪-5味丸联合草酸艾司西酞普兰治疗首次抑郁发作的临床效果

Clinical Efficacy Study of Traditional Mongolian medicine Zadi-5 Pills Combined with Escitalopram Oxalate in the Treatment of first-episode Depression

中文关键词:  蒙药匝迪5味丸、草酸艾司西酞普兰、首次抑郁发作

英文关键词:Traditional Mongolian medicine Zadi-5 Pills, Escitalopram Oxalate, First-episode Depression

中文摘要:

      背景 抑郁障碍全球患病率较高，且存在治疗缺口。草酸艾司西酞普兰作为临床常用抗抑郁药，其作用靶点单一且容易引起胃肠道不适等副反应。蒙药匝迪-5味丸具有多靶点抗抑郁机制及改善肠道菌群等独特优势，但目前尚缺乏二者联合治疗首次抑郁发作的随机对照试验证据，且现有联合研究未系统评估代谢安全性及药物相互作用。目的 探讨匝迪-5味丸联合草酸艾司西酞普兰对首次抑郁发作患者的临床疗效，为蒙医药治疗抑郁障碍提供参考。方法 采用随机对照试验。纳入2023年1月—2024年12月在内蒙古精神卫生中心门诊或住院治疗的、符合《国际疾病分类（第10版）》（ICD-10）抑郁发作诊断标准的103例患者，且均为首次发作。采用Excel软件，通过RAND函数生成随机数，将103例患者随机分为研究组（n=52）和对照组（n=51）。两组均接受草酸艾司西酞普兰治疗，由5 mg/d起始渐加量至20 mg/d，早餐后服用；研究组在此基础上加用匝迪-5味丸，13粒/d，晚睡前服用。两组疗程均为6周。于治疗前及治疗第2、4、6周末，采用汉密尔顿抑郁量表24项版（HAMD-24）评定抑郁症状严重程度，并于上述时间点当日7:00空腹采集静脉血，检测肝功能（谷草转氨酶、谷丙转氨酶）、甘油三酯及草酸艾司西酞普兰血药浓度，评估药物不良反应及代谢安全性。结果 共100例患者完成研究，研究组和对照组各50例。重复测量方差分析结果显示，HAMD-24评分的时间与组别交互效应有统计学意义（F交互=18.070，P＜0.05），研究组第4、6周末评分低于对照组（P＜0.05）。研究组各时间点HAMD-24评分减分率均高于同期对照组，差异均有统计学意义（P均＜0.01）。甘油三酯组别与时间的交互效应有统计学意义（F交互=3.381，P＜0.05），研究组甘油三酯水平呈下降趋势，对照组甘油三酯水平呈上升趋势。肝功能（谷丙转氨酶与谷草转氨酶）及草酸艾司西酞普兰血药浓度的组别与时间的交互效应均无统计学意义（P均＞0.05）。结论 与单用草酸艾司西酞普兰相比，匝迪-5味丸联合草酸艾司西酞普兰对改善首次抑郁发作患者抑郁症状的效果更好，且未增加肝损伤风险及药物代谢相互作用；联合用药组甘油三酯呈下降趋势，提示其对血脂代谢可能具有潜在改善作用。

英文摘要:

      Background The global prevalence of depressive disorders is high, with a significant treatment gap remaining. Escitalopram oxalate, a commonly used antidepressant, has a single therapeutic target and is frequently associated with adverse reactions such as gastrointestinal discomfort. The traditional Mongolian medicine Zadi-5 Pills offers unique advantages through multi-target antidepressant mechanisms and modulation of intestinal flora. However, high-quality randomized controlled trial evidence supporting the combination of Zadi-5 Pills and escitalopram oxalate for first-episode depression is currently lacking, and existing combination studies have not systematically evaluated metabolic safety or drug interactions. Objective To observe the clinical efficacy of Zadi-5 Pills combined with escitalopram oxalate in patients with depressive episodes, and to provide evidence for the treatment of first-episode depression with Mongolian medicine. Methods This study was designed as a randomized controlled trial. A total of 103 patients who met the diagnostic criteria for depressive episode according to the International Classification of Diseases, Tenth Edition (ICD-10), and were experiencing their first episode, were recruited from the outpatient and inpatient departments of Inner Mongolia Mental Health Center between January 2023 and December 2024. Participants were randomly assigned to either the study group (n=52) or the control group (n=51) using Excel randomization. Both groups received escitalopram oxalate, starting at 5 mg/d and gradually increasing to 20 mg/d, taken after breakfast; the study group additionally received Zadi-5 Pills at 13 pills/d before bedtime, with both medications administered continuously for 6 weeks. The 24-item Hamilton Depression Rating Scale (HAMD-24) was used to assess the severity of depressive symptoms at baseline and at the end of weeks 2, 4, and 6. At the corresponding time points, fasting venous blood samples were collected at 7:00 a.m. to measure liver function (aspartate aminotransferase [AST], alanine aminotransferase [ALT]), triglycerides, and plasma concentration of escitalopram oxalate, so as to evaluate adverse drug reactions and metabolic safety. Results Ultimately, 100 patients completed the study (50 in each group). Repeated measures ANOVA showed a statistically significant group-by-time interaction effect for HAMD-24 scores (Fint=18.070, P<0.05), with the study group scoring lower than the control group at weeks 4 and 6 (P<0.05). The reduction rate of HAMD-24 scores in the study group was significantly higher than that in the control group at all time points (P<0.01). Regarding safety, a significant group-by-time interaction effect was observed for triglycerides (Fint=3.381, P<0.05), with triglyceride levels showing a downward trend in the study group and an upward trend in the control group. No statistically significant interaction effects were found for liver function or plasma drug concentration (all P>0.05). Conclusion Compared with escitalopram oxalate monotherapy, the combination of Zadi-5 Pills and escitalopram oxalate demonstrated superior efficacy in improving depressive symptoms in patients with first-episode depression, without increasing the risk of liver injury or drug metabolic interactions; triglyceride levels showed a downward trend in the combination group, suggesting a potential beneficial effect on lipid metabolism.