| 张泽雨,黄永清,齐玉梅,杜文志,白淑英.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[J].四川精神卫生杂志,2026,(3):199-205.Zhang Zeyu,Huang Yongqing,Qi Yumei,Du Wenzhi,Bai Shuying,Clinical efficacy of the traditional Mongolian medicine Zadi-5 pills combined with escitalopram oxalate in the treatment of first-episode depression[J].SICHUAN MENTAL HEALTH,2026,(3):199-205 |
| 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 of the traditional Mongolian medicine Zadi-5 pills combined with escitalopram oxalate in the treatment of first-episode depression |
| 投稿时间：2025-11-05 |
| DOI：10.11886/scjsws20251105001 |
| 中文关键词: 匝迪-5味丸 草酸艾司西酞普兰 首次抑郁发作 |
| 英文关键词:Zadi-5 pills Escitalopram oxalate First-episode depression |
| 基金项目:内蒙古自治区卫生健康科技计划项目（项目名称：蒙药匝迪5味丸联合草酸艾司西酞普兰治疗抑郁症的临床疗效研究，项目编号：202202107） |
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| 中文摘要: |
| 背景 在全球范围内，抑郁障碍的患病率较高，且存在治疗缺口。草酸艾司西酞普兰作为临床常用的抗抑郁药，其作用靶点单一且易引起胃肠道不适等不良反应。蒙药匝迪-5味丸具有多靶点抗抑郁机制及改善肠道菌群的独特优势，但目前尚缺乏草酸艾司西酞普兰与匝迪-5味丸联合治疗首次抑郁发作的随机对照试验，且缺少对其代谢安全性及药物相互作用的研究。目的 探讨匝迪-5味丸联合草酸艾司西酞普兰治疗首次抑郁发作的效果及安全性，为蒙医药治疗抑郁发作提供参考。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、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，均为首次发作。采用Excel软件的RAND函数生成随机数，将患者分为研究组（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，逐渐加量至20 mg/d，研究组在此基础上加用匝迪-5味丸，13粒/d。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）以及甘油三酯和草酸艾司西酞普兰血药浓度。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评分的组别与时间的交互效应有统计学意义（F交互=18.070，P<0.01），治疗第4、6周末，研究组HAMD-24评分均低于对照组（P均<0.05）。治疗后各时间点，研究组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<0.05）。甘油三酯水平组别与时间的交互效应有统计学意义（F交互=3.381，P<0.05），治疗后，研究组甘油三酯水平呈下降趋势，对照组呈上升趋势。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治疗首次抑郁发作的效果更好，且未增加肝损伤风险；联合用药对血脂代谢可能具有潜在的改善作用。 |
| 英文摘要: |
| Background The global prevalence of depressive disorders is high， with a significant treatment gap remaining. Escitalopram oxalate， as a commonly used antidepressant in clinical practice， has a single target and is prone to cause adverse reactions such as gastrointestinal discomfort. The traditional Mongolian medicine Zadi-5 pills has a multi-target anti-depression mechanism and unique advantages such as improving the intestinal flora. However， there is currently a lack of randomized controlled trial evidence for the combined treatment of first-episode depression， along with insufficient research on its metabolic safety and potential drug interactions.Objective To explore the efficacy and safety of Zadi-5 pills combined with escitalopram oxalate in the treatment of the first-episode depression， so as to provide references for Mongolian medicine in depression management.Methods A randomized controlled trial was conducted. A total of 103 patients with first-episode depression who were treated in the outpatient or inpatient departments of the Inner Mongolia Autonomous Region Mental Health Center from January 2023 to December 2024 and met the diagnostic criteria for depressive episode as defined in International Classification of Diseases， tenth edition （ICD-10） were included. Random numbers were generated using the RAND function in Excel software， and the patients were divided into the study group （n=52） and the control group （n=51）. Both groups received escitalopram oxalate treatment， starting from 5 mg/d and gradually increasing to 20 mg/d. The study group additionally received Zadi-5 pills， 13 pills per day. The treatment duration for both groups was 6 weeks. Before treatment and at the 2nd， 4th， and 6th weeks of treatment， the severity of depressive symptoms was evaluated using the Hamilton Depression Scale-24 item （HAMD-24）. At these time points， blood was collected on an empty stomach at 7∶00 for the detection of liver function （aspartate aminotransferase， alanine aminotransferase）， triglycerides， and the blood concentration of escitalopram oxalate.Results A total of 100 patients completed the study， with 50 cases in the study group and the control group. The results of the repeated measures ANOVA showed that the interaction effect between group and time in the HAMD-24 score was statistically significant （F interaction= 18.070， P<0.01）. At the end of the 4th and 6th weeks of treatment， the HAMD-24 score of the study group was lower than those of the control group （P<0.05）. At each time point after treatment， the reduction rate of the HAMD-24 score in the study group was higher than those of the control group， and the differences were all statistically significant （P<0.05）. The interaction effect between the triglyceride level groups and time was statistically significant （Finteraction=3.381， P<0.05）.After treatment， the triglyceride levels in the study group showed a downward trend， while those in the control group showed an upward trend. There was no statistically significant interaction effect between the groups and time for liver function （aspartate aminotransferase and alanine aminotransferase） and the blood concentration of escitalopram oxalate （P>0.05）.Conclusion Compared with escitalopram oxalate treatment alone， the combination of Zadi-5 pills and escitalopram oxalate is more effective in treating the first-episode depression， without increasing the risk of liver damage. The combined medication may have a potential beneficial effect on lipid metabolism. ［Funded by Inner Mongolia Autonomous Region Health Science and Technology Planning Project （number， 202202107）］ |
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