归脾合剂联合抗抑郁药对心脾两虚型抑郁症患者心率变异性及临床疗效的影响

Effect of Guipi Mixture Combined with Antidepressants on Heart Rate Variability and Clinical Efficacy in Patients with Heart-Spleen Deficiency Depression

摘要: 目的：探讨归脾合剂联合抗抑郁药对心脾两虚型抑郁症患者心率变异性(HRV)及临床症状的影响。方法：纳入符合ICD-10抑郁发作及中医心脾两虚证诊断标准的患者58例，随机分为对照组(抗抑郁药，30例)与研究组(抗抑郁药 + 归脾合剂，28例)。本研究为探索性试验，样本量基于可行性及效应量预估确定(详见讨论)。治疗8周后，比较两组HRV时域指标(SDNN, RMSSD)、频域指标(LF, HF, LF/HF, TP)、HAMD评分、HAMA评分、SF-36评分、中医症状积分及不良反应。结果：治疗前两组基线资料及主要结局指标差异无统计学意义(P > 0.05)。治疗后，研究组SDNN、RMSSD、TP、HF均显著高于对照组(P < 0.01或P < 0.005)，LF/HF显著低于对照组(P < 0.01)；研究组LF高于对照组(P = 0.007，提示性差异，未达校正后标准)；研究组HAMD、HAMA、中医症状积分显著低于对照组(P < 0.01或P < 0.005)，SF-36评分显著高于对照组(P < 0.01)。两组不良反应发生率差异无统计学意义(P > 0.05)。相关性分析显示，HAMD减分率与ΔSDNN呈显著正相关(r = 0.61, P < 0.01)，中医气虚质转化分与LF/HF呈中度负相关(r = −0.55, P < 0.01)。结论：归脾合剂可改善心脾两虚型抑郁症患者的自主神经功能(增强迷走神经活性、调节交感–迷走平衡)，增强抗抑郁疗效，改善生活质量，且安全性良好。HRV可作为该证型疗效评估的潜在客观生理指标。

Abstract: Objective: To investigate the effects of Guipi Mixture combined with antidepressants on heart rate variability (HRV) and clinical symptoms in patients with depression of the heart-spleen deficiency type. Methods: A total of 58 patients meeting the ICD‑10 criteria for depressive episodes and the traditional Chinese medicine diagnostic criteria for heart-spleen deficiency syndrome were enrolled and randomly assigned to a control group (antidepressants alone, n = 30) or a study group (antidepressants plus Guipi Mixture, n = 28). This was an exploratory trial, and the sample size was determined based on feasibility and estimated effect sizes (see Discussion for details). After 8 weeks of treatment, the two groups were compared in terms of HRV time‑domain indices (SDNN, RMSSD), frequency‑domain indices (LF, HF, LF/HF, TP), HAMD scores, HAMA scores, SF‑36 scores, traditional Chinese medicine symptom scores, and adverse reactions. Results: Before treatment, there were no statistically significant differences between the two groups in baseline characteristics or primary outcome measures (P > 0.05). After treatment, the study group showed significantly higher SDNN, RMSSD, TP, and HF than the control group (P < 0.01 or P < 0.005), and significantly lower LF/HF than the control group (P < 0.01). LF was higher in the study group than in the control group (P = 0.007, indicative of a suggestive difference that did not reach the corrected significance threshold). The study group also had significantly lower HAMD, HAMA, and traditional Chinese medicine symptom scores (P < 0.01 or P < 0.005) and significantly higher SF‑36 scores (P < 0.01) compared with the control group. No statistically significant difference was found in the incidence of adverse reactions between the two groups (P > 0.05). Correlation analyses revealed that the HAMD reduction rate was significantly positively correlated with ΔSDNN (r = 0.61, P < 0.01), and the traditional Chinese medicine qi‑deficiency constitution transformation score was moderately negatively correlated with LF/HF (r = −0.55, P < 0.01). Conclusion: Guipi Mixture can improve autonomic nervous function in patients with depression of the heart‑spleen deficiency type (by enhancing vagal activity and modulating sympathetic‑vagal balance), enhance antidepressant efficacy, improve quality of life, and has a favorable safety profile. HRV may serve as a potential objective physiological indicator for evaluating therapeutic response in this syndrome type.