天王补心丹方组联合右佐匹克隆治疗心不藏神型不寐患者的疗效观察

Observation on the Efficacy of Tianwang Buxin Dan Formula in Treating Insomnia of the “Heart Failing to Store the Spirit” Type

摘要: 目的：探讨天王补心丹方组单用及联合右佐匹克隆治疗心不藏神型不寐的疗效差异，为中西医结合治疗提供循证依据。方法：采用随机对照试验设计，纳入186例符合DSM-5诊断标准的心不藏神型不寐患者，分为中药组、西药组及中西药组，疗程30天。通过多导睡眠图(PSG)监测睡眠结构，匹茨堡睡眠质量指数(PSQI)评估主观睡眠质量。结果：客观睡眠改善：中西药组治疗后总睡眠时间延长至(449.74 ± 47.60) min，睡眠效率提升至(90.76 ± 2.15)%，入睡潜伏期缩短至(15.08 ± 3.88) min，均显著优于中药组(P < 0.05)及西药组(P < 0.01)。主观症状缓解：中西药组PSQI总分降幅达(9.55 ± 1.92)分，优于中药组(8.00 ± 2.01)分及西药组(5.08 ± 2.50)分(P < 0.01)，其中入睡潜伏期评分(0.89 ± 0.58)及白天功能紊乱评分(0.90 ± 0.63)改善最显著。组间差异：中西药组在睡眠效率、觉醒时间等指标上呈现统计学优势(均P < 0.01)。结论：中西药联合方案可作为心不藏神型不寐的治疗策略，为临床提供兼具循证依据与中医特色的优化选择。

Abstract: Objective: To compare the efficacy differences between Tianwang Buxin Dan formula alone and its combination with eszopiclone in treating insomnia of the “heart failing to store the spirit” type, providing evidence-based support for integrated traditional Chinese and Western medicine therapies. Methods: A randomized controlled trial design was employed, enrolling 186 patients diagnosed with “heart failing to store the spirit” type insomnia according to DSM-5 criteria. Participants were divided into three groups: traditional Chinese medicine (TCM) group, Western medicine (WM) group, and combined TCM-WM group, with a 30-day treatment course. Polysomnography (PSG) was used to monitor sleep architecture, and the Pittsburgh Sleep Quality Index (PSQI) evaluated subjective sleep quality. Results: Objective sleep improvement: The combined TCM-WM group showed significant enhancements, with total sleep time extended to (449.74 ± 47.60) minutes, sleep efficiency increased to (90.76 ± 2.15)%, and sleep latency shortened to (15.08 ± 3.88) minutes, all superior to the TCM group (P < 0.05) and WM group (P < 0.01). Subjective symptom relief: The combined group achieved the greatest reduction in PSQI total score (9.55 ± 1.92 points), outperforming the TCM group (8.00 ± 2.01 points) and WM group (5.08 ± 2.50 points) (P < 0.01), with the most notable improvements in sleep latency (0.89 ± 0.58 points) and daytime dysfunction (0.90 ± 0.63 points). Intergroup differences: The combined group demonstrated statistically superior outcomes in sleep efficiency and wake time (all P < 0.01). Conclusion: The integrated TCM-WM regimen represents an optimized therapeutic strategy for “heart failing to store the spirit” type insomnia, offering clinical benefits supported by evidence-based practice and traditional Chinese medicine principles.