加味甘麦大枣汤联合耳穴压豆与艾司唑仑片治疗血亏阴虚型卒中后失眠临床研究

Clinical Study on Modified Ganmai Dazao Decoction Combined with Auricular Point Seed-Pressing and Estazolam Tablets for Post-Stroke Insomnia of Blood Insufficiency and Yin Deficiency Type

摘要:

目的：观察加味甘麦大枣汤联合耳穴压豆与艾司唑仑片治疗血亏阴虚型卒中后失眠的疗效。方法：选取2022年7月—2025年6月嘉兴市中医医院收治的102例血亏阴虚型卒中后失眠患者作为研究对象，按随机数字表法分为对照组与联合组各51例。对照组给予艾司唑仑片联合耳穴压豆治疗，联合组在对照组基础上加用加味甘麦大枣汤治疗，2组均连续治疗4周。治疗前后评估睡眠质量［匹兹堡睡眠质量指数（PSQI） 评分］，监测多导睡眠图参数（睡眠潜伏期、觉醒时间、总睡眠时间、睡眠效率），检测炎性因子指标［Toll样受体4 （TLR4） mRNA、核因子-κB （NF-κB） mRNA、白细胞介素-6 （IL-6）］、神经递质指标［肾上腺素（E）、去甲肾上腺素（NE）、多巴胺（DA）］。比较2组的临床疗效及不良反应发生率。结果：治疗4周后，联合组总有效率高于对照组（P＜0.05）。2组PSQI评分均较治疗前降低，睡眠潜伏期、觉醒时间均较治疗前缩短，总睡眠时间均较治疗前增加，睡眠效率均较治疗前提高，差异均有统计学意义（P＜0.05）。联合组PSQI评分低于对照组，睡眠潜伏期、觉醒时间均短于对照组，总睡眠时间长于对照组，睡眠效率高于对照组，差异均有统计学意义（P＜0.05）。2组TLR4 mRNA、NF-κB mRNA、IL-6及E、NE、DA水平均较治疗前下降（P＜0.05），联合组上述6项指标均低于对照组（P＜0.05）。联合组不良反应发生率为9.80%（5/51），对照组不良反应发生率为5.88%（3/51），2组比较，差异无统计学意义（P＞0.05）。结论：在艾司唑仑片联合耳穴压豆的基础上加用加味甘麦大枣汤治疗血亏阴虚型卒中后失眠患者，可有效减轻炎症反应，改善睡眠质量，且安全性较好。

Abstract:

Abstract： Objective： To observe the curative effect of modified Ganmai Dazao Decoction combined with auricular point seed-pressing for post-stroke insomnia of blood insufficiency and yin deficiency type. Methods：A total of 102 patients with post-stroke insomnia of blood insufficiency and yin deficiency type admitted to Jiaxing Hospital of Traditional Chinese Medicine from July 2022 to June 2025 were enrolled. The patients were divided into the control group and the combination group using the random number table method，with 51 cases in each group. The control group was treated with Estazolam Tablets combined with auricular point seed-pressing. The combination group was treated with modified Ganmai Dazao Decoction based on the treatment in the control group. Both groups were treated continuously for four weeks. Before and after treatment， sleep quality [Pittsburgh Sleep Quality Index （PSQI） scores] was assessed， polysomnography parameters （sleep latency，awakening time，total sleep time，sleep efficiency） were monitored，and inflammatory factor indicators [Toll-like receptor 4（ TLR4） mRNA，nuclear factor-κB（ NF-κB） mRNA，interleukin- 6 （IL-6）] and neurotransmitter indicators [epinephrine （E），norepinephrine （NE），dopamine （DA）] were measured. The clinical efficacy and incidence of adverse reactions were compared between the two groups. Results： After four weeks of treatment， the total effective rate in the combination group was higher than that in the control group （P＜ 0.05）. After treatment，the PSQI scores in both groups decreased compared with those before treatment，sleep latency and awakening time were shortened compared with those before treatment，total sleep time was increased compared with that before treatment， and sleep efficiency was improved compared with that before treatment， with statistically significant differences （P＜0.05）. The PSQI score in the combination group was lower than that in the control group， sleep latency and awakening time were shorter than those in the control group，total sleep time was longer than that in the control group， and sleep efficiency was higher than that in the control group， with statistically significant differences （P＜0.05）. After treatment，the levels of TLR4 mRNA，NF-κB mRNA，IL-6，E，NE，and DA in both groups decreased compared with those before treatment （P＜0.05）， and the levels of above six indicators in the combination group were all lower than those in the control group （P＜0.05）. The incidence of adverse reactions was 9.80% （5/51） in the combination group and 5.88% （3/51） in the control group， and the difference between the two groups was not statistically significant （P＞0.05）. Conclusion： Adding modified Ganmai Dazao Decoction to the treatment with Estazolam Tablets combined with auricular point seed-pressing for patients with post-stroke insomnia of blood insufficiency and yin deficiency type can effectively alleviate inflammatory response，improve the patients' sleep quality，and demonstrate a favorable safety profile.