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OA

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.