【目的】 探讨基于《黄帝内经》（简称《内经》）“肌肉枯，气道涩”理论，以健脾活血化痰法中药治疗老年失眠症的临 床疗效。【方法】 将 120例老年失眠症患者随机分为观察组和对照组，每组各 60例。对照组给予口服右佐匹克隆片治疗，观 察组给予口服健脾活血化痰中药汤剂治疗，疗程均为4周。观察2组患者治疗前后匹兹堡睡眠质量指数（PSQI）评分、失眠严 重程度指数（ISI）评分、多导睡眠图（PSG）相关参数[包括总睡眠时间（TST）、觉醒次数（AN）、睡眠潜伏期（SL）]、大脑动脉[包 括大脑前动脉（ACA）、大脑中动脉（MCA）、大脑后动脉（PCA）] 平均血流速度以及血清 5-羟色胺（5-HT）、褪黑素（MT）水平 的变化情况，并评价2组患者的临床疗效和安全性。【结果】（1）治疗4周后，观察组的总有效率为93.33%（56/60），略高于对 照组的 90.00%（54/60），但差异无统计学意义（P＞0.05）。（2）治疗后，2 组 PSQI 量表各项评分及总分均较治疗前降低（P＜ 0.05），且观察组对睡眠质量、睡眠时间、睡眠效率、日间功能评分及总分的降低程度均明显优于对照组（P＜0.05），而2组 的入睡时间、睡眠障碍评分无显著性差异（P＞0.05）；停药 4 周后，观察组 PSQI 量表的各项评分均较治疗后继续降低（P＜ 0.05），而对照组均无明显变化，差异均无统计学意义（P＞0.05）。（3）治疗后，2组 ISI评分均较治疗前降低（P＜0.05），且观 察组的降低程度明显优于对照组（P＜0.05）；停药4周后，观察组的ISI评分较治疗后继续下降（P＜0.05），而对照组无明显变 化，差异无统计学意义（P＞0.05）。（4）治疗后，2组的TST、AN、SL等PSG相关参数均较治疗前改善（P＜0.05），且观察组对 TST 及 AN 的改善程度均明显优于对照组（P＜0.05）。（5）治疗后，观察组的 ACA、MCA、PCA 平均血流速度均较治疗前改善 （P＜0.05），而对照组均较治疗前无明显变化，差异均无统计学意义（P＞0.05）；组间比较，观察组对ACA、MCA、PCA平均 血流速度的改善程度均明显优于对照组（P＜0.05）。（6）治疗后，2组血清5-HT、MT水平均较治疗前升高（P＜0.05），且观察 组的升高程度均明显优于对照组（P＜0.05）。（7）观察组的不良反应发生率为5.00%（3/60），略低于对照组的13.33%（8/60），但 差异无统计学意义（P＞0.05）。【结论】 基于 《内经》“肌肉枯，气道涩”理论，以健脾活血化痰中药治疗老年失眠症疗效确 切，可有效改善患者睡眠质量和日间功能，提高睡眠效率，增加睡眠时间，减少觉醒次数，降低失眠严重程度，改善脑功 能，调节神经递质水平，远期疗效显著且安全可靠。

Objective To explore the clinical efficacy of Chinese herbal medicine with the actions of invigorating spleen， activating blood and resolving phlegm in the treatment of senile insomnia based on the theory of “muscular atrophy，qi-passage blockage” recorded in Huang Di Nei Jing（The Yellow Emperor’s Inner Classic， shortened as Nei Jing）. Methods A total of 120 elderly patients with insomnia were randomly divided into observation group and control group，with 60 cases in each group. The control group was treated with oral use of Dexzopiclone Tablets，and the observation group was treated with oral use of decoction of Chinese herbal medicine for invigorating spleen，activating blood and resolving phlegm. The course of treatment covered 4 weeks. Before and after treatment，the two groups were observed in the changes of Pittsburgh Sleep Quality Index（PSQI）score， Insomnia Severity Index（ISI）score， polysomnography（PSG）related parameters of total sleep time（TST）， number of awakenings（AN）and sleep latency（SL），mean blood flow velocity of anterior cerebral artery（ACA）， middle cerebral artery（MCA），and posterior cerebral artery（PCA），and serum levels of 5-hydroxytryptamine （5-HT）and melatonin（MT）. After treatment，the clinical efficacy and safety of the two groups were evaluated. Results（1）After 4 weeks of treatment， the total effective rate of the observation group was 93.33%（56/60）， which was slightly higher than 90.00%（54/60）of the control group， but the difference was not statistically significant（P＞0.05）.（2）After treatment，the item scores and total scores of PSQI in the two groups were lower than those before treatment（P＜0.05）， and the decrease of the scores of sleep quality， sleep time， sleep efficiency，and daytime function as well as total scores in the observation group was significantly superior to that in the control group（P＜0.05）. However， there was no significant difference of time for falling asleep and sleep disorder scores between the two groups（P＞0.05）. After 4 weeks of drug withdrawal，the item scores of PSQI in the observation group continued to decrease compared with those after treatment（P＜0.05）， but there was no significant difference in the control group（P＜0.05）. （3）After treatment，the ISI scores in the two groups were decreased when compared with those before treatment（P＜0.05），and the decrease in the observation group was superior to that in the control group（P＜0.05）. After 4 weeks of drug withdrawal，the ISI score of the observation group continued to decrease compared with that after treatment （P＜0.05）， while the control group had no significant change，and the difference was not statistically significant（P＞0.05）.（4）After treatment，the PSG related parameters such as TST，AN and SL in the two groups were improved when compared with those before treatment（P＞0.05），and the improvement of TST and AN in the observation group was superior to that in the control group（P＞0.05）.（5）After treatment， the mean blood flow velocity of ACA， MCA and PCA in the observation group was improved compared with that before treatment（P＜0.05），while there was no significant change in the control group compared with that before treatment（P＞0.05）. The improvement of the mean blood flow velocity of ACA，MCA and PCA in the observation group was significantly superior to that in the control group （P＜0.05）.（6）After treatment， the levels of serum 5-HT and MT in the two groups were increased when compared with those before treatment（P＜0.05），and the increase in the observation group was superior to that in the control group（P＜0.05）.（7）The incidence of adverse reactions in the observation group was 5.00%（3/60）， which was slightly lower than 13.33%（8/60）in the control group，but the difference was not statistically significant （P＞0.05）. Conclusion Based on the theory of“muscular atrophy，qi-passage blockage” recorded in Nei Jing， the Chinese herbal medicine for invigorating spleen，activating blood and resolving phlegm exerts certain effect in treating senile insomnia. It can effectively improve the sleep quality and daytime function of patients， enhance sleep efficiency， increase sleep time， reduce the number of awakenings， alleviate the severity of insomnia， improve brain function，and regulate the level of neurotransmitters，with remarkably long-term effect and reliable safety.

R256.23

国家中医药管理局梅建强全国名中医药传承工作室建设项目（国中医药办人教函[2022]245号；国中医药办人教函[2022]75号）； 河北省中医药管理局科研计划项目（编号：2022021）