【目的】探究疏肝解郁方治疗气郁痰阻型失眠伴轻中度抑郁的疗效及其对睡眠质量、负性情绪、血清炎症因子水平的影响。 【方法】将96例气郁痰阻型失眠伴轻中度抑郁患者随机分为研究组和对照组，每组各48例。对照组给予常规西药治疗，研究组在对照组的基础上联合疏肝解郁方治疗，均持续治疗2个月。观察2组患者治疗前后中医证候积分、匹兹堡睡眠质量指数 （PSQI） 评分、失眠严重程度指数 （ISI） 评分、抑郁自评量表 （SDS） 评分、汉密尔顿抑郁量表 （HAMD） 评分、脑血流参数以及血清5-羟色胺 （5-HT） 、肿瘤坏死因子α （TNF-α） 、P物质 （SP） 、白细胞介素6 （IL-6） 水平的变化情况，并比较2组患者的临床疗效和不良反应发生率。 【结果】（1） 疗效方面，治疗2个月后，研究组的总有效率为91.67% （44/48） ，对照组为72.92% （35/48） ，组间比较 （χ2检验） ，研究组的临床疗效明显优于对照组 （P＜0.05） 。 （2） 量表评分方面，治疗后，2组患者的中医证候积分及PSQI、ISI、HAMD、SDS评分均较治疗前明显降低 （P＜0.05） ，且研究组的降低幅度均明显优于对照组 （P＜0.01） 。 （3） 脑血流参数方面，治疗后，2组患者的双侧大脑动脉血流平均流速 （Vm） 、最大峰值流速 （Vs） 均较治疗前明显升高（P＜0.05） ，血管阻力指数 （RI） 均较治疗前明显降低 （P＜0.05） ，且研究组对Vm、Vs的升高幅度及对RI的降低幅度均明显优于对照组 （P＜0.01） 。 （4） 血清炎症因子和神经递质水平方面，治疗后，2组患者的血清TNF-α、IL-6、SP水平均较治疗前明显降低 （P＜0.05） ，血清5-HT水平均较治疗前明显升高 （P＜0.05） ，且研究组对血清TNF-α、IL-6、SP水平的降低幅度及对血清5-HT水平的升高幅度均明显优于对照组 （P＜0.01） 。 （5） 不良反应方面，治疗期间，研究组的不良反应发生率为10.42%（5/48） ，对照组为16.67% （8/48） ，组间比较，差异无统计学意义 （P＞0.05） 。 【结论】疏肝解郁方治疗气郁痰阻型失眠伴轻中度抑郁患者疗效确切，可有效调控神经递质及炎症因子水平，改善脑血流参数，缓解失眠、抑郁等临床症状，且具有较高的安全性。

Objective To investigate the clinical efficacy of Shugan Jieyu Prescription in the treatment of insomnia with mild-to-moderate depression differentiated as qi stagnation and phlegm obstruction type，and to observe its effects on sleep quality，negative emotion，and serum inflammatory factor levels. Methods Ninety-six insomnia patients with mild-to-moderate depression of qi stagnation and phlegm obstruction type were divided into the study group and the control group，with 48 patients in each group. The control group was treated with conventional western medicine，and the study group was treated with Shugan Jieyu Prescription on the basis of treatment for the control group， and both groups were treated for two continuous months. The changes of traditional Chinese medicine （TCM） syndrome score，Pittsburgh Sleep Quality Index （PSQI） score，Insomnia Severity Index （ISI） score，Self-Depression Scale （SDS） score，Hamilton Depression Scale （HAMD） score，cerebral blood flow parameters，and serum levels of neurotransmitters and inflammatory factors such as 5-hydroxytryptamine，tumor necrosis factor α （TNF-α） ，substance P （SP） ，and interleukin 6 （IL-6） in the patients of the two groups before and after treatment were observed. After treatment，the clinical efficacy and incidence of adverse reactions of the two groups were compared. Results （1） After two months of treatment，the total effective rate of the study group was 91.67% （44/48），while that of the control group was 72.92% （35/48），and the intergroup comparison （by chi-square test） showed that the clinical efficacy of the study group was significantly superior to that of the control group （P＜0.05） . （2） After treatment，the scores of TCM syndrome，PSQI，ISI，HAMD，and SDS of patients in the two groups were significantly decreased when compared with those before treatment （P＜0.05），and the decrease in the study group was significantly superior to that in the control group （P＜0.01） . （3） After treatment，the mean flow velocity （Vm） and maximum peak flow velocity （Vs） of bilateral cerebral arterial blood flow in the two groups of patients were significantly increased （P＜0.05） and the resistance index （RI） of cerebral arteries was significantly decreased when compared with those before treatment （P＜0.05） . The increase of Vm and Vs and the decrease of RI in the study group were significantly superior to those in the control group （P＜0.01） . （4） After treatment，the levels of TNF-α，IL-6，and SP in the two groups of patients were significantly decreased （P＜0.05） and the serum 5-HT level was significantly increased when compared with those before treatment （P＜0.05） ，and the decrease of serum TNF-α，IL-6，and SP levels and the increase of serum 5-HT level in the study group were significantly superior to those in the control group （P＜0.05） . （5） During the treatment，the incidence of adverse reactions in the study group was 10.42%（5/48） and that in the control group was 16.67% （8/48） . The intergroup comparison showed that the difference was not statistically significant （P＞0.05） . Conclusion ShuganJieyu Prescription exerts certain efficacy in treating insomnia patients with mild-to-moderate depression of qi stagnation and phlegm obstruction type， which can effectively regulate the levels of neurotransmitters and inflammatory factors， improve the parameters of cerebral blood flow， and alleviate the clinical symptoms of insomnia and depression，with high safety.

R277.7

上海市科技计划项目 （编号：22Y11920800）；上海市中医医院未来发展计划 （2021年） 传承人才项目 （编号：WLJH2021ZY-MZY022）；上海市静安区科委资助项目 （编号：2023QT04）