【目的】探索中药复方黄连温胆汤加减方治疗痰热内扰型高血压病合并睡眠障碍患者的有效性和安全性。 【方法】将70例痰 热内扰型高血压病合并睡眠障碍患者随机分为对照组和观察组，每组各35例。对照组患者给予常规西药治疗，观察组在对 照组的基础上联合黄连温胆汤加减方治疗，疗程为4周。观察2组患者治疗后临床疗效总评量表 （CGI） 的评分情况及治疗前 后中医证候积分、匹兹堡睡眠质量指数 （PSQI） 评分、血压水平、血清同型半胱氨酸 （Hcy） 、白细胞介素6 （IL-6） 、白细胞介 素10 （IL-10） 、白细胞介素8 （IL-8） 水平的变化情况，并评价2组患者的用药安全性。 【结果】（1） 治疗4周后，观察组的CGI 评分为 （1.63 ± 0.60） 分，较对照组的 （2.74 ± 0.82） 分有明显降低，差异有统计学意义 （P＜0.01） 。 （2） 治疗后，2组患者的中医 证候积分、收缩压、舒张压和PSQI评分均较治疗前明显降低 （P＜0.01） ，且观察组对中医证候积分、收缩压、舒张压和PSQI 评分的降低幅度均明显优于对照组 （P＜0.05或P＜0.01） 。 （3） 治疗后，2组患者的血清Hcy、IL-6和IL-8水平均较治疗前明显 降低 （P＜0.01） ，血清IL-10水平均较治疗前明显升高 （P＜0.01） ，且观察组对血清Hcy、IL-6和IL-8水平的降低幅度及对血 清IL-10水平的升高幅度均明显优于对照组 （P＜0.01） 。 （4） 治疗过程中，2组患者均未出现与治疗相关的不良反应和并发症发 生。 【结论】黄连温胆汤加减方对痰热内扰型高血压病合并睡眠障碍患者具有明确的治疗效果，不仅可以降低患者血压及血 清Hcy水平，还能对炎症因子水平进行调控，且具有较高的安全性。

Objective To investigate the efficacy and safety of Chinese herbal compound modified Huanglian Wendan Decoction in the treatment of hypertension complicated with sleep disorders of phlegm-heat harassing the interior type. Methods A total of 70 patients with hypertension complicated with sleep disorders of phlegm-heat harassing the interior type were randomly divided into a control group and an observation group，35 cases in each group. The patients in the control group were treated with conventional western medicine，and the patients in the observation group were treated with modified Huanglian Wendan Decoction on the basis of treatment for the control group. The course of treatment covered four weeks. The Clinical Global Impression （CGI） score， traditional Chinese medicine （TCM） syndrome score，Pittsburgh Sleep Quality Index （PSQI） score，blood pressure，and serum levels of homocysteine （Hcy），interleukin 6 （IL-6），interleukin 10 （IL-10） and interleukin 8 （IL-8）levels in the two groups were observed before and after treatment. Moreover，the safety of medication was evaluated in the two groups. Results （1） After four weeks of treatment，the CGI score of the observation group was （1.63 ± 0.60） points， which was significantly lower than that of the control group [ （2.74 ± 0.82） points]， and the difference was statistically significant （P＜0.01） . （2） After treatment，the TCM syndrome score，systolic blood pressure，diastolic blood pressure and PSQI score of the two groups were significantly decreased compared with those before treatment （P＜0.01），and the decrease of TCM syndrome score，systolic blood pressure，diastolic blood pressure and PSQI score in the observation group was significantly superior to that in the control group （P＜ 0.05 or P＜0.01） . （3）After treatment， the levels of serum Hcy， IL-6 and IL-8 in the two groups were significantly decreased compared with those before treatment （P＜0.01）， and the serum IL-10 level was significantly increased compared with that before treatment （P＜0.01） . The decrease of serum Hcy，IL-6 and IL-8 levels and the increase of serum IL-10 level in the observation group were significantly superior to those in the control group （P＜0.01） . （4）During the treatment， no treatment-related adverse reactions or complications occurred in the two groups. Conclusion Modified Huanglian Wendan Decoction has certain efficacy on patients with hypertension complicated with sleep disorders of phlegm-heat harassing the interior type. The decoction can not only reduce the blood pressure and serum Hcy level of the patients，but also regulate the level of inflammatory factors with high safety.

R259.441

广东省自然科学基金面上项目 （编号：2022A1515012268）；佛山市自筹经费类科技创新项目 （编号：2220001004978）