【目的】评价平肝胶囊 （以龙胆泻肝汤加减组方而成） 治疗高血压合并焦虑抑郁障碍的临床疗效，为“心肝同治”高血 压提供更多临床证据支持。【方法】将2022年1月至2023年12月在广东省第二中医院心血管科就诊的150例肝阳上亢型高血 压合并焦虑抑郁障碍患者采用简单随机法随机分为对照组和观察组，每组各75例。对照组给予常规西药降压药物治疗，观 察组在对照组的基础上给予平肝胶囊治疗，疗程为8周。观察2组患者治疗前后收缩压和舒张压、焦虑自评量表 （SAS） 和抑 郁自评量表 （SDS） 评分的变化情况，并评价2组患者的中医证候疗效和用药安全性。【结果】（1） 脱落情况方面，研究过程中， 观察组脱落6例，对照组脱落4例，最终共有140例患者纳入疗效统计，其中观察组69例、对照组71例。 （2） 中医证候疗效方 面，治疗8周后，观察组的总有效率为91.8% （64/69） ，对照组为66.2% （47/71） ；组间比较 （非参数秩和检验） ，观察组的中医 证候疗效明显优于对照组 （P < 0.01） 。 （3） 血压情况方面，治疗后，2组患者的收缩压和舒张压均较治疗前明显下降 （P < 0.01） ， 且观察组的下降幅度均明显优于对照组 （P < 0.01） 。 （4） 焦虑抑郁障碍改善方面，治疗后，2组患者的SAS和SDS评分均较治疗 前明显下降 （P < 0.01） ，且观察组的下降幅度均明显优于对照组 （P < 0.01） 。 （5） 安全性方面，治疗过程中，2组患者均未见明 显不良反应，且2组患者的肝、肾功能等实验室指标均无异常，具有较高的安全性。【结论】平肝胶囊能明显减少肝阳上亢型 高血压合并焦虑抑郁障碍患者的躯体化症状及负面情绪；平肝胶囊联合西药降压药物对于肝阳上亢型高血压合并焦虑抑郁 障碍患者有明显的降压作用，且无明显不良反应，具有较高的安全性。

Objective To evaluate the clinical efficacy of Pinggan Capsules（derived from modified Longdan Xiegan Decoction）in the treatment of hypertension complicated with anxiety and depression，so as to provide more clinical evidence to support the therapy for hypertension from the perspective of simultaneous treatment of heart and liver. Methods A total of 150 patients with hypertension complicated with anxiety and depression of upper hyperactivity of liver yang type who admitted to the Cardiovascular Department of Guangdong Second Traditional Chinese Medicine Hospital from January 2022 to December 2023 were randomly divided into a control group and an observation group by simple randomization method，with 75 patients in each group. The control group was treated with conventional western drugs of antihypertension，and the observation group was treated with Pinggan Capsules on the basis of treatment for the control group. The course of treatment covered eight weeks. The changes of systolic blood pressure（SBP），diastolic blood pressure（DBP），and the scores of Self-Rating Anxiety Scale（SAS）and Self-Rating Depression Scale（SDS）before and after treatment in the two groups of patients were observed. After treatment， the traditional Chinese medicine（TCM）syndrome efficacy and the safety of medication in the two groups of patients were evaluated. Results（1）Six cases in the observation group and four cases in the control group fell off during the study， and a total of 140 patients were finally included in the efficacy statistics， including 69 cases in the observation group and 71 cases in the control group.（2）After eight weeks of treatment，the total effective rate for TCM efficacy in the observation group was 91.8%（64 /69），and that in the control group was 66.2%（47 / 71）； the intergroup comparison（tested by non-parametric rank sum test）showed that the TCM syndrome efficacy in the observation group was significantly superior to that in the control group（P < 0.01）. （3）After treatment， SBP and DBP in the two groups were decreased significantly compared with those before treatment（P < 0.01），and the decrease in the observation group was significantly superior to that in the control group（P < 0.01）.（4）After treatment， the SAS and SDS scores in both groups were decreased significantly compared with those before treatment（P < 0.01）， and the decrease in the observation group was significantly superior to those in the control group（P < 0.01）.（5）During the treatment，no obvious adverse reactions were found in the two groups of patients，and the laboratory findings of liver and kidney function of the two groups were normal， showing relatively high safety. Conclusion Pinggan Capsules can significantly reduce the somatic symptoms and negative emotions of patients with hypertension complicated with anxiety and depression of upper hyperactivity of liver yang type，and their combined use with antihypertensive drugs exert obvious antihypertensive effects，without obvious adverse reactions while with higher safety.

R259.441

广东省中医药局科研项目（编号：202106081715414980）