地黄饮子胶囊联合西医常规疗法治疗难治性高血压阴阳两虚证临床研究

王春亮，来于

石家庄市中医院，河北 石家庄 050051

摘要：目的 评价地黄饮子胶囊联合西医常规疗法治疗难治性高血压阴阳两虚证临床疗效，探讨其可能的作用机制。方法 采用随机数字表法将96例患者分为观察组和对照组各48 例。2组均行西医常规治疗，在此基础上，观察组予地黄饮子胶囊，对照组予淀粉胶囊，每次5粒，每日2次，口服。2组均连续治疗3个月。观察2组中医疗效，比较2组治疗前后中医症状评分、血压、内皮功能、神经内分泌激素水平，并评价血压下降与神经内分泌激素水平变化的关系。结果 观察组总有效率为 85.41%（41/48），对照组为 31.25%（15/48），

2 组比较差异有统计学意义（P＜0.05）。与本组治疗前比较，观察组中医症状评分明显降低（P＜0.05）；2 组

治疗后比较，观察组中医症状评分明显低于对照组（P＜0.05）。与本组治疗前比较，2组治疗后诊室血压、24 h

平均血压、日间平均血压、夜间平均血压明显下降（P＜0.05）；2组治疗后比较，观察组上述血压指标明显低

于对照组（P＜0.05）。与本组治疗前比较，2 组治疗后内皮功能无明显变化（P＞0.05）。与本组治疗前比较，

观察组血浆甲氧基肾上腺素、甲氧基去甲肾上腺素、内皮素-1、肾素活性明显降低（P＜0.05），一氧化氮水平

明显升高（P＜0.05），醛固酮水平无明显变化（P＞0.05）；2 组治疗后比较，观察组血浆甲氧基肾上腺素、甲

氧基去甲肾上腺素、内皮素-1、肾素活性明显低于对照组（P＜0.05），一氧化氮水平明显高于对照组（P＜0.05）。

观察组血压下降与神经内分泌激素水平变化未见相关性（P＞0.05）。结论 地黄饮子胶囊联合西医常规疗法治疗难治性高血压阴阳两虚证疗效较好，可降低患者血压，改善神经内分泌激素水平及中医症状。关键词：地黄饮子胶囊；阴阳两虚证；难治性高血压；神经内分泌激素；内皮功能；临床研究

中图分类号：R259.441 文献标识码：A 文章编号：1005-5304(2020)12-0021-05

DOI：10.19879/j.cnki.1005-5304.202003673 开放科学（资源服务）标识码（OSID）：

Clinical Study on Dihuang Yinzi Capsules Combined with Western Routine Therapy for Treatment of Resistant Hypertension with Yin-yang Deficiency Syndrome

WANG Chunliang, LAI Yu Shijiazhuang TCM Hospital, Shijiazhuang 050051, China

Abstract: Objective To evaluate the clinical efficacy and the possible mechanism of Dihuang Yinzi Capsules combined with Western routine therapy for resistant hypertension with yin-yang deficiency syndrome. Methods Totally 96 patients were randomly divided into observation group (48 cases) and control group (48 cases). Both groups were treated with Western routine medicine. On this basis, observation group was administered with Dihuang Yinzi Capsules, while the control group was given starch capsules, 5 capsules each time, twice a day, orally. Both groups were treated continuously for 3 months. TCM efficacy of the two groups was observed, TCM symptom scores, blood pressure, endothelial function, and neuroendocrine hormone levels before and after treatment in the two groups were compared, and the relationship between the decrease in blood pressure and the changes in neuroendocrine hormone levels was evaluated. Results After treatment, the total effective rate was 85.41% (41/48) in the observation group, and 31.25% (15/48) in the control group, with statistical significance (P<0.05). Compared with before treatment, the TCM symptom scores decreased significantly in observation group (P<0.05); After treatment, TCM symptom scores in observation group were significantly lower than those of the control group (P<0.05).

Compared with before treatment, blood pressure of clinic, 24 h mean blood pressure, and mean blood pressure of day and night decreased significantly in two groups (P<0.05); After treatment, the above indexes of blood pressure in observation group were significantly lower than those of the control group (P<0.05). Compared with before treatment, methoxepinephrine, normetanephrine, endothelin-1, and renin decreased significantly while nitric oxide increased significantly (P<0.05) in observation group, but plasma aldosterone did not significantly change (P>0.05); After treatment, the plasma methoxyadrenaline, methoxynorepinephrine, endothelin-1, renin activity of the observation group were significantly lower than those of the control group (P<0.05), and the level of nitric oxide was significantly higher than that of the control group (P<0.05). There was no correlation between the decrease in blood pressure and changes in neuroendocrine hormone levels in the observation group (P>0.05). Conclusion Dihuang Yinzi Capsules combined with Western routine therapy has good efficacy for resistant hypertension with yin-yang deficiency syndrome, which can reduce blood pressure, improve the level of neuroendocrine hormones and TCM symptoms.

Keywords: Dihuang Yinzi Capsules; yin-yang deficiency syndrome; resistant hypertension; neuroendocrine hormone; endothelial function; clinical study

难治性高血压（resistant hypertension，RH）是高血压治疗中的难点，随着人口老龄化及肥胖、睡眠呼吸暂停低通气综合征、慢性肾脏病等增多，其发病率逐渐升高。血压控制不佳可导致心、脑、肾等靶器官损害，从而导致临床血管事件的发生，积极有效地使

血压达标是高血压治疗的重要环节[1]。笔者临证以国

医大师李士懋教授学术思想[2]为指导，在西医常规治疗基础上应用地黄饮子胶囊治疗RH阴阳两虚证疗效显著。本研究采用地黄饮子胶囊联合西医常规疗法治疗 RH阴阳两虚证，评价患者中医症状改善情况、动态血压、神经内分泌激素水平及内皮功能变化，现报道如下。

1 资料与方法

1.1 一般资料

选取 2018 年 11 月－2019 年 11 月石家庄市中医院高血压科 RH 患者 96 例，采用随机数字表法分为观察组和对照组各 48 例。本研究经石家庄市中医院

医学伦理委员会审查批准（2017年 1 月）。

1.2 中医辨证标准

参照《中药新药临床研究指导原则（试行）》[3]制定阴阳两虚证辨证标准。主症：头痛、眩晕、腰膝酸软、畏寒肢冷；次症：心悸、气短、耳鸣、夜尿频；舌脉：舌淡、苔白，脉沉细。具备主症2项，或主症

1项加次症2项，参考舌脉即可辨证。

1.3 西医诊断标准

[4]

参照《中国高血压防治指南（2018年修订版）》制定RH诊断标准。在改善生活方式基础上应用可耐受的足够剂量且合理的3种降压药物（包括一种噻嗪类利尿剂）治疗至少4周后，诊室和诊室外（包括家庭血压或动态血压监测）血压值仍在目标水平之上，或至少需要4种药物才能使血压达标。

1.4 纳入标准

①年龄 40～65 岁；②诊断 RH 至少 1 年以上； ③符合阴阳两虚证辨证标准；④患者对本研究知情，并签署知情同意书。

1.5 排除标准①继发性高血压；②冠心病、糖尿病及严重肥胖

（体质量指数≥40 kg/m2）；③依从性差，不能完成试验。

1.6 中止及剔除标准①治疗过程中自动退出者；②未按规定用药者； ③就诊资料不全者；④研究过程中发现其他疾患需更换治疗方案者。

1.7 治疗方法

2 组患者降压药物剂量及用法按入组前降压方

案[4]执行。观察组予地黄饮子胶囊（含熟地黄15 g、巴戟天 10 g、山萸肉 10 g、石斛 10 g、肉苁蓉 10 g、炮附子 10 g、五味子 10 g、肉桂 5 g、茯苓 15 g、麦冬 10 g、石菖蒲 10 g、远志 10 g，石家庄市中医院制

剂室煎药后制成颗粒剂，装入胶囊，2 g/粒），对照组予淀粉胶囊（石家庄市中医院制剂室提供，胶囊质量

和外观同地黄饮子胶囊，2 g/粒），均每次 5粒，每日早晚餐后口服，连续治疗3个月。

1.8 观察指标

1.8.1 中医症状评分

参照《中药新药临床研究指导原则（试行）》[3]进行中医症状评分。主症按无、轻、中、重分别计0、

2、4、6分。各项评分之和为中医症状积分。