中药配方颗粒剂治疗原发性高血压的多中心、随机对照、非劣效性临床研究

衷敬柏; 冯学功; 鲁卫星; 申香莲; 李红英; 李东伟; 苏凤哲; 孟祥然; 苏敬泽; 陆芳; 赵阳

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中药配方颗粒剂治疗原发性高血压的多中心、随机对照、非劣效性临床研究

临证承启 | 更新时间：2022-08-31

- 中药配方颗粒剂治疗原发性高血压的多中心、随机对照、非劣效性临床研究
- Clinical study of traditional Chinese medicine formula granules on multi-center, randomized controlled and non-inferiority of essential hypertension
- 上海中医药杂志 2015年49卷第10期页码：35-38
- 作者机构：
  
  1. 中国中医科学院西苑医院心血管科,北京,100091
  2. 北京市中西医结合医院脑病科,北京,100039
  3. 北京中医药大学附属第三医院心血管科,北京,100029
  4. 北京王府中西医结合医院内分泌科,北京,102209
  5. 北京市怀柔区中医院心血管科,北京,101400
  6. 北京按摩医院内科,北京,100035
  7. 北京市通州区中西医结合骨伤医院内科,北京,101100
  8. 北京市房山区中医医院内科,北京,102400
  9. 北京市宣武区中医院心血管科,北京,100053
  10. 中国中医科学院西苑医院临床药理研究所,北京,100091
- 作者简介：
- 基金信息：
  
  中国中医科学院优势病种资助项目(CACMS 08Y0024)
- DOI：
  中图分类号：
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衷敬柏, 冯学功, 鲁卫星, 等. 中药配方颗粒剂治疗原发性高血压的多中心、随机对照、非劣效性临床研究[J]. 上海中医药杂志, 2015,49(10):35-38.

ZHONG Jing-bai, FENG Xue-gong, LU Wei-xing, et al. Clinical study of traditional Chinese medicine formula granules on multi-center, randomized controlled and non-inferiority of essential hypertension[J]. Shanghai Journal of Traditional Chinese Medicine, 2015,49(10):35-38.
衷敬柏, 冯学功, 鲁卫星, 等. 中药配方颗粒剂治疗原发性高血压的多中心、随机对照、非劣效性临床研究[J]. 上海中医药杂志, 2015,49(10):35-38. DOI：

ZHONG Jing-bai, FENG Xue-gong, LU Wei-xing, et al. Clinical study of traditional Chinese medicine formula granules on multi-center, randomized controlled and non-inferiority of essential hypertension[J]. Shanghai Journal of Traditional Chinese Medicine, 2015,49(10):35-38. DOI：

摘要

目的：观察中药配方颗粒剂治疗1、2级原发性高血压的临床疗效方法：采用多中心区组随机对照的方法,将227例1、2级原发性高血压患者分为治疗组(116例)与对照组(111例)。治疗组予中药配方颗粒剂(复方黄芩汤或复方仙麦汤),对照组予中药饮片汤剂(复方黄芩汤或复方仙麦汤)。两组疗程均为1个月,观察血压值(SBP、DBP)、血压达标率、中医证候积分及用药安全性。脱落、剔除病例共26例。疗程4周,采用非劣效检验分析两组在诊室血压平均下降水平、血压达标率以及中医证候积分情况,以及不良事件发生的差异性结果：①试验期间,符合FAS集225例,其中治疗组115例,对照组110例；PPS集201例,其中治疗组99例,对照组102例。②在FAS与PPS集中,治疗前后组内比较,两组SBP与DBP水平差异均有统计学意义(P<0.05)；而组间SBP与DBP水平治疗前后差值比较,差异均无统计学意义(P>0.05),非劣效检验成立。③组间治疗后血压达标率比较,差异均无统计学意义(P>0.05)。④组间治疗后中医证候积分比较,差异均无统计学意义(P>0.05)。⑤组间不良反应发生率比较,差异均无统计学意义(P>0.05) 结论：中药配方颗粒剂治疗1、2级原发性高血压的疗效并不劣于传统中药饮片汤剂。

Abstract

Objective:To investigate the effect and safety of traditional Chinese medicine formula granules (FG) and Chinese Herbs Pieces (CHP) on grade 1-2 hypertension patients Methods:227 cases were divided into treatment group (116 cases) and control group (111 cases) , the cases in treatment group were treated with traditional Chinese medicine formula granules (Compound radix scutellariae Decoction or Compound Xianmai Decoction ) while the case of control group were treated with traditional Chinese medicine slice decoction(Compound radix scutellariae Decoction or Compound Xianmai Decoction ), 1 month for each group. SBP, DBP, rate of reaching blood pressure standard, TCM syndrome score and drug safety were observed. 26 cases were rejected. The course was 4 weeks. Clinic average decline in blood pressure, rate of reaching blood pressure standard, TCM syndrome score efficacy and difference of adverse events of the two groups were analyzed by the method of non-inferiority test Results:①During the test, there were 225 case accord with FAS and in which 115 case in treatment group and 110 cases in control group; there were 201 case accord to PPS and in which 99 case in treatment group and 102 case in control group. ②In FAS and PPS, compared in each group before and after the treatment, there were statistical significance in the differences of SBP and DBP(P<0.05), but there was no statistical significance in the differences of SBP and DBP between the two groups(P>0.05), and non-inferiority test was established . ③There was no statistical significance in the differences of rates of reaching blood pressure standard between the two groups(P>0.05). ④There was no statistical significance in the differences of TCM syndrome score between the two groups(P>0.05). ⑤There was no statistical significance in the differences of adverse events between the two groups(P>0.05) Conclusion:The effect of traditional Chinese medicine formula granules on grade 1-2 hypertension patients was not worse than that of traditional Chinese medicine slice decoction.

关键词

原发性高血压中药配方颗粒中药饮片复方黄芩汤复方仙麦汤

Keywords

essential hypertensionChinese medicine formula granulestraditional Chinese medicine slice decoctioncompound radix scutellariae decoctioncompound Xianmai decoction

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