| 彭煜暄;李洪峥;黄明艳;廖飞飞;任成欢;龙霖梓;曲 华;付长庚;彭 军;陈可冀.清达颗粒干预不同焦虑水平1级高血压病随机对照研究[J].中国中西医结合杂志,2023,43(11):1291-1296 |
| 清达颗粒干预不同焦虑水平1级高血压病随机对照研究 |
| Effect of Qingda Granules in Treating Grade 1 Hypertension Patients with Different Levels of Anxiety： A Randomized Controlled Trial |
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| DOI：10.7661/j.cjim.20230827.057 |
| 中文关键词: 清达颗粒 高血压病 焦虑 汉密尔顿焦虑量表 随机对照试验 |
| 英文关键词:Qingda Granules hypertension anxiety Hamilton Anxiety Rating Scale randomized controlled trial |
| 基金项目:国家自然科学基金联合基金项目（No.U22A20372）;第五批全国中医临床优秀人才研修项目（No.020600008） |
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| 中文摘要: |
| 目的 评价清达颗粒对不同焦虑水平的1级高血压病患者的诊室血压及焦虑评分干预效果。方法 本研究已在中国临床试验注册中心注册（No. ChiCTR2000033890）。采用多中心、随机、双盲、非劣效临床试验设计，将552例1级高血压病患者随机分为试验组（276例）和对照组（276例）。治疗组给予清达颗粒加缬沙坦胶囊模拟剂，对照组给予缬沙坦胶囊加清达颗粒模拟剂，疗程4周，停药后随访4周。观察两组患者治疗前后的诊室血压及汉密尔顿焦虑量表（HAMA）评分变化。结果 最终纳入分析468例，其中治疗组231例和对照组237例。治疗4周后，治疗组内HAMA评分7分的患者收缩压和脉压差的降幅明显高于HAMA评分＜7分的患者（P＜0.05）。治疗组与对照组同期比较，相同焦虑水平患者的血压降幅差异无统计学意义（P>0.05）。与本组治疗前比较，治疗4周末及停药4周末两组HAMA评分均降低（P＜0.05），两组间比较，差异无统计学意义（P>0.05）。结论 清达颗粒在改善不同焦虑水平1级高血压患者的诊室血压及焦虑评分方面疗效不劣于缬沙坦胶囊。 |
| 英文摘要: |
| Objective To evaluate the effects of Qingda Granules （QDG） on office blood pressure （OBP） and the anxiety score in patients with grade 1 hypertension with different levels of anxiety. Methods This study was registered in the Chinese Clinical Trial Registry （No. ChiCTR2000033890）. A randomized， multicenter， double-blinded， non-inferiority clinical trial design was adopted. A total of 552 patients with grade 1 hypertension were randomly assigned to the treatment group（276 cases） and the control group（276 cases）. The treatment group was administered with QDG and valsartan capsule simulation agent， while the control group was treated with valsartan capsules and QDG simulation agent. The duration of treatment was 4 weeks， which was followed by 4 weeks of observation. The change of OBP and Hamilton Anxiety Rating Scale （HAMA）scores were observed before and after treatment in the two groups. Results Final recruited qualified patients were 468， including 231 cases in the treatment and 237 cases in control group. In the treatment group， systolic blood pressure and the pulse pressure difference were significantly higher for the patients with HAMA scores of7 than for those with HAMA scores of ＜7 after 4 weeks of treatment （P＜0.05）. There was no significant difference in the blood pressure reductions of the patients in the treatment and control groups with the same levels of anxiety over the same period （P>0.05）. Compared with basline， the HAMA scores decreased at 4 and 8 weeks after treatment in the two groups （P＜0.05）， but with no significant difference between the two groups （P>0.05）. Conclusion The effects of QDG on OBP and anxiety in patients with grade 1 hypertension with different anxiety levels appear non-inferior to those of valsartan capsules.
（ClinicalTrials.gov Registry，No.NCT03444896） |
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