潜阳活血膏辅助治疗高血压病血瘀阳亢证临床研究

Clinical study of Qianyang Huoxue Ointment in the adjuvant treatment of hypertension patients with blood-stasis yang hyperactivity

目的评价潜阳活血膏辅助治疗高血压病血瘀阳亢证临床疗效。方法将符合入选标准的2020年1月-2021年6月中国科学技术大学附属第一医院60例高血压病血瘀阳亢证患者,按随机数字表法分为2组,每组30例。对照组给予西医常规降压治疗,观察组在对照组基础上服用潜阳活血膏。2组均连续治疗28 d。分别于治疗前后进行中医症状评分,行24 h动态血压监测;分别于治疗前及治疗后7、14、28 d测量诊室血压,记录治疗期间的不良反应,评价临床疗效及中医证候疗效。结果观察组临床总有效率为93.3%(28/30)、对照组为70.0%(21/30),2组比较差异有统计学意义(χ^(2)=5.46,P=0.020);观察组中医证候疗效总有效率为90.0%(27/30)、对照组为66.7%(20/30),2组比较差异有统计学意义(χ^(2)=4.81,P=0.028)。观察组治疗后眩晕、头痛、五心烦热、失眠、耳鸣、健忘、腰膝酸软评分及总评分均低于对照组(t值分别为5.77、7.02、6.97、6.31、6.23、7.49、9.60、8.16,P值<0.01)。观察组治疗后7、14、28 d收缩压、舒张压水平均低于对照组(F值分别为99.18、49.32,P值均<0.001)。观察组治疗后24 h动态血压中清晨收缩压[(143.91±5.04)mmHg比(149.18±4.93)mmHg,t=4.09]、舒张压[(92.35±2.98)mmHg比(95.66±2.97)mmHg,t=4.31]水平低于对照组(P<0.01)。2组治疗期间未见明显不良反应。结论在西医常规治疗基础上服用潜阳活血膏可改善高血压病血瘀阳亢证患者的临床症状,有效控制血压,提高临床疗效。

Objective To evaluate the effect of Qianyang Huoxue Ointment in the adjuvant treatment of patients with hypertension and blood-stasis yang hyperactivity.Methods According to random number table method,60 patients with hypertension of blood-stasis yang hyperactivity in The First Affiliated Hospital of University of Science and Technology of China were divided into two groups between January 2020 and June 2021,30 in each group.The control group was given routine anti-hypertension therapy,while observation group was treated with Qianyang Huoxue Ointment on basis of control group.All patients were continuously treated for 28 d.Before and after treatment,TCM symptoms were scored.24h ambulatory blood pressure were recorded.The blood pressure was measured before treatment and at 7,14 and 28 d after treatment.Adverse events during treatment were recorded.Clinical efficacy and efficacy on TCM syndromes were evaluated.Results The differences in total clinical response rate between observation group and control group were statistically significant[93.3%(28/30)vs.70.0%(21/30),χ^(2)=5.46,P=0.020],and differences in total response rate of efficacy on TCM syndromes between observation group and control group were statistically significant[90.0%(27/30)vs.66.7%(20/30),χ^(2)=4.81,P=0.028].After treatment,scores of TCM syndromes(dizziness,headache,burning sensation,insomnia,tinnitus,forgetfulness,soreness and weakness of waist and knees)and total score in observation group were significantly lower than those in the control group(t=5.77,7.02,6.97,6.31,6.23,7.49,9.60,8.16,P<0.01).At 7,14 and 28 d after treatment,levels of systolic blood pressure and diastolic blood pressure in observation group were significantly lower than those in the control group(F=99.18,49.32,P<0.001).At 24 hour after treatment,levels of systolic blood pressure[(143.91±5.04)mmHg vs.(149.18±4.93)mmHg,t=4.09]and diastolic blood pressure[(92.35±2.98)mmHg vs.(95.66±2.97)mmHg,t=4.31]in observation group were significantly lower than those in the control group(P<0.01).There were no significant adverse events between both groups.Conclusion The application of Qianyang Huoxue Ointment on basis of routine western medicine can improve clinical symptoms,control blood pressure level and improve clinical efficacy in the patients with hypertension of blood-stasis yang hyperactivity.