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作 者:杜学航 Du Xuehang(Shanghai Kaibao Pharmaceutical Co.,Ltd.,Shanghai 201401,China)
出 处:《江苏科技信息》2021年第20期64-70,共7页Jiangsu Science and Technology Information
基 金:上海市2018年度“科技创新行动计划”生物医药领域科技支撑项目,项目名称:“双翘感冒颗粒”Ⅱ期临床研究,项目编号:18401933200。
摘 要:目的:观察芪参胶囊治疗稳定型劳累性心绞痛(气虚血瘀证)的疗效。方法:将符合纳入标准的中医辨证为气虚血瘀症型患者240例随机分为对照组和试验组,各120例。对照组给予YXTJN 4粒/次,3次/日,口服;试验组给予芪参胶囊,3粒/次,芪参胶囊模拟剂,1粒/次,3次/日,口服。两组疗程均为6周。结果:(1)心绞痛症状疗效统计分析表明,结果实验组治疗总有效率为84.17%,明显高于对照组的55%,且治疗后实验组每周平均发作次数较对照组更少,每次持续时间更短(P<0.05)。(2)两组受试者治疗前后中医证候总积分表明,芪参胶囊治疗冠心病心绞痛能有效改善胸痹证候。(3)两组治疗后硝酸甘油用量较治疗前均减少,且硝酸甘油服用量在试验组下降值明显优于对照组。(4)西雅图心绞痛量表总分均有所增加,试验组增加值显著高于对照组。(5)安全性统计结果表明,试验组无严重不良事件。结论:芪参胶囊能减少心绞痛的发作次数和程度,改善胸痛、胸闷、心悸等症状,减少心绞痛的发作次数和程度,具有良好的治疗效果,并且安全性好。Objective:To observe the curative effect of Qishen Capsule in the treatment of stable fatigue angina pectoris(qi deficiency and blood stasis syndrome).Methods:240 patients with qi deficiency and blood stasis syndrome were randomly equally divided into control group and experimental group.The control group was given YXTJN four capsules/time,three times/day orally.The experimental group was given Qishen Capsule,three capsules/time and Qishen Capsule Simulant,one capsule/time,three times/day orally.The course of treatment was six weeks in both groups.Results:(1)Statistical analysis of curative effect on symptoms of angina pectoris showed that the total effective rate in the experimental group was 84.17%,which was significantly higher than that in the control group.After treatment,the average number of attacks in the experimental group was less than that in the control group,and the duration of each attack was shorter than that in the control group P<0.05.(2)The total score of TCM syndrome before and after treatment showed that Qishen Capsule could effectively improve the syndrome of chest obstruction in patients with angina pectoris.(3)After treatment,the dosage of nitroglycerin in both groups was lower than that before treatment.(4)The total score of Seattle Angina Pectoris Scale increased,and the increase value of the test group was significantly higher than that of the control group.(5)The safety statistics results showed that there were no serious adverse events in the trial group.Conclusion:Qishen Capsule can reduce the number and degree of angina pectoris,improve the symptoms of chest pain,chest distress,palpitation and so on,reduce the number and degree of angina pectoris.It has a good therapeutic effect and good safety.
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