世界中医药

目的：探讨益心舒胶囊联合富马酸比索洛尔(Bisoprolol fumarate，BIS)的中西药联合药物方案治疗肥厚型心肌病、有临床症状/体征患者的临床价值。方法：选取2013年1月至2017年12月北京潞河医院收治的确诊为肥厚型心肌病、有临床症状/体征（中医辨证为气血痹阻型）患者160例作为研究对象，按就诊顺序随机分为对照组和观察组，每组80例。对照组应用BIS治疗，观察组应用BIS+益心舒胶囊治疗。疗程均为1个月。观察2组患者治疗前后心功能指标（左室舒张末期压、左室流出道压力阶差）、NYHA心功能分级、自觉症状、生命质量的改善情况，以及临床总疗效。结果：1）2组总有效率分别是9643%和7857%，2组比较差异有统计学意义(χ2=3840,P=0045)。2）治疗后2组左室舒张末期压、左室流出道压力阶差及心功能分级均较其治疗前明显改善（P<005）。观察组左室舒张末期压（t=9048,P=0000）、左室流出道压力阶差（t=3345,P=0001）、心功能分级（t=4637,P=0000）的改善均较对照组明显。3）治疗后2组患者的自觉症状、生命质量均较治疗前明显改善（均P<005）。2组间治疗后自觉症状（t=24199，P=0000）、生命质量评分（t=8627,P=0000）比较，差异均有统计学意义（均P<005）。4）治疗用药期间2组均未出现与药物相关的不良反应。观察组异常心率减慢出现2例（225%，2/80），对照组出现9例（1011%，9/80），2组不良反应发生率的比较，差异有统计学意义（χ2=7320，P=0007）。结论：益心舒胶囊联合BIS的中西药联合药物方案治疗肥厚型心肌病患者可以获得更为理想的临床效果，患者的自觉症状和生命质量的改善更为显著，且心功能指标的改善更佳。

English Summary:

To explore the clinical value of Yixinshu capsule combined with Bisoprolol fumarate in the treatment of hypertrophic cardiomyopathy on patients with clinical symptoms/signs.Methods:From January 2013 to December 2017，160 patients with hypertrophic cardiomyopathy and clinical symptoms/signs(qi-blood obstruction syndrome)were enrolled in Luhe Hospital of Beijing for clinical observation.All the patients were divided into 2 groups according to the order of visiting，the control group(80 cases)and the observation group(80 cases).The control group was treated with BIS，and the observation group was treated with BIS+Yixinshu capsule.The course of treatment was 1 month.The changes of left ventricular end-diastolic pressure，left ventricular outflow tract pressure gradient and NYHA cardiac function grading，the improvement of patients' conscious symptoms and quality of life，and the overall clinical efficacy(total effective rate)before and after treatment were investigated.Results:1)After treatment，the total effective rates of the 2 groups were 9643% and 7857%，respectively.The observation group had a higher total effective rate(χ2=3840，P=0045).2)After treatment，left ventricular end-diastolic pressure，left ventricular outflow tract pressure gradient and cardiac function grading in both groups were significantly improved compared with those before treatment(P<005).The improvement of left ventricular end-diastolic pressure(t=9048，P=0000)，left ventricular outflow tract pressure gradient(t=3345，P=0001)and cardiac function classification(t=4637，P=0000)in the observation group were more significant than those in the control group.3)After treatment，the 2 groups of patients had significant improvement compared with before treatment(P<005).There were significant differences in conscious symptoms(t=24199，P=0000)and quality of life(t=8627，P=0000)between the 2 groups.4)Heart rate slowed down in 2 cases(225%，2/80)in the observation group and 9 cases(1011%，9/80)in the control group.There was a significant difference in the incidence of adverse reactions between the 2 groups(χ2=7320，P=0007).Conclusion:Yixinshu capsule combined with BIS combined with traditional Chinese and Western medicine can achieve better clinical effects in patients with hypertrophic cardiomyopathy.The improvement of patients' conscious symptoms and quality of life is more significant，and the improvement of cardiac function index is better.

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