CAJ | 학술논문

目的：评价益心舒胶囊治疗扩张型心肌病并慢性心力衰竭（DCM-CHF）患者的临床疗效。方法将120例DCM-CHF患者随机分为益心舒胶囊治疗组（A组，60例）和对照组（B组，60例），两组均采用标准的抗慢性心力衰竭药物治疗，包括利尿剂、洋地黄、血管紧张素转换酶抑制剂（ACEI）和血管紧张素II受体阻滞剂（ARB）、β受体阻滞剂及抗血小板聚集药等基础治疗。A组患者在标准的抗慢性心力衰竭药物治疗基础上加用益心舒胶囊（1.2g，每日3次口服）。对患者治疗前及治疗3月后进行心功能分级评定，采用6min步行距离评估患者的活动能力、利用心脏超声评价心脏射血分数、对患者进行生活质量评分，并对患者因心衰急性加重而住院治疗的入院率进行比较。结果经3月治疗后，两组患者的总有效率无统计学差异，但治疗组患者略高于对照组（81% vs 75.4%，P＞0.05）。两组患者治疗后心功能、活动能力、生活质量评分、心脏射血分数均较治疗前有明显改善，但加用益心舒胶囊治疗组患者的6min步行距离（530.6±105.8 vs 487.5±110.6，P＜0.05）及生活质量评分（11.5±12.4 vs 21.5±12.4，P<0.05）明显优于对照组，加用益心舒胶囊治疗组患者因心衰而住院的比率低于对照组（6.9% vs 14%，P＜0.05）。两组安全性指标比较无统计学差异。结论在标准的抗慢性心力衰竭药物治疗基础上加用益心舒胶囊有助于改善扩张型心肌病并慢性心力衰竭患者的活动能力，提高生活质量。
목적：평개익심서효낭치료확장형심기병병만성심력쇠갈（DCM-CHF）환자적림상료효。방법장120례DCM-CHF환자수궤분위익심서효낭치료조（A조，60례）화대조조（B조，60례），량조균채용표준적항만성심력쇠갈약물치료，포괄이뇨제、양지황、혈관긴장소전환매억제제（ACEI）화혈관긴장소II수체조체제（ARB）、β수체조체제급항혈소판취집약등기출치료。A조환자재표준적항만성심력쇠갈약물치료기출상가용익심서효낭（1.2g，매일3차구복）。대환자치료전급치료3월후진행심공능분급평정，채용6min보행거리평고환자적활동능력、이용심장초성평개심장사혈분수、대환자진행생활질량평분，병대환자인심쇠급성가중이주원치료적입원솔진행비교。결과경3월치료후，량조환자적총유효솔무통계학차이，단치료조환자략고우대조조（81% vs 75.4%，P＞0.05）。량조환자치료후심공능、활동능력、생활질량평분、심장사혈분수균교치료전유명현개선，단가용익심서효낭치료조환자적6min보행거리（530.6±105.8 vs 487.5±110.6，P＜0.05）급생활질량평분（11.5±12.4 vs 21.5±12.4，P<0.05）명현우우대조조，가용익심서효낭치료조환자인심쇠이주원적비솔저우대조조（6.9% vs 14%，P＜0.05）。량조안전성지표비교무통계학차이。결론재표준적항만성심력쇠갈약물치료기출상가용익심서효낭유조우개선확장형심기병병만성심력쇠갈환자적활동능력，제고생활질량。
Objective To evaluate the efficacy of Yixinshu Capsule on patients with dilated cardiomyopathy and chronic congestive heart failure.Methods 120 cases of patients with dilated cardiomyopathy and chronic congestive heart failure were divided randomly into 2 groups:Treatment Group (n=60),treated with routine anti-heart failure therapy(including diuretic agent,digitalis,angiotensin converting enzyme inhibitor,angiotensin II receptor blocker,β receptor blocker and platelet aggregation inhibitor) alone,and Treatment Group (n=60),treated with routine treatment plus Yixinshu capsule(1.2g/time,orally,3 times per day) for three months.The cardiac function was evaluated with NYHA functional class and left ventricular ejection fraction (LVEF) measured with ultrasonic cardiogram,exercise capacity was assessed with 6 minute walk test (6MWT),quality of life were evaluated using the Minnesota Living with Heart Failure Questionnaire (MLHFQ).Results After 3 months of therapy,the total effective rate in treatment group was superior to that in control group, but without significant difference (81%,75.4%,χ2=15.48,P>0.05). The cardiac function,exercise activity,scores of MLHFQ,LVEF were improved in the two groups,but the exercise capacity and the quality of life of the treatment group of patients were better than that of the control group(6MWT:530.6±105.8 vs 487.5±110.6,P<0.05;MLHFQ:11.5±12.4 vs 21.5±12.4,P<0.05).There were more patients in control group who needed to be in hospital than that in treatment group(6.9% vs 14%,P<0.05). Conclusion On the basis of routine anti-heart failure therapy,Yixinshu capsule makes for improving the exercise capacity and quality of life of patients with dilated cardiomyopathy combined with chronic congestive heart failure.