血府逐瘀胶囊联合西地那非治疗先天性心脏病术后肺动脉高压的临床研究

Clinical Investigation on Xuefu Zhuyu Capsule Combined with Sildenafil for Treating Postoperative Residual Pulmonary Arterial Hypertension in Congenital Heart Disease

目的观察血府逐瘀胶囊联合西地那非治疗先天性心脏病术后肺动脉高压的疗效及安全性。方法选取2012年7月—2017年6月在湖南中医药大学第一附属医院心胸外科收治的左向右分流型先天性心脏病在外循环下行直视修补术(动脉导管未闭行动脉导管结扎术)后残留肺动脉高压的病人60例,随机分为对照组及试验组,每组30例。对照组在常规治疗基础上给予枸橼酸西地那非治疗,试验组在对照组的基础上给予血府逐瘀胶囊治疗,疗程为12周。观察两组病人治疗前后肺动脉压(SPAP)、心排血量(CO)、心脏指数(CI)、左心室射血分数(LVEF)、右心室直径(RVD)、血氧分压(PaO2)、N末端脑钠肽前体(NT-proBNP)、6 min步行距离(6WMD)、血红蛋白(Hb)、白细胞(WBC)、血小板(PLT)、丙氨酸氨基转移酶(ALT)、天冬氨酸氨基转移酶(AST)、尿素氮(BUN)、血肌酐(Cr)、国际标准化比值(INR)以及治疗期间临床不良反应发生情况。结果治疗前两组病人SPAP、CO、CI、LVEF、RVD、PaO2、NT-proBNP、6WMD比较差异无统计学意义(P>0.05);治疗后两组病人SPAP、CO、CI、LVEF、RVD、PaO2、NT-proBNP、6WMD均较治疗前明显改善(P<0.05);且治疗后试验组SPAP、CO、CI、LVEF、RVD、PaO2、NT-proBNP、6WMD较对照组改善更明显(P<0.05)。治疗前后两组病人Hb、WBC、PLT、ALT、AST、BUN、Cr、INR比较差异无统计学意义(P>0.05);两组病人不良反应发生率比较差异无统计学意义(P>0.05)。结论血府逐瘀胶囊联合西地那非治疗先天性心脏病术后肺动脉高压的疗效优于单用西地那非治疗。

Objective To observe the efficacy and safety of Xuefu Zhuyu capsule combined with Sildenafil for treating postoperative residual pulmonary arterial hypertension in congenital heart disease.Methods From July 2012 to June 2017,sixty patients with left-toright shunting congenital heart disease undergoing ductus arteriosus ligation who were existed residual pulmonary arterial hypertension were randomly divided into the control group and the test group,with 30 cases in each group.Patients in the control group received Sildenafil threapy,and patients in the test group were treated with sildenafil and Xuefu Zhuyu capsule for 12 weeks.The pulmonary artery pressure(SPAP),cardiac output(CO),cardiac index(CI),left ventricular ejection fraction(LVEF),right ventricular diameter(RVD),blood oxygen partial pressure(PaO2),NT-proBNP,6 minutes walking distance(6WMD),hemoglobin(Hb),white blood cells(WBC),platelet(PLT),alanine aminotransferase(ALT),aspertate aminotransferase(AST),urea nitrogen(BUN),creatinine(Cr),international standard ratio(INR)and clinical adverse reactions were observed in two groups before and after treatment.Results There was no statistical difference in SPAP,CO,CI,LVEF,RVD,PaO2,and NT-proBNP between two groups before treatment(P>0.05).The SPAP,CO,CI,EF,RVD,PaO2,and NT-proBNP in two groups improved significantly after treatment(P<0.05),and those in test group SPAP,CO,CI,EF,RVD,PaO2,and NT-proBNP improved significantly than those in control group after treatment(P<0.05).There was no statistical difference in Hb,WBC,PLT,ALT,AST,BUN,Cr,and INR before and after treatment(P>0.05).There was no significant difference in adverse reactions between two groups(P>0.05).Conclusion The therapy effect of Xuefu Zhuyu capsule combined with Sildenafil is better than Sildenafil alone in the treatment of postoperative residual pulmonary arterial hypertension in congenital heart disease.