波生坦联合西地那非治疗先天性心脏病合并肺动脉高压患儿的临床疗效及安全性评价

目的：探讨波生坦联合西地那非治疗先天性心脏病合并肺动脉高压患儿的临床疗效及不良反应发生情况。方法：选择2015年1月到2016年1月某院收治的90例先天性心脏病合并肺动脉高压患儿，随机分为对照组和试验组，各45例。对照组患儿给予西地那非治疗，试验组患儿给予波生坦联合西地那非治疗，两组患儿均治疗3个月。评价并比较两组患儿的临床疗效。检测并比较两组患儿治疗前后WHO肺动脉高压功能分级。采用右心导管检测测量并比较两组患儿治疗前后平均肺动脉压（mPAP）和肺血管阻力（PVR）。观察并比较两组患儿治疗期间不良反应的发生情况。结果：治疗后，试验组患儿的总有效率为95.56%，明显高于对照组患儿的73.33%，差异具有统计学意义（χ²=8.46，P=0.003 6）。治疗前，两组WHO肺动脉高压功能分级比较差异无统计学意义（P>0.05）；治疗后，两组WHO肺动脉高压功能Ⅱ级患儿均明显多于治疗前，WHO肺动脉高压功能Ⅲ级、Ⅳ级患儿均明显少于治疗前，差异均具有统计学意义（P<0.05），同时试验组WHO肺动脉高压功能Ⅱ级患儿均明显多于对照组，WHO肺动脉高压功能Ⅲ级、Ⅳ级患儿均明显少于对照组，差异均具有统计学意义（P<0.05）。治疗前，两组患儿的mPAP、PVR比较，差异均无统计学意义（P>0.05）；治疗后，两组患儿的mPAP、PVR均明显小于治疗前，并且试验组患儿的mPAP、PVR均明显小于对照组，差异均具有统计学意义（P<0.05）。治疗期间，两组患儿的不良反应发生率比较，差异无统计学意义（χ²=1.01，P=0.908）。结论：波生坦联合西地那非治疗先天性心脏病合并肺动脉高压患儿临床疗效显著，且安全性较好，值得在临床上推广应用。

Clinical efficacy and safety of bosentan combined with sildenafil in pediatric patients with pulmonary artery hypertension and congenital heart disease

OBJECTIVE To study the clinical efficacy and safety of bosentan combined with sildenafil in pediatric patients with pulmonary artery hypertension and congenital heart disease. METHODS Ninety patients with pulmonary artery hypertension and congenital heart disease were enrolled in this study in a hospital from January 2015 to January 2016. The subjects were divided into control group (n=45) and treatment group (n=45) randomly. Patients in control group were treated with sildenafil, those in treatment group were treated with bosentan combined with sildenafil. All patients were treated for three months. The clinical efficacy was compared between two groups. WHO pulmonary hypertension function class, mean pulmonary arterial pressure (mPAP) and pulmonary vascular resistance (PVR) were compared between two groups before and after treatment. The adverse reactions during the treatment were compared between two groups. RESULTS The total effective rate was 95.56% in treatment group, significantly higher than 73.33% of the control group (χ²=8.46, P=0.003 6). No significant difference was observed in WHO pulmonary hypertension function class between the two groups before treatment (P>0.05). After treatment, patients with WHO Ⅱ level were significantly increased, patients with WHO Ⅲ and Ⅳ levels were significantly decreased in both groups, particularly significant in the treatment group (P<0.05). No significant difference was found in mPAP and PVR between two groups before treatment (P>0.05). After treatment, the mPAP and PVR were significantly decreased in both groups, but more obviously in treatment group than that of the control group (P<0.05). During the treatment, no significant difference was observed in the incidence of adverse reactions between the two groups (χ²=1.01, P=0.908). CONCLUSION Bosentan combined with sildenafil has good clinical efficacy and safety in pediatric patients with pulmonary artery hypertension and congenital heart disease, and this combination is worthy of clinical application.