国产与进口球囊治疗儿童肺动脉瓣狭窄的临床对比研究

发布时间：2018-05-08 17:31

本文选题：经皮球囊肺动脉瓣成形术 + 国产　；参考：《重庆医科大学》2013年硕士论文

【摘要】：目的：通过与进口球囊扩张导管(CRISTAL BALLOON)行经皮球囊肺动脉瓣成形术(percutaneous balloon pulmonary valvuloplasty，PBPV)治疗儿童肺动脉瓣狭窄(pulmonary stenosis,PS)比较，评价国产心血管扩张球囊导管的临床有效性和安全性。方法：采用单盲对照分组方法选择我院2012年2月~2013年2月预首次行PBPV的住院患儿，家长签订知情同意书后，按纳入标准和排除标准筛选受试者共12例，随机归入试验组和对照组各6例。试验组采用徐州亚太科技有限公司研制的心血管扩张球囊导管，对照组采用法国进口BALT EXRUSION，Inc.生产的球囊扩张导管(CRISTAL BALLOON)，行PBPV。对比研究患儿术中/术后即刻治疗效果(心导管造影检查)，术前及术后1天、术后1、3、6月随访的观察临床症状、体征、心电图、超声心动图检查，术前、术后6个月的心脏X线胸片检查及各期不良事件或其他并发症等。结果：两组患儿治疗前在PTG、年龄、身高、体重等差异无统计学意义(P0.05)。术前试验组有2例合并房间隔缺损(atrial septaldefect,ASD)，其中1例需同时行ASD堵闭术，另1例有术前近期上呼吸道感染史，对照组有4例合并ASD，其中3例同时需行ASD堵闭术。PBPV术中两组患儿肺动脉瓣瓣环直径、球囊型号、球瓣比、手术操作时间无统计学显著差异(P0.05),扩瓣后试验组肺动脉收缩压(pulmonary artery pressure,PAP)由(24.17±4.40)mmHg上升到(26.00±4.73)mmHg，右心室收缩压(right ventricular pressure，RVP)及PTG分别由(92.00±45.07)mmHg和(67.83±43.92)mmHg下降到(52.00±22.32)mmHg和(26.00±22.88)mmHg，对照组PAP由(23.00±3.46)mmHg上升到(23.33±2.25)mmHg，RVP及PTG分别由(71.67±24.73)mmHg和(48.67±24.38)mmHg下降到(36.33±6.86)mmHg和(13.0±5.18)mmHg。术后试验组因有1例反应性右室流出道狭窄(rightventricular outflow tract obstruction, RVOTO)，对照组4例可疑反应性RVOTO，给予普萘洛尔(0.5~1.0mg/kg·d)，分二至三次口服，持续6月。两组患儿均进行了门诊及电话随访，临床症状均得到有效缓解，心脏杂音减轻，身高体重与各自同龄儿童相比的差距减小。所有患儿术后1天，术后1，3，6月压差较术前均有明显下降，差异有统计学意义(P0.05)，虽然两组压差下降趋势存在一定差异，但两组间每个时段的压差相比差距无统计学意义(P0.1)。两组患儿各随访时段的平均右室内径无统计学差异(P0.1)，在短时间内均有不同程度的下降(P0.05)。术后1天复查心脏彩超示肺动脉瓣反流(pulmonary regurgitaion，PR)及三尖瓣反流(tricuspid regurgitation，TR)情况较术前略有加重，但均在中度及以下，在之后随访过程中，两组反流情况均有改善，术后3月较为明显，两组差异无统计学意义(P0.1)。两组患儿术后6月心胸比率(cardiothoracic ratio，CR)较术前均有下降，其中对照组两个时段的差异有统计学意义，而试验组不明显，两个时段两组患儿间的差异无统计学意义(P0.1)，两组患儿“肺少血”的情况均得到解除。结论：国产心血管扩张球囊导管治疗儿童肺动脉瓣狭窄安全有效，，与进口球囊比较，价格更低，型号更多，值得推广应用。
[Abstract]:Objective: To evaluate the clinical efficacy and safety of domestic vascular dilatation balloon catheter (CRISTAL BALLOON) by comparing with percutaneous balloon pulmonary valvuloplasty (PBPV) in the treatment of pulmonary stenosis (pulmonary stenosis, PS) in children.
Methods: a single blind control group was used to select the first PBPV hospitalized children in our hospital in February ~2013 February 2012. After the parents signed the informed consent book, 12 cases were selected according to the inclusion criteria and the exclusion criteria, and 6 cases were randomly assigned to the experimental group and the control group. The experimental group adopted the cardiovascular expansion developed by Xuzhou Asia Pacific Science and technology limited company. The balloon catheter was used in the control group. The control group adopted the balloon dilatation catheter (CRISTAL BALLOON) produced by BALT EXRUSION and Inc. in the control group. The immediate treatment effect (cardiac catheterization) was performed by PBPV. in children. The clinical symptoms, signs, electrocardiogram, echocardiography, preoperative, and preoperative follow-up were observed before and 1 days after the operation. Chest X-ray examination and adverse events or other complications after 6 months.
Results: there was no significant difference in PTG, age, height and weight before treatment in the two groups (P0.05). There were 2 cases with atrial septal defect (atrial septaldefect, ASD) in the pre operation group, of which 1 cases had ASD occlusion at the same time, the other 1 had a history of preoperative upper respiratory infection, and 4 cases with ASD in the control group, 3 of them needed ASD closure at the same time. There was no significant difference in the diameter of pulmonary valve rings in the two groups of.PBPV, and there was no statistically significant difference between the balloon type, the ball valve ratio and the operation time (P0.05). The pulmonary systolic pressure (pulmonary artery pressure, PAP) in the experimental group increased from (24.17 + 4.40) mmHg to (26 + 4.73) mmHg, and the right ventricular systolic pressure (right ventricular pressure, RVP) and the score were divided. The (92 + 45.07) mmHg and (67.83 + 43.92) mmHg decreased to (52 + 22.32) mmHg and (26 + 22.88) mmHg, and the control group increased from (23 + 3.46) mmHg to (23.33 + 2.25) mmHg, RVP and PTG decreased from (71.67 +%) mmHg and mmHg to mmHg and (22.32) mmHg. Rightventricular outflow tract obstruction (RVOTO), 4 cases of suspicious reactive RVOTO in the control group, were given propranolol (0.5~1.0mg/kg. D), from two to three times, for June. All two groups of children were followed up by outpatient and telephone, the clinical symptoms were effectively relieved, heart murmur reduced, height and weight and their children of the same age. The difference was decreased at 1 days after operation, and the difference was statistically significant (P0.05) at the 1 day after operation. Although there was a significant difference between the two groups, there was no difference in the difference of pressure between the two groups at each period (P0.1). The average right ventricular diameter in the two groups of children was not unified. The study difference (P0.1) was reduced in a short time (P0.05). 1 days after the operation, the cases of pulmonary regurgitaion (PR) and three apex regurgitation (tricuspid regurgitation, TR) were rechecked slightly more than before the operation, but both of them were in the middle degree and below. In the follow-up process, the two groups of reflux were improved. In March, the two groups had no statistical significance (P0.1). The rate of cardiothoracic ratio (CR) in the two groups was lower than that before the operation, and the difference between the two periods of the control group was statistically significant, but the experimental group was not significant, and there was no significant difference between the two groups of children in the two periods (P0.1), and the two group of children "lung" The condition of less blood was relieved.
Conclusion: the domestic balloon catheter in the treatment of pulmonary stenosis in children is safe and effective. Compared with the imported balloon, the cost is lower and the model is more type. It is worth popularizing.

【学位授予单位】：重庆医科大学
【学位级别】：硕士
【学位授予年份】：2013
【分类号】：R725.4

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