本文選題：經(jīng)皮球囊肺動脈瓣成形術(shù) + 國產(chǎn)�。� 參考：《重慶醫(yī)科大學(xué)》2013年碩士論文

【摘要】：目的：通過與進口球囊擴張導(dǎo)管(CRISTAL BALLOON)行經(jīng)皮球囊肺動脈瓣成形術(shù)(percutaneous balloon pulmonary valvuloplasty，PBPV)治療兒童肺動脈瓣狹窄(pulmonary stenosis,PS)比較，評價國產(chǎn)心血管擴張球囊導(dǎo)管的臨床有效性和安全性。 方法：采用單盲對照分組方法選擇我院2012年2月~2013年2月預(yù)首次行PBPV的住院患兒，家長簽訂知情同意書后，按納入標準和排除標準篩選受試者共12例，隨機歸入試驗組和對照組各6例。試驗組采用徐州亞太科技有限公司研制的心血管擴張球囊導(dǎo)管，對照組采用法國進口BALT EXRUSION，Inc.生產(chǎn)的球囊擴張導(dǎo)管(CRISTAL BALLOON)，行PBPV。對比研究患兒術(shù)中/術(shù)后即刻治療效果(心導(dǎo)管造影檢查)，術(shù)前及術(shù)后1天、術(shù)后1、3、6月隨訪的觀察臨床癥狀、體征、心電圖、超聲心動圖檢查，術(shù)前、術(shù)后6個月的心臟X線胸片檢查及各期不良事件或其他并發(fā)癥等。 結(jié)果：兩組患兒治療前在PTG、年齡、身高、體重等差異無統(tǒng)計學(xué)意義(P0.05)。術(shù)前試驗組有2例合并房間隔缺損(atrial septaldefect,ASD)，其中1例需同時行ASD堵閉術(shù)，另1例有術(shù)前近期上呼吸道感染史，對照組有4例合并ASD，其中3例同時需行ASD堵閉術(shù)。PBPV術(shù)中兩組患兒肺動脈瓣瓣環(huán)直徑、球囊型號、球瓣比、手術(shù)操作時間無統(tǒng)計學(xué)顯著差異(P0.05),擴瓣后試驗組肺動脈收縮壓(pulmonary artery pressure,PAP)由(24.17±4.40)mmHg上升到(26.00±4.73)mmHg，右心室收縮壓(right ventricular pressure，RVP)及PTG分別由(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，對照組PAP由(23.00±3.46)mmHg上升到(23.33±2.25)mmHg，RVP及PTG分別由(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。術(shù)后試驗組因有1例反應(yīng)性右室流出道狹窄(rightventricular outflow tract obstruction, RVOTO)，對照組4例可疑反應(yīng)性RVOTO，給予普萘洛爾(0.5~1.0mg/kg·d)，分二至三次口服，持續(xù)6月。兩組患兒均進行了門診及電話隨訪，臨床癥狀均得到有效緩解，心臟雜音減輕，身高體重與各自同齡兒童相比的差距減小。所有患兒術(shù)后1天，術(shù)后1，3，6月壓差較術(shù)前均有明顯下降，差異有統(tǒng)計學(xué)意義(P0.05)，雖然兩組壓差下降趨勢存在一定差異，但兩組間每個時段的壓差相比差距無統(tǒng)計學(xué)意義(P0.1)。兩組患兒各隨訪時段的平均右室內(nèi)徑無統(tǒng)計學(xué)差異(P0.1)，在短時間內(nèi)均有不同程度的下降(P0.05)。術(shù)后1天復(fù)查心臟彩超示肺動脈瓣反流(pulmonary regurgitaion，PR)及三尖瓣反流(tricuspid regurgitation，TR)情況較術(shù)前略有加重，但均在中度及以下，在之后隨訪過程中，兩組反流情況均有改善，術(shù)后3月較為明顯，兩組差異無統(tǒng)計學(xué)意義(P0.1)。兩組患兒術(shù)后6月心胸比率(cardiothoracic ratio，CR)較術(shù)前均有下降，其中對照組兩個時段的差異有統(tǒng)計學(xué)意義，而試驗組不明顯，兩個時段兩組患兒間的差異無統(tǒng)計學(xué)意義(P0.1)，兩組患兒“肺少血”的情況均得到解除。 結(jié)論：國產(chǎn)心血管擴張球囊導(dǎo)管治療兒童肺動脈瓣狹窄安全有效，，與進口球囊比較，價格更低，型號更多，值得推廣應(yīng)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.

【學(xué)位授予單位】：重慶醫(yī)科大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2013
【分類號】：R725.4

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