国产GK双叶瓣的临床应用研究_临床医学论文.docVIP

国产GK双叶瓣的临床应用研究_临床医学论文 国产GK双叶瓣的临床应用研究_临床医学论文 【摘要】 目的 观察和评价国产GK型双叶式人工心脏瓣膜（GK双叶瓣）植入人体后的早期临床疗效和近期随访结果。方法 对61例心脏瓣膜病变患者行人工心脏瓣膜置换手术，其中二尖瓣置换术（MVR）34例，主动脉瓣置换术（AVR）16例，二尖瓣及主动脉瓣双瓣置换术（MVR+AVR）11例。共植入GK双叶瓣72枚，其中二尖瓣45枚，主动脉瓣27枚。术后监测血液相容性和血流动力学指标，并定期随访和检查是否有与瓣膜相关的并发症发生。同期选取进口瓣膜（Edward双叶瓣）对照组，在相同条件下，换瓣病人在监护室住院时间、术后住院时间、使用升压药物时间、平均住院费用、术后机械故障发生率，术后心功能恢复程度构成比方面进行对比两者的质量差异。结果 GK双叶瓣组无手术死亡（术后30天内）；随访61例，随访1年至2年6个月，远期因外伤死亡1例；61患者术后心功能均从Ⅲ～Ⅳ级提高为Ⅰ～Ⅱ级，血流动力学性能及血液相容性良好，生活质量改善。GK双叶瓣与进口Edward双叶瓣病人在监护室住院时间、术后住院时间及使用升压药时间差异均无显著性，而在平均住院费用上，国产瓣膜组则明显低于进口瓣膜组，两组术后随诊期内均未发生机械瓣故障，同期术后心功能恢复程度构成比也无明显差别。 结论 北京思达医用装置有限公司生产的GK双叶瓣在故障发生率，近、中期疗效判定上，与进口双叶瓣间无明显差别。早期临床应用获得了满意的效果，中、远期结果有待进一步随访观察。因其在住院医疗费用上则显著低于进口瓣膜。故在现阶段，就我国经济状况而言，GK双叶瓣可作为一种安全、可靠、物美、价廉的理想选择。 【关键词】 人工心脏瓣膜； 心脏瓣膜假体植入； 比较 【Abstract】 Objective To introduce a new type of bilobed flap mechanical prosthetic heart valve （GK bilobed flap valve） and evaluate clinically the early hemodynamic effect and short term follow-up after its replacement.Methods Sixty-one patients with heart diseases were operated upon. The mitral valve replacement was performed in 34 patients，aortic valve replacement in 16 patients and double valve replacement in 11 patients. A total of 72 GK bilobed flap mechanical valve were implanted. There were 45 in mitral position and 27 in aortic position. Blood consistency and hemodynamics were monitored. Follow-up was carried out routinely to check whether there were valve-related complications. Meanwhile，in the same condition，20 patients with heart valve disease were performed on heart valve replacement with native GK-double-leaflet mechanical heart. Their postoperative outcome was compared with another 20 patients who underwent heart valve replacement with Edward-double-leaflet ones in their ICU stay，hospital stay，after operation and assistant time of hypertension drug.Results There was no early mortality （lt;30d）. Only one patient died of trauma 2 months after the operation. Follow-up was 100% and extended 1 to 2.5 years. Without valve-relat