摘要
目的:我们上一阶段的临床试验证实了携带肝细胞生长因子基因(Ad-hGF)的腺病毒在冠状动脉内治疗中的安全性。Y病。本研究旨在评价经皮心内膜注射治疗急性心肌梗死后心力衰竭的安全性和有效性。 方法:30例心肌梗死后心力衰竭患者(实验组15例,对照组15例)。该研究包括心源性药物治疗。实验组采用经皮心内膜Ad-HGF基因转移技术,采用导管为基础的心肌内给药系统。安全观察组测量Y参数,并与随访结果进行比较.在bo中测量了基线到6个月随访期间的疗效参数的平均差异(Md)。TH组与对照组进行比较。 结果:实验组在6个月随访期间未发生严重不良事件.实验组左室舒张末期内径明显降低。(LVDd)(68.5 vs 65.8MD:-2.69±1.08,P=0.03),超声心动图左室射血分数(35.2 vs 39.3,MD:4.05±0.86,P=0.0005)和单光子发射计算机断层显像(27.7比30.6,MD:2.9±0)。8,P=0.003)随访6个月,与基线比较,对照组无显着性差异(P>0.003)。与对照组相比,实验组的l值有明显的改善幅度。术后随访6个月,左室舒张末期(2.6vs.2.69,MD:-5.3±1.4,P=0.0009)和超声心动图左室射血分数(-2vs.4.05,MD:6.1±1.6,P=0.0008)。 结论:经皮心内膜注射Ad-HGF对改善心肌梗死后心力衰竭患者的左室射血分数、降低左室舒张功能有潜在的疗效。
关键词: 基因治疗,肝细胞生长因子,梗死后心力衰竭,经皮心内膜注射,Ad-HGF,超声心动图。
Current Gene Therapy
Title:Safety and Efficacy of Adenovirus Carrying Hepatocyte Growth Factor Gene by Percutaneous Endocardial Injection for Treating Post-infarct Heart Failure: A Phase IIa Clinical Trial
Volume: 18 Issue: 2
关键词: 基因治疗,肝细胞生长因子,梗死后心力衰竭,经皮心内膜注射,Ad-HGF,超声心动图。
摘要: Objective: Our previous phase I clinical trial has confirmed the safety of Adenovirus carrying Hepatocyte Growth Factor gene (Ad-HGF) by intracoronary administration for treating severe coronary artery disease. This study was performed to evaluate the safety and efficacy of Ad-HGF by percutaneous endocardial injection for treating post-infarct heart failure.
Methods: A total of 30 patients (15 in the experimental group and 15 in the control group) with postinfarct heart failure who were not indicated to revascularization and had received the optimal standardized medication therapy were included in the study. Percutaneous endocardial Ad-HGF gene transfer was injected with a catheter-based intramyocardial delivery system in the experimental group. Safety parameters were measured and compared between baseline and follow-ups in the experimental group. The Mean Difference (MD) of efficacy parameters from baseline to 6-month follow-up was measured in both groups and compared with each other.
Results: No one suffered from serious adverse events in the experimental group during the 6-month follow-up. The experimental group revealed significant lower left ventricular end-diastolic dimension (LVDd) (68.5 vs. 65.8 MD: -2.69±1.08, P=0.03) and higher LVEF of both echocardiograph (35.2 vs. 39.3, MD: 4.05±0.86, P=0.0005) and single photon emission computed tomography (27.7 vs. 30.6, MD: 2.9±0.8, P=0.003) in the 6-month follow-up than that in the baseline, but the control group did not (P>0.05). Compared to the control group, the experimental group showed significant improvement ranges of lower LVDd (2.6 vs. -2.69, MD: -5.3±1.4, P=0.0009) and higher echocardiographic LVEF (-2 vs. 4.05, MD: 6.1±1.6, P=0.0008) from baseline to 6-month follow-up.
Conclusion: Percutaneous endocardial administration of Ad-HGF is safe and potentially efficient in improving LVEF and lowering LVDd of patients with post-infarct heart failure.
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Safety and Efficacy of Adenovirus Carrying Hepatocyte Growth Factor Gene by Percutaneous Endocardial Injection for Treating Post-infarct Heart Failure: A Phase IIa Clinical Trial, Current Gene Therapy 2018; 18 (2) . https://dx.doi.org/10.2174/1566523218666180404162209
DOI https://dx.doi.org/10.2174/1566523218666180404162209 |
Print ISSN 1566-5232 |
Publisher Name Bentham Science Publisher |
Online ISSN 1875-5631 |
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