经皮心内膜注射携带肝细胞生长因子基因的腺病毒治疗梗死性心力衰竭的安全性和疗效：一项 2a 期临床试验。
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.
机构信息
Department of Cardiology, the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.
Department of Technological, MicroPort Medical Co. Ltd., Shanghai, China.
出版信息
Curr Gene Ther. 2018;18(2):125-130. doi: 10.2174/1566523218666180404162209.
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.
目的
我们之前的 I 期临床试验已经证实，经冠状动脉内给药的腺病毒携带肝细胞生长因子基因（Ad-HGF）治疗严重冠状动脉疾病是安全的。本研究旨在通过经皮心内膜注射评估 Ad-HGF 治疗心肌梗死后心力衰竭的安全性和疗效。
方法
共纳入 30 例（实验组 15 例，对照组 15 例）心肌梗死后心力衰竭患者，这些患者不适宜进行血运重建且已接受最佳标准化药物治疗。实验组通过基于导管的心肌内递送系统经皮心内膜注射 Ad-HGF 基因。在实验组中，测量安全性参数并与基线和随访时进行比较。在两组中测量从基线到 6 个月随访的疗效参数的平均差值（MD），并相互比较。
结果
在 6 个月的随访期间，实验组中没有人发生严重不良事件。实验组左心室舒张末期内径（LVDd）明显降低（68.5 对 65.8 MD：-2.69±1.08，P=0.03），且超声心动图（35.2 对 39.3，MD：4.05±0.86，P=0.0005）和单光子发射计算机断层扫描（27.7 对 30.6，MD：2.9±0.8，P=0.003）的 LVEF 均明显升高，而对照组则无变化（P>0.05）。与对照组相比，实验组的 LVDd 降低范围明显更大（2.6 对-2.69，MD：-5.3±1.4，P=0.0009），超声心动图 LVEF 升高范围更大（-2 对 4.05，MD：6.1±1.6，P=0.0008），从基线到 6 个月随访。
结论
经皮心内膜注射 Ad-HGF 治疗心肌梗死后心力衰竭安全有效，可提高 LVEF，降低 LVDd。
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