Clinical study of hepatocyte growth factor in the treatment of diabetic lower limb arteriosclerosis obliterans

Ling Zhang, Zhixiang Su, Yongquan Gu, S. Cui, Lianrui Guo, Jian-ming Guo
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Abstract

OBJECTIVE: The objective of this study was to investigate the safety and efficacy of hepatocyte growth factor (HGF) gene therapy in the patients with diabetic lower limb arteriosclerosis obliterans, provide theoretical support for better coordination of clinical operation and anesthesia, ensure medical safety, and improve the quality of nursing. MATERIALS AND METHODS: Twenty-one patients with Grade 4–6 (Rutherford classification) and limb ischemia who met the inclusion criteria were divided into four dose groups, including three cases in the 4 mg group, six cases in the 8 mg group, five cases in the 12 mg group, and seven cases in the 16 mg group. The dosage of each group was divided into equal doses, which were injected intramuscularly on the 1st and 15th days of treatment, respectively. The dosage of each injection point was 0.25 mg/0.5 ml. Adverse reactions, visual analog scale (VAS) scores for pain and ulcer healing were observed on the 1st, 8th, 15th, 21st, 28th, 59th, and 91st days after the treatment. The ankle-brachial index (ABI) was measured on the 1st, 28th, 59th, and 91st days after the treatment. RESULTS: Complications, serious adverse reactions, and abnormal test results did not occur in the patients during the operation. After the operation, the pain had significantly reduced in 17 cases, the average VAS score of all cases decreased from 5.95 to 1.64 (P < 0.05), and the pain disappeared completely in four cases. The average ABI of all cases increased from 0.49 to 0.63 (P < 0.05), five cases had ulcer, and four cases had gangrene. After treatment, one case of ulcer and one case of gangrene healed completely, and three cases of ulcer and one case of gangrene improved significantly, and one case of ulcer and two cases of gangrene had no significant change. CONCLUSION: HGF gene therapy can effectively treat diabetic lower limb arteriosclerosis obliterans, relieve the clinical symptoms and improve the quality of life. The smooth operation is inseparable from the cooperation of nurses, including careful preoperative visit, strict aseptic operation during the operation, follow-up visit regularly after the operation, and mastering the changes in patients' condition in the whole process to provide high-quality nursing for patients.
肝细胞生长因子治疗糖尿病下肢动脉硬化闭塞症的临床研究
目的:探讨肝细胞生长因子(HGF)基因治疗糖尿病下肢动脉硬化闭塞患者的安全性和有效性,为更好地协调临床手术与麻醉、保障医疗安全、提高护理质量提供理论支持。材料与方法:21例符合纳入标准的4 - 6级(卢瑟福分级)肢体缺血患者分为4个剂量组,其中4 mg组3例,8 mg组6例,12 mg组5例,16 mg组7例。各组剂量分成等剂量,分别于治疗第1天、第15天肌内注射。各注射点剂量为0.25 mg/0.5 ml。于治疗后第1、8、15、21、28、59、91天观察不良反应、疼痛及溃疡愈合视觉模拟评分(VAS)。分别于治疗后第1天、第28天、第59天、第91天测定踝肱指数(ABI)。结果:术中未发生并发症、严重不良反应及检查结果异常。术后17例患者疼痛明显减轻,VAS平均评分由5.95降至1.64 (P < 0.05), 4例患者疼痛完全消失。所有病例的平均ABI由0.49上升至0.63 (P < 0.05),溃疡5例,坏疽4例。治疗后1例溃疡、1例坏疽完全愈合,3例溃疡、1例坏疽明显好转,1例溃疡、2例坏疽无明显变化。结论:HGF基因治疗可有效治疗糖尿病下肢动脉硬化闭塞症,缓解临床症状,提高生活质量。手术的顺利进行离不开护士的配合,包括周密的术前访视,术中严格的无菌操作,术后定期随访,全程掌握患者病情的变化,为患者提供高质量的护理。
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