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ORIGINAL ARTICLE
Year : 2022  |  Volume : 5  |  Issue : 3  |  Page : 88-90

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


Department of Vascular Surgery, Xuanwu Hospital, Capital Medical University, Beijing, China

Date of Submission01-Aug-2022
Date of Decision25-Aug-2022
Date of Acceptance06-Sep-2022
Date of Web Publication10-Nov-2022

Correspondence Address:
Dr. Jianming Guo
No. 45 Changchun Street, Xicheng District, Beijing 100053
China
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2589-9686.360871

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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.

Keywords: Diabetic foot, diabetic lower limb arteriosclerosis obliterans, hepatocyte growth factor


How to cite this article:
Zhang L, Su Z, Gu Y, Cui S, Guo L, Guo J. Clinical study of hepatocyte growth factor in the treatment of diabetic lower limb arteriosclerosis obliterans. Vasc Invest Ther 2022;5:88-90

How to cite this URL:
Zhang L, Su Z, Gu Y, Cui S, Guo L, Guo J. Clinical study of hepatocyte growth factor in the treatment of diabetic lower limb arteriosclerosis obliterans. Vasc Invest Ther [serial online] 2022 [cited 2022 Dec 9];5:88-90. Available from: https://www.vitonline.org/text.asp?2022/5/3/88/360871




  Introduction Top


Diabetic foot caused by diabetic lower limb arteriosclerosis obliterans is one of the late complications of diabetes. It has the characteristics of pain, long course of treatment, difficult treatment, high cost, high disability rate, and high mortality. Clinically, for patients with severe ischemia, based on symptomatic treatment with antiplatelet drugs and arterial vasodilators by prostaglandin E1, individualized open surgery or endovascular interventional treatment are used according to the patient's condition, such as vascular bypass grafting and stenting. The purpose is to reconstruct the blood supply and improve the blood flow at the ischemic site. However, these methods are limited by strict indications, equipment, technology, and other conditions. Besides, elderly patients with the weak body and poor distal outflow tract, the patients cannot tolerate routine surgery and get poor therapeutic effect.[1] With the development of medical technology, recombinant human hepatocyte growth factor (HGF) gene therapy for diabetic lower limb arteriosclerosis obliterans has begun to be popularized in clinical practice. From November 2018 to August 2019, 21 patients were treated by recombinant HGF gene therapy in our hospital. Now, the cases were reported as follows.


  Materials and Methods Top


General information

Twenty-one patients (5 females and 16 males) with diabetic lower limb arteriosclerosis obliterans were selected and treated with recombinant human HGF gene. The age ranged from 31 to 80-year-old, the average age was 62.2 years old, there were 11 patients with left lesions and 10 patients with right lesions. All the patients had resting pain, five cases had ulcer and four cases had foot gangrene. Exclusion criteria: severe heart and brain diseases, malignant tumors, those who may undergo amputation in recent 3 months, the occlusion or stenosis of abdominal aorta artery and common iliac artery was >70%. Before the trial, each patient signed the informed consent form.

Operation methods

The vital signs of patients were monitored routinely after entering the operation room. Venous access was established, we selected the cephalic vein or basilic vein of the forearm to puncture with the No. 16 indwelling needle and fixed it properly. Pressure sore pads were placed on the operating table. Diabetes mellitus patients with lower limb occlusive disease are mostly older, with a longer course, poor general, nutritional status, and low immunity. Therefore, during the operation, we kept them warm with air heating blankets. Meanwhile, we should pay attention to the temperature to prevent ischemia exacerbation, which resulted from increased oxygen consumption. Constant temperature liquid was selected for intravenous infusion, which can effectively maintain the central body temperature. Studies have shown that intravenous infusion of 1 l of liquid at ambient temperature or one unit of 4°C blood in adults can reduce the average body temperature by about 0.25°C. Therefore, heating the perfused blood or liquid to 37°C can prevent hypothermia, reduce wound infection rate, shorten hospital stay, and reduce bleeding.[2] Intravenous general anesthesia was used in all operations. Patients took the supine position after the anesthesia. According to the results of angiography or computed tomography angiography, we assisted the doctor to mark the injection point with a marker pen, after placing a ruler to record the injection site with the photo, the drug was injected. The distance between two injection points should be at least 2 cm. Intramuscular injection was performed in the operation room on the 1st and 15th days, respectively. The dosage of each group was divided into equal amounts. The injection site was designed according to the location of the patient's arterial lesion and the possible direction of collateral vessels. The dosage of each injection point was 0.25 mg/0.5 ml, and the interval between injection points was 2 cm.

Data recording

The adverse reactions, visual analog scale (VAS) score and ulcer healing were observed on the 1st, 8th, 15th, 21st, 28th, 59th, and 91st days after treatment. Ankle-brachial index (ABI) indexes were measured on the 1st, 28th, 59th, and 91st days after the treatment.

Statistical method

SAS 9.1.3 software (SAS company, Cary, NC, United States) was used for statistical analysis. The measurement data were expressed by mean ± standard deviation (±s) Paired t-test was used for intragroup comparison. One-way ANOVA was used for intergroup comparison, and Chi-square test was used for counting data. P < 0.05 indicated that the difference is statistically significant.


  Result Top


There were no complications and serious adverse reactions in the 21 patients receiving HGF gene therapy.

Pain measuring

VAS scores of pain were measured before administration, and on the 8th, 15th, 21st, 28th, 59th, and 91st days of treatment. The results are shown in [Table 1]. At different time points before and after administration, the VAS score of the dose I Group decreased significantly from the 28th day (P < 0.05), and the decrease was highly significant on the 91st day (P < 0.01). The VAS scores of 21st, 28th, and 59th in the dose Ⅱ Group decreased significantly (P < 0.05), but there was no significant difference on the 91st day (P > 0.05). There was a significant difference in VAS score from the 21st day in the dose Ⅲ Group (P < 0.05), and there was a highly significant difference on the 28th–91st days (P < 0.01). The VAS score of the dose IV Group decreased significantly from the 15th day to the 91st day (P < 0.01).
Table 1: visual analog scale score of pain in each dose group

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Ankle-brachial index

ABI indexes were checked before treatment, on the 28th, 59th, and 91st days. The results are shown in [Table 2]. At the end of the study, the ABI value of the dose I Group increased by 0.02, the dose II Group increased by 0.07, the dose III Group increased by 0.08, and the dose IV Group increased by 0.25 (P < 0.05).
Table 2: Ankle-brachial index test results of each group

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  Discussion Top


Diabetes foot caused by diabetic lower limb arteriosclerosis obliterans is one of the late serious complications of diabetes. The traditional treatments for diabetes foot include blood glucose control, anti-infective therapy, local dressing, artificial blood vessel or bypass graft, and interventional therapy. Treatments for many patients are not ideal, and most patients eventually undergo amputation. Amputation can not only seriously affect the quality of life but also cause serious psychological trauma to the patients.[3] HGF gene therapy has the advantages of shorter operative time and less pain. The results showed that there were no diabetes complications or serious adverse reactions occurred in the 21 patients. During the 3-month follow-up period, we found that the average VAS score of all patients was reduced from 5.95 to 1.64 (P < 0.05). The pain was significantly relieved in 17 cases; the remission rate was 80.9%. The pain disappeared completely in four cases, and the effective rate was 19%. In five cases with ulcers, three cases had obvious ulcer improvement and one case had complete ulcer healing, and the effective rate was 80%. The average ABI increased from 0.49 to 0.63 (P < 0.05). This study had shown that HGF gene therapy could effectively treat diabetic lower limb arteriosclerosis obliterans, relieve the clinical symptoms and improve the quality of life. However, we must emphasize that the long-term effects of the treatment need further observation. At the same time, the success of the operation is inseparable from the cooperation of nurses in the operation room. During the preoperative visits, we can understand the patients' conditions, communicate with the patients, give the patients psychological comfort and support, alleviate the patients' negative emotions, make the patients accept the operation in a positive mood, and establish the patients' confidence to overcome the disease. Strict aseptic condition during the operation can avoid postoperative infection, aggravating symptoms, and psychosomatic damage to the patients. At the same time, nurses are also required to constantly update their knowledge structure, improve their ability to deal with new technologies and new businesses, and continuously improve the quality of nursing.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Zhengli T, Xitao S, Zhengya YU. Effect of outflow tract on the prognosis of femoral popliteal artery angioplasty in diabetic patients. J Capital Med Univ 2012;33:50-4.  Back to cited text no. 1
    
2.
Muhs BE, Gagne P, Sheehan P. Peripheral arterial disease: Clinical assessment and indications for revascularization in the patient with diabetes. Curr Diab Rep 2005;5:24-9.  Back to cited text no. 2
    
3.
Qinfang Y, Liying L, Beijuan Z. Psychological nursing of a patient with diabetic foot amputation and suicidal tendency. J Nurs 2004;19:75.  Back to cited text no. 3
    



 
 
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