To investigate the efficacy and safety of recombinant human epidermal growth factor (rhEGF) in advanced diabetic foot ulcers (DFU) A double-blind trial was carried out to test two rhEGF dose levels in type 1 or 2 diabetes patients with Wagner's grade 3 or 4 ulcers, with high risk of amputation. Subjects were randomised to receive 75 (group I) or 25 mug (group II) rhEGF through intralesional injections, three times per week for 5-8 weeks together with standardised good wound care. Endpoints were granulation tissue formation, complete healing and need of amputation. Safety was assessed by clinical adverse events (AEs) and laboratory evaluations. Forty-one patients were included. After 5-8 weeks of treatment, 83% patients in the higher dose group and 61% in group II achieved useful granulation tissue covering more than 98% of the wound area. At long-term assessment, 13 (56.5%) patients healed in group I and 9 (50%) in group II. The mean time to complete healing in group I was 20.6 weeks (95% CI: 17.0-24.2) and 19.5 weeks (16.3-22.7) in group II. After 1-year follow-up, only one patient relapsed. Amputation was not necessary in 65% and 66.7% of groups I and II, respectively. The AEs rates were similar. The most frequent were sepsis (33%), burning sensation (29%), tremors, chills and local pain (25% each). rhEGF local injection enhances advanced DFU healing and reduces the risk of major amputation. No dose dependency was observed.
LH. Intralesional administration of epidermal growth factor-based formulation (Heberprot-P) in chronic diabetic foot ulcer: treatment up to complete wound closure. Int Wound J 2009;6:67-72. ABSTRACT Previous studies have shown that an epidermal growth factor-based formulation (Heberprot-P) can enhance granulation of high-grade diabetic foot ulcers (DFU). The aim of this study was to explore the clinical effects of this administration up to complete wound closure. A pilot study in 20 diabetic patients with full-thickness lower extremity ulcers of more than 4 weeks of evolution was performed. Mean ulcer size was 16Á3 AE 21Á3 cm 2 . Intralesional injections of 75 mg of Heberprot-P three times per week were given up to complete wound healing. Full granulation response was achieved in all 20 patients in 23Á6 AE 3Á8 days. Complete wound closure was obtained in 17 (85%) cases in 44Á3 AE 8Á9 days. Amputation was not necessary in any case and only one relapse was notified. The most frequent adverse events were tremors, chills, pain and ardour at site of administration and local infection. The therapeutic scheme of intralesional Heberprot-P administration up to complete closure can be safe and suitable to improve the therapeutic goal in terms of healing of chronic DFU.
Thrombolysis with recombinant streptokinase is efficacious and safe for the treatment of prosthetic heart valve thrombosis. It does not contraindicate surgical treatment if there is no total response, because patient goes to surgery in better hemodynamic conditions with lower risk. Nowadays it can be considered as first-line treatment in all patients with prosthetic heart valve thrombosis regardless of functional class unless specific contraindications exist.
Pulmonary aspergillosis presents with a variety of clinical forms including invasive pulmonary aspergillosis, chronic necrotising aspergillosis, aspergilloma, chronic cavitary pulmonary aspergillosis and allergic bronchopulmonary aspergillosis. Haemoptysis is a devastating complication of pulmonary aspergillosis and a common indication for surgery. We report a case of a 54-year-old man with a history of pulmonary tuberculosis and diabetes mellitus, who presented with productive cough and haemoptysis for 2 months. Chest CT revealed a 30 mm diameter soft tissue mass in the upper lobe of the right lung. Haemoptysis subsided with conservative measures, but 2 weeks later the patient developed a new episode of persistent haemoptysis, which was only partially controlled with bronchial arterial embolisation. He underwent right upper and middle lobectomy. Histology examination confirmed the presence of a fungal cavitary lesion. The patient was started on voriconazole, and recovered with no recurrence at 18 months follow-up.
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