Efficacy and Safety of Alprostadil in Patients with Peripheral Arterial Occlusive Disease Fontaine Stage IV: Results of a Placebo Controlled Randomised Multicentre Trial (ESPECIAL).

OBJECTIVES: The aim was to assess the efficacy and safety of alprostadil in patients with peripheral arterial occlusive disease (PAOD) Fontaine Stage IV. METHODS: This was a multinational, prospective, randomised, double blind, placebo controlled, parallel group trial. Patients with Stage IV PAOD were equally randomised to either 4 weeks of alprostadil treatment twice daily or to placebo treatment twice daily. The primary efficacy variables were the rate of complete healing of all necrosis and ulceration 12 weeks after the end of treatment and the frequency of major amputations 24 weeks after the end of treatment. RESULTS: A total of 840 patients were randomised between 2004 and 2013. At baseline, no major differences between treatment groups were found. The rate of "complete healing" was 18.4% in patients on alprostadil and 17.2% in patients on placebo. The rates of "major amputations" were 12.6% in patients on alprostadil and 14.6% in patients on placebo. The adjusted difference between alprostadil and placebo including their 95% confidence intervals was 1.1 (-4.0 to 6.3) for "complete healing" and -2.1 (-6.7 to 2.5) for "major amputations." In the subgroup of diabetic patients the rates of major amputations were numerically lower in the alprostadil than placebo group (10.6% vs. 17.4%). Within the total cohort a non-significant difference in "decrease in ulcer area ≥50%" was reached in 30.2% of patients on alprostadil and in 24.3% of patients on placebo at end of treatment. CONCLUSIONS: In this study, superiority of alprostadil over placebo could not be shown. Nevertheless, a slight numerical but not clinically relevant advantage for alprostadil emerged from the "area decrease of ulcers by ≥ 50%," indicating that a healing effect may have started. The results have to be considered in the light of several limitations in study design and conduct.

Cryopreserved arterial allografts in the treatment of prosthetic graft infections.

AIM: The purpose of this study was to evaluate the effectiveness of cryopreserved arterial allografts in the management of prosthetic graft infection. MATERIAL AND METHODS: Over a 5-year period 45 patients with infection of prosthetic vascular grafts were treated. There were 39 intra-abdominal infected grafts (group I) and six extra-abdominal infected grafts (group II). Treatment consisted of total graft removal and in situ or extra-anatomic implantation of cryopreserved arterial allografts. Six patients were operated on as an emergency. Four patients presented with aorto-enteric fistula. Follow-up ranged from 30 to 78 months. RESULTS: There were six in-hospital deaths and two additional patient deaths during follow-up, yielding an overall mortality rate of 18%. Six patients died due to complications directly related to infection or insertion of an allograft. Combined short and long-term mortality rate was much higher in patients operated on as an emergency (67%) compared to elective cases (11%). Patients with aorto-enteric fistula had the highest mortality rate (75%). Primary and secondary 3-year allograft patency rates for group I were 84 and 94%, respectively and for group II were 60 and 80%, respectively. CONCLUSIONS: Aortic allografts are useful in the treatment of infection of major vascular prosthetic grafts, except for patients with aorto-enteric fistula. Patients with infection of the prosthetic graft should be promptly assessed for graft removal, since results of elective surgery are much better than results of emergency procedures.

[A case of maxillary neurosarcoma]. / Przypadek nerwiakomiesaka (neurosarcoma) szczeki.

A case of neurosarcoma located in maxillary sinus is presented. The patient was 62 years old women who complained of nasal obstruction, epistaxis and headache. Results of physical examination showed a giant mass filling the nasal cavity and maxillary sinus. The lesion was completely resected by lateral rhinotomy way. After the operation histopathological diagnosis was difficult, one pathologist recognised schwannoma benignum other one sarcoma. Finally postoperative diagnosis was schwannoma benignum, it was misdiagnosis. Two years later the patient was surgically treated again because of tumor recurrence. These time pathological diagnosis was neurosarcoma. Radiotherapy was done as well. The patient died 18 months after treatment, tumor regrowth and generalization metastases was reason of the death.

[Tumors of the parotid glands in the material of the Department of otolaryngology of the Medical Academy in Warsaw in 1986-1995]. / Guzy slinianek przyusznych w materiale Kliniki Otolaryngologii AM w Warszawie w latach 1986-1995.

In the Department of Otolaryngology, Medical Academy in Warsaw, 332 patients were surgically treated between 1986 and 1995 because of parotid gland tumors. In 275 cases benign tumors, in 57 cases--malignant tumors were observed. The majority of benign tumors were pleomorphic adenoma (61.45%) and lymphadenoma (22.54%); the majority of malignant tumors were adenocarcinoma (28%), adenoid cystic carcinoma (21%), mucoepidermoid carcinoma (15.78%). All patients with benign tumors were surgically treated, patients with malignant tumors were operated on and irradiated. The surgical procedure used superficial parotidectomy and total parotidectomy with preservation of facial nerve where possible. Ten patients required total parotidectomy with facial nerve resection because of malignant tumors, six patients had neck dissection performed. Of the 57 patients treated on account of malignant tumors 43 survived; 14 patients died of a local recurrence or generalization neoplasm disease.

[Metastasis of the cutis malignant melanoma of the parotid gland]. / Przerzut czerniaka skóry do slinianki przyusznej.

The authors presented a rare case of metastases of the cutis malignant melanoma to the parotid nodes. The attention was directed towards clinical aspects and diagnostic difficulties. Basing on data from the literature frequency and possibilities of cutis malignant melanoma metastases were analysed.

[Glandular ear neoplasms]. / Nowotwory ucha pochodzenia gruczolowego.

A case of ceruminoma was described. The authors also presents actual opinions about glandular tumors of the middle and external ear, their classification and treatment.

[Reconstructive surgery in an advanced laryngeal neoplasm]. / Chirurgia rekonstrukcyjna w zaawansowanym raku krtani.

The case of the extensive laryngeal cancer recurrence after radiotherapy was described. The authors were discussed treatment surgery it with reconstruction of the tissue defect. The skin defect was reconstructed with the pectoralis mayor myocutaneous island flap, the pharyngeal secondary fistula was reconstructed with the Trapezius myocutaneous flap.

[Indications and counterindications for topical corticosteroidotherapy]. / Wskazania i przeciwskazania do miejscowej kortykosteroidoterapii.

This paper presents indications for topical corticosteroidotherapy in rhinitis and nasal polyps. The differential diagnosis including etiology and pathogenesis of diseases especially aspirin intolerance, are taken into consideration. The main indication for topical corticosteroidotherapy is local nasal eosinophilia. The authors everyday clinical practice help to establish considerations for the use of corticosteroids.

[Topographic anatomy of the nose and paranasal sinuses for the needs of endoscopic surgery]. / Anatomia topograficzna nosa i zatok przynosowych dla potrzeb chirurgii endoskopowej.

The paper presents topographic anatomy of the nose and paranasal sinuses, which excellent known is necessary for surgeon who operates using endoscopic method. The difficulties and dangerous situations during operations as a consequence of the surgical activity in such complicated region are also described.