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.

Peripheral arteries of the extremities in acute ischemia.

Changes in peripheral arteries of the extremities during acute ischemia were examined in 108 patients with embolism and 18 with arterial injuries. All patients were divided into four degrees of ischemia due to our own original classification. It can be stated that patients with the first degree of ischemia presented patent peripheral arteries. The rest of the patients presented different changes in the peripheral arteries such as thrombus or their patency was failed by the rigidity of the non-striated muscles of the arterial wall or by the pressure of the oedematous muscles. A new factor, decreasing after operation, an inflow of blood to the leg or to the hand, was found. It was an opening of the arteriovenous fistulas at the level of obstruction. The diagnostic value of the different tests for intraoperative assessment of the patency of the peripheral arteries is the discussed, emphasizing the value of the intraoperative arteriography.

[Evaluation of the effect of auditory fatigue on the human ear by auditory brain stem responses (ABR). I. Effect of auditory fatigue on temporary threshold shifts of ABR]. / Ocena wplywu zmeczenia sluchowego na narzad sluchu czlowieka za pomoca sluchowych potencjalów pnia mózgu (ABR). I. Wplyw zmeczenia sluchowego na wartosci parametrów czasowych ABR.

The effects of auditory fatigue on auditory brainstem responses (ABR) were investigated in 23 normal-hearing subjects. ABR was recorded before and after exposure to fatiguing noise. Behaviourally, the auditory fatigue was tested using a temporary threshold shifts (TTS) paradigm. The latency of waves I, III, V and interwave intervals I-III, III-V, I-V were analysed as functions of stimulus intensity. In post-exposure recordings a threshold elevation, significant increase of all waves latency, increase of interwave-interval III-V at 40,50,60 dB nHL and unaltered intervals I-III, I-V were observed.

[Evaluation of the effect of auditory fatigue on the human ear based on the measurement of brain stem auditory potentials (ABR). II. Relation of temporary auditory threshold shift and changes in the latency of wave V]. / Ocena wplywu zmeczenia sluchowego na narzad sluchu czlowieka za pomoca s¿chowych potencjalów z pnia mózgu (ABR). II. Zwiazek miedzy czasowym przesunieciem progu slyszenmia i zmianami latencji fali V.

The relationship between temporary threshold shift (TTS) and latency changes of auditory brainstem responses (ABR) induced by noise exposure was studied in 23 normal-hearing subjects. Shift in latency wave V at 40 dB nHL of stimulus intensity as a result of auditory fatigue showed no significant correlation with TTS at 4 kHz. The great intersubject variability of shifts in latency wave V as a result of auditory fatigue suggests that this shift may be a useful measure of individual susceptibility to noise.

[The value of total contact casting in treatment of neuropathic foot ulcers in diabetic patients]. / Przydatnosc opatrunku unieruchamiajacego w leczeniu owrzodzen neuropatycznych stopy u chorych na cukrzyce.

Neuropathic foot ulcers in diabetic patients pose great difficulties in treatment. Total contact casting is one of the available methods. It is thought to distribute the pressure evenly over the entire surface of the foot. The purpose of the study was the evaluation of the total contact casting as a method of treatment of neuropathic foot ulcers in diabetic patients. Ten diabetic patients with neuropathic foot ulcers were treated with total contact casting. The inclusion criteria were good arterial blood supply and the absence of bone, joints or surrounding soft tissue infection. The mean area of the ulcers was 1.9 cm2 (1.3-3.6 cm2). The average duration of the ulcer prior to commencement of the treatment was 10 months. Total contact cast was applied after thorough surgical debridement and covering of the ulcer with occlusive dressing. The casts were changed every six to ten days. The ulcers healed in 9 out of 10 treated patients. The healing time averaged two months. In one patient development of soft tissue infection necessitated discontinuation of the treatment and performing open ray amputation. In four patients superficial ulcerations of the skin of the dorsal aspect of the toes developed. They resulted in prolonged duration of the treatment. Total contact casting in adequately qualified and reliable patients is safe and effective method of treatment of neuropathic foot ulcers in diabetes.

[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.

[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.

[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.

[Investigation of variability in the vascularity of trapezius musculo-cutaneous flaps]. / Badanie zmiennosci unaczynienia skórno-miesniowych platów z miesnia czworobocznego.

The search on the human body cadavers was done to determine the exact localization of the various cutaneous island flaps depending on the course of the blood vessels. The latex solution stained with the prussian blue was injected directly into the thyro-cervical trunk or subclavian arteries. Afterwards the island musculocutaneous flaps from various regions of the trapezius muscle were performed. The whole number of the performed flaps were 20. The search confirmed the possibility of formation island flaps from various regions of the trapezius muscle.

[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.

[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.

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.