Randomized clinical trial of compression plus surgery versus compression alone in chronic venous ulceration (ESCHAR study)--haemodynamic and anatomical changes

BACKGROUND: The aim of this study was to evaluate the anatomical and haemodynamic effects of superficial venous surgery and compression on legs with chronic venous ulceration. METHODS: Legs with open or recently healed ulceration and saphenous reflux were treated with multilayer compression bandaging or superficial venous surgery plus compression as part of a clinical trial. Venous duplex imaging was performed before treatment and at 1 year. Legs were stratified before surgery as having no deep reflux, segmental deep reflux or total deep reflux. Venous refill times (VRTs) were calculated before treatment and at 1 year using photoplethysmography, with and without a narrow below-knee cuff inflated to 80 mmHg. RESULTS: Of 214 legs investigated, 112 were treated with compression and 102 with compression plus surgery. Saphenous surgery abolished deep reflux in ten of 22 legs with segmental deep reflux and three of 17 with total deep reflux. Overall median (range) VRT increased from 10 (3-48) to 15 (4-48) s 1 year after surgery (P < 0.001). Preoperative change in VRT on application of a below-knee tourniquet correlated with actual change in VRT following surgery. CONCLUSION: Superficial venous surgery resulted in a significant haemodynamic benefit for legs with venous ulceration despite co-existent deep reflux; residual saphenous reflux was common.     

Are urological procedures in tetraplegic patients safely performed without anesthesia? a report of three cases

Background

Some tetraplegic patients may wish to undergo urological procedures without anaesthesia, but these patients can develop autonomic dysreflexia if cystoscopy and vesical lithotripsy are performed without anaesthesia.

Case presentation

We describe three tetraplegic patients, who developed autonomic dysreflexia when cystoscopy and laser lithotripsy were carried out without anesthesia. In two patients, who declined anaesthesia, blood pressure increased to more than 200/110 mmHg during cystoscopy. One of these patients developed severe bleeding from bladder mucosa and lithotripsy was abandoned. Laser lithotripsy was carried out under subarachnoid block a week later in this patient, and this patient did not develop autonomic dysreflexia. The third patient with C-3 tetraplegia had undergone correction of kyphoscoliotic deformity of spine with spinal rods and pedicular screws from the level of T-2 to S-2. Pulmonary function test revealed moderate to severe restricted curve. This patient developed vesical calculus and did not wish to have general anaesthesia because of possible need for respiratory support post-operatively. Subarachnoid block was not considered in view of previous spinal fixation. When cystoscopy and laser lithotripsy were carried out under sedation, blood pressure increased from 110/50 mmHg to 160/80 mmHg.

Conclusion

These cases show that tetraplegic patients are likely to develop autonomic dysreflexia during cystoscopy and vesical lithotripsy, performed without anaesthesia. Health professionals should educate spinal cord injury patients regarding risks of autonomic dysreflexia, when urological procedures are carried out without anaesthesia. If spinal cord injury patients are made aware of potentially life-threatening complications of autonomic dysreflexia, they are less likely to decline anaesthesia for urological procedures. Subrachnoid block or epidural meperidine blocks nociceptive impulses from urinary bladder and prevents occurrence of autonomic dysreflexia. If spinal cord injury patients with lesions above T-6 decline anaesthesia, nifedipine 10 mg should be given sublingually prior to cystoscopy to prevent increase in blood pressure due to autonomic dysreflexia.     

Modulation of active pharmaceutical material release from a novel 'tablet in capsule system' containing an effervescent blend.

The objective of the present study was to obtain programmed drug delivery from hard gelatin capsules containing a hydrophilic plug (HPMC or guar gum). The significance of factors such as type of plug (powder or tablet), plug thickness and the formulation of fill material on the release pattern of diltiazem HCl, a model drug, was investigated. The body portion of the hard gelatin capsules was cross-linked by the combined effect of formaldehyde and heat treatment. A linear relationship was observed between weight of HPMC K15M and log % drug released at 4 h from the capsules containing the plug in powder form. In order to accelerate the drug release after a lag time of 4 h, addition of an effervescent blend, NaHCO(3) and citric acid, in the capsules was found to be essential. The plugs of HPMC in tablet form, with or without a water soluble adjuvant (NaCl or lactose) were used for obtaining immediate drug release after the lag time. Sodium chloride did not cause significant influence on drug release whereas lactose favourably affected the drug release. The capsules containing HPMC K15M tablet plug (200 mg) and 35 mg effervescent blend in body portion of the capsule met the selection criteria of less than 10% drug release in 4 h and immediate drug release thereafter. It is further shown that the drug release was also dependant on the type of swellable hydrophilic agent (HPMC or guar gum) and molecular weight of HPMC (K15M or 20 cPs). The results reveal that programmed drug delivery can be obtained from hard gelatin capsules by systemic formulation approach.     

Correlation between karyotype and quantitative immunophenotype in acute myelogenous leukemia with t(8;21).

Acute myelogenous leukemia with t(8;21) is a distinct clinicopathologic entity in which the malignant myeloblasts display a characteristic pattern of surface antigen expression. Quantitative analysis of surface marker expression in patients with this chromosomal abnormality compared to acute myelogenous leukemia patients with a different karyotype has not been reported. From 305 consecutive newly diagnosed acute myelogenous leukemia patients underwent immunophenotyping and cytogenetic analysis at our center; 16 patients (5.2%) had a t(8;21). Fluorescence intensity values were obtained, using a set of reference microbeads, by conversion of mean channel fluorescence to molecular equivalent of soluble fluorochrome. Patients with t(8;21) displayed higher levels of CD34, HLA-DR and MPO expression (P < 0.001 for each) and lower levels of CD13 (P = 0.03) and CD33 (P = 0.02) expression. In order to study the sensitivity, specificity and predictive value of these markers, molecular equivalent of soluble fluorochrome thresholds were statistically determined. The statistically established threshold for each of the individual markers (CD34 > 60.5 x 10(3), HLA-DR > 176.1 x 10(3), MPO > 735.1 x 10(3), CD13 < 24.3 x 10(3) and CD33 < 17.3 x 10(3)) had a sensitivity of 100%, a specificity of 62-92% and a positive predictive value of 7-45%. In multivariate analysis, two quantitative patterns (CD34 > 60.5 x 10(3) and MPO > 176.1 x 10(3); CD33 < 17.3 x 10(3) and MPO > 176.1 x 10(3)) had a sensitivity, specificity and positive predictive value of 100%. These aberrant phenotypic patterns might help identify patients with t(8;21) at diagnosis and could be useful in minimal residual disease monitoring.