Pharmacologic C5-complement suppression reduces blood loss during on-pump cardiac surgery

BACKGROUND: Inflammation contributes to morbidity following on-pump cardiac surgery. Complement activation during cardiopulmonary bypass has been associated with the postoperative bleeding and tissue injury. This study examines the pharmacology and impact on blood loss of complement C5 suppression with pexelizumab in patients undergoing cardiac surgery with cardiopulmonary bypass. METHODS: Pexelizumab, a humanized monoclonal antibody single-chain fragment that binds to the human C5 complement component, was studied in a Phase II multicentered clinical trial. CABG (n = 800) and CABG with concomitant valve surgery (n = 114) patients were evaluated. Patients were randomized to either: pexelizumab bolus (2.0 mg/kg) + placebo infusion; pexelizumab bolus (2.0 mg/kg) + pexelizumab infusion (0.05 mg/kg/hour for 24 hours); or placebo bolus + placebo infusion. Pharmacology, chest tube drainage, and transfusion requirements were assessed. RESULTS: Mean maximum pexelizumab serum concentration was similar for bolus and bolus + infusion-treated patients. Complement-dependent serum hemolytic activity was completely suppressed within 1 hour following pexelizumab bolus, however, suppression was maintained for a longer duration in the bolus + infusion compared to the bolus-only treated patients. A reduction in chest tube drainage was observed for all pexelizumab-treated patients, although transfusion of blood products was similar across all study groups. CONCLUSION: Pexelizumab administration inhibits complement-dependent hemolytic activity and is associated with a reduction in postoperative chest tube drainage in patients undergoing cardiac surgery requiring cardiopulmonary bypass. Further, clinical studies are needed to assess the value of complement attenuation in this setting.     

A validated patient reported measure of urinary urgency severity in overactive bladder for use in clinical trials

PURPOSE: Overactive bladder (OAB) is a syndrome consisting of urinary urgency with or without urge incontinence, usually with increased urinary frequency and nocturia. In response to current limitations in OAB clinical research a new patient reported measure of urgency severity associated with OAB has been developed, namely the Indevus Urgency Severity Scale (IUSS). We report the measurement properties of the IUSS. MATERIALS AND METHODS: Validation study data were collected alongside a phase III clinical trial of 20 mg trospium chloride twice daily vs placebo in patients with OAB associated with urge incontinence. We evaluated IUSS item variability, known group, content, criterion and construct validity, test-retest reliability, responsiveness and respondent burden. RESULTS: A total of 658 patients were evaluated at baseline and 579 were reevaluated at week 12. IUSS demonstrated good item variability. Greater urgency severity was associated with increased symptom bother and worse health related quality of life, as measured by the OAB QOL questionnaire. IUSS had a significant positive association with essential clinical and quality of life outcomes, demonstrating content validity. IUSS was highly responsive to a decrease in the average number of patient toilet voids per 24 hours to 7 or fewer toilet voids and average urge incontinence episodes per 24 hours to zero. It discriminated between patients who had above and below the median number of toilet voids and urge incontinence episodes per 24 hours. IUSS also had good test-retest reliability and content validity, and it created minimal respondent burden. CONCLUSIONS: IUSS is a validated patient reported measure of urgency severity for collecting event specific information in the context of a clinical trial.     

Mechanisms of pulmonary dysfunction after on-pump and off-pump cardiac surgery: a prospective cohort study

Background  

Pulmonary dysfunction following cardiac surgery is believed to be caused, at least in part, by a lung vascular injury and/or atelectasis following cardiopulmonary bypass (CPB) perfusion and collapse of non-ventilated lungs.     

Treatment of myofascial trigger points in common shoulder disorders by physical therapy: A randomized controlled trial [ISRCTN75722066]

Background  

Shoulder disorders are a common health problem in western societies. Several treatment protocols have been developed for the clinical management of persons with shoulder pain. However available evidence does not support any protocol as being superior over others. Systematic reviews provide some evidence that certain physical therapy interventions (i.e. supervised exercises and mobilisation) are effective in particular shoulder disorders (i.e. rotator cuff disorders, mixed shoulder disorders and adhesive capsulitis), but there is an ongoing need for high quality trials of physical therapy interventions. Usually, physical therapy consists of active exercises intended to strengthen the shoulder muscles as stabilizers of the glenohumeral joint or perform mobilisations to improve restricted mobility of the glenohumeral or adjacent joints (shoulder girdle). It is generally accepted that a-traumatic shoulder problems are the result of impingement of the subacromial structures, such as the bursa or rotator cuff tendons. Myofascial trigger points (MTrPs) in shoulder muscles may also lead to a complex of symptoms that are often seen in patients diagnosed with subacromial impingement or rotator cuff tendinopathy. Little is known about the treatment of MTrPs in patients with shoulder disorders.     

Internal fixation in compound type III fractures presenting after golden period

Objective:

Patients often reach the hospital late after passage of golden hours (initial 6 hours) after sustaining high-velocity injuries. The decision of internal fixation in Gustilo''s Type IIIA and IIIB fractures becomes a formidable challenge in patients reaching late. The purpose of the present study was to find out if internal fixation could be safely undertaken in these patients.

Materials and Methods:

Sixty-three patients, having 70 compound fractures (46 Type IIIA and 24 IIIB), which were internally fixed after 6h but within 24h after injury, were included in the present analysis. Follow-up ranged from 18 to 48 months with mean of 28 months.

Result:

Overall infection rate noted was (n = 11) 15.71% (8.7% in IIIA, and 29.16% in IIIB). The difference in deep infection rate between Type IIIA and Type IIIB was found to be statistically significant (P value < 0.01). Nonunion was seen in five fractures. Functional evaluation using Katenjian''s criteria, showed 62.85% (44 fractures of 70) good to excellent results.

Conclusion:

Satisfactory results may be obtained in Gustilo''s Type IIIA and IIIB fractures even if fixed after the golden period, provided strict protocol such as aggressive debridement, prophylactic antibiotic coverage, early soft tissue reconstruction and timely bone grafting is followed. The primary coverage of the wound is discouraged.     

Nonanemic Patients Do Not Benefit from Autologous Blood Donation Before Total Hip Replacement

To avoid the potential risks of allogeneic transfusion during total hip arthroplasty (THA), the use of preoperative autologous blood donation (PABD) has been utilized. We performed a retrospective chart review of 283 patients undergoing THA that either donated 1 U of autologous blood (188 patients) or did not donate autologous blood before surgery (95 patients) in order to investigate the difference in postoperative transfusion rate (autologous and allogeneic), the incidence of allogeneic transfusion, and the difference in cost of each protocol. In addition, the study compared transfusion rates in patients with and without preoperative anemia (hemoglobin (Hb) ≤ 12.5 g/dL). At 0.75 transfusions per patient versus 0.22 transfusions per patient, the PABD patients had a significantly higher overall transfusion rate. PABD significantly reduced the need for allogeneic blood in anemic patients (Hb ≤ 12.5 g/dL) from 52.6% to 11.8%. PABD did not have the same affect in nonanemic patients (allogeneic transfusion rate 5.7% versus 4.0%). The study demonstrated that nonanemic patients undergoing THA do not benefit from PABD, but it is effective for anemic patients.     

Neonatal brain: color Doppler imaging. Part I. Technique and vascular anatomy

Color Doppler imaging (CDI) can demonstrate the relative direction and velocity of blood flow in color, superimposed on a conventional gray-scale ultrasound image that depicts stationary tissue. Twenty-five infants were studied with portable CDI in the coronal, sagittal, and axial planes. Bilateral antegrade flow was noted in the anterior, middle, and posterior cerebral arteries in all patients. Multiplanar CDI can image flow in the circle of Willis and its tributaries and branches.     

Current status of the rheumatologists’ workforce in Latin America: a PANLAR collaborative study

Clinical Rheumatology - Studies conducted by various scientific societies have shown that the demand for specialized rheumatology care is greater than the projected growth of the workforce. Our...