Alpha-interferon with ribavirin in the treatment of hemodialysis patients with hepatitis C

INTRODUCTION: Hepatitis C Viral (HCV) infection is the leading cause of chronic liver disease in end-stage renal disease patients (ESRD). The impact of HCV on patient and graft survival posttransplantation is controversial. The most successful approach is to eliminate the virus while the patient is on dialysis prior to transplantation. The main aim of this pilot study was to assess the efficacy of combined alpha-interferon (alpha-IFN) and ribavirin treatment of HCV hemodialysis (HDx) patients, by comparing the sustained virological response to that obtained by local historical data on treatment with alpha-IFN alone. A secondary aim was to establish the optimal therapeutic dose of ribavirin in this regimen. METHODS: Twenty HCV-HDx patients who were histologically (liver biopsy) and virologically (HCV-PCR)-positive were selected randomly. They received combination therapy with 3 million units (MU) of alpha-IFN and 200 mg of ribavirin three times a week. Initially nine patients were treated for 24 weeks. Later, another 11 patients were randomly selected to give the combination for 48 weeks. RESULTS: Six of the nine patients who were treated for 24 weeks (66%) became HCV-PCR-negative by the end of the treatment period. They continued to have a sustain virologic response at 6 months after the cessation of therapy. Six of the 11 patients (55%) who were treated for 48 weeks became HCV-PCR-negative at the end, and at 6 months after cessation of treatment. Of the first six responders, 4 (66%) maintained a sustained virologic response at 1 year postcessation of therapy. Nine of the 11 patients had genotype 4 and 1. No side effects were reported for a ribavirin dose of 200 mg three times a week. CONCLUSION: This pilot study suggests that combination treatment for 24 weeks and 48 weeks with 3 MU alpha-IFN and 200 mg ribavirin three times a week, elicited a sustained virologic response in HDx patients with HCV infection better than IFN alone with minimal side effects. A prospective, double-blind, controlled study using pegylated INF plus ribavirin is currently underway.     

Functional hepatic regeneration following hepatectomy using galactosyl-human serum albumin liver scintigraphy

In extended hepatectomy and liver transplantation, accurate estimation of functional hepatic regeneration is more important than volumetric regeneration. We investigated the usefulness of measuring the functional hepatic volume by 99m-technetium galactosyl-human serum albumin scintigraphy (GSA). Extended hepatectomy was performed in 32 patients. These patients were divided into subgroups with or without chronic hepatitis or cirrhosis. Functional hepatic volume GSA scintigraphy (GSA-LV) and determination of hepatic volume by CT (CT-LV) measurements were performed preoperatively, at 2 and 4 weeks and at 3 and 6 months after surgery. The preoperative GSA-LV values were significantly correlated with the hepatocyte volume and the 15-minute retention rate of indocyanine green (ICGR15). Similarly, the hepatocyte volume correlated well with the CT-LV and ICGR15. However, the CT-LV correlated only with the ICGR15. Recovery of the GSA-LV was delayed, and about 90% of the volumetric and functional regeneration was observed within 6 months after the hepatectomy. In contrast, the CT-LV in patients with normal liver remnants returned to approximately 90% of the initial volume within 1 month after the hepatectomy, whereas patients with injured livers regeneration showed gradual recovery to approximately 80% of the preoperative value by 6 months after hepatectomy. We conclude that measurement of functional hepatic volume using the GSA-LV is useful to evaluate hepatic function based on hepatocyte volume.     

Induced preconditioning of cardiac performance in coronary bypass surgery--sevoflurane vs propofol

Twenty ASA III and IV adult patients scheduled for elective coronary artery surgery were included in the study. Anesthesia was induced and maintained with either sevoflurane (sevoflurane group; n = 10) or propofol (propofol group; n = 10). All preoperative cardiac medications were continued until the morning of surgery. There were significant decreases in mean arterial blood pressure, cardiac index and ejection fraction after CPB in propofol group compared with sevoflurane. Further, the plasma creatine kinase myocardial isoenzyme concentrations were significantly higher in propofol group but did not approach the critical values needed for diagnosis of myocardial infarction. Conclusion: It is concluded that, sevoflurane appears to be associated with better hemodynamic stability before and after CPB than propofol. This could be attributed to cardioprotective effect of sevoflurane during ischemia and reperfusion.     

Role of ulnar forearm free flap in oromandibular reconstruction

The ulnar forearm flap is not frequently utilized for oromandibular reconstruction. This study evaluated the usefulness of the ulnar free flap for reconstruction. A retrospective study of 32 patients was conducted. The ulnar forearm flap was combined with an osseous flap in 24 patients. Nine females and 23 males with a mean age of 58.15 years comprised our study population. Squamous-cell carcinoma was the diagnosis in 93.75% of cases (56.25% T4), of which 20% were recurrent. Functional evaluation of swallowing was based on the University of Washington Questionnaire (UWQ). The mean hospital stay was 9.8 days. The external carotid (100%) was the recipient artery, and the internal jugular (74.07%) was the main recipient vein. Overall flap survival was 96.8%. One flap was lost due to unsalvageable venous thrombosis. Major local complications were seen in 9.4% of cases and included partial flap loss, hematoma, and an orocutaneous fistula. At the time of this study, 21 patients were available for functional evaluation. Speech was rated excellent and good in 33.3% of patients. Swallowing was found good in 28.6% of patients. Chewing was rated excellent and good in 47.6% of patients. Cosmetic acceptance was rated good in 71.4% of cases. The ulnar forearm is a useful free flap in oromandibular reconstruction. It is available when the radial artery is the dominant artery of the hand. Being more hidden, it may be more cosmetically accepted. It affords pliable soft tissue for lining and/or covering of oromandibular defects, and can be used as a second choice after other free-flap failures.     

Aneurysm enlargement following endovascular aneurysm repair: AneuRx clinical trial

OBJECTIVE: The purpose of this study was to determine the incidence and significance of aneurysm enlargement, with or without treatment, in relation to the primary end points of rupture, surgical conversion, aneurysm-related death, and survival following endovascular repair. METHOD: Aneurysm (AAA) size changes and clinical outcome of all patients treated from 1997 through 1998 during the Phase II AneuRx multicenter clinical trial of endovascular AAA repair were reviewed. Aneurysm dimensions and the presence or absence of endoleak were determined by an independent core laboratory, with enlargement or shrinkage defined as a diameter change of 5 mm or more compared with baseline. RESULTS: Among 383 patients (89% men, 11% women, age 73 +/- 9 years), with a mean device implant time of 36 +/- 11 months (median = 39 months), aneurysm diameter decreased from 5.7 +/- 1.0 at baseline to 5.2 +/- 1.0 at 3 years (P =.0001). A total of 46 patients (12%) experienced AAA enlargement, 199 patients (52%) had no change in AAA diameter, and 138 patients (36%) had a decrease in AAA diameter of 5 mm or more. Significant risk factors for enlargement included age (enlargement patients were 4 years older on average than patients with aneurysms that decreased in size; P =.002) and the presence of an endoleak (P <.001). Among patients with endoleak at any time, 17% had aneurysm enlargement, whereas only 2% of patients without endoleak had aneurysm enlargement (P <.001). Patients with enlargement were more likely to undergo secondary endovascular procedures and surgical conversions (P <.001). Twenty patients (43%) with enlargement underwent treatment, and 26 patients were untreated. There were two deaths following elective surgical conversion and one death in a patient with untreated enlargement and a type I endoleak. Three aneurysms ruptured: one with enlargement, one with no change, and one with a decrease in aneurysm size; all three aneurysms were larger than 6.5 cm. Kaplan-Meier analysis showed that freedom from rupture at 3 years was 98% with enlargement, 99% with no change, and 99% with decrease in AAA size (log-rank test, not significant). Freedom from AAA death at 3 years was 93% in patients with enlargement, 99% in no increase, and 99% in decrease (P =.005). Survival at 3 years was 86% with increase, 82% with no change, and 93% with decrease (P =.02). CONCLUSIONS: Aneurysm enlargement following endovascular repair was not associated with an increased risk of aneurysm rupture or decrease in patient survival during a 3-year observation period. Aneurysm size rather than enlargement may be a more meaningful predictor of rupture. Close follow-up and a high re-intervention rate (43%) may account for the low risk of rupture in patients with enlargement. The long-term significance of aneurysm enlargement following endovascular repair remains to be determined.     

Factors influencing the quality of life after burst fractures of the thoracolumbar transition

Introduction Dorsal stabilisation has represented the standard procedure for the treatment of burst fractures of the thoracolumbar spine for a long time, but in the last few years the combined dorsoventral stabilisation has gained in significance due to its higher mechanical stability. However, there are no data yet available indicating whether the patients benefit from the combined operation with regard to their postoperative quality of life and what the advantages are in comparison with the dorsal procedures. Therefore, the question was researched in the framework of a matched-pairs analysis of patients suffering from an unstable fracture of the thoracolumbar transition.Materials and methods From a consecutive series of patients treated in our clinic between 1995 and 2000, 10 patients with combined and 10 patients with a purely dorsal stabilisation were selected and included in the study. Their quality of life was summed up in retrospect with the SF-36 questionnaire. The X-rays were analysed, and the Cobb angle as well as the sagittal index were calculated. Only patients with burst fractures of the thoracolumbar transition without accompanying co-morbidity and neurological deficits were included in the study. Both of the treated groups were matched with regard to sex, age and radiological patterns of injury.Results Patients who had undergone only a dorsal stabilisation showed a significant loss of correction according to the sagittal index at the time of the examination (0.88±0.02 postoperative vs 0.77±0.03 at 4 years postoperatively, p=0.01). In the group of patients treated with the combined therapy, there was no statistically relevant loss of correction with regard to the sagittal vertebral profile. The SF-36 questionnaire showed a reduced quality of life in both groups compared with an age-referenced norm population, especially concerning the parameters of bodily health. No statistically relevant difference was observed between the two groups. Further, there was no statistically relevant association between the parameters of the SF-36 and the clinical and radiological data. After performing several regression analyses it could be shown that the patients mental health is a strong predictor of the postoperative vitality (r=0.803, p<0.01). However, none of the remaining parameters was able to predict the postoperative quality of life.Conclusion The patients in this study showed a reduced quality of life, independent of the method of surgical treatment. Although better radiological results could be seen for the combined procedure, regarding the postoperative quality of life no advantage could be proved compared with the dorsally stabilized patients. Furthermore, there was no relation between the radiological results and the quality of life parameters. Therefore, it can be assumed that the injury itself seems to be the main cause of the decreased quality of life after a burst fracture of the thoracolumbar transition.     

Relevance of methodological design for the interpretation of efficacy of drug treatment of premature ejaculation: a systematic review and meta-analysis

The aim of this systematic review and meta-analysis is to evaluate whether the design and methodology of drug-treatment studies of premature ejaculation affect the efficacy outcome differently. Therefore, methodological, design and efficacy data from 79 studies (3034 males), published between 1943 and 2003, are reviewed. A meta-analysis is performed on 43 selective serotonin reuptake inhibitors (SSRIs) and clomipramine studies (1514 males), published between 1973 and 2003; these studies were pooled to provide a summary variance-weighted effect size. The antidepressant-induced percentage increase of the intravaginal ejaculation latency time (IELT) was calculated and examined against various methodological items. A significant difference in efficacy between SSRIs was observed. Using daily treatment, paroxetine appeared more effective than the other SSRIs. Retrospective use of a questionnaire, subjective reports, single-blind and open study designs generate far greater variability of ejaculation time both at baseline and during active drug treatment than real time assessment by stopwatch. In conclusion, at daily treatment, the overall efficacy of paroxetine, clomipramine, sertraline and fluoxetine is comparable, but paroxetine exerts the strongest ejaculation delay. Only eight (18.5%) studies on antidepressant treatment fulfilled all criteria used in evidence-based medicine, for example, randomised, double-blind studies with prospective real time (stopwatch) assessment of the IELT at each intercourse. Single-blind studies, open designs, retrospective reporting, or the use of a questionnaire to assess ejaculation time should be avoided.