The influence of osteoporosis in femoral fracture healing time

Aim

In order to assess the effect of osteoporosis on healing time, the files of 165 patients with femoral shaft fractures that were treated in our institution with locked-reamed intramedullary nailing were retrospectively reviewed.

Patients and methods

Patients with open fractures, pathological fractures, revision surgery, severe brain injuries and prolonged ITU stay were excluded. In all patients the Singh-index score for osteoporosis and the canal bone ratio (CBR) were assigned. Sixty-six patients fulfilled the inclusion criteria. Patients were divided into two groups; group A (29 patients) consisted of patients over 65 years old with radiological evidence of osteoporosis and group B (37 patients) of patients between 18 and 40 years old with no signs of osteoporosis.

Results

In all group A patients Singh score ≤4 and CBR > 0.50 were assigned, suggesting the presence of osteoporosis, whereas all group B patients were assigned with Singh score ≥5 and CBR < 0.48. Fractures of group A healed in 19.38 ± 5.9 weeks (12-30) and in group B 16.19 ± 5.07 weeks (10-28), P = 0.02.

Conclusions

Fracture healing of nailed femoral diaphyseal fractures is significantly delayed in older osteoporotic patients. Further studies are required to clarify the exact impact of osteoporosis in the whole healing process.     

Humeral head necrosis rate at mid-term follow-up after open reduction and angular stable plate fixation for proximal humeral fractures

Introduction

Short-term follow-up of angular stable fixation for proximal humeral fractures has been well documented in the literature. Longer follow-up series are difficult to find. However, especially regarding the risk of avascular humeral head necrosis longer follow-up series are high of clinical relevance.

Methods

Forty-eight patients with a mean age of 66 years and treated with open reduction and angular stable internal fixation for proximal humeral fractures were followed up for a mean of 45 months. The clinical and radiographic follow-up (Constant Score (CS), age and gender related Constant Score (agCS), Constant Score in comparison to the contralateral side (%CS) and shoulder anterior-posterior and lateral view and axial view X-rays) was performed postoperatively.

Results

Clinical results after 45 months showed a mean CS of 66.2 ± 15.4 points with a mean agCS of 90.0 ± 23.1%. Evaluation of the %CS showed 77.7 ± 17.8%. %CS results showed no significant differences after 45 months in comparison to those obtained after 12 months. However, incidence of avascular necrosis of the humeral head doubled over the follow-up period from 4 cases at 12 months follow-up to 9 cases at final follow-up.

Conclusion

Results of open reduction and internal fixation with angular stable implants for proximal humeral fractures are reliable, however long-term complications such as avascular necrosis of the humeral head need to be evaluated further on since its incidence increases over the time.     

Health and cost consequences of surgical versus conservative treatment for a comminuted proximal humeral fracture in elderly patients

Objective

This study aims to evaluate the costs and health outcome for surgical and conservative treatment of displaced proximal humeral fractures.

Design

This study is a randomised controlled trial.

Participants

This study included 50 patients aged 60 or older admitted to hospital with a severely displaced three- or four-part fracture.

Interventions

The patients were treated surgically with an angular stable interlocking implant (25 patients) or conservative treatment (25 patients).

Main outcome measure

The outcomes measured included quality-adjusted life years (QALYs) and societal costs.

Results

At 12 months’ follow-up, the mean difference in the number of QALYs was 0.027 (95% confidence interval (CI) = −0.025, 0.078) while the mean difference in total health-care costs was €597 in favour of surgery (95% CI = −5291, 3777).

Conclusion

There was no significant difference in QALYs or costs between surgical and conservative treatment of severe displaced proximal humeral fractures.     

Micafungin Does Not Influence the Concentration of Tacrolimus in Patients After Allogeneic Hematopoietic Stem Cell Transplantation

Background

Tacrolimus is commonly used in stem cell transplant recipients for prophylaxis of graft-vs-host disease. Micafungin is widely used as a strong antifungal agent in empirical therapy in patients with febrile neutropenia. Both tacrolimus and micafungin are substrates of cytochrome P450 3A4 in vitro. Therefore, there is risk of drug interaction with concomitant administration of these drugs.

Objective

To estimate the drug interaction of tacrolimus and micafungin by evaluating the pharmacokinetics in 6 patients who had undergone allogeneic stem cell transplantation.

Results

The mean (SD) concentration-dose ratio of tacrolimus in all patients at 1, 4, 8, and 24 hours after concomitant administration of micafungin was 607 ± 306, 653 ± 328, 699 ± 340 and 671 ± 403 (ng/mL)/(mg/kg/d), respectively, and without micafungin was 756 ± 314 (ng/mL)/(mg/kg/d). The percentage of the concentration-dose ratio in patients treated with tacrolimus and micafungin vs patients treated with tacrolimus alone was 98%, 105%, 112%, and 108% at 1, 4, 8, and 24 hours, respectively. For both tacrolimus and micafungin, the 90% confidence intervals for the primary pharmacokinetic parameters (ie, the concentration-dose ratio at each point) ranged from 80% to 125%.

Conclusion

We conclude that there is no drug interaction between tacrolimus and concomitantly administered micafungin in stem cell transplantation recipients.     

Minimally invasive osteosynthesis in septic conditions

Background and purpose

Management of pyogenic spondylodiscitis in adults remains controversial. The aim of this study was to evaluate the results of a minimally invasive method for deformity correction and stabilization of these lesions with percutaneous osteosynthesis.

Methods

Ten patients were included in this study and treated with a two-step procedure: posterior percutaneous osteosynthesis completed by complementary intervertebral grafting via an anterior access. Postoperative evaluation was clinical and radiological with measurement of local sagittal deformity and restitution of vertebral body height.

Results

In this series, bacteriologic identification was possible and pain was controlled in every case. On postoperative evaluation, the implants were always properly positioned. The mean local sagittal deformation was +2.1° preoperatively and −8.4° postoperatively. The mean increase in vertebral body height was measured at 8 mm postoperatively. At the last follow-up, a moderate loss of correction was noted (mean: 2° and 3 mm) and all patients but one showed solid bony fusion.

Conclusion

Percutaneous osteosynthesis in septic conditions in association with an anterior graft provides satisfactory clinical and radiographic results. It provides a valuable alternative for deformity correction and spinal stabilization with a minimally invasive access in patients with comorbidities.     

Ghosts in the machine: a multi-institutional comparison of laparoscopic and open pyloromyotomy

Introduction

The purpose of this study was to compare laparoscopic and open pyloromyotomy using data from multiple centers in the United States.

Methods

Children's hospitals that have a predominant surgical approach to pyloromyotomy were identified in the Pediatric Health Information System database. Using 2005 data, institutions were stratified into open (OPEN) and laparoscopic (LAP) groups. Patients with significant comorbid conditions were excluded. Group differences were compared using t tests and Mann-Whitney nonparametric tests for continuous variables and exact tests for categorical variables.

Results

A total of 3 hospitals were in the LAP group (n = 207), and 4 hospitals were in the OPEN group (n = 357). The LAP group had a longer mean length of stay (LAP = 2.5 ± 1.7, OPEN = 2.1 ± 1.4 days; P = .02). Mean total hospital charges were similar in both groups (LAP = $11 307 ± 9499, OPEN = $11 245 ± 4841; P = .93), but there was significant skewness of the distribution for the LAP group. Nonparametric analysis demonstrated a statistically significant difference in charges (LAP median = $9727, min = $5075, max = $94 323, OPEN median = $10 001, min = $1614, max = $46 461; P = .004). Four patients in the LAP group had charges ranging from approximately $56 000 to $94 000, which may have resulted from surgical complications.

Conclusion

Prolonged length of stay and skewed hospital charge data in patients undergoing laparoscopic pyloromyotomy may be the result of rare but serious complications associated with the laparoscopic approach.     

Usefulness of the secretory unit of islet transplant objects (SUITO) index for evaluation of clinical autologous islet transplantation

Background

Assessing the engrafted islet mass is important in evaluating the efficacy of islet transplantation. We previously demonstrated that the average secretory unit of islet transplant objects (SUITO) index within 1 month of allogeneic islet transplantation was an excellent predictor of insulin independence. However, the usefulness of the SUITO index for evaluating autologous islet transplantation has not been explored. The purpose of the present study was to assess the relationship between the SUITO index and clinical outcomes after total pancreatectomy followed by autologous islet transplantation.

Methods

We performed 27 total pancreatectomies followed by autologous islet transplantation from October 2006 to January 2011. Cases were divided into an insulin-independent group (IIG; n = 12) and an insulin-dependent group (lDG; n = 15). The SUITO index was calculated by the formula [fasting C-peptide (ng/mL)/fasting glucose (mg/dL) −63] × 1,500. The average SUITO index within the first month of transplantation except for days 0, 1, and 2, maximum SUITO index, and most recent SUITO index were calculated in each case, and values were compared between the IIG and the IDG.

Results

The average SUITO index within 1 month was significantly higher in the IIG than in the IDG (24.6 ± 3.4 vs 14.9 ± 2.0, respectively; P < .02). The maximum SUITO indices were 45.7 ± 7.7 in the IIG and 30.1 ± 8.1 in the IDG (not significant), and the recent SUITO indices were 36.9 ± 6.7 in the IIG and 22.8 ± 6.1 in the IDG (not significant).

Conclusions

The average SUITO index within 1 month was an excellent predictor of insulin independence after total pancreatectomy followed by autologous islet transplantation.     

Renal cell carcinoma (RCC) in patients with end-stage renal disease exhibits many favourable clinical, pathologic, and outcome features compared with RCC in the general population

Background

Patients with end-stage renal disease (ESRD) are at risk of developing renal tumours.

Objective

Compare clinical, pathologic, and outcome features of renal cell carcinomas (RCCs) in ESRD patients and in patients from the general population.

Design, setting, and participants

Twenty-four French university departments of urology participated in this retrospective study.

Intervention

All patients were treated according to current European Association of Urology guidelines.

Measurements

Age, sex, symptoms, tumour staging and grading, histologic subtype, and outcome were recorded in a unique database. Categoric and continuous variables were compared by using chi-square and student statistical analyses. Cancer-specific survival (CSS) was assessed by Kaplan-Meier and Cox methods.

Results and limitations

The study included 1250 RCC patients: 303 with ESRD and 947 from the general population. In the ESRD patients, age at diagnosis was younger (55 ± 12 yr vs 62 ± 12 yr); mean tumour size was smaller (3.7 ± 2.6 cm vs 7.3 ± 3.8 cm); asymptomatic (87% vs 44%), low-grade (68% vs 42%), and papillary tumours were more frequent (37% vs 7%); and poor performance status (PS; 24% vs 37%) and advanced T categories (≥3) were more rare (10% vs 42%). Consistently, nodal invasion (3% vs 12%) and distant metastases (2% vs 15%) occurred less frequently in ESRD patients. After a median follow-up of 33 mo (range: 1-299 mo), 13 ESRD patients (4.3%), and 261 general population patients (27.6%) had died from cancer. In univariate analysis, histologic subtype, symptoms at diagnosis, poor PS, advanced TNM stage, high Fuhrman grade, large tumour size, and non-ESRD diagnosis context were adverse predictors for survival. However, only PS, TNM stage, and Fuhrman grade remained independent CSS predictors in multivariate analysis. The limitation of this study is related to the retrospective design.

Conclusions

RCC arising in native kidneys of ESRD patients seems to exhibit many favourable clinical, pathologic, and outcome features compared with those diagnosed in patients from the general population.     

Combination of BAY 60-4552 and vardenafil exerts proerectile facilitator effects in rats with cavernous nerve injury: a proof of concept study for the treatment of phosphodiesterase type 5 inhibitor failure

Background

Radical prostatectomy (RP) is frequently responsible for erectile dysfunction (ED). Post-RP patients often show a failure to respond to phosphodiesterase type 5 (PDE5) inhibitors.

Objective

The acute effect of BAY 60-4552, the soluble guanylate cyclase (sGC) stimulator, and vardenafil were evaluated alone or in combination on erectile responses to electrical stimulation of the cavernous nerve (ES CN) in rats with cavernous nerve (CN) crush injury-induced ED.

Design, setting, and participants

Male adult Sprague-Dawley rats underwent laparotomy (sham, n = 10) or bilateral CN crush injury (n = 56). After 3 wk of recovery, erectile function was evaluated under urethane anaesthesia following ES CN at different frequencies.

Measurements

The acute effects of intravenous (IV) injection of vehicle, vardenafil 0.03 mg/kg, BAY 60-4552 0.03 mg/kg or 0.3 mg/kg, or a BAY 60-4552 0.03 mg/kg plus vardenafil 0.03 mg/kg combination were evaluated in CN-crushed rats.

Results and limitations

Bilateral CN crush injury followed by a 3-wk recovery period decreased erectile responses to ES CN by about 50%. In CN-crushed rats, IV vardenafil 0.03 mg/kg and BAY 60-4552 (0.03 or 0.3 mg/kg) increased erectile responses to ES CN to the same extent: Δ intracavernosal pressure/mean arterial pressure (ICP/MAP) at 10 Hz ES CN was 21 ± 1% after vehicle, 25 ± 3% (p < 0.001) after vardenafil, and 26 ± 5% and 27 ± 5% after BAY 60-4552 0.03 mg/kg (p < 0.01) and 0.3 mg/kg (p < 0.001), respectively. The combination of vardenafil with BAY 60-4552 in CN-crushed rats totally restored erectile responses to ES CN equivalent to sham rats (ΔICP/MAP at 10 Hz ES CN: 34 ± 4% after BAY 60-4552/vardenafil combination vs 39 ± 4% in sham rats; not significant).

Conclusions

The present study supports the concept that the combined administration of a sGC stimulator, BAY 60-4552, and vardenafil provides synergistic beneficial effects and might therefore salvage patients who experience treatment failures with PDE5 inhibitors after RP.     

Effect of intravenous erythromycin on the colonic motility of children and young adults during colonic manometry

Purpose

Erythromycin is successfully used as a gastroduodenal prokinetic agent. Given the limited available treatments for colonic dysmotility, further investigation into erythromycin's effect on colonic motility is warranted. We aimed to study the effect of erythromycin on colonic motility in pediatric patients with recalcitrant chronic constipation/encopresis and other suspected colonic motility disorders.

Methods

Patients referred for colonic manometry were eligible for enrollment. Fasting motility was recorded for 1 to 2 hours, then erythromycin lactobionate (EL), 3 mg/kg, was administered intravenously, and colonic motility was monitored for 1 to 2 hours after erythromycin. Manometry was then continued per routine. The motility index (MI) of pressure tracings at each pressure transducer was calculated for each patient for a period of 15 and 60 minutes before and after EL infusion. Change in MI was compared by Wilcoxon signed rank test.

Results

Twenty patients were enrolled. The most common indication was constipation with encopresis. Seventy percent of patients had normal colonic manometry, and 30% of patients demonstrated a neuropathy. Average MI for the 60-minute period before and after EL infusion were 254 ± 74 mm Hg/h and 253 ± 94 mm Hg/h, respectively (P = .55). Average MI for the 15-minute period before and after EL infusion were 64 ± 23 mm Hg/15 min and 69 ± 32 mm Hg/15 min, respectively (P = .45).

Conclusions

Administration of intravenous EL resulted in no changes in colonic MI in pediatric patients referred for colonic manometry. Further studies on potential colokinetic agents are warranted in this population of patients.     

Mitigation of Cytokine Storm by Intraoperative Use of Renal Replacement Therapy During Combined Liver-Kidney Transplantation

Background

Combined liver-kidney transplantation (CLKT) is a widely used multiorgan transplantation with good graft survival rates. Previous studies have shown beneficial effects of renal replacement therapy in critically ill patients. This observation led us to use intraoperative continuous veno-venous hemofiltration (CVVH) during multiorgan transplantations.

Methods

We analyzed (CRP) inflammatory response parameters of tumor necrosis factor (TNF)α, interleukin(IL)-6, procalcitonin (PCT) and C-reactive protein (CRP) at various stages of the combined transplantations.

Results

All patients survived with well-functioning grafts. Mean ± SD follow-up was 32.8 ± 14.2 months. During the whole operation we used intraoperative CVVH starting at the beginning and continuing in the intensive care unit (ICU) afterward (mean ± SD, 11.2 ± 8.4 hours). Intraoperative TNFα, IL-6, CRP, and PCT were measured before surgery, during hepatectomy in the anhepatic phase, before and after liver reperfusion, exactly before kidney reperfusion, after kidney reperfusion, and upon arrival in the ICU. The wash-out of cytokines together with hemodynamic stability gave optimal circumstances for recovery of the transplanted organs.

Conclusions

CVVH-based therapy offered stable intraoperative parameters, prevention of fluid overload, correction of metabolic disturbances, and wash-out of cytokines, which gave optimal circumstances for recovery of transplanted organs.     

Magnetic resonance imaging measurement of the anorectal striated muscle complex in normal children

Purpose

The aim of the study was to describe and establish a normal measurement of the striated muscle complex (SMC) in healthy children using body phased-array or head coil magnetic resonance imaging.

Methods

Imaging was performed in 20 boys and 20 girls (age range, from 3 months to 14 years; average age, 3.2 years) without anorectal disorders. The dimensions of the puborectalis muscle (PR) and external anal sphincter (EAS) were measured in different planes.

Results

There was a close positive correlation between absolute width and length of SMC and age (P < .05), whereas there was no correlation between the relative width and length of SMC and age (P > .05). Normal relative length of the PR and EAS were measured as 0.47 ± 0.04 and 0.41 ± 0.04, respectively, and the normal relative width of PR and posterior EAS were 0.50 ± 0.04 and 0.44 ± 0.04 in children younger than 14 years.

Conclusions

The width and length of PR and EAS increase progressively with age. The relative width and length of PR and EAS were not variable with age. A relative width and length of PR and EAS were chosen as objective criteria for normal SMC in children younger than 14 years.     

Monitoring the natural evolution and response to treatment of post liver transplant recurrent hepatitis C using transient elastography: preliminary results

Objectives

To perform a prospective analysis of changes in liver stiffness (LS) using transient elastography (TE) in a consecutive series of patients with post-liver transplant (LT) recurrent hepatitis C, either left to their natural evolution or receiving antiviral treatment.

Methods

We examined the results from 17 comparisons of TE (baseline vs follow-up) from 11 patients. We evaluated: (1) upon inclusion in the study: age, sex, genotype, time transpired since LT, and baseline fibrosis (F0-4; Scheuer), and (2) during the follow-up period: time elapsed between the two TE and either specific treatment (B) or absence of treatment (A).

Results

Mean patient age was 56.8 ± 7.9 years, with a male/female ratio of 10:1. Ten of the eleven patients had genotype 1b. The median time transpired between the LT and inclusion in the study was 28 months (range: 6-142 months). The mean time transpired between the two TE was 11.3 ± 4.5 months. In the 11 patients from group A (9 F1/2 F2; 13 “paired” TE), a predictable increase in LS was produced in 10 cases and a paradoxical result was produced in 3 cases. In the four patients in group B (3 F2/1 F1; 4 “paired” TE), a decrease in LS was produced in 3 cases and a paradoxical result in 1 case.

Conclusions

In our study of patients left to their natural evolution, a slow increase of LS was normal. However, antiviral treatment appeared to decrease LS. TE can be very useful as a complementary test to biopsy for monitoring post-LT recurrent hepatitis C. A longer follow-up period and larger sample size could confirm these preliminary results.     

Laparoendoscopic single-site upper urinary tract surgery: assessment of postoperative complications and analysis of risk factors

Background

Laparoendoscopic single-site surgery (LESS) has been developed in an attempt to minimise the morbidity and scarring associated with surgical intervention.

Objective

To evaluate the incidence of and the risk factors for complications in patients undergoing LESS upper urinary tract surgery.

Design, setting, and participants

Between September 2007 and February 2011, 192 consecutive patients underwent LESS for upper urinary tract diseases at four institutions.

Measurements

All complications occurring at any time after surgery were captured, including the inpatient stay as well as in the outpatient setting. They were classified as early (onset <30 d), intermediate (onset 31-90 d), or late (onset >90 d) complications, depending on the date of onset. All complications were graded according to the modified Clavien classification.

Results and limitations

The patient population was generally young (mean: 55 ± 18 yr of age), nonobese (mean body mass index [BMI]: 26.5 ± 4.8 kg/m²), and healthy (mean preoperative American Society of Anaesthesiologists [ASA] score: 2 ± 1). Forty-six patients had had prior abdominal surgery. Mean operative time was 164 ± 63 min, with a mean estimated blood loss (EBL) of 147 ± 221 ml. In 77 cases (40%), the surgeons required additional ports, with a standard laparoscopy conversion rate of 6%. Mean hospital stay was 3.3 ± 2.3 d, and the mean visual analogue scale (VAS) score at discharge was 1.7 ± 1.43. Thirty-three complications were recorded—30 early, 2 intermediate, and 1 late—for an overall complication rate of 17%. Statistically significant associations were noted between the occurrence of a complication and age, ASA score, EBL, length of stay (LOS), and malignant disease at pathology. Univariable and the multivariable analyses showed that a higher ASA score (incidence rate ratio [IRR]: 1.4; 95% confidence interval [CI], 1.0-2.1; p = 0.034) and malignant disease at pathology (IRR: 2.5; 95% CI, 1.3-4.7; p = 0.039) represented risk factors for complications. Poisson regression analysis over time showed a 23% non-statistically significant reduction in risk of complications every year (IRR: 0.77; 95% CI, 0.5-1.19; p = 0.242).

Conclusions

Malignant disease at pathology and high ASA score represent a predictive factor for complication after LESS for upper urinary tract surgery. Thus, surgeons approaching LESS should start with benign diseases in low-surgical-risk patients to minimise the likelihood of postoperative complications.     

Effectiveness of Rex shunt in the treatment of portal hypertension

Background

Children with portal venous thrombosis often have severe symptoms secondary to portal hypertension including recurrent upper gastrointestinal (UGI) bleeds and hypersplenism. We report results of the use of the mesenterico-left portal bypass (Rex shunt) in 5 consecutive patients.

Methods

A retrospective chart review of all patients with portal venous thrombosis who underwent Rex shunt procedure was performed. Children were evaluated preoperatively with magnetic resonance angiogram, Doppler ultrasound, and mesenteric angiogram. Postoperative ultrasounds were performed in follow-up.

Results

All patients had evidence of portal hypertension and hypersplenism. The average age of the patients was 13.2 ± 4.9 (7-19) years. The patient had an average of 2.6 ± 1.7 UGI bleeds requiring banding and 3.4 ± 4.2 U of blood transfused before undergoing the shunt. The mean operative time was 383 ± 46 minutes, and length of stay was 10.4 ± 7.1 days. In follow-up of 18.8 ± 5.2 months (11-24 months), all but 1 patient had a patent shunt. One narrowed shunt was successfully dilated by percutaneous angioplasty. Thrombocytopenia improved significantly in patients with functioning shunts but did not correlate with a significant decrease in splenic size.

Conclusions

The Rex shunt reestablishes normal hepatopedal portal flow, and in patients with functioning shunts, no recurrent UGI bleeds or transfusions were required or evidence of encephalopathy were noted.     

Impact of biventricular and left ventricular pacing on hemodynamics and left ventricular dyssynchrony compared with right ventricular pacing in the early postoperative period following cardiac surgery

Objectives

The aims of this study were to test the hypotheses that in the postoperative period following corrective surgery for congenital heart defects: (i) atrio-right ventricular (RA-RV) pacing decreases cardiac output (CO) compared with right atrial (RA) pacing, (ii) atrio-biventricular (RA-BiV) and left ventricular (RA-LV) pacing improves CO compared with RA-RV pacing.

Study design

Prospective observational study.

Patients

Children 0-2 years of age referred for surgery of congenital heart defects were studied during intrinsic rhythm and atrial, atrio-right ventricular, atrio-left ventricular and atrio-biventricular pacing. CO, extrapolated from mean systolic aortic velocity (MSAV), and left ventricular dyssynchrony were assessed using transthoracic echocardiography.

Results

RA-RV pacing induced a significant decrease in CO (MSAV 0.52 ± 0.19 m/s to 0.46 ± 0.16 m/s, p = 0.01) and a significant increase in LV dyssynchrony (8.7 ± 7.9 ms to 33 ± 21 ms, p = 0.001). RA-BiV pacing induced a significant increase in CO (MSAV 0.46 ± 0.16 m/s to 0.52 ± 0.18 m/s, p = 0.01) and a significant decrease in LV dyssynchrony (33 ± 21 ms to 7 ± 4 ms, p = 0.0003) compared with RA-RV pacing. RA-LV pacing induced a significant decrease in LV dyssynchrony (33 ± 21 ms to 9 ± 7 ms, p = 0.0007) without a significant improvement of CO compared with RA-RV pacing.

Conclusions

RA-BiV pacing improves CO compared with RA-RV pacing in the early postoperative period following pediatric cardiac surgery. This improvement is related to a reduction in left ventricular dyssynchrony.     

Clinical Application of Cordyceps sinensis on Immunosuppressive Therapy in Renal Transplantation

Objective

We sought to explore the adjunctive effects of Cordyceps sinensis (CS) in clinical renal transplantation.

Materials and Methods

Patients (n = 202) were divided randomly by lottery into a treatment (n = 93) and a control group (n = 109). Patients in the treatment group were treated with CS 1.0 g 3 times a day in addition to the immunosuppressive regimen given to the control group. We compared patient and graft survivals, incidence, time and severity of acute rejection episodes, chronic allograft nephropathy (CAN), hepatotoxicity and nephrotoxicity, biochemistry parameters including indicators of liver and kidney functions, fats, proteinuria, dosages, and whole blood concentrations of cyclosporine (CsA).

Results

Patient and graft survival rates, serum creatinine (SCr), and blood urea nitrogen (BUN) were not significantly different between the 2 groups (P > .05). Serum uric acid (UA) and 24-hour urinary total protein (24-hour UTP) were significantly lower in the treatment group than in the control group (P < .05). The incidences (11.83% vs 15.60%) and times to acute renal allograft rejection (23.48 ± 7.22 vs 22.27 ± 8.03 days posttransplantation) were not significantly different between the treated and control groups (P > .05). Patients receiving thymoglobulin antirejection therapy (3 cases) were fewer in the heated versus control group (13 cases; P = .014). The incidences of hepatotoxicity and nephrotoxicity in the treated group were 12.90% and 19.35%, significantly lower than 24.77% and 33.94% in the control group, respectively (P < .05). At 2 to 6 months posttransplantation, the CsA dosages in the treated group were significantly lower than those in the control group (P < .05). The whole blood trough CsA concentrations in the treated group were significantly lower than those in the control group at 3 to 6 months posttransplantation (P < .05). The decreasing trends of the 2 aforementioned parameters in the treatment group were approximately linear among treated subjects compared with approximately quadratic in the control group (P < .05). The incidence of CAN in the treated group was 7.53%, which was significantly lower than 18.35% in the control group (P = .024). The 24-hour UTP level in CAN patients within the treated group was significantly lower than the control group after transplantation (P = .045). The differences in total bilirubin, SCr, serum UA, and total cholesterol levels among otherwise normal patients in the treated group were significantly lower than those among the control group (P < .05).

Conclusions

The use of CS may allow decreased dosages and concentrations of CsA causing fewer side effects without an increased risk of acute rejection. In addition, CS with reduced dose CsA may decrease proteinuria and retard CAN progression.     

Cancer-specific and other-cause mortality after radical prostatectomy versus observation in patients with prostate cancer: competing-risks analysis of a large North American population-based cohort

Background

Initial treatment options for low-risk clinically localized prostate cancer (PCa) include radical prostatectomy (RP) or observation.

Objective

To examine cancer-specific mortality (CSM) after accounting for other-cause mortality (OCM) in PCa patients treated with either RP or observation.

Design, setting, and participants

Using the Surveillance Epidemiology and End Results Medicare-linked database, a total of 44 694 patients ≥65 yr with localized (T1/2) PCa were identified (1992-2005).

Intervention

RP and observation.

Measurements

Propensity-score matching was used to adjust for potential selection biases associated with treatment type. The matched cohort was randomly divided into the development and validation sets. Competing-risks regression models were fitted and a competing-risks nomogram was developed and externally validated.

Results and limitations

Overall, 22 244 (49.8%) patients were treated with RP versus 22450 (50.2%) with observation. Propensity score-matched analyses derived 11 669 matched pairs. In the development cohort, the 10-yr CSM rate was 2.8% (2.3-3.5%) for RP versus 5.8% (5.0-6.6%) for observation (absolute risk reduction: 3.0%; relative risk reduction: 0.5%; p < 0.001). In multivariable analyses, the CSM hazard ratio for RP was 0.48 (0.38-0.59) relative to observation (p < 0.001). The competing-risks nomogram discrimination was 73% and 69% for prediction of CSM and OCM, respectively, in external validation. The nature of observational data may have introduced a selection bias.

Conclusions

On average RP reduces the risk of CSM by half in patients aged ≥65 yr, relative to observation. The individualized protective effect of RP relative to observation may be quantified with our nomogram.