Effects of Sustained‐Release Beraprost in Patients With Primary Glomerular Disease or Nephrosclerosis: CASSIOPEIR Study Results

TRK‐100STP, a sustained‐release preparation of the orally active prostacyclin analogue beraprost sodium, targets renal hypoxia. This study aimed to show the superiority of TRK‐100STP over placebos in patients with chronic kidney disease (with either primary glomerular disease or nephrosclerosis) to determine the recommended dose. CASSIOPEIR (Chronic Renal Failure Asian Study with Oral PGI₂ Derivative for Evaluating Improvement of Renal Function) was a randomized, double‐blind, placebo‐controlled study conducted at 160 sites in seven Asia‐Pacific countries and regions. Eligible patients (n = 892) were randomized to TRK‐100STP 120, 240 μg, or placebo for a treatment period of up to 4 years. The primary efficacy endpoint was time to first occurrence of a renal composite: doubling of serum creatinine or occurrence of end‐stage renal disease. No significant differences were observed in composite endpoints between TRK‐100STP and placebo (P = 0.5674). Hazard ratios (95% CI) in the TRK‐100STP 120 and 240 μg vs. placebo groups were 0.98 (0.78, 1.22) and 0.91 (0.72, 1.14), respectively. The overall incidence of adverse events and adverse drug reactions was comparable between treatment arms.     

Effects of low‐frequency intravaginal electrical stimulation on female urinary incontinence,quality of life,and urinary symptoms: A pilot study

This study investigated the effects of a low‐frequency home‐based incontinence therapy device on quality of life (QoL) and urinary symptoms in women with urinary incontinence. From May 2017 to February 2018, 34 patients, aged ≥ 20 years, with involuntary urine leakage >2 times/week, were recruited to this study. Patients with severe pelvic organ prolapse, pregnancy, virgin status, and psychological problems were excluded. The incontinence home‐care device treatments were administered in 12‐minute sessions, twice daily for 8 weeks. Simultaneously, hyperthermic conditions of 35°C to 40°C and microvibrations were administered. All patients completed urinary incontinence questionnaires (King's Health Questionnaire [KHQ], Bristol Female Lower Urinary Tract Symptoms [BFLUTS] questionnaire, and the Overactive Bladder Symptom Score [OABSS]) before treatment, as well as 4 and 8 weeks into treatment. Changes in the questionnaire responses over time were compared. Two participants dropped out of the study and there was one screening failure, leaving 31 patients for analysis. After 4 weeks treatment, there were significant improvements in symptoms, such as role limitation, physical limitation, social limitation, personal relationship, emotion, sleep/energy, and severity measures. After 8 weeks treatment, almost all parameters on the KHQ revealed symptomatic improvement. On the BFLUTS, voiding times during activity, nocturia, urgency, urge incontinence, incontinence frequency, stress incontinence, volume leakage, strain to start, intermittency, reduced stream, acute retention, incomplete emptying, and stopping flow showed significant improvements. On the OABSS, almost all storage symptoms improved. Low‐frequency electrical stimulation devices were effective at improving urinary incontinence, which became evident as the duration of treatment increased. Improvement of urgency and frequency was more evident after treatment.     

The Effect of the Statewide Sharing Variance on Geographic Disparity in Kidney Transplantation in the United States

Background and objectives

The Statewide Sharing variance to the national kidney allocation policy allocates kidneys not used within the procuring donor service area (DSA), first within the state, before the kidneys are offered regionally and nationally. Tennessee and Florida implemented this variance. Known geographic differences exist between the 58 DSAs, in direct violation of the Final Rule stipulated by the US Department of Health and Human Services. This study examined the effect of Statewide Sharing on geographic allocation disparity over time between DSAs within Tennessee and Florida and compared them with geographic disparity between the DSAs within a state for all states with more than one DSA (California, New York, North Carolina, Ohio, Pennsylvania, Texas, and Wisconsin).

Design, setting, participants, & measurements

A retrospective analysis from 1987 to 2009 was conducted using Organ Procurement and Transplant Network data. Five previously used indicators for geographic allocation disparity were applied: deceased-donor kidney transplant rates, waiting time to transplantation, cumulative dialysis time at transplantation, 5-year graft survival, and cold ischemic time.

Results

Transplant rates, waiting time, dialysis time, and graft survival varied greatly between deceased-donor kidney recipients in DSAs in all states in 1987. After implementation of Statewide Sharing in 1992, disparity indicators decreased by 41%, 36%, 31%, and 9%, respectively, in Tennessee and by 28%, 62%, 34%, and 19%, respectively in Florida, such that the geographic allocation disparity in Tennessee and Florida almost completely disappeared. Statewide kidney allocations incurred 7.5 and 5 fewer hours of cold ischemic time in Tennessee and Florida, respectively. Geographic disparity between DSAs in all the other states worsened or improved to a lesser degree.

Conclusions

As sweeping changes to the kidney allocation system are being discussed to alleviate geographic disparity—changes that are untested run the risk of unintended consequences—more limited changes, such as Statewide Sharing, should be further studied and considered.     

Underweight Body Mass Index as a Predictive Factor for Surgical Site Infections after Laparoscopic Appendectomy

Purpose

Analyses of risk factors associated with surgical site infections (SSIs) after laparoscopic appendectomy (LA) have been limited. Especially, the association of an underweight body mass index (BMI) with SSIs has not been clearly defined. This study aimed to identify the impact of underweight BMI in predicting SSIs after LA.

Materials and Methods

The records of a total of 101 consecutive patients aged ≥16 years who underwent LA by a single surgeon between March 2011 and December 2012 were retrieved from a prospectively collected database. The rate of SSIs was compared among the underweight, normal and overweight and obese groups. Also, univariate and multivariate analyses were performed to identify the factors associated with SSIs.

Results

The overall rate of SSIs was 12.8%. The superficial incisional SSI rate was highest in the underweight group (44.4% in the underweight group, 11.0% in the normal group, and 0% in the overweight and obese group, p=0.006). In univariate analysis, open conversion and being underweight were determined to be risk factors for SSIs. Underweight BMI was also found to be a significant predictor for SSIs in multivariate analysis (odds ratio, 10.0; 95% confidence interval, 2.0-49.5; p=0.005).

Conclusion

This study demonstrated underweight BMI as being associated with SSIs after LA. Surgeons should be more cautious to prevent SSIs in patients that are underweight when performing LA.