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.     

High-Dose Inhaled Budesonide May Substitute for Oral Therapy After an Acute Asthma Attack

Patients attending the emergency room with acute asthma, participating in a study comparing salbutamol (albuterol in the United States) via a dry powder inhaler (Turbuhaler®) with pressurized metered-dose inhaler (pMDI), were included in this 1-week follow-up study with the aim of assessing whether inhaled budesonide via Turbuhaler may be an alternative to prednisolone tablets after an acute asthma attack. Eighty-one patients with a mean age of 38 years and forced expiratory volume in 1 sec (FEV₁) of 64% predicted normal value after treatment with salbutamol were randomized in this double-blind, double-dummy, parallel-group study. The doses given were budesonide 1600 μg b.i.d. or prednisolone in daily doses from 40 mg (day 1) decreased to 5 mg (day 7). FEV₁ was recorded before and after the 7-day treatments and peak expiratory flow (PEF) morning and evening, clinical symptoms (visual analogue scale 0-100), and doses of rescue medication (terbutalineTurbuhaler 0.25 mg/dose) were recorded daily. The mean increase in FEV, from baseline to day 7 was 1 7.3% in the budesonide Turbuhaler group and 1 7.6% in the prednisolone group. Mean values of morning PEF increased from day 1 to day 7 by 67 L/min in the budesonide Turbuhaler group and by 57 L/min in the prednisolone group (not significant). There were no statistically significant differences between the groups in clinical symptoms and in the number of doses of rescue medication. Because of disease deterioration, five patients in the Turbuhaler group and three in the prednisolone group needed additional symptomatic as well as corticosteroid treatment. Inhaled budesonide in high doses may be a substitute for oral therapy as follow-up treatment after an acute asthma attack.     

Trends in COPD mortality and hospitalizations in countries and regions of Asia-Pacific

Background and objective: The growing burden of COPD in the Asia‐Pacific region supports the need for more intensive research and analysis of the epidemiology of COPD to raise awareness of the disease and its causes, to ensure the development of effective national health policies and to facilitate equitable deployment of finite health‐care resources in the prevention and management of COPD. This study estimated and compared COPD mortality and hospital morbidity rates and trends in these rates over time across countries and regions of Asia‐Pacific. Methods: Data consistent with standard definitions of COPD (ICD‐9/ICD‐10) for the period 1991–2004 were obtained from national health statistics agencies. For countries/regions with complete national mortality and hospitalization data (Australia, Pacific Canada (British Columbia, Hong Kong, South Korea and Taiwan), annual age‐standardized mortality and hospitalization rates were calculated for men and women aged ≥ 40 years. Negative binomial regression modelling was used to estimate rate ratios for country/region, gender and age differences and general trends over time. Results: Mortality rates per 10 000 population ranged 6.4–9.2 in men, 2.1–3.5 in women and 3.7–5.3 overall in 2003. Corresponding ranges for morbidity were 32.6–334.7, 21.2–129 and 28.1–207.3 per 10 000. Trend analysis of data since 1997 produced annual percentage changes in mortality versus hospitalization of ?4.4% versus ?0.7% in Australia, ?3.6% versus 7.5% in Pacific Canada (British Columbia), ?7.15% versus ?5.6% in Hong Kong and ?2.9% versus ?4.2% in Taiwan. Conclusions: In Asia‐Pacific, overall mortality and morbidity rates are high and trends in mortality and morbidity vary between countries/regions. Differences in rates and trends for men and women most likely reflect the different trends in historical and prevalent smoking profiles for COPD in the different countries and regions.     

Comparison between specified percentage and fifth percentile criteria for spirometry interpretation in Thai patients

OBJECTIVES: The present study was conducted to determine the degree of agreement between the interpretation of spirometry using a specified percentage of predicted value (SPC) and the fifth percentile (FPC) as the cut off between normal and abnormal. METHODOLOGY: Spirometric values were collected for 1754 subjects attending the respiratory service at Siriraj Hospital between February 2000 and April 2001. These values included forced vital capacity (FVC), forced expiratory volume in 1 s (FEV1), FEV1/FVC, maximal mid-expiratory flow (FEF25-75%) and peak expiratory flow (PEF). A comparison of results between SPC and FPC was performed. The SPC cut-off values for FVC, FEV1, FEV1/FVC, FEF25-75% and PEF were 80% predicted, 80% predicted, 70%, 65% predicted and 80% predicted, respectively. The FPC cut-off values were calculated from reference equations for the Thai population. Inter-rater agreement was calculated as the kappa score. RESULTS: High kappa scores were obtained for FVC (0.84), FEV1 (0.88) and FEF25-75% (0.80). However, poor agreement was found for FEV1/FVC (0.72) and PEF (0.61). When the cut-off values for SPC were modified to 90% of predicted values for FEV1/FVC and to 65% of predicted values for PEF, agreement was substantially improved to 0.92 and 0.89, respectively. CONCLUSIONS: Interpretation by SPC using cut-off values of 80% predicted for FVC and FEV1 and 65% predicted for FEF25-75% resulted in good agreement with FPC. However, the SPC cut-off values for FEV1/FVC and PEF should be modified to 90% predicted and 65% predicted, respectively.     

Results of chimney modification technique in ureterointestinal anastomosis of Hautmann ileal neobladder in bladder cancer

BACKGROUND: To evaluate the surgical technique and functional outcome of a new application of the chimney modification to the popular Hautmann ileal neobladder. This modification used 3-5 cm chimney tubularized ileal segment for the bilateral ureterointestinal anastomosis. METHODS: Between December 2000 and July 2004, 15 patients (14 men, 1 woman) with invasive bladder cancer underwent radical cystectomy and Hautmann neobladder with chimney modification at Siriraj Hospital, Bangkok. Mean age was 61.7 years (range, 43-72 years). Perioperative morbidity, early and late urinary diversion-related complications, other surgical complications, follow-up results of ureterointestinal anastomosis, renal function and metabolic disorders were evaluated. Patients were interviewed about their continence, voiding function and potency. RESULTS: At a mean follow-up of 29.5 months, two patients had died of cancer progression. Of the 15 patients, nine (60%) had 10 early complications. Eight complications were related to the neobladder and two were not. Three (20%) patients had three late complications. Two complications were neobladder-related and one was not. There was no perioperative mortality. There was no ureteroileal anastomosis stricture in this series. Neobladder-ureteral reflux was demonstrated in eight of 22 ureteral units in 11 patients in whom cystography was performed. All patients had normal upper urinary tract without evidence of urinary obstruction. All 14 men (93% of study sample) had spontaneous urination, normal renal function and no metabolic acidosis. Good and satisfactory continence in the day and night were 93% and 73%, respectively. All male patients experienced impotence postoperatively. Only one sought treatment and was successfully treated with sildenafil. The one woman in this study required intermittent catheterization to empty the neobladder completely. She also had renal insufficiency with serum creatinine of 2.2 mg/dL and hyperchloraemic metabolic acidosis. CONCLUSION: New chimney modification in Hautmann ileal neobladder is simple and safe. Complications are acceptable. Follow-up results of renal and voiding functions are satisfactory. This operation can maintain good quality of life for patients with bladder cancer undergoing radical cystectomy.     

Restrictive lung disease and serum TGF-beta1 in thalassemia major children

A cross sectional study was performed in 21 thalassemia major (TM) children at King Chulalongkorn Memorial Hospital during March to August, 2003 to determine whether restrictive lung disease (RLD) was related to serum transforming growth factor-beta 1 (TGF-beta1). All studied patients (57% female, age 11.2 +/- 2.6 yrs, duration of transfusion 7.7 +/- 4.1 yrs) never had desferoxamine treatment and their pulmonary function, serum ferritin and serum TGF-beta1 were evaluated. Five (24%) had RLD. RLD patients had significantly longer durations of transfusion and higher serum ferritin levels than non-RLD patients (9.1 +/- 1.9 vs 5.5 +/- 3.2 yrs; p = 0.03 and 3,816.6 +/- 1,715.9 vs 2,084.5 +/- 1,504.8 ng/ml; p = 0.04, respectively). TM children had lower serum TGF-beta1 levels than normal children (7.9 vs 78.8 pg/ml; p < 0.001). The serum TGF-beta1 level was not different between RLD and non-RLD patients (13.3 vs 4.2 pg/ml; ns), concluding that RLD was related to longer duration of transfusion and higher serum ferritin but not related to serum TGF-beta1 levels.     

Allergen sensitization to aeroallergens including Blomia tropicalis among adult and childhood asthmatics in Thailand

To study prevalence of allergen sensitization among asthmatics in Thailand, skin prick tests (SPT) were performed in 84 pediatric, 71 adult asthmatics and 71 adult volunteers. Allergen extracts used for testing included common allergens in Thailand and in Singapore. The incidence of positive SPT to any allergen among the three groups (childhood, adult patients and adult controls) were 64.3%, 43.7% and 35.2%, respectively. Dermatophagoides were the most common allergens sensitized by both pediatric (58.3%) and adult asthmatics (40.8%). Twenty-four children (28.6%) and 8 adult patients (11.3%) were sensitized to storage mites (Blomia tropicalis and/or Austroglyciphagus malaysiensis). All patients sensitized to Blomia tropicalis were sensitized to Dermatophagoides. Twenty-seven percent and 15.5% of childhood and adult asthmatics were sensitized to cockroach allergens. The rates of sensitization to oil palm pollen in childhood and adult asthmatics were 8.3% and 5.6%, respectively. Sensitization to other pollens and spores were less than 5%. This study confirms the importance of Dermatophagoides among Thai asthmatics.     

Prevalence of Mycoplasma and Chlamydia pneumonia in severe community-acquired pneumonia among hospitalized children in Thailand

Pneumonia is the leading cause of pediatric morbidity and mortality worldwide, and Mycoplasma pneumoniae and Chlamydia pneumoniae are the two most common atypical pathogens. This study was designed to determine the prevalence and clinical impact of mycoplasma and chlamydia pneumonia in children hospitalized with severe pneumonia. Children 1 month-15 years old with a diagnosis of severe pneumonia (WHO criteria) were recruited between March 2005 and March 2006. Serologic studies were performed for anti-M. pneumoniae and anti-C. pneumoniae IgG/M on admission and 2-4 weeks afterward using ELISA. Of 52 patients, 13 (25%) were positive for Mycoplasma, 8 (15%) were positive for Chlamydia, 4 (7.6%) were positive for a mixed infection and 27 (52%) were negative. The subjects' mean age was 23.8+/-4.1 months. The mean of initial oxygen saturation on admission was 87.5+/-1.2%. Fever and prolonged cough were the leading symptoms. The mean of hospitalization was 18.8+/-2.6 days, chlamydia pneumonia had the longest duration, 30+/-10.2 days and 13/52 (25%) study subjects developed respiratory failure. Only 10% were treated with adequate antibiotic prior to serologic results. There was one mortality (1/52, 2%). Our study suggests that mycoplasma and chlamydia infections are commonly found among children hospitalized with severe pneumonia. Coverage with an appropriate antibiotic should be considered to hasten recovery.     

Lidocaine Levels During the First Two Hours of Infiltration of Dilute Anesthetic Solution for Tumescent Liposuction: Rapid Versus Slow Delivery

BACKGROUND: Tumescent anesthesia for liposuction with dilute lidocaine has been well documented to result in peak serum levels 4-14 hours after infiltration. Pharmacokinetic studies have shown that the rate of lidocaine absorption is related not only to dilution, but also to the speed of subcutaneous infiltration. Early studies with a more concentrated solution of lidocaine (1.0%) have shown that with rapid infusion, peak plasma levels may occur within 30 minutes. OBJECTIVE: To determine whether rapid absorption of lidocaine may occur during infusion of tumescent solution by varying the rate of infusion of dilute lidocaine solution (0.05% or 0.1%) and observing serum levels of lidocaine within the first 2 hours of the procedure. METHODS: Eighteen patients participated in this study and were infused with a standard liposuction tumescent formula consisting of lidocaine either 0.05% or 0.1%. The rates of infusion of tumescent anesthesia ranged from 27.1 mg/min up to 200 mg/min infused over a period of 5 minutes to 2 hours. Total lidocaine infused ranged from 7.4 to 57.7 mg/kg. Serum levels of lidocaine were taken every 15 minutes during the first hour of the procedure and repeated at 2 hours. RESULTS: In all 18 patients, lidocaine levels remained significantly below the toxic range and were always less than 2.0 microgram/ml. In 11 patients, lidocaine levels at all time intervals were less than 0.5 microgram/ml. In seven patients, the lidocaine levels ranged from 0.6 to 1.9 microgram/ml at varying intervals. There was no correlation between the maximum dose of lidocaine (mg/kg) or rate of lidocaine delivered (mg/ml) with plasma levels of lidocaine. CONCLUSION: Despite variability, the serum levels of lidocaine remained well within safety limits during infusion of tumescent solution and the first hours of the procedure when infused in rates up to 200 mg/min with spinal needles and/or small diameter multiholed infusion cannulas.