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.     

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.     

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.     

Both EMLA and Placebo Cream Reduced Pain during Extracorporeal Piezoelectric Shock Wave Lithotripsy with the Piezolith 2300

Background: The objectives were to determine whether a eutectic mixture of local anesthetic (EMLA) or placebo cream reduces pain during extracorporeal piezoelectric shock wave lithotripsy (EPSWL), and to determine which of the components of the application (i.e., the occlusive dressing, the cream, or the local anesthetic) contributes to analgesia.

Methods: A randomized, double blind, crossover study (part 1) was performed in 12 patients who were scheduled for EPSWL procedures on an ambulatory basis who received the first treatment without any intervention and who had verbal pain scores of 70 or more (on a 0-to-100 scale). For the next two treatments at 2-week intervals, patients were randomly assigned to receive either 10 g EMLA or 10 g placebo cream and then crossed over to receive the other. The cream and occlusive dressing were left in place and immersed in water throughout the procedure. Verbal numeric pain score was assessed at 5 min after receiving the maximal tolerable intensity of shock wave and at the end of the procedure. The study continued (part 2) in 202 ambulatory patients; 125 men and 77 women, American Society of Anesthesiologists physical status I and II, subjected to EPSWL were randomly allocated into five groups who received (1) nothing on the skin (control), (2) plastic occlusive dressing, (3) placebo cream and plastic occlusive dressing, (4) EMLA cream and plastic occlusive dressing, (5) EMLA cream and plastic occlusive dressing for 60 min to achieve cutaneous anesthesia, which was removed before EPSWL. Pain score was evaluated 10 min into the procedure and at the end of the procedure.

Result: Both parts of the study showed that patients who received either EMLA or placebo cream with dressing throughout the procedure experienced less pain and tolerated higher energy levels compared with the control. Patients who received only pre-EPSWL cutaneous anesthesia of EMLA and who received only the occlusive dressing did not have a reduction in pain score.     

Acute respiratory illness in patients with COPD and the effectiveness of influenza vaccination: a randomized controlled study

STUDY OBJECTIVES: To determine the effectiveness of influenza vaccination on influenza-related acute respiratory illness (ARI) and overall ARI in patients with COPD, and its relationship to the degree of airflow obstruction. DESIGN: Stratified, randomized, double-blind, placebo-controlled trial. SETTING: From June 1997 to November 1998 at a single university hospital. Patients and interventions: One hundred twenty-five patients with COPD were stratified based on their FEV(1) as having mild, moderate, and severe COPD. Within each group, they were randomized to the vaccine group (62 patients who received purified, trivalent, split-virus vaccine) or the placebo group (63 patients). MEASUREMENTS: The number of episodes and severity of total ARI, classified as outpatient treatment, hospitalization, and requirement of mechanical ventilation; and the number of episodes and severity of influenza-related ARI. RESULTS: The incidence of influenza-related ARI was 28.1 per 100 person-years and 6.8 per 100 person-years in the placebo group and vaccine group, respectively (relative risk [RR], 0.24 [p = 0.005]; vaccine effectiveness, 76%). The incidences were 28.2, 23.8, and 31.2 per 100 person-years in the patients with mild, moderate, and severe COPD, respectively, in the placebo group, and 4.5, 13.2, and 4.6 per 100 person-years in the patients with mild, moderate, and severe COPD, respectively, in the vaccine group (RR, 0.16 [p = 0.06]; vaccine effectiveness, 84%; RR, 0.55 [p = 0.5]; vaccine effectiveness, 45%; and RR, 0.15 [p = 0.04]; vaccine effectiveness, 85%, in the patients with mild, moderate, and severe COPD, respectively). Bivariate analysis revealed that the effectiveness of influenza vaccination was not modified by the severity of COPD, comorbid diseases, age, gender, or current smoking status. There was no difference in the incidence or severity of total ARI between the placebo group and the vaccine group. CONCLUSIONS: Influenza vaccination is highly effective in the prevention of influenza-related ARI regardless of the severity of COPD. Influenza vaccination does not prevent other ARIs unrelated to influenza. The effectiveness of influenza vaccination in the prevention of overall ARI in patients with COPD will depend on how much the proportion of influenza-related ARI contributes to the incidence of total ARI. Influenza vaccination should be recommended to all patients with COPD.     

Ergotism unresponsive to multiple therapeutic modalities, including sodium nitroprusside, resulting in limb loss

Unlike epidemics in past centuries, patients suffering from peripheral vascular ischemia related to ergotism now rarely lose a limb because of vasodilator therapies. We report a patient with ischemia from ergotamine tartrate who failed to recover with medical therapy, resulting in limb amputation.