A Randomized Controlled Trial of Seroconversion After 20 Mg versus 40 mg Intramuscular Hepatitis B Virus Vaccination in Patients with Chronic Kidney Disease Stage 3.

Background: There is as yet no guideline for hepatitis B virus (HBV) vaccination in chronic kidney disease (CKD). There is also insufficient evidence to support the theory that the immune response to a double dose (40 µg) of HBV vaccine is greater than that achieved by the standard dose (20 µg). Objective: To compare seroconversion of the four-dose regimen (at 0, 1, 2, 6 months) of intramuscular recombinant DNA HBV vaccination using the standard 20 µg with that of 40 µg in patients with CKD stage 3. Material and Method: This study included 39 patients with CKD stage 3 who had neither history of HBV vaccination nor markers of HBV infection, namely hepatitis B surface antigen (HBs Ag), antibody to hepatitis B core antigen (anti-HBc), or antibody to hepatitis B surface antigen (anti-HBs). After randomization, 20 patients were given 20 µg and 19 patients received 40 µg of vaccine in a four-dose regimen of HBV immunization. Immune response was assessed by measuring anti-HBs at the 2nd, 6th, 7th and 12th months. Anti-HBs at levels equal to or more than 10 IU/L were considered to constitute seroconversion. Results: Rates of seroconversion in the 20 µg versus the 40 µg groups at the 2nd, 6th, 7th, 12th month were 50.0%:52.6% (p = 0.869), 65.0%:100.0% (p = 0.004), 95.0%:100.0% (p = 0.323) and 80.0%:100.0% (p = 0.040) respectively. Six months after completing the vaccination, some patients (20.0%) in the 20 µg group had lost their immune response while all in the 40 µg group still maintained their seroconversion. During the study, there was no significant change in eGFR in the two groups (p>0.05), and minor adverse effects including local pain, malaise, fatigue, and dizziness were not significantly different between the two groups. Conclusion: Seroconversion rates of the two groups were not significantly different after completion of HBV vaccination, but only patients in the group receiving the double dose were able to maintain seroconversion 6 months later. The proper hepatitis B vaccination for patients with CKD stage 3 with negative makers of HBV should be immunization with a four-dose regimen using 40 µg of vaccine.

Survival Rates and Mortality Risk Factors of Thai Patients with Type 2 Diabetes Mellitus.

Background: Type 2 diabetes mellitus (T2DM) is a common public health problem due to both its micro- and macro-vascular chronic complications. Data on survival rates and mortality risk factors of T2DM in Thailand need to be investigated and updated. Objective: To assess the survival rate and mortality risk factors in T2DM patients. Material and Method: This study is a part of the Thai DMS Diabetes Complications project which is a prospective observational 4-year study of Thai T2DM patients. All patients were recruited from out-patient departments of seven public hospitals and received standard treatment from their doctors. Their clinical and laboratory status were evaluated annually over 4 years, with particular emphasis on diabetic nephropathy, retinopathy and neuropathy. Outcomes at the end of the four-year study were expressed as survival or death, and causes of mortality were identified. Results: 1,097 from 1,120 stable T2DM patients were enrolled. After 4 years of follow-up, 80 patients (7.3%) had died. Causes of death were: cardiovascular disease (20 cases, 25.0%); infection (20 cases, 25.0%); malignancy (10 cases, 12.5%); end-stage renal disease (4 cases, 5.0%); and other causes (26 cases, 32.5%). Survival rates at 1, 2, 3, and 4 years were 98.9, 97.5, 96.2 and 92.7% respectively. Hazard ratios (95% CI) of all-cause mortality were being over 60 years old 1.84 (1.15-2.94) and having diabetic nephropathy 1.75 (1.12-2.75). Survival rates from cardiovascular mortality at 1, 2, 3, and 4 years were 99.2, 98.4, 97.4 and 94.5% respectively. Hazard ratios (95% CI) of cardiovascular mortality were: female gender 1.75 (1.05-2.94); diabetic nephropathy 1.72 (1.03-2.88); and diabetic retinopathy 1.74 (1.02-2.94). Conclusion: The survival rate of Thai patients with T2DM over the 4 years was 92.7%. Being over 60 years old and having diabetic nephropathy were associated with all-cause mortality. Female gender, diabetic nephropathy and diabetic retinopathy were associated with cardiovascular mortality.

Renal Protective Effects of Combination of Diltiazem and ACEI/ARB on the Progression of Diabetic Nephropathy: Randomized Controlled Trial.

Background: Strict control of blood sugar and maintenance of normal blood pressure levels are the standard treatments shown to delay the progression of diabetic nephropathy in type 2 diabetic patients. The recommended antihypertensive medications for diabetic nephropathy are angiotensin-converting enzyme inhibitors (ACEI) or angiotensin II receptor blockers (ARB). Previous studies have shown that a non-dihydropyridine calcium channel blocker (diltiazem) could reduce urinary protein excretion in type 2 diabetic patients. Objective: To evaluate the effects of the combinations of diltiazem and ACEI/ARB treatment compared with ACEI/ARB alone in type 2 diabetic patients with diabetic nephropathy. Material and Method: A prospective, randomized, double-blind, placebo-controlled multicenter trial was conducted at the out-patient departments of Rajavithi Hospital (Bangkok) and Ban-phaeo Hospital (Samut Sakhon). A total of 106 type 2 diabetic patients with hypertension and urine protein/creatinine (UPCr) >0.3 gm/gm who had received ACE/ARB were randomized into two groups: a diltiazem group (ACEI/ARB + sustained-release diltiazem 120 mg daily) (50 cases) and a placebo group (ACEI/ARB + placebo) (56 cases). Intention-to-treat analysis was utilized with the data of patients who withdrew from the study before its completion date. Results: 39 cases in the diltiazem group (78.0%) and 38 in the placebo group (67.9%) completed the 1-year treatment. The diltiazem group achieved better preservation of glomerular filtration rate and had lower proteinuria than the placebo group (p<0.05), whereas blood pressure was similar in the two groups. Four patients in the diltiazem group and one patient in the placebo group developed severe pedal edema and discontinue treatment. Conclusion: A combination of diltiazem and ACE/ARB could reduce proteinuria and preserve kidney function in type 2 diabetic patients with diabetic nephropathy.

A 4-year prospective study on long-term complications of type 2 diabetic patients: the Thai DMS diabetes complications (DD.Comp.) project.

OBJECTIVE: To assess the clinical course of long-term diabetic complications; diabetic retinopathy, nephropathy, and foot problems in Thai patients with type 2 diabetes. MATERIAL AND METHOD: Patients with type 2 diabetes were followed for four years between March 2006 and September 2010. Seven hospitals in all levels of care under the Ministry of Public Health Thailand were included in the present study. A physical examination and a diabetic complications assessment were performed each year during the study period, by physician specialists in the related areas. RESULTS: Among 1,120 patients who participated in the present study, 705 (62.95%) patients completed the 4-year follow-up time. There were 88 (7.86%) patients reported deaths during the present study period. The mean age was 59.14 +/- 10.12 years. The average duration of diabetes was 7.30 +/- 6.14 years. Approximately 57.32% of patients had a family history of diabetes. The average plasma glucose level and HbA1C were 153 to 160 mg/dl and 8.25 to 8.75%. Moreover less than one-fourth of patients had HbA1C below 7%. The prevalence for diabetic retinopathy and nephropathy were approximately 23.7% and 38.3%. In addition, more than 15% of patients had diabetic foot problems, loss of protective sensation and pedal pulse deficit. Finally, the incidence rates were 80.1 per 1,000 person-years (95% CI 69.7, 91.8) for diabetic retinopathy, and 91.1 per 1,000 person-years (95% CI 78.8, 105.1) for diabetic nephropathy CONCLUSION: Problems regarding poor diabetes control exist in Thai diabetes patients. It results in high prevalence and incidence of diabetic complications. As such, it is crucial to establish the country's diabetes management plan as well as evaluate the long-term complications in diabetic patients annually, in order for patients to receive the benefits of early treatment and prevent further complications.

Efficacy of the trivalent influenza vaccination in Thai patients with hemodialysis or kidney transplant compared with healthy volunteers.

OBJECTIVE: To evaluate the immune response to trivalent influenza vaccination in Thai patients with hemodialysis (HD) or kidney transplant (KT) compared with healthy volunteers. MATERIAL AND METHOD: This was a cross-sectional study in Thai healthy volunteers and patients with HD and KT who received the trivalent influenza vaccine provided by the Ministry of Public Health of Thailand from 1 November 2011 to 31 December 2011. Each subject was injected intramuscularly with one dose (0.5 milliliter) of trivalent influenza vaccine containing viral strains recommended by the WHO for the 2011 influenza season (southern hemisphere). Blood samples before and 6 weeks after the vaccination were measured for immune response using a hemagglutination-inhibition antibody assay. RESULTS: Subjects consisted of 30 healthy volunteers, 30 patients with HD and 30 patients with KT Prevalence of pre-vaccination seroprotective (SP) immunity in each group (healthy volunteers, HD, KT) was as follows: against H1N1 (33.3%: 23.3%: 10.0%), H3N2 (80.0%: 26.7%: 23.3%) and B (60.0%: 20.0%: 3.30%) viral strains, respectively. Those who were seronegative (SN) before testing positive after one dose of this vaccine were as follows: H1N1 (100.0%: 73.9%: 74.1%), H3N2 (66.7%: 86.4%: 34.8%) or B (58.3%: 66. 7%: 48.3%) viral strains, respectively. The healthy group showed significantly higher SP immune response for H1N1 than the HD and KT groups (p = 0.023). The HD group had significantly higher SP immune response for H3N2 than the KT groups (p = 0.001). Immune responses for the B vaccine in all groups were not different. No major adverse event was found in any group. CONCLUSION: Immune response for H1N1 vaccine in the HD and KT groups was slightly less than that of the healthy group. Immune response for H3N2 vaccine in the KT groups was less than in the healthy and HD groups. Immune responses for B vaccine in all groups were not different.

The Thai DMS Diabetes Complications (DD.Comp.) project: prevalence and risk factors of diabetic retinopathy in Thai patients with type 2 diabetes mellitus.

OBJECTIVE: To determine the prevalence of diabetic retinopathy (DR) among patients with type 2 diabetes mellitus (T2DM) in Thailand and their associated risk factors. MATERIAL AND METHOD: A cross-sectional, multi-sites, hospital-based study was carried out between June and December 2006. Diabetic patients from the outpatient department of seven public hospitals (3 tertiary, 2 secondary and 2 community hospital) in Thailand were performed by retinal specialist. RESULTS: One thousand seven of 1,120 diabetic patients received retinal examination using indirect ophthalmoscope. Patients were divided into two groups (absent and present DR). Most patients in both groups were female (72.7 and 68.0%). The prevalence of DR was 24.0% (n = 242), mild NPDR 9.4% (n = 95), moderate NPDR 10.5% (n = 106), severe NPDR 1.3% (n = 13), and proliferative (PDR) 2.8% (n = 28). Age at onset, duration of DM, systolic blood pressure, body mass index (BMI), fasting plasma glucose (FPG), HbA1c, Triglyceride (TG), alcohol consumption, foot ulcer, and proteinuria were recorded. Metformin and insulin taking were statistically, significantly different among these groups. There is more prevalent NPDR and PDR in insulin-taking than non-insulin-taking groups. The grading of diabetic retinopathy is associated with the duration of diabetes. In multivariate regression analysis, associated risk factors of DR patients were the duration of DM, HbA1c levels, and proteinuria. CONCLUSION: Diabetic retinopathy was present in about one fourth of type 2 diabetic patients in this study. Associated risk factors of DR were the duration of DM, HbA1c levels, and proteinuria. Regular screening for DR especially in T2DM with associated risk factor should be done for early treatment.

Prevalence of factors predisposing to foot complication and their relation to other risks.

BACKGROUND: Diabetic neuropathy and peripheral vascular disease (PVD) have been identified as major risk factors for diabetic foot ulceration and amputation in patients with type 2 diabetes mellitus (T2DM) but in Thailand have been a few of prospective studied about the prevalence and risk factors of diabetic neuropathy and PVD. OBJECTIVE: To evaluate the prevalence of diabetic neuropathy and PVD in Thai patients with T2DM and to determine other factors that related with them. MATERIAL AND METHOD: A cross-sectional study of 899 Thai T2DM patients from the out-patient department of seven public hospitals in Thailand between January 2007 and September 2008 was performed. Histories of these patients, complete physical examinations, feet examination, and blood with urine chemistry were obtained. RESULTS: Most of the patients were females with the average age of 59.64 years, the average of body mass index (BMI) was 27.32 kg/m2, the average duration of diabetes was 8.12 years and 85.17% of patients were HbA1C > or = 7%. Diabetic patients with PVD group compared with no PVD group, there were statistically significant differences for duration of having diabetes (OR 1.08; 95% CI [1.01-1.16]; p-value 0.047), creatinine level (OR 1.62; 95% CI [1.12-2.33]; p-value 0.01), present diabetic neuropathy (OR, 7.37; 95% CI [2.52-21.59]; p-value < 0.001). Patients with diabetic neuropathy group compared with no diabetic neuropathy group, there were statistically significant differences of age (OR, 1.04; 95% CI [1.01-1.06]; p-value 0.003), duration of having diabetes (OR, 1.04; 95% CI [1.01-1.07]; p-value 0.008), on ACEI or ARB drug (OR, 1.77; 95% CI [1.24-2.55]; p-value 0.002), HbA1C (OR, 1.14; 95% CI [1.03-1.27]; p-value 0.012), creatinine level (OR, 1.38; 95% CI [1.04-1.79]; p-value 0.014), present diabetic retinopathy (OR, 1.96; 95% CI [1.22-3.13]; p-value 0.005), present PVD (OR, 7.37; 95% CI [2.52-21.59]; p-value < 0.001), present diabetic nephropathy with microalbuminuria (OR, 1.74; 95% CI [1.12-2.69]; p-value 0.013). CONCLUSION: Two percent of T2DM patients had PVD that associated with duration of diabetes, creatinine level, and diabetic neuropathy and 15% of T2DM patients had diabetic neuropathy that depended on age, duration of having diabetes, on ACEI or ARB drug, creatinine level, HbA1C, diabetic retinopathy, diabetic nephropathy, and PVD.

Prevalence of infectious diseases of immigrant workers receiving health examinations at Rajavithi Hospital.

BACKGROUND: There are rapidly increasing numbers of immigrant workers coming for jobs in Thailand. These immigrant workers often harbor some serious communicable diseases. OBJECTIVE: To describe the prevalence of infectious diseases in these immigrant workers. MATERIAL AND METHOD: This is a retrospective study of immigrant workers who presented for check-ups needed for work permits at Rajavithi Hospital during 1 January 2008 to 31 December 2010. They were examined for serious infectious disease including pulmonary TB, elephantiasis, leprosy, syphilis and malaria. Their health status was analyzed. RESULTS: A total of 102,090 immigrant workers were examined. The majority of cases were female (58.4%) and 94.3% of the population was under the age of 40. Workers from Burma constituted the most cases, (78.9%), followed by workers from Laos (14.0%) and Cambodia (7.0%). The prevalence of infectious diseases in all workers was 1,612.3 cases per 100,000 population. Patients with pulmonary TB, elephantiasis, leprosy, syphilis and malaria were 1,112.7, 7.8, 4.9, 465.3 and 21.5 cases per 100,000 population respectively. The prevalence of TB in Burmese, Lao and Cambodian workers was 1,119.3, 885.9 and 1,493.2 cases per 100,000 population respectively. The prevalence of syphilis in Burmese, Lao and Cambodian workers was 467.8, 258.1 and 851.2 cases per 100,000 population respectively. CONCLUSION: Immigrant workers with infectious diseases were 1,612.3 cases per 100,000 population. Those harboring these serious transmitted diseases may be an important factor in these diseases becoming widespread in Thailand.

An open label, randomized controlled study of oral calcitriol for the treatment of proteinuria in patients with diabetic kidney disease.

BACKGROUND: The progression of diabetic kidney disease (DKD) is highly correlated with proteinuria. Previous studies have suggested that vitamin D treatment may reduce proteinuria and has the potential to delay the progression of renal disease. OBJECTIVE: To evaluate efficacy of oral calcitriol to decrease proteinuria in type 2 diabetic mellitus (T2DM) patients with DKD. MATERIAL AND METHOD: In this 16-week, open label, prospective, randomized controlled study, 91 patients with T2DM with estimated glomerular filtration rate (eGFR) greater than 15 ml/min/1.73 m2 and urine protein to creatinine ratio (UPCR) greater than 1 g/g were enrolled. They were randomly assigned to receive either oral calcitriol 0.5 mcg twice weekly (n = 46) or without oral calcitriol (n = 45). The primary outcome was determined by the change of UPCR from baseline after 16 weeks of treatment of both groups. RESULTS: At randomization, the mean UPCR was 3.7 + 2.2 g/g in the calcitriol group and 3.4 +/- 2.1 g/g in the control group. The mean UPCR at 16-week follow-up was 2.9 +/- 1.7 g/g in the calcitriol group and 3.5 +/- 2.3 g/g in the control group. Percent changes in UPCR from baseline to the last evaluation in the calcitriol and control groups were -18.7% and +9.9% (p < 0.01) respectively. Patients with 30% or more decrement in proteinuria occurred 43.5% of the time in the calcitriol group and 11.1% in the control group (p < 0.01). The eGFR and blood pressure did not differ significantly between the two groups. No serious adverse side effects were noted in either group. CONCLUSION: Calcitriol treatment can reduce proteinuria in patients with DKD without serious adverse events.

Assessment of blood flow in hemodialysis patients using buttonhole technique for arteriovenous fistula by ultrasound dilution.

BACKGROUND: The rope-ladder technique is the traditional AVF cannulation technique for HD. The buttonhole technique with repeated puncture with a blunt AV needle into a single selected site of AVF is a reliable alternative technique and has been used in Thailand for a few years. The ultrasound dilution technique is a noninvasive method to measure and monitor vascular access blood flow of patients receiving HD. There is no previous report about the evaluation of access blood flow in the buttonhole technique. OBJECTIVE: To measure vascular access blood flow by noninvasive ultrasound dilution in HD patients using the buttonhole technique for cannulation of AV needle to AVF and investigate the factors associated with impaired vascular access blood flow. MATERIAL AND METHOD: A cross-sectional study evaluating HD patients using the buttonhole technique at the outpatient HD center of Rajavithi Hospital and National Kidney Foundation at the Priest Hospital in Thailand was performed. The blood flow rate of AVF was measured by the ultrasound dilution technique. After starting HD with cannulated AV needle to AVF by the buttonhole technique and increasing dialyzer blood flow rate according to their HD prescription, measurements of blood flow of vascular access were evaluated within the first hour of the HD session by 2 consecutive measurements. RESULTS: A total of sixty eight HD patients were recruited. All patients had functioning AVF and received an adequate dialysis delivery dose, but 14.7% of them had impaired access blood flow. The average access flow rate was 1,326 +/- 858.8 ml/min. The average access flow rate of patients with good and impaired access flow rates was 1,497.8 +/- 812.4 and 330.0 +/- 135.0 ml/min. The factors associated with impaired access blood flow were old age, diabetes mellitus and dyslipidemia. CONCLUSION: This present study suggests that annual direct measurement of access blood flow as ultrasound dilution technique is an acceptable tool to screen AVF dysfunction, especially HD patients of old age, and/or with diabetes mellitus and dyslipidemia.

Risk factors of infectious peritonitis of CAPD patients in Rajavithi Hospital.

OBJECTIVE: Continuous ambulatory peritoneal dialysis (CAPD) is a renal replacement therapy for end stage renal disease (ESRD) patients. Peritoneal infection, peritonitis is a major cause of death and technical failure in ESRD patients receiving CAPD treatment. Previous studies demonstrated that lower serum albumin, higher body mass index, and diabetic kidney disease were associated with increase in incidence of peritonitis. However the demographics of the patients in the Rajavithi hospital such as race, gender, age, socioeconomic status and various other factors were different from the patients in the previous studies. The present study was conducted to investigate the risk factors of peritonitis, causative organisms, and route of infection among CAPD patients in Rajavithi Hospital. MATERIAL AND METHOD: This is a retrospective descriptive study. All patients in the present study are ESRD patients who received CAPD treatment during March 2009 to February 2011 and adhered with the treatment for at least 1 year. The patients were divided into two groups 1) the patients who got infectious peritonitis within 1 year after catheter implantation and 2) the patients who did not get or got infectious peritonitis after 1 years. The medical records were reviewed and the data were analyzed to identify the risk factors of peritonitis, frequency of causative organisms, and the route of infection. RESULTS: Of 27 patients, 16 patients (59.3%) had peritonitis within the first year, and 11 patients (40.7%) had no peritonitis or had peritonitis after the first year. The risk factors associated with peritonitis were diabetes (62.5 % in patients with peritonitis within first year vs. 18.2% in the patients who had no peritonitis or had peritonitis after the first year, p = 0.047) and higher blood sugar level (139.5 +/- 34.6 mg/dl in patients with peritonitis within first year vs. 115.9 +/- 23.4 mg/dl 18.2% in the patients who had no peritonitis or had peritonitis after the first year, p = 0.011). Transluminal peritoneal catheter route was the route of infection in every subject in the present study. The major causative agents were gram-positive bacteria. CONCLUSION: Diabetic kidney disease and high fasting blood sugar were the risk factors of peritonitis and trans-luminal peritoneal catheter are the major route of infection in the present study. Therefore, good blood sugar control and strict adherence with sterile technique for peritoneal dialysis would decrease the incidence of peritonitis in CAPD patients.

Prevalence and risk factors of diabetic nephropathy among Thai patients with type 2 diabetes mellitus.

BACKGROUND: Diabetic nephropathy (DN) is the leading cause of end stage renal disease. Clinically, DN is classified into 3 stages: microalbuminuria (MA), macroalbuminuria and ESRD. The prevalence and risk factors of DN among patients with type 2 diabetes mellitus (T2DM) in Thailand have not been well studied. OBJECTIVE: To assess the prevalence of DN in patients with T2DM and to determine their associated risk factors. MATERIAL AND METHOD: A cross-sectional study evaluating 877 T2DM patients from the out-patient department of seven public hospitals in Thailand was performed. Three random spot urine samples from all patients were collected during 3 consecutive months. Normoalbuminuria, MA and macroalbuminuria were defined as the presence of at least two out of three spot urine tests for urine albumin/creatinine ratio showing less than 30, 30-300 and more than 300 mg/gm respectively. RESULTS: Most patients were female, 60 years of age or older, with BMI above 25 kg/m2, a family history of DM, uncontrolled blood pressure, HbA1c above 7.0% and LDL above 100 mg/dl. The prevalence of normoalbuminuria, MA and macroalbuminuria was 62.8, 26.0 and 11.2% respectively. The prevalence of diabetic retinopathy in T2DM with normoalbuminuria, MA and microalbuminuria was 18.5, 35.5 and 48.0% respectively. Associated risk factors of DN were the duration of DM, HbA1c levels and uncontrolled hypertension. CONCLUSION: The prevalence of all DN was 37.2%. Associated risk factors of DN were the duration of DM, HbA1c levels and uncontrolled hypertension.

Accuracy of urine dipstick test for microalbuminuria in type 2 diabetes mellitus patients.

BACKGROUND: Testing for microalbuminuria (MA) is an important tool for detection of the earliest clinical manifestation of diabetic nephropathy Dipstick test for MA is commonly used for screening MA but this dipstick test has not been validated in Thai patients with DM. OBJECTIVE: To evaluate the diagnostic accuracy of the dipstick test for MA in random spot urine samples of type 2 diabetic mellitus patients, using urinary albumin to creatinine ratio (UACR) as the reference standard method. MATERIAL AND METHOD: Type 2 diabetic mellitus patients from the out-patient department of seven public hospitals were recruited. Random spot urine samples from all patients were screened for microalbuminuria by Combi-Screen dipstick test and UACR. RESULTS: A total of 6,223 urine samples from 899 diabetic patients were screened for MA. From UACR criteria, these urine samples were classified as normoalbuminuria (4,016 samples, 64.5%), MA (1,795 samples, 28.8%) and macroalbuminuria (412 samples, 6.6%). The dipstick test for MA had an overall sensitivity of 83.7%, specificity of 92.6% with a positive predictive value of 83.4% and a negative predictive value of 92.7%. The area under the receiver operating characteristics curve of the dipstick test for MA is 0.9427. CONCLUSION: The dipstick test for MA may be a useful method to initially screen for MA in Thai patients with type 2 DM.

Length of normal kidneys in Thai adults.

BACKGROUND: The length of kidney plays important role in diagnosing chronic kidney diseases. Kidney length can be measured by ultrasound, a cheap, convenient and noninvasive method. There is no report on the length of kidney in healthy Thai people. OBJECTIVE: To measure the length of normal kidneys in Thai adults volunteers by ultrasonography. MATERIAL AND METHOD: Healthy volunteers were recruited and the study was performed from April 2008 to June 2009. All volunteers were examined by the same standard ultrasound machine and the same radiologist throughout the study period. RESULTS: A total of 509 healthy volunteers were enrolled. The average lengths of left and right kidney were 10.24 +/- 0.70 and 10.09 +/- 0.68 cm, respectively. Male kidney was bigger than the female kidney. Kidney length slightly increased until the age of 50 and become smaller at the age of 60 or more. Kidney length showed no correlation with age, body weight, body mass index and body surface area. CONCLUSION: The average lengths of left and right kidney were 10.24 +/- 0.70 and 10.09 +/- 0.68 cm, respectively. The length below 9.00 cm may indicate the state of kidney diseases.

The effects of lowering LDL cholesterol with simvastatin plus ezetimibe in patients with chronic kidney disease (Study of Heart and Renal Protection): a randomised placebo-controlled trial.

BACKGROUND: Lowering LDL cholesterol with statin regimens reduces the risk of myocardial infarction, ischaemic stroke, and the need for coronary revascularisation in people without kidney disease, but its effects in people with moderate-to-severe kidney disease are uncertain. The SHARP trial aimed to assess the efficacy and safety of the combination of simvastatin plus ezetimibe in such patients. METHODS: This randomised double-blind trial included 9270 patients with chronic kidney disease (3023 on dialysis and 6247 not) with no known history of myocardial infarction or coronary revascularisation. Patients were randomly assigned to simvastatin 20 mg plus ezetimibe 10 mg daily versus matching placebo. The key prespecified outcome was first major atherosclerotic event (non-fatal myocardial infarction or coronary death, non-haemorrhagic stroke, or any arterial revascularisation procedure). All analyses were by intention to treat. This trial is registered at ClinicalTrials.gov, NCT00125593, and ISRCTN54137607. FINDINGS: 4650 patients were assigned to receive simvastatin plus ezetimibe and 4620 to placebo. Allocation to simvastatin plus ezetimibe yielded an average LDL cholesterol difference of 0·85 mmol/L (SE 0·02; with about two-thirds compliance) during a median follow-up of 4·9 years and produced a 17% proportional reduction in major atherosclerotic events (526 [11·3%] simvastatin plus ezetimibe vs 619 [13·4%] placebo; rate ratio [RR] 0·83, 95% CI 0·74-0·94; log-rank p=0·0021). Non-significantly fewer patients allocated to simvastatin plus ezetimibe had a non-fatal myocardial infarction or died from coronary heart disease (213 [4·6%] vs 230 [5·0%]; RR 0·92, 95% CI 0·76-1·11; p=0·37) and there were significant reductions in non-haemorrhagic stroke (131 [2·8%] vs 174 [3·8%]; RR 0·75, 95% CI 0·60-0·94; p=0·01) and arterial revascularisation procedures (284 [6·1%] vs 352 [7·6%]; RR 0·79, 95% CI 0·68-0·93; p=0·0036). After weighting for subgroup-specific reductions in LDL cholesterol, there was no good evidence that the proportional effects on major atherosclerotic events differed from the summary rate ratio in any subgroup examined, and, in particular, they were similar in patients on dialysis and those who were not. The excess risk of myopathy was only two per 10,000 patients per year of treatment with this combination (9 [0·2%] vs 5 [0·1%]). There was no evidence of excess risks of hepatitis (21 [0·5%] vs 18 [0·4%]), gallstones (106 [2·3%] vs 106 [2·3%]), or cancer (438 [9·4%] vs 439 [9·5%], p=0·89) and there was no significant excess of death from any non-vascular cause (668 [14·4%] vs 612 [13·2%], p=0·13). INTERPRETATION: Reduction of LDL cholesterol with simvastatin 20 mg plus ezetimibe 10 mg daily safely reduced the incidence of major atherosclerotic events in a wide range of patients with advanced chronic kidney disease. FUNDING: Merck/Schering-Plough Pharmaceuticals; Australian National Health and Medical Research Council; British Heart Foundation; UK Medical Research Council.

Efficacy and safety of enoxaparin during hemodialysis: results from the HENOX study.

BACKGROUND: Low molecular weight heparins (LMWHs) have been suggested as an anticoagulant in hemodialysis (HD) since they provide convenient usage, safety and effective outcomes. OBJECTIVE: Determine clinical efficacy and safety of enoxaparin sodium for the anticoagulation effect during HD in 99 clinically stable end-stage renal disease (ESRD) patients. MATERIAL AND METHOD: This prospective open-label study was conducted in seven hemodialysis centers in Thailand HD prescription during the present study was similar to the previous prescriptions including the type of dialyzer. Enoxaparin sodium 0.7 mg/kg was administered into a pre-dialyzer arterial line at the beginning of the HD session. The anticoagulation effect was monitored by visual inspection of the HD line hourly and inspection of the dialyzer at the end of HD session. Vascular access compression time was monitored at both arterial and venous sites separately at the end of the HD. RESULTS: HD with enoxaparin sodium resulted in no fibrin/clot formation in a hemodialysis line in 97 cases (98%), and no significant clot formation in a dialyzer in 96 cases (97%). The mean vascular compression time was 5.63 +/- 1.90 minutes at the arterial site and 5.72 +/- 2.61 minutes at the venous site. Neither major adverse events nor major hemorrhages were reported Prolonged activated partial thromboplastin times (aPTT) at 30 minutes after hemodialysis were reported in two cases. These abnormal aPTT cases returned to normal levels within 24 hours and 72 hours, respectively. CONCLUSION: The present study suggests that a single-dose regimen of enoxaparin sodium 0.7 mg/kg is an effective, well-tolerated, and convenient alternative to sodium heparin.

Effects of dual blockade of renin-angiotensin system in type 2 diabetes mellitus patients with diabetic nephropathy.

BACKGROUND: Angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARB) have been shown to delay the progression to proteinuria and kidney failure in hypertensive type 2 diabetic patients with diabetic nephropathy. Further synergistic effect may be obtained by combined therapy with both ARB and ACE inhibitors. OBJECTIVE: To evaluate the effect of dual blockage of the renin-angiotensin system by adding maximal recommended dose of ARB with maximal recommended dose of ACE inhibitors in type 2 diabetic patients with diabetic nephropathy. MATERIAL AND METHOD: Type 2 diabetic patients with urine protein/creatinine (UPCr) > 0.5 gm/gm and hypertension who received maximal recommended dose of ACE inhibitors (Enalapril 40 mg/day) over three months were randomized to two groups. ARB group received adding maximal recommended dose of ARB (Telmisartan 80 mg/day) and control group received previous ACE inhibitors only for 24 weeks. RESULTS: Eighty patients were enrolled. ARB group led to significantly reduced UPCr from baseline at week 8, 12, and 24 (2.65 +/- 1.81, 2.24 +/- 1.85, 2.24 +/- 1.88 and 1.98 +/- 1.73 gm/gm respectively, p < 0.05) but UPCr in the control group was unchanged (1.97 +/- 1.56, 1.85 +/- 1.27, 1.97 +/- 1.11 and 1.96 +/- 1.42 gm/gm respectively, p > 0.05). ARB group induced an additional reduction in proteinuria of 29.25% (95% CI 9.68-48.82) compared with control group. By the end of the present study, glomerular filtration rate had fallen from 41.76 +/- 12.16 to 37.84 +/- 13.59 ml/min/1.73 m2 in ARB group and 50.89 +/- 29.43 to 49.41 +/- 29.85 ml/min/1.73 m2 in control group (p > 0.05). Serum potassium had changed from 4.51 +/- 0.48 to 4.58 +/- 0.13 mEq/L in ARB group and 4.60 +/- 0.58 to 4.40 +/- 0.13 mEq/L in the control group (p > 0.05). No other serious adverse effects were reported during treatment. CONCLUSION: Adding maximal recommended dose of ARB with maximal recommended dose of ACE inhibitors in type 2 diabetic patients can reduce proteinuria more than ACE inhibitors alone. This treatment is safe and well tolerated.

Anemia and survival in Thai hemodialysis patients: evidence from national registry data.

BACKGROUND: Anemia is a major contributor to morbidity and mortality in chronic dialysis patients. The K/DOQI guideline recommends the target hemoglobin of 11-12 g/dl (hematocrit of 33-36%). However the appropriate hematocrit level for Thai hemodialysis patients has been controversial. OBJECTIVE: To investigate the influence of anemia on mortality in Thai chronic hemodialysis patients who initiated their dialysis from 1999 through 2003. MATERIAL AND METHOD: The data from the Thailand Renal Replacement Therapy Registry who has conducted an annual report of chronic dialysis patients throughout Thailand since 1997 was used. Data of twice- and thrice-weekly hemodialysis patients who had recorded hematocrit from 1999 through 2003 were processed and confirmed before final analysis. Records of 3,211 hemodialysis patients from 301 centers were included. RESULT: The original kidney diseases were diabetes mellitus (31.5%) and hypertension (20.9%). Most patients received twice-weekly hemodialysis (86.3%). The mean hematocrit was 29.3 +/- 5.5%. Most patients (72.8%) had hematocrits of less than 33%. Kaplan-Meier analysis showed patients with hematocrit of ?33% or more had better survival than patients with hematocrits of less than 33% (p <0.01). Patients with hematocrits of less than 27, 27-29.9, 30-32.9 and 36% or more had mortality risks of 1.90 (95% CI: 1.31-2.76, p <0.01), 2.10 (95% CI: 1.42-3.09, p <0.01), 1.74 (95% CI: 1.18-2.56, p <0.01) and 1.174 (95% CI: 0.73-1.90, p = 0.51) respectively, compared to those with hematocrit of 33-35.9%. CONCLUSION: The best survival can be achieved in Thai patients with hematocrits of at least 33%.