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1.
Transplant Proc ; 51(2): 509-511, 2019 Mar.
Article in English | MEDLINE | ID: mdl-30879578

ABSTRACT

The renal replacement therapy in Saudi Arabia has 3 main modalities: hemodialysis, peritoneal dialysis, and renal transplantation. Hemodialysis is one of the fastest growing industries of health care providers in Saudi Arabia. OBJECTIVE: We aimed to review the health indicators of renal replacement therapy. MATERIALS AND METHODS: We used the Saudi Center for Organ Transplantation Annual Report 2016. RESULTS: Patients with end-stage renal disease on hemodialysis and peritoneal dialysis totaled 17,687. Saudi Arabia increased the numbers of dialysis centers and also added 2 more sectors. The Ministry of Health hospitals have 55% of the centers, government non-Ministry of Health has 9%, private and charitable hospitals have 21%, the King Abdullah Hemodialysis Project has 2%, and the outsourcing dialysis programs have 13%. There are 243 dialysis units in Saudi Arabia. Most dialysis centers are in the central region (30%); 27% are in the western region, 19% are in the southern region, 13% are in the eastern region, and 11% are in the northern region. The average net increase of dialysis patients is 6.2% annually and is projected to reach 22,000 by 2020. Causes of renal failure are mainly diabetic nephropathy (40%) and hypertensive nephropathy (38%). Hepatitis C virus positivity is at 12% and hepatitis B surface antigen positivity is at 4%. From the year 2000 renal transplantation from deceased and living donation has tripled in number, with a total of 798 kidneys transplanted. CONCLUSION: Renal replacement therapy is increasing and dialysis center numbers are expected to increase. Renal transplantation numbers have improved both from living and deceased donors but further actions toward the promotion of the organ donation in Saudi Arabia is essential.


Subject(s)
Kidney Failure, Chronic/therapy , Kidney Transplantation/statistics & numerical data , Peritoneal Dialysis/statistics & numerical data , Renal Dialysis/statistics & numerical data , Adult , Female , Humans , Male , Middle Aged , Saudi Arabia , Tissue and Organ Procurement/statistics & numerical data
2.
Sci Rep ; 8(1): 13275, 2018 09 05.
Article in English | MEDLINE | ID: mdl-30185803

ABSTRACT

The airway epithelium regulates responses to aeroallergens, acting as a physical and immunological barrier. In asthma, epithelial barrier function and the expression of adherens junction protein E-cadherin is compromised, but it is unknown whether this is cause or consequence of the disease. We hypothesized that airway epithelial loss of E-cadherin is a critical step in the development of manifestations of asthma. We generated a transgenic mouse model with conditional loss of E-cadherin in lung epithelial cells at birth and onwards. We observed normal lung development at the time of birth in mice lacking E-cadherin in the lung epithelium. However, E-cadherin deficiency led to progressive epithelial damage in mice growing into adulthood, as evidenced by airway epithelial denudation, decreased zonula occludens (ZO)-1 expression, loss of ciliated cells, and enlarged alveolar spaces. In addition, spontaneous goblet cell metaplasia with mucus production was observed. These epithelial changes were accompanied by elevated levels of the epithelial-derived chemokine CCL17, infiltration of eosinophils and dendritic cells, and mucus production. In conclusion, loss of E-cadherin induces features in the lung reminiscent of those observed in asthma, indicating that the disruption of E-cadherin-mediated cell-cell contacts may play a key role in the development of asthma manifestations.


Subject(s)
Cadherins/metabolism , Respiratory Mucosa/metabolism , Respiratory Mucosa/pathology , Adherens Junctions/metabolism , Animals , Asthma/metabolism , Cadherins/genetics , Cadherins/physiology , Chemokine CCL17/metabolism , Dendritic Cells/immunology , Disease Models, Animal , Eosinophils/metabolism , Epithelial Cells/metabolism , Epithelium/metabolism , Goblet Cells/metabolism , Lung/pathology , Metaplasia/metabolism , Mice , Mice, Inbred C57BL , Mice, Transgenic , Tight Junctions/metabolism , Zonula Occludens-1 Protein/metabolism
3.
J Perinatol ; 37(5): 596-601, 2017 05.
Article in English | MEDLINE | ID: mdl-28277490

ABSTRACT

OBJECTIVE: Erythropoietin (EPO) is neuroprotective after asphyxia in animal studies. The efficacy and safety of EPO monotherapy in term neonates with hypoxic ischemic encephalopathy (HIE) is uncertain. STUDY DESIGN: Hundred term neonates with moderate or severe HIE were randomized by random permuted block algorithm to receive either EPO 500 U kg-1 per dose in 2 ml saline intravenously (50 neonates) on alternate days for a total of five doses with the first dose given by 6 h of age (treatment group) or 2 ml of normal saline (50 neonates) similarly for a total of five doses (placebo group) in a double-blind study. No hypothermia was given. The primary outcome was combined end point of death or moderate or severe disability at mean age of 19 months (s.d., 0.61). RESULTS: Death or moderate or severe disability occurred in 40% of neonates in the treatment group vs 70% in the placebo group (risk ratio, 0.57; 95% confidence interval (CI) 0.38 to 0.85; P=0.003). Death occurred in 16% of patients in both the groups (risk ratio, 1.0; 95% CI 0.33 to 2.9; P=0.61). The risk of cerebral palsy was lower among survivors in the treatment group (risk ratio, 0.52; 95% CI 0.25 to 1.03; P=0.04) and lesser number of babies were on anticonvulsants at assessment (risk ratio, 0.47; 95% CI 0.20 to 1.01; P=0.03). Neonatal brain magnetic resonance imaging showed more abnormalities in the placebo group (relative risk, 0.66; 95% CI 0.42 to 1.03; P=0.04)). Improvement in other neurological outcomes was not significant. CONCLUSION: EPO monotherapy reduces the risk of death or disability in term neonates with moderate or severe encephalopathy.


Subject(s)
Asphyxia Neonatorum/drug therapy , Asphyxia Neonatorum/mortality , Brain/diagnostic imaging , Erythropoietin/administration & dosage , Hypoxia-Ischemia, Brain/complications , Cerebral Palsy/epidemiology , Double-Blind Method , Female , Humans , India , Infant , Infant, Newborn , Longitudinal Studies , Magnetic Resonance Imaging , Male , Prospective Studies , Severity of Illness Index , Term Birth
4.
Indian J Cancer ; 51(2): 170-5, 2014.
Article in English | MEDLINE | ID: mdl-25104203

ABSTRACT

BACKGROUND: Technical advancement in imaging has helped to stage and plan treatment modality for carcinoma rectum with still some objectives controversial. AIMS: The aim of our study was to evaluate the accuracy of multidetector row computed tomography (MDCT) with multiplanar reformations in the pre-operative staging of rectal carcinoma and correlation with intraoperative and histopathologic staging of retrieved specimen with respect to the depth of tumor invasion (T-staging), lymph node metastasis (N-staging) and mesorectal fascia (MRF) involvement. MATERIALS AND METHODS: The study was a prospective one and consisted of 52 patients with biopsy proved rectal carcinoma. MDCT studies were performed on a 64-slice computed tomography system. Images were reconstructed in axial, coronal and sagittal planes. MDCT findings were compared with intraoperative and pathologic (reference standard) findings. Sensitivity, specificity, positive predictive value, negative predictive value and accuracy were assessed. RESULTS: The diagnostic accuracy of MDCT for T1/T2, T3 and T4 lesions was 77%, 86.5% and 100%, respectively. For perirectal lymph node metastasis (N+), the diagnostic accuracy of MDCT was 84.1%. The diagnostic accuracy of MDCT for MRF involvement was 91%. CONCLUSION: MDCT is a reliable radiological tool for local staging of rectal cancer with excellent accuracy rates for T and N-staging of rectal cancer.


Subject(s)
Carcinoma/diagnostic imaging , Neoplasm Staging/methods , Rectal Neoplasms/diagnostic imaging , Tomography, X-Ray Computed/methods , Adolescent , Adult , Aged , Aged, 80 and over , Carcinoma/pathology , Female , Humans , Image Interpretation, Computer-Assisted , Male , Middle Aged , Prospective Studies , Rectal Neoplasms/pathology , Sensitivity and Specificity , Young Adult
5.
Indian J Cancer ; 51(4): 560-4, 2014.
Article in English | MEDLINE | ID: mdl-26842195

ABSTRACT

AIM: The development of sphincter saving procedures for low carcinoma rectum has been the consequence of oncological and technological factors. The major disadvantage associated with these procedures is the development of anterior resection syndrome because of the resection of rectal reservoir. Colonic J pouch (CJP) neorectum has been practiced as an antidote to overcome this problem. We are working at a tertiary care center, which is a high volume center for rectal cancers. We thought it worthwhile to assess the efficacy of J Pouch neorectum viz.-a-viz. a straight coloanal anastomosis for low rectal cancers. MATERIALS AND METHODS: Hospital based prospective randomized study (June 2007-December 2009) low rectal cancers (4-12 cm from the anal verge). One group (20 patients) subjected to low/ultralow anterior resection with straight anastomosis (SA) and other group (22 patients) to CJP. The two groups were compared on the basis of functional outcome. RESULTS: Anastomotic leak, strictures, frequency of bowel movements, nocturnal bowel movements, use of retarding medication and incontinence to solids, liquids and gases were seen more in SA group. All these findings were statistically significant. CONCLUSIONS: We conclude that CJP has a significant functional advantage over SA and improves the overall quality-of-life in patients of low rectal cancers and the advantage persisted over a period of more than 30 months.


Subject(s)
Anal Canal/surgery , Colon/surgery , Colonic Pouches , Fecal Incontinence/etiology , Rectal Neoplasms/surgery , Adult , Anastomosis, Surgical/adverse effects , Anastomosis, Surgical/methods , Anastomotic Leak/etiology , Colonic Pouches/adverse effects , Colonic Pouches/physiology , Constriction, Pathologic/etiology , Defecation/physiology , Female , Humans , Male , Middle Aged , Prospective Studies , Quality of Life , Rectal Neoplasms/pathology
6.
Article in English | MEDLINE | ID: mdl-22690366

ABSTRACT

OBJECTIVE: Low vitamin D levels are common in psychiatric patients, but a need for vitamin D supplementation in these individuals remains controversial. Low vitamin D levels are reportedly associated with high prevalence of cardiometabolic risk factors, and both are common in psychiatric patients, but the relationship between diagnosis and severity of illness and cardiometabolic risk status and the effect of vitamin D treatment on them is not known. We studied these relationships and effect of vitamin D(3) treatment on them in 290 long-term psychiatric inpatients. METHOD: All patients admitted to the hospital during April 2009-March 2010 who agreed to 25-hydroxyvitamin-D testing were included. Serum 25-hydroxyvitamin D level, Brief Psychiatric Rating Scale (BPRS) score, body mass index, blood pressure, and fasting levels of blood glucose, triglycerides, high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) were measured at baseline, and changes after vitamin D(3) treatment for up to 12 months were observed. For the purposes of this study, 25-hydroxyvitamin-D levels < 32 ng/mL were considered as "low"; < 20 ng/mL, as "insufficient"; and < 12 ng/mL, as "deficient." RESULTS: A serum 25-hydroxyvitamin-D level < 32 ng/mL was found in 90.0% of patients, and a level <20 ng/mL was found in 48.6% of patients. A BPRS score > 36 was present in 56.0% of patients; obesity, in 75.7%; hypertension, in 44.8%; low HDL-C, in 43.6%; high triglycerides, in 31.2%; high LDL-C, in 17.8%; and increased glucose, in 14.6%. Serum 25-hydroxyvitamin-D levels correlated poorly with BPRS score and the other variables listed above (R, -0.02 to -0.22). After vitamin D(3) treatment, 25-hydroxyvitamin-D level increased to ≥ 20 ng/mL in all patients and ≥ 32 ng/mL in 85% of patients, but despite > 124% increase in mean 25-hydroxyvitamin-D level, mean improvement in other variables was < 12%. CONCLUSIONS: Nearly half of our patients had vitamin D levels < 20 ng/mL, putting them at risk for poor bone health and requiring vitamin D supplementation. Cardiometabolic risk factors were also highly prevalent, but correlated poorly with vitamin D levels in their severity. Increasing vitamin D levels to ≥ 32 ng/mL was not associated with improvement in BPRS score or any cardiometabolic risk factor, emphasizing that intensification of therapeutic measures other than vitamin D supplementation is required.

7.
Transplant Proc ; 44(1): 94-100, 2012 Jan.
Article in English | MEDLINE | ID: mdl-22310589

ABSTRACT

BACKGROUND: Cyclosporine (CsA) remains a mainstay of immunosuppressive maintenance regimens in developing countries, but its effects on long-term kidney allograft survival are still unclear. Our aim was to assess a generic microemulsion CsA (Sigmasporin) for long-term impact on graft function and patient survival among stable renal transplant patients. METHODS: Over a 36-month period, patients with transplantations from >6 months earlier were maintained on CsA doses of 2-8 mg/kg/d to keep C(2) within the recommended therapeutic range. We assessed 25 efficacy and tolerability parameters of scheduled intervals. RESULTS: Twenty-seven patients (9 female, 18 male) from 6 centers in 4 Middle-Eastern countries were enrolled between 2004 and 2009. Their average age was 35.1 ± 9.8 years, body mass index ranged from 15.7 to 41.2 kg/m(2), and average time from transplantation was 2.2 ± 1.6 years. Within the 36-month observation period the CsA dose was reduced by 17.3% from 2.89 ± 0.88 mg/kg/d to achieve C(2) levels of 600-1000 ng/mL. After 36 months the glomerular filtration rate declined by 8.2% from an overall baseline mean of 72.7 ± 23.5 mL/min/1.73 m(2). It improved in 11.1% of patients and remained unchanged in 44.4%. No new cases of hypertension or diabetes mellitus were reported, and there was 1 case of borderline hyperlipidemia. Graft functions were stable, apart from 2 incidences of CsA nephrotoxicity. Both graft and patient 3-year survival rates were 100%. CONCLUSIONS: On a 3-year basis, Sigmasporin Microral was effective to maintain stable renal functions in kidney transplant patients, with safety and tolerability profiles similar to those reported in the international literature.


Subject(s)
Cyclosporine/therapeutic use , Drugs, Generic/therapeutic use , Immunosuppressive Agents/therapeutic use , Kidney Transplantation , Kidney/drug effects , Kidney/surgery , Adult , Chemistry, Pharmaceutical , Cyclosporine/administration & dosage , Cyclosporine/adverse effects , Drugs, Generic/administration & dosage , Drugs, Generic/adverse effects , Emulsions , Female , Graft Rejection/immunology , Graft Rejection/prevention & control , Graft Survival/drug effects , Humans , Immunosuppressive Agents/administration & dosage , Immunosuppressive Agents/adverse effects , Kidney/physiopathology , Kidney Diseases/chemically induced , Kidney Transplantation/immunology , Male , Middle Aged , Middle East , Prospective Studies , Time Factors , Treatment Outcome , Young Adult
8.
Steroids ; 76(14): 1554-9, 2011 Dec 20.
Article in English | MEDLINE | ID: mdl-21964577

ABSTRACT

Pregnenolone (1) was used as a template to develop new anticancer compounds. Ring-D modification of 1 resulted in the synthesis of benzylidenes 2-17, pyrazolines 18-76, pyrazoles 85-91, hydrazones 77-84, and oximes 92-107 derivatives. The structure of compound 107 was also deduced through single crystal X-ray diffraction studies. The inclusion of furanyl and pyridyl rings to pregnenolone skeleton increases the cytotoxicity of all compounds significantly. Among benzylidene derivatives, only heterocyclic enone 8 (IC50=0.74 µM/mL against HepG2), and 17 (IC50=4.49 µM/mL against HepG2, IC50=5.01 µM/mL against MDA-MB-230 cancer cell line) exhibited a significant activity. The cytotoxicity data of pyrazoline derivatives 18-76 revealed that only furanyl bearing pyrazolines 40, 42-44, 48, and 49 exhibited significant activities. While all (O-carboxymethyl) oximes, hydazones, and pyrazoles derivatives of pregnenolone did not show any significant activity against both the cell lines. Thus the furanyl bearing enone 8 (IC50=0.74 µM/mL against HepG2), and its pyrazoline derivative 48 (IC50=0.91 µM/mL against MDA-MB-230 cancer cell lines) were identified as the most active compounds in all derivatives of pregnenolone.


Subject(s)
Antineoplastic Agents/chemistry , Antineoplastic Agents/pharmacology , Pregnenolone/analogs & derivatives , Pregnenolone/pharmacology , Antineoplastic Agents/chemical synthesis , Hep G2 Cells , Humans , Inhibitory Concentration 50 , Pregnenolone/chemical synthesis , Structure-Activity Relationship
9.
Int J Nephrol ; 2010: 342901, 2010 Oct 25.
Article in English | MEDLINE | ID: mdl-21152200

ABSTRACT

Aim. To assess the degree of satisfaction among hemodialysis patients and the factors influencing this satisfaction. Methods. Patients were recruited from 3 Saudi dialysis centers. Demographic data was collected. Using 1 to 10 Likert scale, the patients were asked to rate the overall satisfaction with, and the overall impact of, their dialysis therapy on their lives and to rate the effect of the dialysis therapy on 15 qualities of life domains. Results. 322 patients were recruited (72.6% of the total eligible patients). The mean age was 51.7 years (±15.4); 58% have been on dialysis for >3 years. The mean Charlson Comorbidity Index was 3.2 (±2), and Kt/V was 1.3 (±0.44). The mean satisfaction score was (7.41 ± 2.75) and the mean score of the impact of the dialysis on the patients' lives was 5.32 ± 2.55. Male patients reported worse effect of dialysis on family life, social life, energy, and appetite. Longer period since the commencement of dialysis was associated with adverse effect on finances and energy. Lower level of education was associated with worse dialysis effect on stress, overall health, sexual life, hobbies, and exercise ability. Conclusion. The level of satisfaction is affected by gender, duration on dialysis, educational level, and standard of care given.

10.
Clin Nephrol ; 74 Suppl 1: S85-8, 2010 Nov.
Article in English | MEDLINE | ID: mdl-20979970

ABSTRACT

Chronic kidney disease (CKD) is a common and costly health problem in the Middle East. The incidence of CKD is still unknown, and the incidence of end-stage renal disease (ESRD) is estimated at 100 - 140 incident cases per million population in the Middle East countries. Most of the available statistics about prevalence are of treated ESRD. Published population-based studies for incidence and prevalence of CKD and ESRD are still lacking in most of the Middle East countries. This negatively affects the health planning and effectiveness of preventive and therapeutic measures in the region. The prevalence of renal replacement therapy varies among the different countries in the Middle East. The infrastructure for these services is also variable among these countries and affects the outcome, which as yet cannot be measured accurately. The low gross national income of the Middle East countries is a major factor in negating the implementation of research, planning, and improvement of the services for CKD patients. To overcome the obstacles for the renal services in the Middle East countries, the constraints on health expenditure need to be surmounted, which is not an easy task, and related appropriately to the gross national income. Awareness within the medical community and the public at large about the advances of therapeutic and preventive measures is also an important factor for progress toward better kidney health in the Middle East.


Subject(s)
Kidney Failure, Chronic/epidemiology , Humans , Kidney Failure, Chronic/therapy , Kidney Transplantation/trends , Middle East/epidemiology , Prevalence , Tissue and Organ Procurement/trends
11.
Transplant Proc ; 42(1): 273-6, 2010.
Article in English | MEDLINE | ID: mdl-20172328

ABSTRACT

OBJECTIVE: To study the influence of nonimmunologic factors on the outcome of extended criteria deceased donor (DD) kidney transplants. METHOD: This is a retrospective study of DD transplantation carried out from January 1, 2003 to December 31, 2007, to investigate the impact on graft survival and function of donor renal function at retrieval, cold ischemia time (CIT), delayed graft function (DGF), acute rejection episodes (ARE), age, and weight of donors and recipients, transplant center activities, cause of donor death, donor-recipient gender pairing and size of the donating intensive care unit (ICU). RESULTS: At retrieval, the frequency of donors with a creatinine clearance <60 mL/min, using the Cockcroft-Gault formula, and age >40 years were 31.7% and 32%, respectively. CIT > 24 hours, DGF, and ARE occurred in 27.1%, 33.4%, and 16.5% of cases, respectively. The overall 1- and 5-year graft and patient survival rates were 88% and 79.8% and 96.6% and 92.3%, respectively. The graft function was inferior with occurrences of ARE (P = .0001), DGF (P = .0001), CIT > 20 hours (P = .005), nontraumatic the donor death (P = .022), and donor ICUs bed capacity <20 (P = .03). The odds ratio (OR) for graft loss with DGF, ARE, and donors right kidneys were 7.74 (95% confidence interval [CI] 6-13.4; P = .0001), 4.47 (95% CI, 2.6-7.6; P = .0001) and 1.7 (95% CI, 1-2.8; P = .045), respectively. Graft function was not influenced by donor renal function at retrieval, donor weight, or donor- recipient gender pairings. CONCLUSION: CIT and ARE had an impact on both graft survival and function. DGF and cerebrovascular accidents as the cause of donor death negatively affected graft function during follow-up. ICU center experience had a positive impact on graft survival. Patient survival was affected by recipient age >50 years and female to male donation versus other gender pairings. Neither donor age nor acute terminal rise in the donor serum creatinine affected graft function or survival, or patient mortality.


Subject(s)
Cadaver , Kidney Transplantation/physiology , Tissue Donors , Adolescent , Adult , Body Weight , Cause of Death , Creatinine/metabolism , Female , Graft Rejection/epidemiology , Graft Survival , Humans , Intensive Care Units/organization & administration , Intensive Care Units/standards , Kidney Transplantation/immunology , Kidney Transplantation/mortality , Male , Middle Aged , Survival Rate , Young Adult
12.
Transplant Proc ; 40(7): 2245-51, 2008 Sep.
Article in English | MEDLINE | ID: mdl-18790205

ABSTRACT

The trial objective was to investigate the feasibility and safety of conversion to a generic microemulsion cyclosporine in stable renal transplant patients premaintained on Neoral. We enrolled 75 patients from seven centers in five Middle Eastern countries monitored them for 6 months after conversion to Sigmasporin Microral. Readings at 0, 0.5, 1, 2, 3, 4.5, and 6 months included cyclosporine blood level, serum creatinine, liver enzymes, lipid profile, blood sugar, blood pressure and adverse events. Patients included 54 men and 21 women of mean age 38.9 +/- 10.7 years at 30.3 +/- 29.3 months post-transplantation maintained on Sigmasporin Microral dose of 2.8 +/- 1.0 mg/kg per day; they were observed to be stable throughout the study period as reflected by the therapeutic blood C0 level of 181.6 +/- 102.1 and C2 of 759.2 +/- 384.4. Their absorption profile as represented by C2/C0 was 4.9 +/- 2.8, and C2/cyclosporine dose of 282.3 +/- 128.8. An average serum creatinine level of 116.1 +/- 29.5 micromol/L denoted stable graft function and their liver enzymes did not change during the study. No new-onset cases of hypertension, diabetes mellitus, or hyperlipidemia were reported among the patients. Graft function was stable for all patients, except for two incidences of mild acute rejection and two of mild cyclosporine nephrotoxicity; graft and patient survival rates were both 100%. Results of this 6-month study showed that Sigmasporin Microral was effective to maintain stable renal function in kidney transplant patients converted from Neoral with similar safety and tolerability profiles as those reported in the literature.


Subject(s)
Cyclosporine/therapeutic use , Kidney Transplantation/immunology , Adult , Aged , Chemistry, Pharmaceutical , Creatinine/blood , Cyclosporine/administration & dosage , Cyclosporine/blood , Drug Therapy, Combination , Female , Follow-Up Studies , Graft Survival/drug effects , Graft Survival/immunology , Humans , Immunosuppressive Agents/administration & dosage , Immunosuppressive Agents/blood , Immunosuppressive Agents/therapeutic use , Kidney Failure, Chronic/surgery , Kidney Function Tests , Kidney Transplantation/physiology , Male , Middle Aged , Patient Compliance , Treatment Outcome
13.
Transplant Proc ; 40(7): 2252-7, 2008 Sep.
Article in English | MEDLINE | ID: mdl-18790206

ABSTRACT

We tested a hypothesized pharmacokinetic difference between the reference (Sandimmun Neoral) and test (Sigmasporin Microral) products to prove therapeutic equivalence in an open, multiple fixed dose, one-way crossover, multicenter, and multinational study over a period of 29 days. Forty two stable renal transplant recipients maintained on Sandimmun Neoral were enrolled. Whole blood was collected at day 14 of the study at 0, 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after reference dosing and the same schedule was repeated at day 29 after switching on an mg:mg basis to the test product at day 15 of the study. Analysis of variance was performed for the pharmacokinetic parameters (area under the curve [AUC]0-12, maximum concentration [Cmax]) of cyclosporine using log-transformed values. Tolerability was assessed by vital signs, adverse events, and laboratory investigations. The 90% confidence interval (CI) test for the Ln-transformed, pharmacokinetic parameters was all within the US Food and Drug Administration acceptable range of 80% to 125%, as Ln area under the steady-state curve (AUCss) was within the range of 92.56 to 103.55 and Ln Cmax was within the range of 85.73 to 103.58; the same also applied for AUC0-4, which may be considered the area of greatest inter- and intra-patient variability. Furthermore, in line with the newly adopted recommendations of the Expert Advisory Committee on Bioavailability and Bioequivalence of Health Canada, the 90% CI for AUCss was within the narrow range of 90% to 112%. No significant difference in tolerability was recorded between the two products. Sigmasporin Microral (Julphar) was found to be bioequivalent and clinically interchangeable on an mg:mg basis with Sandimmun Neoral (Novartis).


Subject(s)
Cyclosporine/therapeutic use , Kidney Transplantation/immunology , Adult , Chemistry, Pharmaceutical , Cyclosporine/administration & dosage , Cyclosporine/blood , Drugs, Generic/therapeutic use , Emulsions , Female , Humans , Immunosuppressive Agents/administration & dosage , Immunosuppressive Agents/blood , Immunosuppressive Agents/therapeutic use , Kidney Diseases/classification , Kidney Diseases/surgery , Male , Middle Aged
14.
Indian J Nephrol ; 18(3): 132-3, 2008 Jul.
Article in English | MEDLINE | ID: mdl-20142922

ABSTRACT

Post biopsy arterio-venous fistula in renal transplant range in incidence from 15-16%. Spontaneous resolution of 75% A-V fistulas is seen within four weeks. We report a patient with post biopsy arterio-venous fistula who had developed unexplained hypertension with no definite feature of rejection on biopsy. Doppler application revealed an arterio-venous fistula which showed spontaneous resolution in six weeks.

15.
Exp Clin Transplant ; 5(1): 601-3, 2007 Jun.
Article in English | MEDLINE | ID: mdl-17617050

ABSTRACT

OBJECTIVES: Cytomegalovirus is the most common viral infection following kidney transplant, with overall frequencies of 50% to 80% for the infection and 20% to 60% for cytomegalovirus disease. MATERIALS AND METHODS: We retrospectively analyzed the medical records of 689 kidney transplant recipients at Jeddah Kidney Center in the Kingdom of Saudi Arabia between January 2000 and December 2005 for cytomegalovirus infection and disease. We examined the source of the donated kidneys (deceased versus living donor), the cytomegalovirus serostatus of the donor and recipient, the immunosuppressive protocol, the presence of cytomegalovirus prophylaxis, the clinical presentation of acute cytomegalovirus disease, the patient's response to treatment, and the effect of cytomegalovirus disease on graft and patient survival. RESULTS: Of 689 kidney transplant recipients, 25 (3.6%) had acute cytomegalovirus disease. All 25 patients had cytomegalovirus IgG positive/IgM negative test results prior to transplant. We noticed 2 distinct groups of patients: the first group included 9 patients with cytomegalovirus syndrome, 6 of whom received cytomegalovirus prophylaxis with ganciclovir. All patients in this group had low cytomegalovirus viral loads on polymerase chain reaction, mild disease, and responded to treatment with complete recovery and no adverse effects with respect to themselves or their grafts. The second group included 16 patients with invasive cytomegalovirus disease, 3 of whom received cytomegalovirus prophylaxis. All patients in this group had very high cytomegalovirus viral loads on polymerase chain reaction. Thirteen patients in this group (81%) responded to treatment with full recovery, and normal graft function was maintained in 10 (62%). Of the original 16 patients in this group, 3 (18.8%) died from cytomegalovirus disease and its complications. CONCLUSIONS: We report a low incidence (3.6%) of cytomegalovirus disease at our center. Cytomegalovirus prophylaxis was associated with a milder form of the disease. At our center, treatment of invasive cytomegalovirus disease produced a patient survival rate of 81% and a graft survival rate of 62%.


Subject(s)
Cytomegalovirus Infections/complications , Kidney Diseases/complications , Kidney Diseases/surgery , Kidney Transplantation , Antiviral Agents/therapeutic use , Cytomegalovirus Infections/drug therapy , Cytomegalovirus Infections/physiopathology , Cytomegalovirus Infections/prevention & control , Dose-Response Relationship, Drug , Drug Therapy, Combination , Graft Survival , Humans , Immunosuppressive Agents/administration & dosage , Immunosuppressive Agents/therapeutic use , Retrospective Studies , Severity of Illness Index , Survival Analysis , Tissue Donors
16.
Exp Clin Transplant ; 5(1): 607-9, 2007 Jun.
Article in English | MEDLINE | ID: mdl-17617052

ABSTRACT

OBJECTIVES: Posttransplant erythrocytosis is a well-known complication of renal transplant. It is a persistently elevated hematocrit level equal to or greater than 51%, or a hemoglobin level equal to or greater than 16 g/L, or both, in the absence of other causes. MATERIALS AND METHODS: We retrospectively reviewed this complication in patients who had received a renal transplant at our center between January 1991 and December 2005. RESULTS: Of 1655 renal transplant recipients, 159 patients (9.6%; 154 men, 5 women; mean age, 42 +/- 9 years) developed posttransplant erythrocytosis. The mean follow-up was 96 +/- 4 months. Posttransplant erythrocytosis appeared at an average of 8.2 +/- 5 months after transplant (range, 3-40 months) and lasted an average of 10.3 +/- 3 months (range, 7-35 months). In all 159 patients, the immunosuppressive medication regimen included prednisolone; in 144, cyclosporine was used, and in 108 patients, azathioprine was used, while in another group of patients, the latter 2 were changed to mycophenolate mofetil (n=38) and tacrolimus (n=13). Twenty-four patients (15%) were treated with phlebotomies, while 29 patients (18.2%) were given angiotensin-converting enzyme inhibitors. One hundred six patients were left untreated including 92 patients (57.9%) who received prophylactic anti-platelet medications. Remission of posttransplant erythrocytosis was seen in all treated and untreated patients. No thromboembolic complications occurred. Only 9 patients (5.7%) developed chronic allograft nephropathy during follow-up. CONCLUSIONS: Our findings suggest that posttransplant erythrocytosis is a benign condition affecting males more than females, usually manifesting in the first year after transplant. Remission of posttransplant erythrocytosis can be seen in all patients; however, some patients may require treatment with phlebotomy or angiotensin-converting enzyme inhibitors. Posttransplant erythrocytosis has no adverse effects on renal graft function.


Subject(s)
Kidney Transplantation/adverse effects , Polycythemia/epidemiology , Polycythemia/etiology , Adult , Angiotensin-Converting Enzyme Inhibitors/therapeutic use , Chronic Disease , Female , Follow-Up Studies , Humans , Immunosuppressive Agents/therapeutic use , Incidence , Kidney Diseases/epidemiology , Kidney Diseases/etiology , Male , Middle Aged , Phlebotomy , Polycythemia/therapy , Remission, Spontaneous , Retrospective Studies , Saudi Arabia/epidemiology , Sex Distribution
17.
Prog Transplant ; 17(4): 258-63, 2007 Dec.
Article in English | MEDLINE | ID: mdl-18240690

ABSTRACT

BACKGROUND: Kidneys from deceased donors with acute renal failure are not widely used. OBJECTIVE: To compare outcomes for recipients of kidneys from donors with acute renal failure at organ recovery with outcomes for recipients of kidneys from donors with normal serum levels of creatinine. METHODS: Records of deceased donors and recipients of their organs at the Saudi Center for Organ Transplantation from 2003 to 2005 were reviewed. A total of 33 donors (donating 65 kidneys to 65 recipients) with elevated serum levels of creatinine (>1.7 mg/dL) and 94 donors (donating 188 kidneys to 188 recipients) with normal (<1.1 mg/dL) serum levels of creatinine at organ recovery and their respective recipients were compared. Both groups had normal creatinine levels at admission. RESULTS: Recipients in both groups had similar renal function at discharge and follow-up. Delayed graft function occurred more often (P= .009) in the recipients of kidneys from donors with acute renal failure (47.7%) than in recipients of kidneys from donors with normal creatinine levels (29.8%). Elevation of serum level of creatinine at organ recovery did not correlate significantly with kidney function at discharge or last follow-up or with graft survival. CONCLUSIONS: Survival of patients or grafts at 1, 2, and 3 years did not differ significantly between the recipients in the 2 groups. Only the frequency of delayed graft function differed between the 2 groups.


Subject(s)
Acute Kidney Injury , Donor Selection , Kidney Transplantation , Tissue Donors , Adult , Cadaver , Case-Control Studies , Female , Graft Survival , Humans , Male , Retrospective Studies , Saudi Arabia , Survival Analysis
19.
Transplant Proc ; 37(7): 2909-10, 2005 Sep.
Article in English | MEDLINE | ID: mdl-16213258

ABSTRACT

Organ transplantation is the preferred mode of replacement therapy. Currently acceptable 5-year posttransplantation survival rates are 85% for renal grafts, 70% for liver, and 65% for heart. Organ donation, however, remains a significant factor in organ transplantation, as humans are the only possible donors and the numbers of patients on waiting lists remain high. Several factors affect organ transplantation in countries in the Middle East Society for Organ Transplantation (MESOT) region, including inadequate preventive medicine, differing health infrastructures, poor awareness within the medical community and lay public regarding the importance of organ donation and transplantation, a high level of ethnicity, and poor government support of organ transplantation. Moreover, there is lack of team spirit among transplant physicians, a lack of coordination between groups that manage organ procurement and the transplant centers, and a lack of effective health insurance coverage for many persons. Three models of organ donation and transplantation exist in the MESOT region-the Saudi, Iranian, and Pakistani models. Living-organ donation, the most widely practiced form of donation in countries in the MESOT region, includes kidney and partial liver. Cadaveric organ donation has significant potential in the MESOT region. However, numerous obstacles must be overcome in MESOT countries. Resolution of these obstacles will require continuous work on many fronts. Experiences from all sources must be incorporated into new and improved models that can overcome current inadequacies. Solutions will require continued focus within the medical community, steady support from the lay public and religious institutions, as well as governmental assistance.


Subject(s)
Kidney Transplantation/standards , Organ Transplantation/standards , Humans , Kidney Transplantation/legislation & jurisprudence , Kidney Transplantation/mortality , Middle East , Renal Replacement Therapy/mortality , Saudi Arabia , Societies, Medical , Survival Analysis , Tissue Donors/supply & distribution
20.
Transplant Proc ; 37(5): 2004-6, 2005 Jun.
Article in English | MEDLINE | ID: mdl-15964324

ABSTRACT

We outline a proposal for the use of living unrelated kidney donors for transplantation. This proposal, although recommended by the Saudi National Committee on Renal Transplantation, is still under discussion and has not been implemented yet. We feel that this proposal is ethical with airtight safeguards against commercialization and for the protection of the well-being of the donor with assurance that he or she has not been coerced into donation.


Subject(s)
Kidney Transplantation/ethics , Living Donors/ethics , Fees and Charges , Female , Humans , Infant , Kidney Transplantation/economics , Milk, Human , Mother-Child Relations , Saudi Arabia
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