Safety and efficacy of PDpoetin for management of anemia in patients with end stage renal disease on maintenance hemodialysis: Results from a phase IV clinical trial

Recombinant human erythropoietin (rHuEPO) is available for correcting anemia. PDpoetin, a new brand of rHuEPO, has been certified by Food and Drug Department of Ministry of Health and Medical Education of Iran for clinical use in patients with chronic kidney disease. We conducted this post-marketing survey to further evaluate the safety and efficacy of PDpoetin for management of anemia in patients on maintenance hemodialysis. Patients from 4 centers in Iran were enrolled for this multicenter, open-label, uncontrolled phase IV clinical trial. Changes in blood chemistry, hemoglobin and hematocrit levels, renal function, and other characteristics of the patients were recorded for 4 months; 501 of the patients recruited, completed this study. Mean age of the patients was 50.9 (±16.2) years. 48.7 of patients were female. Mean of the hemoglobin value in all of the 4 centers was 9.29 (±1.43) g/dL at beginning of the study and reached 10.96 (±2.23) g/dL after 4 months and showed significant increase overall (P<0.001). PDpoetin dose was stable at 50-100 U/kg thrice weekly. Hemorheologic disturbancesand changes in blood electrolytes was not observed. No case of immunological reactions to PDpoetin was observed. Our study, therefore, showed that PDpoetin has significantly raised the level of hemoglobin in the hemodialysis patients (about 1.7±0.6 g/dL). Anemia were successfully corrected in 49 of patients under study. Use of this biosimilar was shown to be safe and effective for the maintenance of hemoglobin in patients on maintenance hemodialysis. © A.N. Javidan et al., 2014

The data set development for the National Spinal Cord Injury Registry of Iran (NSCIR-IR): progress toward improving the quality of care

STUDY DESIGN: Descriptive study. OBJECTIVES: The aim of this manuscript is to describe the development process of the data set for the National Spinal Cord Injury Registry of Iran (NSCIR-IR). SETTING: SCI community in Iran. METHODS: The NSCIR-IR data set was developed in 8 months, from March 2015 to October 2015. An expert panel of 14 members was formed. After a review of data sets of similar registries in developed countries, the selection and modification of the basic framework were performed over 16 meetings, based on the objectives and feasibility of the registry. RESULTS: The final version of the data set was composed of 376 data elements including sociodemographic, hospital admission, injury incidence, prehospital procedures, emergency department visit, medical history, vertebral injury, spinal cord injury details, interventions, complications, and discharge data. It also includes 163 components of the International Standards for the Neurologic Classification of Spinal Cord Injury (ISNCSCI) and 65 data elements related to quality of life, pressure ulcers, pain, and spasticity. CONCLUSION: The NSCIR-IR data set was developed in order to meet the quality improvement objectives of the registry. The process was centered around choosing the data elements assessing care provided to individuals in the acute and chronic phases of SCI in hospital settings. The International Spinal Cord Injury Data Set was selected as a basic framework, helped by comparison with data from other countries. Expert panel modifications facilitated the implementation of the registry process with the current clinical workflow in hospitals

The data set development for the National Spinal Cord Injury Registry of Iran (NSCIR-IR): progress toward improving the quality of care

STUDY DESIGN: Descriptive study. OBJECTIVES: The aim of this manuscript is to describe the development process of the data set for the National Spinal Cord Injury Registry of Iran (NSCIR-IR). SETTING: SCI community in Iran. METHODS: The NSCIR-IR data set was developed in 8 months, from March 2015 to October 2015. An expert panel of 14 members was formed. After a review of data sets of similar registries in developed countries, the selection and modification of the basic framework were performed over 16 meetings, based on the objectives and feasibility of the registry. RESULTS: The final version of the data set was composed of 376 data elements including sociodemographic, hospital admission, injury incidence, prehospital procedures, emergency department visit, medical history, vertebral injury, spinal cord injury details, interventions, complications, and discharge data. It also includes 163 components of the International Standards for the Neurologic Classification of Spinal Cord Injury (ISNCSCI) and 65 data elements related to quality of life, pressure ulcers, pain, and spasticity. CONCLUSION: The NSCIR-IR data set was developed in order to meet the quality improvement objectives of the registry. The process was centered around choosing the data elements assessing care provided to individuals in the acute and chronic phases of SCI in hospital settings. The International Spinal Cord Injury Data Set was selected as a basic framework, helped by comparison with data from other countries. Expert panel modifications facilitated the implementation of the registry process with the current clinical workflow in hospitals

Low expression levels of peroxisome proliferator-activated receptor gamma (PPARγ) in gastric cancer and its relationship with tumor progression

Background: Peroxisome proliferator-activated receptor gamma (PPARγ) plays a crucial role in hindering the progression and growth of cancer cells. The function of PPARγ in gastric cancer and its relationship with progression of the disease have not been appropriately defined. Therefore, this study examined the association of PPARγ expression in tumor with advancement of gastric cancer. Methods: In the cross-sectional case-control study, the expression of PPARγ in tumoral and the paired adjacent normal tissues of 50 patients with gastric cancer, who undergone tumor resection at Institute of Imam Khomeini University Hospital, Tehran, Iran, were assayed and compared using quantitative real-time polymerase chain reaction method. Correlation between PPARγ expression in tumor tissue and the cancer progression relevant clinicopathological features was evaluated using the Spearman’s rho correlation test. Findings: The relative expression levels of PPARγ in tumoral tissues were shown to be profoundly decreased compared with their adjacent normal tissues 0.36 (0.15-0.89) vs. 1.01 (0.83-1.16), P < 0.001. There was significant correlation between the relative expression level of PPARγ in tumoral tissues and clinicopathological features such as cancer staging, tumor differentiation, tumor size, and lymphatic and vascular invasion. However, there was no noticeable correlation between the relative PPARγ expression level and other features such as age, gender, and metastasis. Conclusion: Decreased expression of PPARγ in gastric cancer tissue compared to the adjacent normal tissues is inversely associated with the cancer progression and development relevant clinicopathological features; hence, it may play an important role in the pathophysiology of gastric cancer. © 2017, Isfahan University of Medical Sciences(IUMS). All rights reserved

The Most Common Cancers in Iranian Women

&quot;nCancer is the third main cause of death in Iran. This report was provided for explaining most common cancers in Iranian Women. The National Cancer Registry reports from 2003 to 2006, pathologic based cancer registry reports from all of prov&amp;shy;inces of Iran. The age-standardized incidence rate of cancers was 56.80, 75.15, 6.18, 102.43 per 100 000 among fe&amp;shy;males in 2003, 2004, 2005, 2006, respectively. The male to female standard ratio was 1.12. The most common cancer among women was breast cancer. The cancer registration system, is the main tool of management and control of cancers and such impor&amp;shy;tant informa&amp;shy;tion source is not only necessary for epidemiologic studies of the illness, but also for planning and forecasting the events, measuring the accuracy of the studies, and the effects of medical interventions. Without a cancer registry with de&amp;shy;fined standards, we may not be able to formulate, execute, and observe any cancer control plan. According to the results, breast cancer is the most common cancer in Iranian females. Therefore, breast cancer screening should be start in Iran

Omega-3 fatty acids' effect on leptin and adiponectin concentrations in patients with spinal cord injury: A double-blinded randomized clinical trial

Context: Omega-3 fatty acids have been recently proposed to induce neural improvement in patients with spinal cord injury (SCI) while affecting some hormones including leptin and adiponectin. Objectives: We tried to evaluate the effect of omega-3 fatty acids on circulatory concentrations of leptin and adiponectin among these patients. Design: This study is a double-blinded randomized clinical trial with intervention duration of 14 months. Setting: A tertiary rehabilitation center. Participants: Total of 104 patients with SCI who did not meet our exclusion criteria entered the study. Those with history of diabetes, cancer, endocrinology disease, acute infection, and use of special medications were excluded. Patients were divided randomly into the treatment and control group by using permuted balanced block randomization. Intervention: The treatment group received two MorDHA® capsules per day (each capsule contain 465 mg of docosahexaenoic acid (DHA) and 63 mg of eicosapentaenoic acid (EPA)) for 14 months while the control group received placebo capsules with similar color, shape, and taste. Main outcomes measures: Leptin and adiponectin concentrations in plasma were measured at the beginning of trial and then after 6 and 14 months. Results: Fourteen months of treatment with DHA and EPA did not influence concentrations of leptin but adiponectin level was significantly decreased (P: 0.03). Weight was positively correlated with leptin level at stage 0 of trial (P: 0.008, r = 0.41) while this association was attenuated through stages of trial after intervention. Conclusion: Our data show that omega-3 fatty acids may not affect plasma concentrations of leptin but adiponectin level is decreased in patients with SCI. Moreover, this intervention influences the linear relationship between weight and leptin after 14 months administration of DHA and EPA. © The Academy of Spinal Cord Injury Professionals, Inc. 2015

Relationship between leptin and adiponectin concentrations in plasma and femoral and spinal bone mineral density in spinal cord-injured individuals

Background context Previously, the associations between leptin and adiponectin levels with bone mineral density (BMD) have been reported in different populations, and occasionally, controversial results have been demonstrated. Until now, these relationships in spinal cord-injured individuals have not yet been described. Purpose We tried to investigate the correlation between leptin and adiponectin concentrations in plasma and BMD in Iranian patients with spinal cord injury (SCI). Study design/setting Cross-sectional investigation. Patient sample Referred patients with SCI who did not meet our exclusion criteria such as pregnancy, lactation, amputation, history of diabetes, cancer, endocrinology disease, and use of special medications entered the study. Outcome measures Bone mineral density of femoral neck, trochanter, intertrochanteric zone, total hip, and lumbar vertebrae assessed by dual-energy X-ray absorptiometry and serum leptin and adiponectin levels measured by blood sample analysis using immunoassay techniques. Methods Patient demographic characteristics were measured during face-to-face visits. Injury level and Spinal cord Injury Association (ASIA) score were assessed by clinical examination and were confirmed by imaging aids. Measured levels of leptin and adiponectin and dual-energy X-ray absorptiometry results were analyzed with partial correlation analysis method after adjustment for weight, body mass index (BMI), and age. Results Total of 104 patients (19 females and 85 males) entered this investigation. Higher leptin concentration was significantly associated with higher BMD in femoral neck (p=.006, r=0.73), femoral intertrochanteric zone (p=.001, r=0.83), and hip (p=.001, r=0.81) only in female patients, whereas no such association was detected in male participants after adjusting for BMI and age. Leptin and adiponectin levels were not associated with lumbar spine BMD in both genders. Neither injury level nor ASIA score and plegia type (paraplegia or tetraplegia) influenced on leptin and adiponectin concentrations. Conclusions We found no association between leptin concentration and BMD in male individuals, whereas a positive correlation between leptin and BMD of femoral neck, intertrochanter, and hip was observed in female patients that shows a sexual polymorphism in this relationship. However, by considering the low number of female participants, these results should be interpreted cautiously. Lumbar spine BMD was associated with neither leptin nor adiponectin level in both genders. © 2015 Elsevier Inc. All rights reserved