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Background: The efficacy of human recombinant erythropoietins (rHuEPOs) in the treatment of anemia with different etiologies is proven. Development of biosimilar rHuEPO products with lower cost and wider availability is important for the care of anemic patients., Objective: The aim of the present study was to determine the bioequivalence and safety of a biosimilar rHuEPO (Pastopoitin(®)) and compare it with the innovator product Eprex(®), as a standard rHuEPO., Methods: One hundred and seven anemic patients on stable hemodialysis were recruited to this randomized double-blind comparative trial and assigned to either subcutaneous Pastopoitin (n = 50) or Eprex (n = 57). Each study group received rHuEPO at a dose of 80-120 IU/kg/week in 2-3 divided doses for a period of 3 months. Hematologic parameters including Hemoglobin, hematocrit, RBC, EBC, platelet, MCV, MCH and MCHC were checked every 2 weeks. Blood iron, ferritin, TIBC, creatinine, BUN and electrolytes (Na, K, Ca and P) were evaluated monthly over the 3 months., Results: A significant increase in hemoglobin, hematocrit and RBC was observed by the end of study in both Pastopoitin and Eprex groups (p < 0.001). However, these factors were not significantly different between the groups, neither at baseline nor at the end of study (p > 0.05). Likewise, the groups were comparable regarding MCV, MCH, MCHC, iron, ferritin, TIBC, creatinine, BUN and electrolytes at baseline as well as at the end of trial. Adverse events were not serious and occurred with the same frequency in the study groups., Conclusion: Pastopoitin showed comparable efficacy and safety profile with Eprex in anemic patients on hemodialysis. Hence, Pastopoitin may be considered as a rHuEPO with a lower cost and wider availability compared with the innovator product Eprex.

Rosmarinus officinalis L. is a medicinal plant with diverse activities including enhancement microcapillary perfusion. The present study aimed to investigate the clinical efficacy of rosemary oil in the treatment of androgenetic alopecia (AGA) and compare its effects with minoxidil 2%. Patients with AGA were randomly assigned to rosemary oil (n = 50) or minoxidil 2% (n = 50) for a period of 6 months. After a baseline visit, patients returned to the clinic for efficacy and safety evaluations every 3 months. A standardized professional microphotographic assessment of each volunteer was taken at the initial interview and after 3 and 6 months of the trial. No significant change was observed in the mean hair count at the 3-month endpoint, neither in the rosemary nor in the minoxidil group (P > .05). In contrast, both groups experienced a significant increase in hair count at the 6-month endpoint compared with the baseline and 3-month endpoint (P < .05). No significant difference was found between the study groups regarding hair count either at month 3 or month 6 (> .05). The frequencies of dry hair, greasy hair, and dandruff were not found to be significantly different from baseline at either month 3 or month 6 trial in the groups (P > .05). The frequency of scalp itching at the 3- and 6-month trial points was significantly higher compared with baseline in both groups (P < .05). Scalp itching, however, was more frequent in the minoxidil group at both assessed endpoints (P < .05). The findings of the present trial provided evidence with respect to the efficacy of rosemary oil in the treatment of AGA.

Inflammation is a key component in the pathogenesis of sulfur mustard (SM)-induced skin complications. Here, the levels of interleukin (IL) -2, IL-4, IL-6, and IL-10 were evaluated in patients with chronic SM-induced complications. Seventy-four serum samples were collected from SM-injured veterans (SM group; n = 37) and nonchemically injured patients (control group; n = 37) with skin pruritus. The levels of IL-2, IL-4, IL-6, and IL-10 were evaluated by sandwich enzyme-linked immunosorbant assay technique in both nil and mitogen medium. No significant difference was found in pruritus score between SM (74.16 +/- 5.93) and control (74.48 +/- 6.15) groups (P > .05). The mean serum concentrations of IL-2 and IL-6 were found to be significantly elevated in the control compared with the SM group (P < .05). However, no significant difference was observed between the study groups regarding serum levels of IL-4 and IL-10 (P > .05). Serum IL-2 (in both SM and control groups) and IL-6 (in the control group) concentrations were significantly correlated with pruritus score while no significant association was found for IL-4 and IL-10. Serum concentrations of IL-2, IL-6, and IL-10 are significantly decreased in SM-exposed patients with chronic pruritus. Such alterations might represent a plausible mechanism for tissue damage and skin itching following SM exposure. Therefore, variation of ILs may also contribute to skin pruritus induced by SM.

Background: Breast cancer is the most common cancer among women worldwide. The aim of this study was to investigate the relationship between tumor size and axillary lymph node involvement (ALNI) in patients with invasive lesions, to find the best candidates for a full axillary dissection. Additionally, we evaluated the association between tumor size and invasive behavior. The study was based on data from 789 patients with histopathologically proven invasive breast cancer diagnosed in Shohada University hospital in Tehran, Iran (1993-2009). Cinical and histopathological characteristics of tumors were collected. Patients were divided into 6 groups according to primary tumor size: group I (0.1-≤1cm), II (1.1-≤2cm), III (2.1-≤3cm), IV (3.1-≤4cm), V (4.1-≤5cm) and VI (>5cm). The mean(±SD) size of primary tumor at the time of diagnosis was 3.59±2.69 cm that gradually declined during the course of study. There was a significant correlation between tumor size and ALNI (p<0.001). A significant positive correlation between primary tumor size and involvement of surrounding tissue was also found (p<0.001). The mean number of LNI in group VI was significantly higher than other groups (p<0.05).We observed more involvement of lymph nodes, blood vessels, skin and areola-nipple tissue with increase in tumor size.We found 15.3% overall incidence of ALNI in tumors ≤2 cm, indicating the need for more investigation to omit full axillary lymph node dissection with an acceptable risk for tumors below this diameter. While in patients with tumors ≥2 cm, 84.3% of them had nodal metastases, so the best management for this group would be a full ALND. Tumor size is a significant predictor of ALNM and involvement of surrounding tissue, so that an exact estimation of the size of primary tumor is necessary prior to surgery to make the best decision for management of patients with invasive breast cancer.

Background: Recombinant human erythropoietin is the cornerstone of therapy for anemia associated with chronic kidney disease or renal transplantation. However, it is not affordable and available for all patients. The present randomized double-blind trial compared the efficacy and safety of a biogeneric erythropoietin, Epolyrec, with the original product, Eprex, in correcting post-transplantation anemia (PTA)., Methods: Fifty patients who had undergone kidney transplantation surgery and had a hemoglobin level of < 11 g/L and a hematocrit of < 30% were recruited. These patients were randomly assigned to Epolyrec (n = 25) or Eprex (n = 25) at a dosage of 80 - 120 IU/kg body weight, three times/week. Patients were followed-up for two months unless they achieved the target levels for hemoglobin (1 g/L increase compared to baseline) and hematocrit (2 - 3% increase compared to baseline). Hemoglobin, hematocrit, and complete blood count with differential (CBC/DIFF) were evaluated at baseline and at months 1 and 2 of study. Other biochemical parameters were assessed at baseline and at the end of trial., Results: Serum hemoglobin and hematocrit progressively increased from baseline to month 2 in both Epolyrec (p = 0.001) and Eprex (p < 0.001) groups, with no significant difference between the groups (p > 0.05). Mean corpuscular hemoglobin (MCH) and platelet count showed a significant increase during the course of the trial in both Epolyrec (p = 0.041 and 0.004 for MCH and platelet count, respectively) and Eprex (p = 0.036 and 0.003) groups. However, no significant change was observed between the groups regarding erythrocyte count, mean corpuscular volume, white blood cell count or reticulocyte count from baseline to the end of trial in any of the groups (p > 0.05). The incidence of adverse events were generally low in both groups and without any significant difference between Epolyrec and Eprex (p > 0.05)., Conclusions: Epolyrec was equivalent to Eprex with respect to efficacy and safety. Hence, Epolyrec could represent a much more affordable and available biogeneric alternative to Eprex in correcting PTA.

Introduction: Diaper dermatitis (DD) is a common inflammatory disorder among children and infants. The objective of the present randomized and double-blind trial was to compare the therapeutic efficacies of aloe vera cream and Calendula officinalis ointment on the frequency and severity of DD in children., Methods: Sixty-six infants with DD (aged < 3 years) were randomized to receive either aloe cream (n = 32) or Calendula ointment (n = 34). Infants were treated with these drugs 3 times a day for 10 days. The severity of dermatitis was graded at baseline as well as at the end of trial using a 5-point scale. The adverse effects of study medications were assessed during the trial., Results: Although improvement in the severity of DD was observed in both treatment groups (P < 0.001), patients receiving Calendula ointment had significantly fewer rash sites compared to aloe group (P = 0.001). No adverse effect was reported from either of the medications., Discussion: The evidence from this study suggests that topical aloe and in particular Calendula could serve as safe and effective treatment for the treatment of diaper dermatitis in infants.

Background: Recombinant human erythropoietin (rHuEPO) is the cornerstone therapy for anemia associated with chronic kidney disease. However, not all patients with renal anemia receive sufficient doses of rHuEPO due to its high cost. The present trial aimed to evaluate the efficacy of Epolyrec, a biogeneric rHuEPO, in the management of renal anemia in patients on hemodialysis., Methods: Seventy-two patients with end stage renal disease (ESRD) who were receiving hemodialysis were assigned to receive Epolyrec subcutaneously at a dose of 40-80 IU/Kg in 2-3 divided doses after each dialysis session for 12 weeks. Hemoglobin, hematocrit, and CBC/DIFF together with biomarkers of iron status, renal function, and trace elements were evaluated at baseline and during the course of trial., Results: Hemoglobin concentrations and hematocrit progressively increased from baseline (8.45 +/- 1.42 mg/dL and 27.05 +/- 4.64% for hemoglobin and hematocrit, respectively) to the end of trial (10.56 +/- 1.93 and 34.06 +/- 6.70) (p < 0.001). RBC count (p = 0.026), reticulocyte count (p = 0.045), and MCV (p < 0.001) were also significantly increased at the end of trial (3.86 +/- 0.91x10(6)/microL, 0.78 +/- 0.31%, and 93.50 +/- 10.90 fL for RBC count, reticulocyte count, and MCV, respectively) compared to baseline (0.98 +/- 3.38, 0.18 +/- 0.63, and 89.75 +/- 9.35). Serum iron and ferritin were decreased while creatinine and phosphorous increased by the end of trial. No significant change was observed in WBC count, RDW, MCH, MCHC, BUN, PTH, Na, Ca, K, and Mg (p > 0.05). The frequencies of evaluated side effects were generally low and < 10%., Conclusions: Epolyrec is clinically efficacious in the elevation of hemoglobin and hematocrit in anemic ESRD patients receiving hemodialysis. Future comparative trials are warranted to compare the efficacy and safety of Epolyrec to those of innovator products.

Leishmaniasis is a painless chronic skin disease that is caused by the protozoan parasite Leishmania. Due to the importance of this disease and the side effects of chemical drugs, use of drugs of plant origin to treat Leishmaniasis is very important. In the present study, the chemical composition and the anti-Leishmania major activity of the essential oils obtained from Satureja bakhtiarica were evaluated in vitro. The oils were extracted using a Clevenger apparatus and then the chemical composition was analyzed by GC-MS. Promastigotes of L. major were cultured in both N.N.N and RPMI1640 media. GC-MS analysis showed 13 compounds, in which the major components were the phenolic (37.4%) compounds, thymol (22.6%) and p-cymene (19.3%). The essential oil of S. bakhtiarica showed higher activity against L. major than the standard anti-Leishmania drug, glucantime,. Perhaps because of the high concentration of phenolic compounds in the essential oil, all the parasites were killed after 24 hours. The essential oil from S. bakhtiarica is a potential plant drug against leishmaniasis. Further studies are necessary to evaluate this oil in animal models (in vivo) for future drug applications.

The objective of the present study was to assess the ascorbic acid (AA) levels in seminal plasma of the fertile and infertile men and to investigate its relationship with sperm count, motility and normal morphology. Semen samples were provided by fertile [smoker (n = 25), nonsmoker (n = 21)] and infertile men [smoker (n = 23), nonsmoker (n = 32)]. A simplified method of reverse phase high performance liquid chromatography (RP-HPLC) procedure using UV detection was applied for the determination of seminal AA. Fertile subjects, smoker or not, demonstrated significantly higher seminal AA levels than any infertile group (p<0.01). Nonsmokers had high, but no significant, mean AA levels in their seminal plasma compared with smokers. Seminal AA in fertile and infertile (smokers or nonsmokers) males correlated significantly with the percentage of spermatozoa with normal morphology (p<0.01). Seminal AA decreased significantly in infertile men. Decrease of seminal plasma AA is a risk factor for low normal morphology of spermatozoa and idiopathic male infertility. Measurement of seminal AA in the seminal plasma of males with a history of subfertility or idiopathic infertility is necessary and can be helpful in fertility assessment.

Zinc has antioxidative properties and plays an important role in scavenging reactive oxygen species. We hypothesized that in the absence of Zn, the possibility of increased oxidative damage exists that would contribute to poor sperm quality. Therefore, measurement of seminal Zn in the seminal plasma of males with a history of subfertility or idiopathic infertility is necessary and can be helpful in fertility assessment. The primary objective of the present study was to assess the relationship between Zn levels in seminal plasma with sperm quality in fertile and infertile men. Semen samples were provided by fertile (smoker [n = 17], nonsmoker [n = 19]) and infertile men (smoker [n = 15], nonsmoker [n = 21]). After semen analysis, concentrations of Zn, Mg, Ca, Na, and K in the seminal plasma of all groups were determined by atomic absorption spectroscopy. Element concentrations in seminal plasma of all groups were in the order Na > K > Ca > Zn > Mg. Fertile subjects, smoker or not, demonstrated significantly higher seminal Zn levels than any infertile group (P < .001). A trend was observed for a lower Zn levels in seminal plasma of smokers compared with nonsmokers. Seminal Zn in fertile and infertile (smokers or nonsmokers) males correlated significantly with sperm count (P < .01) and normal morphology of sperm (P < .001). There was a significantly positive correlation between seminal Zn with Ca (P < .01) and K (P < .01) levels in all specimens. In conclusion, poor Zn nutrition may be an important risk factor for low quality of sperm and idiopathic male infertility.

In this research we investigated the effect of cigarette smoking on sperm parameters both before and after swim-up. Semen sample provided from fertile smoker (n = 25), fertile nonsmoker (n = 21), infertile smoker (n = 23) and infertile nonsmoker men (n = 32). Semen analysis was performed manually according to the World Health Organization (WHO) standards guidelines. Present research showed that sperm parameters quality in smoker men was approximately lower than nonsmoker men. As well as present research showed that cigarette smoking has dose dependent effect on sperm parameters, but this effect was not significant. Therefore, it appears that cigarette smoking is associated with reduced sperm quality and the risk of idiopathic male infertility in smoker men.