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Objective: This study aims to compare a generic formulation of the drug erlotinib 150 mg tablet to the brand-name version to validate the analytical method and bioequivalence studies.Methods: Erlotinib hydrochloride tablets (test versus reference formulation) were compared in a randomized, two-period crossover study to determine their pharmacokinetic properties and bioequivalence in healthy Iranian volunteers. 14 d passed between each treatment during the washout period. Liquid chromatography-tandem mass spectrometry (LC-MS/MS) was used to analyze erlotinib, and the method validation is presented.Results: Over the range of 6.25-3200 ng/ml, the analytical method was verified as linear (R2= 0.998). The technique was also accurate and precise at various concentrations. The results showed that the pharmacokinetics of the two products were comparable. Following administration of the test and reference products, the geometric averages for (Area under the curve) AUC0-72, AUCinf, and maximum plasma concentration (Cmax) were 104.71 (90% CI, 93.39-117.40), 104.68 (90% CI, 93.47-117.23), and 104.85 (90% CI, 94.61-116.21), respectively. The outcomes fell within the permitted tolerance of 0.8 to 1.25.Conclusion: For the determination of erlotinib in plasma, the used analytical approach is accurate, precise, repeatable, and selective. Additionally, the bioequivalence research revealed no appreciable differences in pharmacokinetic characteristics between the reference and test products. Therefore, it is possible to assert that the generic erlotinib product and the reference product are bioequivalent.
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BACKGROUND@#Bloating is a common gastrointestinal complaint which is difficult to treat.@*OBJECTIVE@#This study investigated the efficacy and compliance of a formulation called KAASER comprised of Trachyspermum ammi (L.) Sprague seed, Zingiber officinale Roscoe. rhizome and Piper nigrum L. berry in the treatment of functional bloating.@*DESIGN, SETTING, PARTICIPANTS AND INTERVENTION@#A total of 106 patients with functional bloating, between 20 and 50 years of age, participated in this double-blind randomized controlled trial. Patients were divided into 3 parallel groups that received 500 mg of placebo, dimethicone or KAASER, three times a day for 2 weeks.@*MAIN OUTCOME MEASURES@#The frequency and severity of bloating were primary outcomes, while the frequencies of eructation, defecation, borborygmus and early satiation were secondary outcomes. All parameters were evaluated at the beginning (week 0), and also weeks 2, 4 and 10 of the study, through self-report checklists with a scoring system.@*RESULTS@#Among the 84 patients who completed the study, the frequency and severity of bloating (P < 0.001), the frequencies of eructation, defecation and borborygmus (P = 0.03) were significantly improved in the group receiving KAASER (36 patients) compared with the dimethicone (35 patients) and placebo (35 patients) groups, during the 3 phases of follow-up. These significant differences persisted through the 2 and 8 weeks of follow-ups after cessation of medication (week 4 and 10). In early satiation, no significant differences were observed among the 3 groups.@*CONCLUSION@#The results showed that KAASER can be effectively used to treat patients suffering from bloating. Bloating, eructation, defecation and borborygmus in the KAASER group remained significantly improved after 2 and 8 weeks of cessation of medication, making this mechanism an interesting area for further investigation.@*TRIAL REGISTRATION@#Registration trial IRCT2015100324327N on Iranian Registry of Clinical Trials.
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Background: Hypertrophic scars are one of the complications following a burn injury. Intralesional corticosteroid injection is an invasive method for treatment of this complication. We had design a single blinded randomized control trial to deliver dexamethasone by phonophoresis and evaluate its efficacy on hypertrophic burn scars characteristics
Methods: 56 cases of hypertrophic burn scar due to burn injury allocated randomly to dexamethasone and control group. Individuals in case group received 10 sessions of dexamethasone 0.4% phonophoresis. Patients in control group had placebo phonophoresis [ultrasound with normal routine aquatic gel without any dexamethasone] with the same protocol. At the beginning of study and one week after last session, hypertrophic scar characteristics and pruritus were measured by "Vancouver Scar Scale", and "5-D Pruritus Scale" respectively in both groups
Results: Despite mild improvement in Vancouver Scar Scale score one week after intervention in dexamethasone phonophoresis group in comparison to control subjects, but this difference was not significant [p<0/08]. Pruritus score perceived subjectively were significantly lower one week after intervention in dexamethasone groups in comparison to control subjects [p<0/01]
Conclusion: Dexamethasone phonophoresis is a safe and effective treatment method for burn hypertrophic scar pruritus, but its efficacy for scar characteristics improvement needs to be evaluated by larger studies with long-term follow up period
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Introduction: Irritable bowel syndrome (IBS) and Inflammatory Bowel Disease (IBD) are two common diseases of lower gastrointestinal symptoms and discomfort. Although research has demonstrated the influence of psychological processes on gastrointestinal functions, few studies compared the role of psychological factors in IBS and IBD disease. The present study aimed to assess the psychological factors in patients suffering from IBS and IBD. Methodology: This current cross-sectional study was done on 90 subjects with diagnosed IBD (15women, 15 men), IBS (15 women, 15 men), and 30 non-IBS/non-IBD in the Gastroenterology Department of Babol University of Medical Sciences. All subjects filled out three questionnaires; Rahim Organizational Conflict Inventory-II (ROCI-II), Symptom Checklist-90-Revised (SCL-90-R), and 20-item Toronto Alexithymia Scale (TAS-20). Results: The IBS and IBD patients had higher scores in unconstructive management conflict (dominating and avoiding) ways than the controls, but did not differ from each other. Although both the IBS and IBD patients had higher alexithymia scores than control subjects, IBS patients were more alexithymic than IBD patients. Significantly, higher scores were found in patients with IBS compared to IBD for some psychiatric symptoms (depression 17.2±11.3 vs 10.7±6.8, anxiety 12.7±8.2 vs 7.5±4.5, and the total score of psychiatric symptoms 115.4±62.6 vs 83.3±44.8). Conclusion: Although both the IBS and IBD patients experienced more psychiatric symptoms, unconstructive conflict management styles, and alexithymia than controls, IBS patients had worse psychiatric and alexithymic symptoms than IBD.
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The association between Helicobacter pylori [HP], as one of the most prevalent infections, and serum glucose level was inconsistent with previous studies. Moreover, there are contradictory reports about the relationship between HP infection and lipid profile. The purpose of this study was to determine the relationship between HP infection with glycemic and lipid profiles in elderly people. This cross-sectional study was conducted on 1,300 subjects over 60 years in Amirkola Health and Ageing Project. After using a standard questionnaire, the venous sampling was done to determine FBS, triglyceride [TG], cholesterol, low density lipoprotein [LDL], high-density lipoprotein [HDL] and IgG anti-HP after a 12-h overnight fast. The information about the individuals was analyzed using SPSS-17. The P < 0.05 was considered statistically significant. The prevalence of HP infection in diabetic and nondiabetic subjects was 77.5% and 75.7%, respectively, which had no statistically significant difference. Also, there was no significant difference between the serum lipid level including TG, LDL and HDL cholesterol with levels of anti-HP antibodies. The rate of HP infection in patients with hypertension was 75% and 78.3% in healthy patients, in which the difference was not statistically significant. In terms of body mass index [BMI], the prevalence of infection in the group with normal BMI was 77.3% and for the overweight and obese elderly population, it was 74.7%, and 77.5%, respectively [P = 0.445]. The findings revealed that in a large population of elderly in the northern part of Iran, HP infection is not associated with BMI, serum glucose and lipid profile as well as blood pressure