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1.
Surg Endosc ; 37(7): 5045-5051, 2023 07.
Artigo em Inglês | MEDLINE | ID: mdl-37277518

RESUMO

BACKGROUND: In this meta-analysis, we aimed to compare the hydrocelectomy versus aspiration and sclerotherapy for treating primary hydrocele. METHODS: We included randomized controlled trials (RCTs) and quasi-RCTs that compared aspiration and sclerotherapy with any type of sclerosants versus hydrocelectomy for primary hydrocele. Studies were identified via a systematic search of the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, and ClinicalTrials.gov. Citation tracking of related articles was performed. Data extraction and quality assessment were performed independently by two authors. The primary and secondary outcome measures were compared and analyzed using the Review Manager 5.3.5 software. RESULTS: Five small RCTs were included in the present study. These 5 RCTs included 335 patients with 342 hydroceles, randomized to aspiration and sclerotherapy (185 patients; 189 hydroceles) and surgery (150 patients; 153 hydroceles). There was no significant difference in clinical cure between sclerotherapy and hydrocelectomy (RR 0.45, 95% CI 0.18 to 1.10). Meta-analysis revealed a significant increase in recurrence in the sclerotherapy group compared with the surgical group (RR 9.43, 95% CI 1.82 to 48.77). There were no significant differences between the two groups in assessing fever, infection, and hematoma. CONCLUSION: Aspiration and sclerotherapy is an efficient technique with a higher recurrent rate; therefore, we recommend aspiration and sclerotherapy for patients at high risk for surgery or avoiding surgery. In addition, included RCTs had low methodological quality, low sample size, and invalidated instruments for outcome assessment. Therefore, there is a great need for further methodologically rigorous RCTs with the registered protocol.


Assuntos
Escleroterapia , Hidrocele Testicular , Masculino , Humanos , Escleroterapia/métodos , Hidrocele Testicular/cirurgia , Avaliação de Resultados em Cuidados de Saúde , Ensaios Clínicos Controlados Aleatórios como Assunto
2.
Int J Aging Hum Dev ; 93(3): 864-880, 2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-33336587

RESUMO

A validation study the Iranian Modified Barthel Index (MBI) in hospitalized acute stroke elderly by classical test theory approach and investigate Rasch analysis for both Iranian version MBI and BI and compare the hierarchical item difficulty of them. Face-to-face interview with 100 geriatric stroke inpatients 60+ or their caregivers was done in a cross-sectional study. First, construct validity of MBI analyzed by the classical test theory, then Rasch analysis were done for BI and MBI. The reliability of the Iranian MBI was significant at 0.955. One factor achieved by the variance of 83.2%. In Rasch analysis for MBI, the most difficult item was stair climbing, whereas the simplest items were bowel and bladder control. In BI, the most difficult items were toilet use and ambulation. The Iranian MBI is very accurate and reliable; therefore the use of MBI to measure better outcomes in stroke elderly inpatients is recommended comparing with BI.


Assuntos
Acidente Vascular Cerebral/diagnóstico , Atividades Cotidianas/psicologia , Idoso , Disfunção Cognitiva/diagnóstico , Estudos Transversais , Feminino , Hospitalização , Humanos , Entrevistas como Assunto , Masculino , Testes de Estado Mental e Demência , Reprodutibilidade dos Testes , Acidente Vascular Cerebral/patologia
3.
Curr Ther Res Clin Exp ; 93: 100608, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33296446

RESUMO

BACKGROUND: Inhalers are the mainstay of treatment for patients suffering from chronic obstructive pulmonary disease. However, incorrect inhaler technique is a considerable challenge. OBJECTIVE: We aimed to evaluate inhaler technique and its association with quality of life in a sample of patients with chronic obstructive pulmonary disease. METHODS: This cross-sectional study included patients with confirmed chronic obstructive pulmonary disease who were prescribed at least 1 inhaler medication on a regular basis. Patients were recruited from the outpatient pulmonary clinic of a hospital in Tehran. Inhaler technique was assessed according to a validated checklist. Patients' quality of life was evaluated using Chronic Obstructive Pulmonary Disease Assessment Test. RESULTS: One hundred seventy-five patients with mean (SD) age of 59.0 (10.1) years were included. Patients' devices were 192 (62.3%) pressurized metered-dose inhalers (including pressurized metered-dose inhalers plus spacer) and 116 (37.7%) dry powder inhalers. Unfortunately, only 2.86% of patients used their inhalers completely correct. The highest rate of errors was committed by patients who used metered-dose inhalers plus spacer. Patients with a higher educational degree had significantly lower rate of errors on average (P = 0.001). The most frequent errors made by patients using pressurized metered-dose inhalers or Turbuhaler was priming the inhaler before the first administration in 90.6% and 78.3% of patients, respectively. Chronic Obstructive Pulmonary Disease Assessment Test scores in patients using different inhaler devices were not significantly different. However, in patients with lower quality of life, significantly more patients had poor inhaler technique (P = 0.0001). CONCLUSIONS: There is still considerable need for interventions to optimize inhaler technique. We also noted that appropriate inhaler technique is associated with better quality of life. (Curr Ther Res Clin Exp. 2020; 81:XXX-XXX).

4.
Med J Islam Repub Iran ; 33: 143, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-32280649

RESUMO

Background: The world's population is growing older. Inappropriate and irrational use of drugs in the elderly is a considerable health concern due to consequences such as increased morbidity and adverse drug events. This study aimed to evaluate the rationality of prescribing and determining the extent of inappropriate prescribing in a sample of geriatric patients in Tehran. Methods: This cross sectional study was performed on 1512 prescriptions of patients aged ≥ 65 years from 5 pharmacies affiliated to Tehran University of Medical Sciences in 2014. Prescription of potentially inappropriate medications (PIMs) was investigated using the Beers Criteria along with WHO prescribing indices. Date were analyzed using SPSS software, and significance level was set at less than 0.05. Results: Mean (SD) age of patients was 73.9(6.7) years. A total of 472 (31.2%) patients received at least 1 PIM. Benzodiazepines were the most frequent drug class and general practitioners (GPs) were the most frequent prescriber of PIMs. The highest and the lowest percentage of prescriptions containing brand-names were prescribed by subspecialists (62.5%) and GPs (42.2%), respectively. Antibiotics and injectable medications were prescribed for 26.8% and 28.5% of patients by GPs. Mean (SD) number of drugs per prescription was 3.57 (1.92). Prescriptions containing systemic antibiotics and PIMs had significantly higher mean number of drugs compared to those without these items (both P < 0.001). Conclusion: There is a need for interventions to improve the quality of prescribing for elderly patients, especially by GPs. Also, there are still some problems in rational use of drugs based on prescribing indices, especially, prescribing brand-names and injectable medications.

5.
Med J Islam Repub Iran ; 29: 309, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26913272

RESUMO

BACKGROUND: Investment in science is vital for the development and well-being of societies. This study aims to assess the scientific productivity of countries by quantifying their publication of systematic reviews taking the gross national income per capita (GNIPC) into account. METHODS: Medline and ISI Web of Science were searched for systematic reviews published between 1st January 2006 and 31st December 2010. The productivity of each country was quantified by exploring the authors' affiliation. The GNIPC was used according to the World Bank Report. Concentration index (CI) was calculated as the index of inequality. RESULTS: CI of percentage of systematic reviews as a function of percentage of countries ranked by GNIPC was 0.82 which indicates inequality in production of systematic reviews in pro rich countries. Countries with high income produced 206.23 times more systematic reviews than low income countries, while this ratio for lower middle and upper middle countries was 9.67 and 12.97, respectively. The highest concentration index was observed in clinical sciences (0.76) and the lowest in public health (0.61). CONCLUSION: This study demonstrates a significant gap between industrialized and nonindustrialized countries in the production of systematic reviews. Addressing this gap needs tremendous national and international efforts.

6.
Cochrane Database Syst Rev ; (11): CD009735, 2014 Nov 13.
Artigo em Inglês | MEDLINE | ID: mdl-25391386

RESUMO

BACKGROUND: Hydrocoeles are common cystic scrotal abnormalities, described as a fluid-filled collection between the visceral and parietal layers of the tunica vaginalis of the scrotum. There are two approaches for treatment of hydrocoeles: surgical open hydrocoelectomy and aspiration followed by sclerotherapy.  OBJECTIVES: We compared the benefits and harms of aspiration and sclerotherapy versus hydrocoelectomy for the management of hydrocoeles. SEARCH METHODS: We searched the Cochrane Renal Group's Specialised Register to 2 August 2014 through contact with the Trials' Search Co-ordinator using search terms relevant to this review. SELECTION CRITERIA: Randomised controlled trials (RCTs) and quasi-RCTs comparing aspiration and sclerotherapy versus hydrocoelectomy for the management of hydrocoeles. DATA COLLECTION AND ANALYSIS: Two authors independently extracted data and assessed risk of bias in the included studies. Random effects meta-analyses were performed using relative risk (RR) for dichotomous outcomes and mean differences (MD) for continuous outcomes, with 95% confidence intervals (CI). MAIN RESULTS: We found four small studies that met the inclusion criteria. These studies enrolled 275 patients with 282 hydroceles. Participants were randomised to aspiration and sclerotherapy (155 patients with 159 hydroceles) and surgery (120 patients with 123 hydroceles). All studies were assessed as having low or unclear risk of bias for selection bias, detection bias, attrition bias and selective reporting bias. Blinding was not possible for participants and investigators based on the type of interventions. Blinding for statisticians was not reported in any of included studies.There were no significant difference in clinical cure between the two groups (3 studies, 215 participants: RR 0.45, 95% CI 0.18 to 1.10), however there was significant heterogeneity (I² = 95%). On further investigation one study contributed all of the heterogeneity. This could be due to the agent used or perhaps due to the fact that this is a much older study than the other two studies included in this analysis. When this study was removed from the analysis the heterogeneity was 0% and the result was significant (in favour of surgery) (2 studies, 136 participants: RR 0.74; 95% CI 0.64 to 0.85).There was a significant increase in recurrence in those who received sclerotherapy compared with surgery (3 studies, 196 participants: RR 9.37, 95% CI 1.83 to 48.4). One study reported a non-significant decrease in fever in the sclerotherapy group (60 participants: RR 0.25, 95% CI 0.06 to 1.08). There was an increased number of infections in the surgery group however this increase was not statistically significant (4 studies, 275 participants): RR 0.31, 95% CI 0.09 to 1.05; I² = 0%). Three studies reported the frequency of pain in the surgery group was higher than aspiration and sclerotherapy group but because of different measurement tools applied in these studies, we could not pool the results. Radiological cure was not reported in any of the included studies. There was no significant difference in haematoma formation between the two groups (3 studies, 189 participants: RR 0.57, 95% CI 0.17 to 1.90; I² = 0%). Only one study reported patient satisfaction at three and six months; there was no significant difference between the two groups. AUTHORS' CONCLUSIONS: Postoperative complications as well as cost and time to work resumption were less in the aspiration and sclerotherapy group; however the recurrence rate was higher. The cure rate in short-term follow-up was similar between the groups, however there is significant uncertainty in this result due to the high heterogeneity. There is a great need for further methodologically rigorous RCTs that assess the effectiveness of different type of sclerosant agents, sclerosing solution concentration and injection volume for the treatment of hydrocoeles. It is important that the RCTs have sufficiently large sample size and long follow-up period. Studies should evaluate clinical outcomes such as pain, recurrence, satisfaction, complications and cure using validated instruments. The protocols for all studies should be registered in clinical trial registries and the reports of these studies should conform with international guidelines of trial reporting such as CONSORT. Cost-effectiveness studies should also be undertaken.


Assuntos
Drenagem/métodos , Escleroterapia/métodos , Hidrocele Testicular/terapia , Adolescente , Adulto , Humanos , Masculino , Complicações Pós-Operatórias , Ensaios Clínicos Controlados Aleatórios como Assunto , Recidiva , Retorno ao Trabalho , Viés de Seleção , Hidrocele Testicular/cirurgia , Fatores de Tempo
7.
Arch Orthop Trauma Surg ; 134(9): 1219-25, 2014 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-25081825

RESUMO

INTRODUCTION: Using lengthening over an intramedullary nail as a technique for cosmetic purposes improves the individuals' quality of life and provides more satisfactory results due to less external fixator period. METHODS: This study reports a case series of 143 individuals who underwent bilateral tibial lengthening over an intramedullary nail for cosmetic purposes together with the review of parameters related to the surgery and complications. Level of satisfaction was measured with the standard visual analog scale at least 1 year after removal of external fixator. RESULTS: In this study, mean (SD) age of patients was 26.6 (7.26) years. 85 (59.4%) participants were male and 58 (40.6%) were female. Mean end lengthening of all individuals was 6.65 cm. The mean external fixator period was 93.7 days. Complication rate was 0.74 per segment but it decreased to 0.45 when pin-tract infection was excluded. Complications were categorized based on Paley et al.'s classification as 129 problems, 85 obstacles and no sequelae. Interestingly, 44 (30.8%) individuals had no problem and obstacle. CONCLUSIONS: Lengthening over an intramedullary nail provides bone formation in equal quality to that obtained by the conventional Ilizarov method, along with lower rate of complications. The large number of individuals involved in our study is a remarkable benefit which could be used as an appropriate sample to compare results for outcomes and complications.


Assuntos
Alongamento Ósseo/métodos , Pinos Ortopédicos , Técnicas Cosméticas , Fixadores Internos , Desigualdade de Membros Inferiores/cirurgia , Tíbia/cirurgia , Adolescente , Adulto , Alongamento Ósseo/instrumentação , Técnicas Cosméticas/instrumentação , Feminino , Seguimentos , Humanos , Masculino , Satisfação do Paciente/estatística & dados numéricos , Complicações Pós-Operatórias/epidemiologia , Resultado do Tratamento , Adulto Jovem
8.
PLoS One ; 19(8): e0307753, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-39173064

RESUMO

BACKGROUND: The administration of intravenous (IV) medications is a technically complicated and error-prone process. Especially, in the hematopoietic stem cell transplantation (HSCT) setting where toxic drugs are frequently used and patients are in critical immunocompromised conditions, medication errors (ME) can have catastrophic reactions and devastating outcomes such as death. Studies on ME are challenging due to poor methodological approaches and complicated interpretations. Here, we tried to resolve this problem using reliable methods and by defining new denominators, as a crucial part of an epidemiological approach. METHODS: This was an observational, cross-sectional study. A total of 525 episodes of IV medication administration were reviewed by a pharmacist using the disguised direct observation method to evaluate the preparation and administration processes of 32 IV medications in three HSCT wards. We reported errors in 3 ratios; 1) Total Opportunities for Error (TOE; the number of errors/sum of all administered doses observed plus omitted medications), 2) Proportional Error Ratio (the number of errors for each drug or situation/total number of detected errors) and, 3) Corrected Total Opportunities for Errors (CTOE; the number of errors/ Sum of Potential Errors (SPE)). RESULTS: A total of 1,568 errors were observed out of 5,347 total potential errors. TOE was calculated as 2.98 or 298% and CTOE as 29.3%. Most of the errors occurred at the administration step. The most common potential errors were the use of an incorrect volume of the reconstitution solvent during medication preparation and lack of monitoring in the administration stage. CONCLUSION: Medication errors frequently occur during the preparation and administration of IV medications in the HSCT setting. Using precise detection methods, denominators, and checklists, we identified the most error-prone steps during this process, for which there is an urgent need to implement effective preventive measures. Our findings can help plan targeted preventive measures and investigate their effectiveness, specifically in HSCT settings.


Assuntos
Administração Intravenosa , Transplante de Células-Tronco Hematopoéticas , Erros de Medicação , Humanos , Erros de Medicação/prevenção & controle , Erros de Medicação/estatística & dados numéricos , Transplante de Células-Tronco Hematopoéticas/efeitos adversos , Estudos Transversais , Feminino , Masculino , Pessoa de Meia-Idade , Adulto
9.
Urol J ; 21(4): 226-233, 2024 Jun 09.
Artigo em Inglês | MEDLINE | ID: mdl-38264867

RESUMO

PURPOSE: Postoperative pulmonary embolism is a leading cause of mortality in patients undergoing major urologic surgeries, presenting a complex challenge in balancing the risks of venous thromboembolism (VTE) and perioperative bleeding. This study examines the current evidence on thromboprophylaxis in urological procedures, focusing on procedure-specific considerations. METHODS: Literature on thromboprophylaxis in urological procedures was reviewed during the past decade. RESULTS: Various mechanical thromboprophylaxis methods, such as compression stockings, pneumatic compression devices, foot pumps, mobilization, and exercises, are available preventive measures. Additionally, unfractionated heparin (UFH) and low molecular weight heparin (LMWH) are commonly used pharmacological agents for VTE prevention, with the choice between mechanical, pharmacological, or combined approaches tailored to individual patient characteristics and surgical requirements. Patient risk stratification into low, medium, and highrisk categories based on age, BMI, and VTE history guides the selection of thromboprophylaxis strategies. Surgical procedures are categorized as oncological or non-oncological, with uro-oncological surgeries posing a higher VTE risk than non-oncological procedures. Consequently, a combination of pharmacological and mechanical prophylaxis is typically recommended for uro-oncological patients, while pharmacological prophylaxis is reserved for high-risk individuals undergoing non-oncological surgeries. Mechanical prophylaxis is advised for high-risk patients undergoing procedures with elevated VTE risk. CONCLUSION: This study summarized an optimal thromboprophylaxis protocol taking into account patient risk factors and the specific urological procedure.


Assuntos
Anticoagulantes , Complicações Pós-Operatórias , Procedimentos Cirúrgicos Urológicos , Tromboembolia Venosa , Humanos , Procedimentos Cirúrgicos Urológicos/efeitos adversos , Tromboembolia Venosa/prevenção & controle , Tromboembolia Venosa/etiologia , Complicações Pós-Operatórias/prevenção & controle , Complicações Pós-Operatórias/etiologia , Anticoagulantes/uso terapêutico , Embolia Pulmonar/prevenção & controle , Embolia Pulmonar/etiologia , Meias de Compressão , Medição de Risco , Dispositivos de Compressão Pneumática Intermitente
10.
J Ultrasound Med ; 32(11): 1957-65, 2013 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-24154900

RESUMO

OBJECTIVES: Sonography for measuring intra-abdominal fat is more accurate than anthropometric measurements. Computed tomographic (CT) angiography has become an accurate noninvasive method for detection of coronary artery disease (CAD). We examined the associations between both sonographic and anthropometric measurements of abdominal adiposity and the presence of CAD on CT angiography. METHODS: We evaluated 83 consecutive patients (70% men; mean age ± SD, 56 ± 10.8 years) who were referred for CT angiography. Clinical and laboratory variables were determined, and CT angiography was performed using a 64-slice scanner. The severity of CAD was defined by visual assessment of any plaque, either calcified or noncalcified. Preperitoneal fat, subcutaneous fat, and visceral fat thicknesses were determined on sonography, and the abdominal fat index was calculated as the preperitoneal fat thickness-to-subcutaneous fat thickness ratio. RESULTS: Coronary artery disease was detected in 56 patients (67%). Patients with CAD had higher visceral fat thickness (9.3 ± 2.0 versus 8.2 ± 2.2 cm; P = .035) and a higher waist-to-hip ratio (0.97 ± 0.07 versus 0.92 ± 0.07; P = .018) than those without CAD. The preperitoneal fat thickness, subcutaneous fat thickness, and abdominal fat index were not correlated with the CAD status. After adjusting for traditional cardiovascular risk factors, however, only a waist-to-hip ratio higher than 0.95 remained significantly associated with the presence of CAD (odds ratio, 4.03; 95% confidence interval, 1.2-13.4). CONCLUSIONS: This study shows that sonographically based obesity measurements are not superior to anthropometric indices in predicting the presence of CAD.


Assuntos
Gordura Abdominal/diagnóstico por imagem , Antropometria/métodos , Angiografia Coronária/métodos , Doença da Artéria Coronariana/diagnóstico , Ecocardiografia/métodos , Tomografia Computadorizada por Raios X/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Algoritmos , Feminino , Humanos , Interpretação de Imagem Assistida por Computador/métodos , Masculino , Pessoa de Meia-Idade , Reprodutibilidade dos Testes , Sensibilidade e Especificidade
11.
Cancer Treat Res Commun ; 36: 100739, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37419057

RESUMO

INTRODUCTION: Clinical trials are increasingly supported by industries while previous studies have shown that industry-supported studies have more favorable results than studies with other sources of funding. In the present study, we investigated the association of industrial funding on the results of clinical trials regarding chemotherapy in prostate cancer. METHODS: A systematic literature search was performed in the Cochrane Library, MEDLINE, and EMBASE to identify clinical trials comparing chemotherapy with treatments such as hormone therapy, surgery, radiotherapy, and placebo in patients with metastatic or non-metastatic prostate cancer. Data were extracted by two reviewers on the financial resources and the positive or negative results of chemotherapy in each study. The quality of articles was evaluated and compared based on Cochrane Critical Appraisal Tool. The trials were divided into two groups; industry funded and those not funded by industry. Association of industry funding and positive outcome was presented as odds ratio. RESULTS: In this study, out of the 91 studies, 80.2% were funded by pharmaceutical companies and 19.8% were funded by government agencies. The end result of 61.6% of the studies funded by pharmaceutical companies was an increase in survival due to chemotherapy, whereas only 27.8% of the studies sponsored by government agencies reported positive results (P-value=0.010). In fact, industry-funded trials more often presented statistically significant positive results for survival (OR: 4.17; CI, 1.34-12.99). In general, there was no significant difference in the degree of bias between the two groups. CONCLUSION: According to this study, despite of the similar quality of studies funded by pharmaceutical companies and government agencies, positive results were more common in studies related to pharmaceutical companies. Therefore, this point should be taken into account when making a decision on the best treatment approach.


Assuntos
Indústria Farmacêutica , Neoplasias da Próstata , Masculino , Humanos , Neoplasias da Próstata/tratamento farmacológico , Preparações Farmacêuticas
12.
Arch Gynecol Obstet ; 286(1): 19-23, 2012 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-22271239

RESUMO

PURPOSE: To investigate the effects of massage and presenting an attendant on pain, anxiety and satisfaction during labor to clarify some aspects of using an alternative complementary strategy. METHODS: 120 primiparous women with term pregnancy were divided into massage, attendant and control groups randomly. Massage group received firm and rhythmic massage during labor in three phases. After 30 min massage at each stage, pain, anxiety and satisfaction levels were evaluated. Self-reported present pain intensity scale was used to measure the labor pain. Anxiety and satisfaction were measured with the standard visual analog scale. RESULTS: Massage group had lower pain state in second and third phases (p < 0.05) in comparison with attendant group but reversely, the level of anxiety was lower in attendant group in second and third phases (p < 0.05) and satisfaction was higher in massage group in all four phases (p < 0.001). The massage group had lower pain and anxiety state in three phases in comparison with control group (p < 0.05). Data analysis of satisfaction level showed higher values in four phases in massage group compared with control (p < 0.001) and comparison of attendant and control groups showed higher satisfaction in attendant group in phases 2, 3 and 4 as well (p < 0.001). Duration of active phase was lower in massage group (p < 0.001). CONCLUSIONS: Findings suggest that massage is an effective alternative intervention, decreasing pain and anxiety during labor and increasing the level of satisfaction. Also, the supportive role of presenting an attendant can positively influence the level of anxiety and satisfaction.


Assuntos
Ansiedade/terapia , Trabalho de Parto/psicologia , Massagem/psicologia , Manejo da Dor , Satisfação do Paciente , Adolescente , Adulto , Cuidadores/psicologia , Feminino , Humanos , Gravidez , Adulto Jovem
13.
BMJ Open ; 12(4): e056872, 2022 04 08.
Artigo em Inglês | MEDLINE | ID: mdl-35396297

RESUMO

OBJECTIVE: Assessing safety and immunogenicity of an inactivated whole virus particle vaccine. DESIGN: Single-centre, double-blind, randomised, placebo-controlled, phase I (stage I: 18-50, stage II: 51-75 years), phase II (18-75 years) clinical trials. SETTING: 29 December 2020 to 22 April 2021. PARTICIPANTS: Stage I-phase I: 56 participants; stage II-phase I: 32; phase II: 280. INTERVENTION: During stage I, participants randomly (3:3:1) received 3 µg, 5 µg vaccine or placebo in a 14-day interval. Participants in stage II received two shots of 5 µg vaccine or placebo (3:1). In phase II, participants received 5 µg vaccine or placebo (4:1) in a 28-day interval. PRIMARY AND SECONDARY OUTCOME MEASURES: Safety assessment and immunogenicity assessment via antibody response and conventional virus neutralisation test (cVNT). RESULTS: All adverse events (AEs) were mild or moderate and transient in both phase I and phase II, and no AEs of special interest were reported. The seroconversion-rate of neutralising, antireceptor binding-domain (RBD) and anti-spike-glycoprotein (anti-S) antibodies 14-days after second dose of 5 µg vaccine in stage I was 70.8% (95% CI 48.9% to 87.4%), 87.5% (95% CI 67.6% to 97.3%), 91.7% (95% CI 73.0% to 99.0%). The antibody titres increased more among 5 µg than 3 µg. The corresponding rates for 3 µg vaccine were 45.8% (95% CI 25.6% to 67.2%), 54.2% (95% CI 32.8% to 74.5%) and 70.8% (95% CI 48.9% to 87.4%), respectively. In stage II, 100% (95% CI 84.6% to 100%), 86.4% (95% CI 65.1% to 97.1%) and 86.4% (95% CI 65.1% to 97.1%) of participants seroconverted for neutralising, anti-RBD and anti-S antibodies. In phase II, the seroconversion rate of neutralising-antibody was 82.8% (95% CI 77.0% to 87.6%), anti-RBD 77.0% (95% CI 70.7% to 82.6%) and anti-S 79.9% (95% CI 73.8% to 85.1%) on day 42. In the cVNT, the sera at 1/64 times dilution would neutralise SARS-CoV-2 among 91.7%, 77.3% and 82.5% of vaccinated participants in phase I-stage I, phase I-stage II and phase II clinical trials, respectively. CONCLUSIONS: These results support further evaluation of this inactivated whole virus particle vaccine. TRIAL REGISTRATION NUMBERS: IRCT20201202049567N1 and IRCT20201202049567N2 for phase I and IRCT20201202049567N3 for phase II.


Assuntos
Vacinas contra COVID-19 , COVID-19 , Adolescente , Adulto , Idoso , Anticorpos Antivirais , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Método Duplo-Cego , Humanos , Pessoa de Meia-Idade , SARS-CoV-2 , Vacinas de Produtos Inativados/efeitos adversos , Vírion , Adulto Jovem
14.
Int J Womens Dermatol ; 6(4): 301-305, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-33015291

RESUMO

BACKGROUND: Defining the quality of life in the patients with epidermolysis bullosa (EB) is important in patient care and management. Evaluation of quality of life requires a valid and reliable scale. The Quality of Life in Epidermolysis Bullosa (EB-QoL) questionnaire, which is an English 17-item questionnaire, has emerged as a useful tool for assessing the quality of life in the patients with EB. OBJECTIVE: This study aimed to evaluate the psychometric properties of the Farsi version of the EB-QoL questionnaire among a group of Iranian patients with EB. METHODS: The Farsi version of the EB-QoL questionnaire was finalized after translation and back-translation. From the 100 patients with EB invited to participate in the study, 83 completed the questionnaire (response rate: 83%). Subsequently, the content validity and construct validity of the questionnaire were assessed. The reliability of the questionnaire was assessed with Cronbach's alpha. Moreover, the correlation between EB-QoL scores and EB severity scores (based on the Birmingham Epidermolysis bullosa severity score scale) was evaluated. RESULTS: A total of 83 patients (40 male and 43 female) with a median age of 15 years (interquartile range, 9-24 years) and an age range between 3 and 43 years were enrolled in this study. Mean ±â€¯standard deviation scores from the EB-QoL questionnaire were 43.7 ±â€¯9.9. The translated EB-QoL questionnaire showed a high internal consistency (Cronbach alpha = 0.90) and adequate item-total correlation. Also, there was a significant correlation between EB-QoL and EB severity scores (r = 0.39; p < .001). CONCLUSION: The Farsi version of EB-QoL questionnaire has acceptable validity and reliability. Thus, the questionnaire can be used for future studies to assess the quality of life among Iranian patients with EB.

16.
J Diabetes Metab Disord ; 17(2): 165-172, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30918851

RESUMO

BACKGROUND: Appropriate pharmacotherapy, self-care and adherence to medications are crucial to diabetes control. We aimed to study the diabetes care and glycemic control in patients with type two diabetes living in an urban area of Iran. METHODS: In this cross-sectional study, patients with type 2 diabetes who attended a referral university affiliated community pharmacy and an accredited pathobiology laboratory in the 17th district of Tehran were evaluated. Data including demographics, medical and drug history were collected. Self-care activity (Diabetes Self-care Activity Measurement Scale) and medication adherence (8-item Morisky Medication Adherence scale) were also assessed. After completing the questionnaires, the patients were referred to the laboratory for Hemoglobin A1c test. RESULTS: Three hundred forty-eight patients (60.3% females) were recruited. The mean (SD) of patients' age was 55.82 (12.72) and 75.3%of them were Illiterate or had primary education. Mean (SD) of Hemoglobin A1c levels was 8.39 (2.03) and 33% of patients had levels higher than 9%. Among study patients, 186 (53.4%) patients received monotherapy for diabetes type 2 and 200 (57.5%) patients had low adherence to medications. Physical activity, blood glucose self-monitoring and foot care were domains of self-care with the fewest practice. Re-using a pen or syringe needle more than once was reported by 83% of patients and mean (SD) time of re-using a pen needle was 9.11 (8.74). CONCLUSION: Poor glycemic control, low medication adherence, inadequate self-care activities, signals of inappropriate pharmacotherapy and inadequate medical visits and monitoring in the study patients highlight the importance of providing accessible and affordable health care services in the region. Moreover, educational needs of the patients should be considered especially in an area in which the majority of patients are old and illiterate and have low socioeconomic status.

17.
Int J Hematol Oncol Stem Cell Res ; 12(2): 142-152, 2018 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-30233777

RESUMO

Background: Patients who receive hematopoietic stem cell transplantation (HSCT) experience several complications that oral mucositis (OM) is a frequent symptom. This study was designed to evaluate the incidence, risk factors, prophylaxis and treatment strategies for established OM. Materials and Methods: We included 173 adult patients who received autologous or allogeneic hematopoietic stem cell transplantation in this study. The World Health Organization oral toxicity scale was used to assess the severity of OM. Patients received two prophylactic regimens: regimen 1 contained nystatin, chlorhexidine, povidone iodine and amphotericin B. Regimen 2 contained nystatin and povidone iodine. 70 patients (40.5%) received the first prophylaxis regimen, 89 patients (51.4%) received the second prophylaxis regimen and the remaining 14 patients (8.1%) were not adherence to the use of the mouthwashes and were excluded from the analysis. Results: OM was detected in 60.7% of patients with mean (SD) age of 38.1±14.6 years. Multivariate analysis showed that only the female gender and the prophylactic regimen were the significant predictors of OM. Conclusion: We found that addition of amphotericin B and chlorhexidine, to the nystatin and povidone iodine resulted in a significant beneficial effect in prevention OM.

18.
Int J Hematol Oncol Stem Cell Res ; 11(3): 209-216, 2017 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-28989587

RESUMO

Background: Although several studies have supported a preventive and therapeutic role of vitamin D (Vit D) for different types of cancers, we face insufficient documentation in acute myeloid leukemia (AML). So, we examined whether the serum calcidiol (25(OH)D) levels at the time of induction therapy have any impact on response and relapse in AML patients. Materials and Methods: Blood samples were collected from 65 patients on days 0 and 28th of treatment to evaluate serum concentration of 25(OH)D and its effects on complete remission (CR) achievement, relapse rate and hospitalization length. Results: Of the 65 patients who were included in the study, 38 were male (58.5%) and 27 were female (41.5%). Median age at the time of treatment was 37 years (range 15-68). 6% of the participants were older than 60 years. In regard to 25(OH)D levels, 81.5% of AML patients were deficient (levels <20 ng/ml). There was a significant difference in CR between patients with sufficient and deficient level of 25(OH)D. Deficient patients had longer length of hospitalization than those with sufficient levels. Also Vitamin D deficient patients had higher serum ALP levels. The mean level of 25(OH)D on treatment day 28th in our study was significantly lower than the baseline value. Conclusion: The results of the study showed that serum 25(OH)D levels deficiency was highly prevalent among Iranian AML patients. Furthermore, higher Vit D levels in AML patients were associated with better outcome in these patients.

19.
Iran J Psychiatry ; 12(4): 229-235, 2017 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-29472948

RESUMO

Objective: Craving for substance abuse is a usual and complicated problem in patients, with opioid addiction who are in opioid detoxifying process. Craving has been added as one of the diagnostic criteria of substance use disorders in DSM-5. The present trial aimed at comparing the effects of celecoxib versus ibuprofen in reducing pain and decreasing the desire to use opiates in patients undergoing opiate detoxification (n = 32). Method: A total of 32 patients (both inpatients and outpatients), who were undergoing opiate detoxification procedure and met the inclusion criteria entered this 4- week study. Participants who suffered from pain due to opiate withdrawal were randomized into 2 groups: Group 1 received celecoxib 200 milligrams once per day and group 2 received ibuprofen 400 milligrams 4 times per day. Self-reported Desire for Drug Questionnaire (DDQ) and 0-10 numeric pain scale were used at baseline and at the end of the study to evaluate changes in opiate craving and pain, respectively. Data analysis was done by SPSS-21 statistical software. Results: In this study, 16 patients received celecoxib 200 milligrams once daily, and 16 received ibuprofen 400 milligrams 4 times daily. After 4 weeks of treatment with both ibuprofen and celecoxib, the results revealed that celecoxib and ibuprofen equally reduced the pain symptoms. After 4 weeks of treatment, with either ibuprofen or celecoxib, significant improvement was observed in decreasing the craving in the celecoxib group, but not in the ibuprofen group. Conclusion: The study revealed a significant difference between the celecoxib and ibuprofen group in reducing craving in patients with opiate craving after 4 weeks of treatment. However there were no significant differences between these two groups in reducing pain.

20.
Pharm Pract (Granada) ; 15(2): 919, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28690693

RESUMO

BACKGROUND: Cardiovascular disease is a major health concern around the world. OBJECTIVE: To assess the outcomes and feasibility of a pharmacy-based cardiovascular screening in an urban referral community pharmacy in Iran. METHODS: A cross sectional study was conducted in a referral community pharmacy. Subjects aged between 30-75 years without previous diagnose of cardiovascular disease or diabetes were screened. Measurement of all major cardiovascular risk factors, exercise habits, medical conditions, medications, and family history were investigated. Framingham risk score was calculated and high risk individuals were given a clinical summary sheet signed by a clinical pharmacist and were encouraged to follow up with their physician. Subjects were contacted one month after the recruitment period and their adherence to the follow up recommendation was recorded. RESULTS: Data from 287 participants were analyzed and 146 were referred due to at least one abnormal laboratory test. The results showed 26 patients with cardiovascular disease risk greater than 20%, 32 high systolic blood pressure, 22 high diastolic blood pressures, 50 high total cholesterol levels, 108 low HDL-C levels, and 22 abnormal blood glucose levels. Approximately half of the individuals who received a follow up recommendation had made an appointment with their physician. Overall, 15.9% of the individuals received medications and 15.9% received appropriate advice for risk factor modification. Moreover, 7.5% were under evaluation by a physician. CONCLUSION: A screening program in a community pharmacy has the potential to identify patients with elevated cardiovascular risk factor. A plan for increased patient adherence to follow up recommendations is required.

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