Nephroprotective effects of L-carnitine against contrast-induced nephropathy in patients undergoing percutaneous coronary intervention: a randomized open-labeled clinical trial

Background: L-carnitine may prevent the incidence of AKI by its antioxidant effects and improving circulation in ischemic conditions. The goal of this trial was to evaluate the impact of L-carnitine on contrast-induced nephropathy in patients undergoing elective PCI

Methods: totally, the patients were randomly allocated to 2 groups. The treatment group received 1 g of L-carnitine orally 3 times a day, 24 hours before the procedure [3 g before PCI] and 2 g after PCI, whereas the control group did not receive L-carnitine. In both groups, the plasma level of neutrophil gelatinase-associated lipocalin [NGAL] was measured at baseline and 12 hours after PCI

Results: our study was conducted on 202 patients [including 91 vs. 111 patients in the treatment and the control group; 31 [34.1%] vs 33 [29.7%] female in carnitine and control group; and ages include 62.0 +/- 9.0 vs 57.0 +/- 11.2 years]. The median plasma levels of NGAL were not different between the carnitine and control groups at baseline [57 [IQR: 22 - 255] vs. 54 [IQR: 29 - 324]; p value = 0.155] and 12 hours after PCI [71 [IQR: 52 - 129] vs. 70 [IQR: 46 - 153]; p value = 0.925], but the changes in the plasma NGAL from baseline to 12 hours after PCI were different between the 2 groups [5 [IQR:-147 - 30] vs. 17 [IQR: -21 - 41]; p value = 0.010]

Conclusion: our results showed that oral L-carnitine was able to prevent an increase in NGAL following contrast medium administration in patients undergoing PCI. More studies should be performed to fully elucidate the nephroprotective effects of L-carnitine

Validity and reliability assessment of the Persian version of therapy-related symptom checklist

Therapy-related symptom checklist for children [TRSC-C] was developed as a symptom assessment tool in children receiving chemotherapy. The objective of the present study was to evaluate the validity and reliability of the Persian version of TRSC-C. This cross-sectional study was conducted in 2013-2014 in Tehran, Iran. TRSC-C was translated using backward-forward approach. The content validity, face validity, and comprehensiveness were investigated based on the opinion of experts. The item content validity index [I-CVI] and scale content validity index [S-CVI] were calculated by the mean approach and inter-rater agreement. The scale was revised based on the comments from a team of five experts, after which it was evaluated by an additional group of four experts. To assess the inter-rater reliability, two raters filled the scale with 29 and 30 patients in the outpatient clinic of Hazrat-e Ali Asghar Hospital. The Cronbach's alpha was calculated and factor analysis was performed. The scores of content validity were analyzed in Excel. Other statistical analyses were performed using the SPSS software version 20.0. Based on the initial assessment, the S-CVI with less conservative approach was 60% for clarity, 33% for relevancy, and 60% for simplicity. After revising the scale, the S-CVI reached 100%. The comprehensiveness and face validity of the scale were appropriate. The scale was inter-rater reliable and the Cronbach's alpha was 0.803. Eleven subscales were found in the TRSC-C. It is concluded that the Persian TRSC-C is a valid and reliable tool for measuring children symptoms. Availability of a valid and reliable checklist is a fundamental step in monitoring the symptoms of patients while receiving chemotherapy

effect of curcumin on some of traditional and non-traditional cardiovascular risk factors: a pilot randomized, double-blind, placebo-controlled trial

Numerous interventional studies in clinical and preclinical setting stated that intake of curcumin may provide protection against cardiovascular disease. The aim of this trial was investigation of curcumin efficiency on some cardiovascular risk factors in patients with coronary artery disease [CAD]. A total of 33 patients with CAD who fulfilled inclusion and exclusion criteria were entered the study. Patients were randomly assigned to receive curcumin or placebo, 500 mg capsules, four times daily for 8 weeks. Lipid profile, blood glucose and high sensitive C-reactive protein [hs-CRP] levels were analyzed at baseline and two months after treatment. Serum levels of triglycerides [P=0.01], LDL-cholesterol [P=0.03] and VLDL-cholesterol [P=0.04] significantly decreased in the curcumin group compared to baseline, without significant changes in total cholesterol, HDL-cholesterol, blood glucose and hs-CRP levels. In all mentioned laboratory parameters, significant difference was not detected between curcumin and placebo. Although curcumin improved some of lipid profile components, it did not show appreciable effect on inflammatory markers in patients with CAD. Therefore, more detailed assessment of metabolic effects or anti-inflammatory activities of curcumin need to perform by extensive human study

review of medication errors in Iran: sources, underreporting reasons and preventive measures

Medication error [ME] is the most common preventable cause of adverse drug events which negatively affects patient safety. Inadequate, low-quality studies plus wide estimation variations in ME from developing countries including Iran, decreases the reliability of ME evaluations. To clarify sources, underreporting reasons and preventive measures of MEs, we reviewed Iran current available literature. We searched Scopus, WOS, PubMed, CINAHL, EBSCOHOST and Persian databases [IranMedex, and SID] up to October 2012. Two authors independently selected and one reviewed and extracted data. Results reported by more than 30% of studies considered as the most important topics. Finally 25 articles were included. All study designs were cross-sectional [except for two interventional studies] and in hospital settings. Nursing staff and students were the most observed populations. Individual factor, with "inadequate knowledge of medication" as its most frequent reason, were the mostly reported source of MEs. Fear and reporting process were two most important reporting barriers. The sense of being reprimanded and ignoring to report respectively were their most frequent factors. Anti-infectives were the most frequent drugs involved in MEs. Preventive measures were varied and reporting of their effectiveness was inconsistent. There are still many research gaps which need to be explored by further studies. Based on our findings, further researches may be focused on design, implementation, and evaluation of a ME reporting system as groundwork, assessing systems-related factors to ME alongside individual factors and evaluating the effectiveness of preventive measures for MEs in trials

Plasma vitamin D status and its correlation with risk factors of thrombosis, P-selectin and hs-CRP level in patients with venous thromboembolism; the first study of iranian population

Low plasma level of vitamin D is linked to the increased risk of cardiovascular diseases such as hypertension, diabetes, dyslipidemia and peripheral vascular diseases. Vitamin D deficiency is a worldwide problem that involves Iranian population. To the best of our knowledge, this was the first investigation on venous thromboembolism [VTE] subjects that assessed the correlation of vitamin D level with plasma P-selectin, hs-CRP, and risk factors of thrombosis. In this prospective study, patients with diagnosis of acute deep vein thrombosis and or pulmonary eboembolism were enrolled. All patients' clinical data, demographics and risk factors of thrombosis were evaluated. Plasma level of P-selectin and hs-CRP were measured by ELISA method. Radio immune assay method was used to determine plasma level of 25-hydroxy vitamin D. In this study, 60 subjects were included. The mean +/- SD plasma 25-hydroxy vitamin D level [25[OH] D] of participants was 21.4 +/- 14.6 ng/mL. The vitamin D deficiency was reported in 60% of patients. No significant relation was found between the plasma 25[OH]D level and P-selectin and hs-CRP. In multiple regression analysis, there was a significant relationship between the level of 25[OH]D and the patients' age [beta = 0.452; p = 0.001], diabetes [beta = 0.280; p = 0.036] and positive family history of cardiovascular diseases [beta = 0.373; p = 0.003]. Vitamin D deficiency is a frequent problem in Iranian VTE patients. Moreover, Plasma level of vitamin D is not associated with increase level of P-selectin and hs-CRP in VTE patients

Study of potential drug-drug interactions in prescriptions of university- based pharmacies

Drug-Drug Interactions [DDIs] are adverse reactions caused by a combination of drugs; they are often predictable and therefore avoidable or manageable. The objective of this study was to evaluate the nature, type and prevalence of potential DDIs in prescriptions dispensed in university-based community pharmacies in Tehran, Iran. From July 2012 to February 2014, sample of 1260 prescriptions were collected from community and outpatient hospital pharmacies affiliated to Tehran University of Medical Sciences [TUMS], Iran. The prescriptions were assessed using the reference text "drug interaction facts". The identified DDIs were categorized according to their level of significance into three classes [minor, moderate, major]. At least one drug-drug interaction was present in 339 [26.9%] of prescriptions and a total of 751 cases of interactions were found in prescriptions. Major DDIs represented 7.3% of all DDIs detected, whereas moderate DDIs were 75% of all DDIs. The mean number of drugs per prescriptions was 3.2, with a median of 4 [range, 2-10].There was a positive association between number of prescribed drugs and occurrence of DDIs [OR: 2.14, 95% CI: 1.9-2.4]. The prescriptions of medical specialist had greater risk of occurrence of moderate severity DDIs than general practitioners [OR: 1.52, 95%CI: 1.08-2.15]. Despite the prescriptions were collected from university-based pharmacies, but the overall prevalence of potential DDIs were high among patients. Physicians should be aware of potentially harmful DDIs. Meanwhile Pharmacists can contribute to the detection and prevention of drug-related injuries. Appropriate education, collaborating drug selection and pharmaceutical care are strongly recommended for physicians and pharmacists

Bibliographic search of publication patterns in rational use of drugs in Iran: a systematic approach

Inappropriate use of drugs is a widespread problem with serious consequences such as increased adverse drug reaction and antimicrobial resistance. Proper interventions would have important financial and public health benefits. Several studies have been performed about Rational Drug Use [RUD] in Iran. To provide a picture of researches were done about RUD and highlight the existing gaps in practice in Iran, a systematic search was conducted by reviewing all papers [English and Persian] found by searching keywords in Pubmed, Web of Science, Google Scholar, CINAHL, Proquest, International Pharmaceutical Abstract [IPA], SID, Iran Medex and MagIran. Retrieved articles were extracted in Access form and exported to Excel for further analysis. After excluding duplicate and irrelevant articles, 466 related articles were remained. Number of publications increased dramatically after 2001. About 73% of studies were cross-sectional. Evaluation of prescribing pattern [15%], self-medication [11.3%] and adverse drug reaction [9.1%] were among the top topics which were studied. Despite an increasing trend in RUD publications in Iran, still large gaps remain to be investigated. Knowing the existing gaps is crucial for policy makers to make investments to solve the problems

Comparison of the effects of enoxaparin and heparin on inflammatory biomarkers in patients with ST-segment elevated myocardial infarction: a prospective open label pilot clinical trial

Heparin and enoxaparin possess anti-inflammatory properties. We compared the effects of these drugs on inflammatory biomarkers in patients with ST-segment Elevated Myocardial Infarction [STEMI]. Thirty four patients with STEMI randomly separated in two groups and received standard doses of heparin and enoxaparin. The serum concentration of Serum Amyloid A [SAA], C-Reactive Protein [CRP], Interleukin [IL]-6. ferritin and Myeloperoxidase [MPO] were measured at baseline ,12 .24 and 48 hours after drug administration. Serum concentrations of SAA [P: 0.02], CRP [P: 0.02] and ferritin [P: 0.01] significantly reduced in heparin group during measurements compared to baseline, circulating levels of IL-6 [P: 0.002], SAA [P: 0.009], CRP [P: 0.01] were significantly decreased in enoxaparin group. The overall difference in inflammatory biomarkers between heparin and enoxaparin group was not significant. Both heparin and enoxaparine reduced serum levels of inflammatory biomarkers in patients with STEMI. This effect may provide additional clinical benefit of these drugs in the treatment of STEMI patients

Impact of UGT1A9 polymorphism on mycophenolic acid pharmacokinetic parameters in stable renal transplant patients

There are wide individual differences in pharmacokinetic parameters of mycophenolate mofetil [MMF] among transplanted patients. Some studies have shown that single nucleotide polymorphisms [SNPs] of the Uridine Diphosphate Glucuronosyl Transferase1A9 [UGT1A9] are responsible for these differences in early days after transplantation. Therefore it was decided to evaluate the influence of UGT polymorphism on MMF pharmacokinetics among stable Iranian transplant patients. This was a cross sectional study from March 2008 through December 2008 in Imam Khomeini Hospital affiliated to the Tehran University of Medical Sciences in Iran. Blood samples were taken from 40 de novo stable Iranian renal transplant patients taking 2 g MMF daily with Sr[Cr]

Comparison of efficacy and tolerability of different brands of amlodipine in patients with mild to moderate hypertension

The efficacy of amlodipine, a calcium channel blocker, in treating systemic hypertension is well established but the most efficacious brand of this drug is still uncertain. The cost of different brands of amlodipine is tremendously different which may affect decision-making in hypertension treatment. The purpose of this study was to compare the efficacy and safety of different brands of amlodipine [Amlodipine, Amlopress, and Norvasc] in the treatment of hypertension in adult patients. This was a double-blind, randomized, three-sequence crossover study. Ambulatory patients with hypertension who had the inclusion criteria were enrolled. Patients were randomized and entered into three groups to receive either brand of amlodipine in a crossover method. After every four weeks of treatment completed, the other brand of drug was prescribed. The total period of the study was 12 weeks for all three drugs including four weeks for each brand. A total of 20 patients entered to the study, 15 completed the 12-week treatment schedule. The absolute reductions in seated and supine systolic blood pressure [SBP] and diastolic blood pressure [DBF] were similar with all three brands during the 4 weeks of treatment. Headache, malaise and weakness were the most common reported adverse effects [AE] with all three drugs. Generic amlodipine had the most AE as compared with other brands. These AE were mild and did not require withdrawal of the drug. There is no statistical difference in lowering blood pressure by three different brands of amlodipine thus everyone which has the lowest price can be the first choice

Leg amputation following intramuscular injection of iron dextran in a 32 year old woman

To inform healthcare professionals of a rare serious reaction leading to leg amputation following intramuscular injection of iron dextran and report comments for preventing such reactions. A case of leg amputation following intramuscular injection of iron dextran reported to Iranian Pharmacovigilance Center was reviewed. Patient and reaction data was collected by assessing the reported yellow card, patient chart review and interviewing with patient and physicians. World Health Organization definition for serious reactions was used to determine the seriousness of the reaction. Naranjo algorithm was used to determine probability scale. The probability of the reaction was determined based on questionnaire of Schumock et al. The studied case is classified as a rare and serious but preventable reaction induced by intramuscular injection of iron dextran in a 32 year old woman. The probability of the reaction is appeared to be [probable] based on Naranjo algorithm. It seems that Iron dextran could cause serious and life threatening adverse effects. It is necessary for healthcare professionals to be informed of such rare but serious reaction in order to apply preventive actions

Pharmacokinetic study of mycophenolic acid in Iranian kidney transplant patients

The purpose of this study was to characterize the pharmacokinetic parameters of mycophenolic acid [MPA] in Iranian kidney transplant patients. Plasma MPA concentration of mycophenolate mofetile [MMF] 1 gram two times a day was measured in 21 Iranian kidney transplant recipients receiving treatment. Patients who entered the study had been transplanted for more than 3 months and their drug level was supposed to be at steady state. MMF concentration was measured with High- Performance Liquid Chromatography [HPLC]. The plasma MPA concentration-time curve was characterized by an early sharp peak at about 1 hour postdose. The mean Area Under Curve [AUC], Cmax and Tmax were 47.0 +/- 18.3 microg.h/ml, 18.6 +/- 8.5 microg/ml and 1.0 +/- 0.5 hours respectively. The plasma MPA concentration-time curve pattern of Iranian patients was similar and consistent with previously reported profiles in other populations taking the same dose.

Evaluation of community pharmacists' knowledge, attitude and practice towards good pharmacy practice in Iran

The principles of pharmaceutical care are embedded in the concept of Good Pharmacy Practice [GPP]. GPP is poorly applied in community pharmacies not only in Asian countries, but even in United States and Europe. The present study was undertaken to evaluate the knowledge, attitude and practice of the community pharmacists in Iran, regarding GPP. A total of 794 pharmacists were evaluated with a reliable and validated KAP [Knowledge, Attitude, and Practice] questionnaire regarding GPP in September 2008. The most important finding in the present study was the pharmacists' low knowledge [Mean= 13.42] and practice [Mean= 29.85] level about GPP, while their attitude towards this subject was at a high level [Mean= 74.83]. Increase in their knowledge of good pharmacy practice aligned with an increase in their attitudes towards this issue. Also increase in our pharmacists' knowledge and attitude aligned with an increase in quality of their practice. The current practice of Iranian community pharmacists needs further improvement. National pharmaceutical organizations should organize educational programs for the community pharmacists to equip them for their main role in community practice: promoting rational drug use.

Penicillin allergy and cross-reactivity with other beta-lactams

Beta-lactams are a group of antibiotics with a broad spectrum of both Gram-negative and Gram-positive coverage. The goal of this study is to evaluate the results from studies regarding Ig-E mediated hypersensitivity to Penicillin and cross-reactivity with other beta-lactams. Review was conducted of both retrospective and prospective studies by searching in PubMed and Medline for the original and systematic review articles by using the keywords: penicillin allergy, beta-lactams and cross-reactivity. The rate of true Penicillin allergy is about 10% of reported cases by the patients. The rate of Ig-E mediated cross-reactivity between Penicillin and Cephalosporins is less than 10% for the first and second generations and less than 5% for the third and fourth generations. According to the reviewed studies, Imipenem has between 9.2% to 25.6% cross-reactivity with Penicillin. Recent studies have shown safe use of Meropenem in patients with penicillin allergy even with positive skin test. The only member of Monobactam family, Aztreonam, has no cross-reactivity with any of Penicillins, Cephalosporins [with the exception of Ceftazidime] and Carbapenems. Due to the low rate of true Penicillin allergy, the patient's self report of this adverse reaction must be justified carefully before avoiding beta-lactams. Even in the cases of true penicillin allergy, Meropenem appears to be safe, if indicated. There are also a few case reports regarding hypersensitivities to Clavulanate itself and also its cross-reactivity with Penicillin.

Effect of oral anticoagulant therapy on coagulation activity and inflammatory markers in patients with atrial fibrillation undergoing ablation: a randomized comparison between dabigatran and warfarin

Atrial fibrillation [AF] is associated with inflammatory and hypercoagulability state. Previous studies evaluated the safety and efficacy of dabigatran and warfarin in prevention of thrombothic complications. This study was intended to assess the influence of these drugs on hemostatic and inflammatory markers among patient underwent pulmonary vein ablation. A total of 100 patients with AF who underwent catheter ablation were randomized to treatment with dabigatran [D] 110 mg twice daily or warfarin [W] adjusted to an * international normalized ratio [INR] of 2.0 to 3.0 for 3 months after ablation procedure. C - reactive protein [CRP], D-dimer, prothrombin fragment Fl + 2 [Fl +2], were measured at baseline before ablation procedures, after 30 days and after 90 days of treatment. After 3 months, the D-dimer was 164.9 +/- 48.9 in Dabigatran and 197.2 +/- 58.6 in warfarin group, Fl + 2 was 0.4 +/- 0.2 in dabigatran and 0.8 +/- 0.2 in warfarin group and CRP level was 1.8 +/- 1.6 in Dabigatran and 5.1 +/- 5 in warfarin group. [All p-values < 0.05] The results showed that treatment with dabigatran made greater changes in the serum level of CRP, D-dimer, Fl + 2. The pattern of changes in serum CRP levels D-dimer, Fl + 2 is much faster and with a greater slope in the dabigatran group

Knowledge, attitudes and practice of nurses regarding adverse drug reaction reporting

Adverse drug reactions [ADR] are ranked as some of the major causes of patient morbidity and mortality. Spontaneous reporting of ADRs has remained the cornerstone of pharmacovigilance and is important in maintaining patient safety. This study was conducted to assess the nurses' knowledge and attitude towards pharmacovigilance, reasons for not reporting ADRs, and their pharmacovigilance practice. A questionnaire was prepared to investigate knowledge, attitude and practice [KAP] of nurses regarding ADR reporting. In November 2009, the questionnaires were given to 500 nurses of a teaching hospital in Tehran. Knowledge and practice of participants were not satisfying; however, their attitude towards pharmacovigilance was at a high level. About 91% of the nurses had never reported an ADR. Most nurses liked to report the ADRs to the physicians [87.1%] and pharmacists in hospital's ADR center [1.8%] rather than the ADR National Center. The main cause of under-reporting of the suspected ADRs was unawareness about the existence of such a national center. Among nurses who had reported ADR for at least once, the majority preferred using phone [10 out of 50] or Yellow Cards [7 out of 50]. Only 1 person out of 50 preferred using internet for submitting the reports. Since the nurses in this study had little knowledge and poor practice regarding the pharmacovigilance and spontaneous reporting system, interventions such as holding pharmacovigilance workshops in the hospitals focusing on the aims of pharmacovigilance, completing the Yellow Card and clarifying the reporting criteria are strongly recommended.

Three years evaluation of drug shortages from educational pharmacies in Tehran

The effectiveness of any drug supply systems in providing a trustworthy supply of essential drugs is a critical issue. To evaluate this effectiveness, it is necessary to watch over the status of the essential medicines in any country impartially and continuously. Some countries and also the World Health Organization [WHO] have codified a list of minimum medicines needed for a basic health care system and published them in assortments as a list of essential medicines. The aim of this study was to give an evaluation of the shortages status in Iran and identify the strengths and weaknesses of policies made in Ministry of Health during the years 2005 to 2008 in providing the essential drugs based on the WHO list of essential medicines. The reports used in this retrospective study were collected from the central purchasing unit of one of the main chain drugstores in the country [13-Aban Pharmacy] every 2 to 3 weeks. In these reports, a drug is added to the list of shortages when the requested drug is not delivered. The reports were studied and the results were analyzed based on the WHO list of essential medicines and the national drug list of Iran. The shortages always included 20 to 40 medicines from the list of essential drugs compiled by WHO. Based on this finding, the Ministry of Health and particularly Food and Drug Organization can compile a National List of Essential Medicines and try to always supply them and prevent their shortage

Evaluation and monitoring of isotretinoin use in Iran

Isotretinoin [13-cis retinoic acid] is used for treatment of nodular cystic acne unresponsive to conventional therapy. It is an expensive, potent teratogenic drug with serious adverse drug reaction [ADRs]. Recently, use of this drug has increased in Iran. To date, there are no published data about the use of isotretinoin in Iran; therefore, this study aims to assess its use in this country. This was a prospective, drug utilization evaluation [DUE] study conducted in an institutional community pharmacy affiliated with Tehran University of Medical Sciences [TUMS]. Drug prescription, administration, and evaluation of appropriateness were recorded and compared with standard protocols. Collected data were analyzed by SPSS software. A total of 274 outpatients treated with isotretinoin enrolled in the study. Of these, 51.3% were prescribed isotretinoin under the usual recommended daily doses of 0.5mg/kg/day. Data also indicated that 33.5% of the patients were given total doses of less than 100 mg/kg [72.4 +/- 17.2 mg/kg] and 12.2% received more than 150 mg/kg. With regards to the teratogenic effects of isotretinoin, only 6.8% of couples simultaneously used two methods of contraception [P = 0.001]. In addition, we detected improper use of isotretinoin for mild and moderate acne in about 20% of cases. The most important finding of this study is that the doses of isotretinoin are incorrect in many cases. Incorrect dosages would decrease drug efficacy and increase the risk of relapse. In addition, patients have not been adequately counseled about isotretinoin's teratogenicity and the seriousness of its adverse effects

Iranian pharmacists' knowledge, attitude and practice regarding counterfeit drugs

Background Awareness of pharmacists about counterfeit drugs is necessary for health improvement in community. The purpose of the present study is to assess the knowledge and measure the professional attitude and practice of Iranian pharmacist about counterfeit drugs. In August 2008, a knowledge, attitude and practice [KAP] study was performed in a national s sample of 794 pharmacists who participated in an Iranian Pharmacist Association congress. A questionnaire was prepared to collect Demographic and professional characteristics, Knowledge, attitude and practice of pharmacists regarding counterfeit drugs. The mean percent of participants who answer each practice questions correctly is 13.62% and none of questions have more than 14.7% of correct answer, while the participants' attitude towards the subject is at high level. None of demographic factors represented a significant relationship with knowledge and the only related parameters with attitude, were age and gender. Increasing age of pharmacists resulted in attitude improvement [p = 0.013] and womems attitudes were better than men [p = 0.05].The only related parameters with practice, were the number of working hours per a week and attitude. Increasing the number of working hours per a week, resulted in decreasing the desirable practice [p = 0.041] and attitude also had a direct relationship with practice [p = 0.011]. Conclusion The most important finding in the present study was the pharmacists low knowledge and practice level about counterfeit drugs, while their attitude towards this subject was at a high level. The results point out the need for designing and implementing educational programs