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   2017| October-December  | Volume 6 | Issue 4  
    Online since January 8, 2018

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The efficacy of crocin of saffron (Crocus sativus L.) on the components of metabolic syndrome: A randomized controlled clinical trial
Tayyebe Kermani, Toba Kazemi, Somayye Molki, Khadije Ilkhani, Gholamreza Sharifzadeh, Omid Rajabi
October-December 2017, 6(4):228-232
DOI:10.4103/jrpp.JRPP_17_26  PMID:29417083
Objective: Metabolic syndrome is a set of cardiac risk factors with increased risk of chronic diseases. The aim of this study is to evaluate the efficacy of crocin of saffron on metabolic syndrome. Methods: This double-blind, randomized clinical trial was conducted on metabolic syndrome patients who were randomly assigned to crocin of saffron or control (placebo) groups. The intervention group received 100 mg/day crocin tablets (a constituent of saffron) for 6 weeks. Then, the changes in metabolic syndrome component were compared between two groups. The trial was registered in the Iranian Registry of Clinical Trials. Data were entered to SPSS 15. Chi-square, Fisher's exact, paired t-test, and independent t-test were used to analyze data. P < 0.05 was defined as statistical significant level. Findings: Totally, 48 patients included in the trial (24 intervention and 24 placebo participants). There were significant reductions from baseline measurements in the levels of total cholesterol (P < 0.001) and triglyceride (P = 0.003) after the 6-week crocin administration. However, this decrease in lipid profile was not significant when compared with placebo group. There was no significant change in other laboratory values, blood pressure, and anthropometric measures. Conclusion: The present study indicated that the dose of about 100 mg crocin of saffron was well tolerated and has no complication for 6 weeks of oral administration. However, the dosage used in our study had no effect on metabolic syndrome. Further studies are required to assess this effect with the higher dosages of crocin as well as long time effects of its administration on metabolic syndrome patients.
  8 1,418 233
Comparing the efficacy of low dose and conventional dose of oral isotretinoin in treatment of moderate and severe acne vulgaris
Gita Faghihi, Fatemeh Mokhtari, Nasrin Motamedi Fard, Narges Motamedi, Sayed Mohsen Hosseini
October-December 2017, 6(4):233-238
DOI:10.4103/jrpp.JRPP_17_30  PMID:29417084
Objective: This study was conducted to compare the effect of low-dose isotretinoin with its conventional dose in patients with moderate and severe acne. Methods: This was a clinical trial conducted on 60 male and female patients with moderate and severe acne vulgaris. The patients were divided into two treatment groups: 0.5 mg/kg/day isotretinoin capsule and low-dose isotretinoin capsule (0.25 mg/kg/day). Patients in both groups received 6-month treatment. At the end of the 6th month and 12th month (6 months after the end of the treatment), they were examined again, and their improvement was determined and compared. Findings: The average severity of acne in the two treatment groups did not differ significantly within any of the study periods. The most common side effects were nose dryness in the low-dose group (17%) and hair thinning and loss in the conventional - dose group (33.2%), although all the patients had dry lips. Conclusion: According to the same severity of the acne in two groups in different study periods, as well as fewer side effects and more patients' satisfaction, the low-dose isotretinoin can be considered in the treatment of acne.
  4 1,849 294
Ciprofloxacin use in hospitalized children: Approved or off-label?
Toktam Faghihi, Leila Yavari Tekmehdash, Mania Radfar, Kheirollah Gholami
October-December 2017, 6(4):193-198
DOI:10.4103/jrpp.JRPP_17_27  PMID:29417077
Objective: Fluoroquinolones are not routinely used as the first-line antimicrobial therapy in pediatrics. The American Academy of Pediatrics (AAP) and the United States Food and Drug Administration (FDA) approved fluoroquinolones on certain indications in children. The aim of this study was to evaluate to what extent and how ciprofloxacin is used on approved indication or as off-label. Besides, dose adequacy and treatment duration were assessed. Methods: In a 10-month observational study, all children receiving systemic ciprofloxacin were assessed. We classified ciprofloxacin prescription to an AAP/FDA or off-label indication. The off-label prescriptions were further categorized to justified and unjustified therapy subgroups. The AAP/FDA category and the justified subgroup constituted the appropriate prescriptions. Findings: During the study period, 32 patients were prescribed ciprofloxacin. In general, 37% (12) of prescriptions determined to be appropriate. Of the appropriate prescriptions, 7 were AAP/FDA-approved indications. Children with Crohn's disease with abdominal abscess and children with infectious bloody diarrhea constituted the off-label; justified therapy subgroup. Unjustified prescriptions mainly occurred in the presence of a suitable alternative antibiotic for ciprofloxacin. Mean ± SD of ciprofloxacin dose (mg/kg/day) and duration (days) were 21.25 ± 6.35 and 13.56 ± 8.48, respectively. Of the appropriate prescriptions, 41% were underdosed. Underdosing was more encountered in patients with cystic fibrosis. Duration of treatment of the appropriate prescriptions was determined to be appropriate. Conclusion: The majority of children were receiving ciprofloxacin off-label and in an inappropriate manner. This issue emphasizes that antimicrobial stewardship program on ciprofloxacin use in pediatric hospitals should be implemented. Further studies evaluating clinical and microbiological outcomes of these programs in children are needed.
  1 2,049 582
Efficacy of intense-pulsed light therapy with topical benzoyl peroxide 5% versus benzoyl peroxide 5% alone in mild-to-moderate acne vulgaris: A randomized controlled trial
Fatemeh Mokhtari, Maryam Gholami, Amir Hossein Siadat, Tohid Jafari-Koshki, Gita Faghihi, Mohammad Ali Nilforoushzadeh, Sayed Mohsen Hosseini, Bahareh Abtahi-Naeini
October-December 2017, 6(4):199-205
DOI:10.4103/jrpp.JRPP_17_29  PMID:29417078
Objective: Acne vulgaris is a disease of pilosebaceous unit with multifactorial pathogenesis and threats patients' social functioning. There is a growing research to find faster, more effective, and easy to use treatments. The aim of this study is to evaluate the efficacy of benzoyl peroxide 5% (BP) with and without concomitant intense-pulsed light (IPL) therapy in mild-to-moderate acne vulgaris. Methods: In this controlled trial, 58 eligible patients with mild-to-moderate acne and Fitzpatrick skin phototype III and IV were randomly allocated to two groups. All patients were asked to use a thin layer of BP every night. The IPL therapy was administered at the end of first, 2nd, and 3rd months. Acne Global Severity Scale (AGSS), Acne Severity Index (ASI), and total lesion counting (TLC) along with patient satisfaction were recorded. Patients were also examined 1 month after the final therapeutic visit. Findings: The IPL group showed greater reduction in AGSS (P < 0.001) and TLC (P = 0.005) than the control group. However, the difference in ASI was not significant (P = 0.12). Patients in IPL groups were more satisfied than control group (P < 0.001). Conclusion: Adding IPL to BP can result better response to BP alone. In acne treatment, combination therapy such as IPL and other topical agents should be kept in mind.
  1 1,623 276
Prescription pattern analysis of nonsteroidal anti-inflammatory drugs in the northeastern iranian population
Majid Zeinali, Jamshid Tabeshpour, Seyed Vahid Maziar, Zhila Taherzadeh, Mohammad Reza Zirak, Danielle Sent, Kamal Razavi Azarkhiavi, Saeid Eslami
October-December 2017, 6(4):206-210
DOI:10.4103/jrpp.JRPP_17_45  PMID:29417079
Objective: Inappropriate nonsteroidal anti-inflammatory drugs (NSAIDs) therapy is a common cause of actual and potential adverse effects, such as bleeding and gastrointestinal ulceration, which exacerbates the patient's medical condition and might even be life threatening. We aimed to evaluate and analyze the prescription pattern of NSAIDs in Northeastern Iranian population and also provide suggestions for a more rational prescription behavior for such drugs. Methods: In this cross-sectional retrospective study, pattern of 1-year prescriptions was inspected based on 9.3 million prescriptions from two insurance companies. Type of NSAIDs, all dispensed doses and the number of NSAIDs ordered per prescription, and the route of administration for each patient were extracted from the databases. The prescription pattern of NSAIDs was analyzed seasonally. Findings: Out of 9,303,585 prescriptions, 19.3% contained at least one NSAID. Diclofenac was the most commonly prescribed NSAID (49.21%). At least two NSAIDs were simultaneously prescribed in 7% of prescriptions. General practitioners prescribed NSAIDs more frequently (67%) than specialists. Orthopedic surgeons and internists more frequently prescribed NSAIDs in comparison with other physicians (6% and 4%, respectively). Gastroprotective agents (GPAs) were coprescribed to only 7.62% of prescriptions. Conclusion: The frequency of NSAIDs prescription was relatively high in Northeast of Iran. A significant number of prescriptions were associated with irrational prescribing in both coadministration of NSAIDs and GPAs and NSAIDs combination. A strategy must be developed and implemented for prescribing and rational use of medications, e.g., continuing medical education regarding the potential risks of NSAIDs, importance of their appropriate and rational use, and necessity of appropriate prescription writing regarding both content and indication.
  - 1,374 316
New indications for dabigatran: A suggestion from a drug use evaluation study
Farzaneh Ashrafi, Najmeh Rezaie, Sarah Mousavi
October-December 2017, 6(4):211-216
DOI:10.4103/jrpp.JRPP_17_54  PMID:29417080
Objective: Dabigatran etexilate is a novel oral anticoagulant with several advantages over warfarin such as no need for routine monitoring and fewer drug interactions. This drug was added to our hospital's formulary in 2012. The objective of this study was to assess the rational drug use of dabigatran at a large teaching hospital. Methods: A prospective cross-sectional study was performed from November to June 2015 at Alzahra teaching hospital, Isfahan, Iran. All patients who received at least one dose of dabigatran were eligible for inclusion. Data were collected on patient demographics, indication, dosing regimen, adverse events, concurrent anticoagulant therapy, and laboratory data (including renal function). Findings: A total of sixty patients were included in our study. The majority of patients (n = 40, 66.7%) was prescribed dabigatran for deep vein thrombosis prophylaxis. Only one patient received dabigatran with appropriate indication, dose, and duration. Thirty-six (60%) of our patients had thrombocytopenia at the time of dabigatran initiation. We also detected that ten patients (16.7%) received this drug for heparin-induced thrombocytopenia (HIT). In 32 patients, platelet levels increased after dabigatran initiation. Only seven patients received the appropriate dose of dabigatran (regarding both indication and renal function). Conclusion: Unlabeled use and incorrect dosing of dabigatran in this study emphasize the need to develop a hospital protocol for dabigatran use within our facility. We suggest proper education of clinicians about novel drugs, pharmacist interventions, and further studies about the safety and efficacy of dabigatran for the new indication (such as HIT).
  - 1,284 227
Pharmacokinetic behavior of phenytoin in head trauma and cerebrovascular accident patients in an iranian population
Shahnaz Alimardani, Sima Sadrai, Hamidreza Taghvaye Masoumi, Pooneh Salari, Atabak Najafi, Behzad Eftekhar, Mojtaba Mojtahedzadeh
October-December 2017, 6(4):217-222
DOI:10.4103/jrpp.JRPP_17_58  PMID:29417081
Objective: Acute brain injury is one of the leading causes of morbidity and mortality worldwide. Phenytoin has been commonly used as an anticonvulsant agent for the treatment or prophylaxis of seizures following acute brain injury. After a severe head injury, several pharmacokinetic changes occur. The aim of this study is the comparative evaluation of phenytoin serum concentration in patients with traumatic and nontraumatic brain injury (TBI). Methods: This prospective observational study was performed on twenty adult brain injury patients who were admitted to an Intensive Care Unit and required phenytoin for the treatment or prophylaxis of postinjury seizures. For all the patients, phenytoin serum concentration was determined in three scheduled time points. Phenytoin serum concentration and pharmacokinetic parameters were compared between patients with TBI and cerebrovascular accident (CVA). Findings: The Vmaxand Kmwere significantly higher in head trauma (HT) patients than the CVA group. The phenytoin concentration (Cp) and the Cp/dose ratio were significantly higher in the CVA group patients during the first sampling (P < 0.05). The Acute Physiology and Chronic Health Evaluation П (APACHE П) score was significantly lower than the baseline at the end of the study in each group of patients (P < 0.05). In addition, no significant correlation was observed between Vmax, Km, Cp, Cp/dose ratio, and APACHE II scores at the time of sampling. Conclusion: Due to significant differences in phenytoin plasma concentration and pharmacokinetic parameters between HT and CVA patients, close attention must be paid to the pharmacokinetic behavior of phenytoin in the efforts to improve the patient's outcome after a severe HT.
  - 1,220 183
Comparison of subacromial ketorolac injection zversus corticosteroid injection in the treatment of shoulder impingement syndrome
Parisa Taheri, Farnaz Dehghan, Sahar Mousavi, Reza Solouki
October-December 2017, 6(4):223-227
DOI:10.4103/jrpp.JRPP_17_57  PMID:29417082
Objective: Subacromial impingement syndrome is the most common cause of shoulder pain and restriction in range of motion in the world. The aim of this study was to compare the efficacy of subacromial injection of ketorolac with the injection of corticosteroid for the treatment of subacromial impingement syndrome. Methods: A total of forty patients were randomly allocated into two groups. Group A received 40 mg of methylprednisolone and Group B received 60 mg of ketorolac as a subacromial injection along with lidocaine. Each patient was evaluated in terms of visual analog scale (VAS) for evaluating pain and Constant's score for function evaluation (pain, activity level, and range of motion with standard goniometry). The patients were re-examined 1 and 3 months after intervention. All the patients educated for simple home exercise. Findings: At 1 and 3 months of follow-up, both treatment arms resulted in an increased range of motion and decreased pain. The difference between the groups was not statistically significant (P > 0.05). In ketorolac group, mean pre- and post-treatment (at 12 weeks) VAS scores were 8.6 (range, 3–9) and 4.5 (range 2–4), respectively. In steroid group, mean pre- and post-treatment (at 12 weeks) VAS scores were 8.3 (range, 3–10) and 3.9 (range, 0–7), respectively. The difference was statistically significant within groups at baseline and 1 (P < 0.001) and 3 (P < 0.001) months after the injection. Conclusion: Subacromial injection of ketorolac has an equivalent outcome to subacromial injection of corticosteroid. The use of ketorolac injections can substantially decrease the pain and increase the range of motion of the shoulder and could be a reasonable alternative in case of corticosteroid contraindications.
  - 1,110 182