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Safety Profile of Biological Drugs in Clinical Practice: A Retrospective Pharmacovigilance Study
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Biological drugs have an active substance that is made by a living organism or derived from a living organism. They are one of the important therapy options used in a wide range of diseases especially life-threatening diseases. Biological therapy opens new opportunities for treating different diseases for which drug therapy is minimal, but they have considerable differences in the safety consequences in comparison with non-biological drugs. The aim of the current study was to assess the post-marketing safety profile of biological drugs used in Iraqi hospitals by the analysis of the reported adverse drug reactions regarding their severity, seriousness, preventability, expectedness, and outcome. It is a retrospective study of the individual case safety reports from the Iraqi Pharmacovigilance Center/Ministry of Health. There were 446 individual case safety reports in the research, involving 899 adverse drug reactions. Rituximab was found to be the drug with the highest number of adverse drug reactions with 241 adverse drug reactions (26.81% out of total adverse drug reactions). Most of the adverse drug reactions were related to general disorders and administration site conditions (22.25%). Regarding severity of adverse drug reactions, the majority of adverse drug reactions were observed in moderate levels [Level 4 (26%), and Level 3 (18%)]. The severe adverse drug reactions in patients below 18 years age group were significantly higher compared to adults and elderly. Seriousness assessment showed that the majority of adverse drug reactions were serious (52%). Rituximab was the drug for which the highest number of serious adverse drug reactions was reported (41.28% of total serious adverse drug reactions), Most of the adverse drug reactions (66%) were probably preventable. Fatality outcome was reported for 3% of adverse drug reactions while 43% of adverse drug reactions were recovered/resolved.

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Publication Date
Tue Dec 29 2020
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Medication Safety in Patients under 18 Years Old; a Retrospective Study based on Iraqi Pharmacovigilance Center Database
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Medication safety is an important part of the comprehensive patient safety term. Medication safety is gaining more attention as the World Health Organization set the goal of decreasing medication harm by (50%) for the next 5 years when launching the third global challenge. Studying medication safety in the risk groups such as young ages, children are crucial to learn more about the effect of medicines in this risk group since they are not included in the clinical trials. Adverse drug reaction is defined as any harm resulted from the drug itself during medical process journey, while medication errors are any harm resulted from the treatment process rather than the drug or it is the result of the failure in a step of the treatment process

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Publication Date
Sun Dec 27 2020
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Analysis of Docetaxel Adverse Drug Reactions: A Retrospective Study Based on Iraqi Pharmacovigilance Center Database
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Docetaxel is an effective treatment approved for many types of cancers, but its effectiveness in clinical practice can be compromised by significant occurrence of adverse drug reactions. The aim of the current study was to measure the distribution of adverse drug reactions of docetaxel reported in Iraq and to assess the causality, severity, seriousness, preventability, expectedness and outcome of these adverse reactions. A retrospective study conducted on individual case safety reports from the Iraqi Pharmacovigilance Center / Ministry of Health. The study included 118 individual case safety report containing 236 adverse drug reactions.
Most of the adverse drug reactions were related to skin and subcutaneous tissue disorders(26.7%), f

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Publication Date
Sun Aug 01 2021
Journal Name
Ibn Al-haitham Journal For Pure And Applied Sciences
Bacteriological Profile and Antibiogram of Bacteria in Sputum Culture of Iraqi Patients: A retrospective study
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       Background: viruses are responsible for a large proportion of lower respiratory tract infections (LRTIs). Other causes of LRTIs are bacteria: Streptococcus pneumoniae, Haemophilus influenzae, Klebsiella pneumoniae, and Staphylococcus aureus being the most common. Sputum samples are commonly used in the microbiological laboratory for diagnosing lower respiratory infections. Objective: The aim of this study to evaluate the causative bacteria and antibiotics sensitivity in culture of sputum samples. Patients Methods: A retrospective study performed in the microbiology department of Al Immamin Al Kahdimin Medical laboratory in Baghdad. The results of sput

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Publication Date
Tue Jun 30 2009
Journal Name
Al-kindy College Medical Journal
Lipid Profile and Antihypertensive Drugs
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Background: Hypertension and dyslipidemia are
cardiovascular risk factors that commonly coexist .
Objective : To evaluate the effects of ß - blocker
(Atenolol) , ACE inhibitor (Captopril) calcium Channel
blocker (Nefidipin ) and diuretics on serum lipid profiles .
Method: Thirty untreated hypertensive and 147
hypertensive patient treated with these antihypertensive
drugs, attending different public health clinics in Basrah
pronivce were enrolled in this study .
Serum lipid profile were determined enzymaticaly using kits
from BioMerieux, France .
Result : The study has revealed that ß-blocker do not
significantly affect total cholesterol ( TC ) and LDLcholesterol , but increase significantly triglycer

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Publication Date
Sun Apr 01 2007
Journal Name
Journal Of The Faculty Of Medicine Baghdad
Clinical And Angiographic Characteristics Of Left Main Coronary Artery Disease, A Retrospective Study
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Background : Left main coronary artery (LMCA) disease represents important and serious portion of coronary artery disease(CAD).
Aim: The aim of this study is to estimate the incidence of LMCA disease among patients with CAD undergoing coronary artery angiography and to evaluate clinical characteristics of patients with LMCA disease.
Methods: The study involved review of clinical notes and coronary angiography of 1020 patients with CAD in Ibin Al Bitar hospital for cardiac surgery between April and September 2004.This review included evaluation of electrocardiogram (ECG), echocardiogram(ECHO), ECG exercise test (EET) and coronary angiography.
Results: Among 56 patients proved to have left main corona

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Publication Date
Mon Jan 08 2024
Journal Name
Al-rafidain Journal Of Medical Sciences ( Issn 2789-3219 )
Recurrence Rate of Pleomorphic Adenoma in Minor Salivary Glands After Surgical Excision: A Retrospective Clinical Study
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Background: Pleomorphic adenoma of the minor salivary gland is a rare benign tumor. It commonly occurs in the hard and soft palates. Treatment by surgical excision achieved success in improving the patient’s health. Objective: To evaluate the recurrence rate after surgical treatment of pleomorphic adenoma in minor salivary glands. Methods: This retrospective study included patients who attended the Maxillofacial Surgery Unit in Ghazi Al-Hariri Hospital, Baghdad, from 2019 to 2021, complaining of soft tissue lumps involving the soft and hard palate, buccal mucosa, and upper lip. After the provisional diagnosis of these lesions, a total surgical excision of the tumor with a safe margin of 1 mm was performed, and the biopsy was sent

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Publication Date
Mon Jan 08 2024
Journal Name
Al-rafidain Journal Of Medical Sciences ( Issn 2789-3219 )
Recurrence Rate of Pleomorphic Adenoma in Minor Salivary Glands After Surgical Excision: A Retrospective Clinical Study
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Background: Pleomorphic adenoma of the minor salivary gland is a rare benign tumor. It commonly occurs in the hard and soft palates. Treatment by surgical excision achieved success in improving the patient’s health. Objective: To evaluate the recurrence rate after surgical treatment of pleomorphic adenoma in minor salivary glands. Methods: This retrospective study included patients who attended the Maxillofacial Surgery Unit in Ghazi Al-Hariri Hospital, Baghdad, from 2019 to 2021, complaining of soft tissue lumps involving the soft and hard palate, buccal mucosa, and upper lip. After the provisional diagnosis of these lesions, a total surgical excision of the tumor with a safe margin of 1 mm was performed, and the biopsy was sent for hist

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Publication Date
Fri Jul 01 2022
Journal Name
Nternational Journal Of Special Education
Comparative Study between a Combination of Plants Extracts and Drugs on Thyroid Hormones and Lipid Profile in Experimental Animals
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The thyroid gland is a vital part of the overall endocrine system, which is regulated some of body function as oxygen use, basal metabolic rate, growth, cellular metabolism and development This study shed light on a number of extracts that have been shown to have beneficial effects on the thyroid and its function, as well as the various factors linked to thyroid dysfunction. The experiment was conducted to determine the effect of a mixture of two extracts of "Fucus vesiculosus (150 mg/ kg) with Coleus forskohlii (1000 mg/ kg) and Rosmarinus officinalis (220 mg/ kg) with Camellia sinensis (1.25 mg/ kg)" on thyroid hormones as well as lipids profile and tested the effectiveness of two drugs one of them stimulates the hormones of the thyroid (

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Publication Date
Mon Oct 16 2023
Journal Name
F1000research
Assessment of general population knowledge, attitude, and practice on safe unused and expired drugs disposal: a cross-sectional study
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Background The appropriate disposal of medication is a well-recognized issue that has convened growing recognition in several contexts. Insufficient awareness relating to appropriate methods for the disposal of unneeded medicine may result in notable consequences. The current research was conducted among the public in Iraq with the aim of examining their knowledge, attitude, and practices regarding the proper disposal of unused and expired medicines. Methods The present study used an observational cross-sectional design that was community-based. The data were obtained from using an online questionnaire. The study sample included people of diverse genders, regardless of their race or occupational status. The study mandated that all pa

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Publication Date
Wed Oct 02 2024
Journal Name
Journal Of Craniofacial Surgery
Maxillofacial Trauma in Females: A Retrospective Study
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Maxillofacial trauma in females is not widely reported. This study aimed to analyze the clinical characteristics and the patterns of maxillofacial injuries in females and to determine the differences in these patterns among different causes. This retrospective study analyzed several variables, including demographic, social, injury-related, and treatment-related variables, and compared these variables in relation to the main etiologies of maxillofacial trauma. The main etiologies of maxillofacial injuries involving females were assault, followed by road traffic accidents, and falls. There were significant differences in relation to the 3 etiologies in age groups (P= 0.002) and marital status (<

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