[Cross-Sectional Study on Adverse Effects of Metformin Hydrochloride on 130 Patients Type 2 Diabetic Admitted to Medical Center and Diabetes Home of Sidi Bel-Abbès]. / Étude Transversale sur les Effets Indésirables de la Chlorhydrate de Métformine chez 130 Patients Diabétiques Type 2 Admis au Centre Médical et à la Maison du Diabète de Sidi Bel-Abbès.

INTRODUCTION: MetforminHydrochloride is an antidiabetic used for many years, currently; it considered the first choice in treatment of type 2 diabetes (T2D). It decreases insulin resistance, does not induce hypoglycaemia, increases glucose utilization in the liver and skeletal muscle, and decreases hepatic glucose production. Its adverse effects (AE) are gastrointestinal, decrease in vitamin B12 absorption, abnormalities of hemogram and rarely skin reactions. The objective of this study was to report the type and frequency of AEs of Metformin Hydrochloride used in the therapeutic management of T2D patients admitted to the medical center and the diabetes home of Sidi Bel-Abbès in Algeria. MATERIALS AND METHODS: A cross-sectional descriptive study was carried out over a period of four months, from January 1st, 2017 to April 30th, 2017, involving 130 patients treated with Metformin Hydrochloride consulting at Mimoun City Diabetes Home and Gambetta Diabetes Center in the town of Sidi Bel-Abbès. The primary outcome measure was the determination of the type and frequency of AEs related to normal dosages or overdose use of Metformin Hydrochloride in T2D. Data were collected from patient records, using a questionnaire, and analyzed using Statistical Package for the Social Sciences, version 20 software. RESULTS: 130 patients were included, including 82 women, with a mean age of 51.08±8.85 years (30-66). One hundred and ninety-eight (198) AEs were reported, an average of 1.52 AEs per patient. Among them, 95 (47.98%) AEs are digestive disorders (30.77% of patients suffered from diarrhea, 10.77% had nausea and vomiting, 8.46% suffered from abdominal pain and bloating, 3.85% lost their taste, 7.69% complained of epigastric cramps and 11.54% of anorexia), 29 (14.65%) AEs are hypoglycaemia, 73 (36.87%) AEs are other symptoms and 1 (0.50%) EI is vitamin B12 deficiency and no cases of lactic acidosis or allergic reaction were reported. Five (3.85%) patients had a total and lasting intolerance to Metformin Hydrochloride leading to its discontinuation following persistent diarrhoea. CONCLUSION: AEs of Metformin Hydrochloride used in the management of T2D patients consulting at the medical center and the Diabetes home of Sidi Bel-Abbès are frequent. Digestive disorders were the most frequent, diarrhea was very frequent and led to discontinuation of treatment in 3.85% of T2D patients, followed by nausea and vomiting, then abdominal pain, bloating and epigastric cramps, and rarely taste metallic. Hypoglycaemia was frequent following its association with insulin, the onset of headaches and fatigue were frequent, but no case of lactic acidosis or allergic reaction was reported. Due to a lack of means, the dosage of homocysteine and methylmalonic acid had not been carried out to confirm the vitamin B12 deficiency in the patient whose level was less than 200ng/mL. A precise assessment of the imputability of reported AEs is necessary.

[Prevalence of Adverse Effects of Tyrosine Kinase Inhibitors Used in Management of Chronic Myeloid Leukemia at Sidi Bel-Abbès University Hospital Center]. / Prévalence des Effets Indésirables des Inhibiteurs de Tyrosine Kinase Utilisés dans le Traitement de la Leucémie Myéloïde Chronique au CHU de Sidi Bel-Abbès.

INTRODUCTION: Chronic myeloid leukemia (CML) is a malignant hemopathy within the framework of chronic myeloproliferative syndromes, predominant on the granular line. Her drug treatment is based on tyrosine kinase inhibitors (TKIs) which inhibit the abnormal BCR-ABL protein kinase that causes CML and thus block the signals that cause cancer cells to multiply abnormally. However, other proteins are also inhibited, so they can cause a wide range of adverse effects (AEs). The objective of this study was to study the prevalence of AEs of TKIs used in the therapeutic management of CML by the hematology department of University Hospital Center (UHC) of Sidi Bel-Abbes in Algeria and that of the ITK discontinuation following an AE. MATERIALS AND METHODS: It was a retrospective descriptive study carried out over a period of four months, from April 01st, 2021 to July 31st, 2021, on CML patients treated with TKI in the hematology department of Sidi Bel-Abbes HUC in Algeria. The primary outcome measure was the prevalence of AEs associated with the use of normal dosages or overdose of the following TKIs: Imatinib, Dasatinib and Nilotinib. Data were collected from patient charts, filled by doctors of hematology department, using questionnaire, and analyzed by Statistical Package for the Social Sciences software, version 20. RESULTS: A total of 40 patients were included, including 22 women, mean age 51.55±11.66years (23-78). Twenty-six patients reported at least one AE. Among the 106 AEs declared, 69 AEs (65.09 %) declared with Imatinib, 26 AEs (24.53 %) with Dasatinib and 11 AEs (10.38 %) with Nilotinib. A predominance of musculoskeletal effects 43 (40.56 %), followed by general disorders 18 (17 %), myelosuppression 14 (13.20 %) and digestive system 12 (11.32 %). AEs were responsible for permanent discontinuation of ITK in three cases (11.54 %), including two cases (07.70 %) on Imatinib because of neutropenia and one case (03.84 %) onDasatinibsuffering from pleural effusion. AEs could be controlled in 13 (50 %) of cases, including 9 (34.62%) by temporary discontinuation and 4 (15.38 %) by reducing the dosage, allowing improvement of symptoms and continuation or reintroduction of treatment. CONCLUSION: The prevalence of AEs was high in the studied population, their occurrence was inevitable, good management of AEs from the start of treatment is necessary to avoid switching to another TKI, especially in good responders. It is recommended to establish a low-sodium diet beforehand for all TKIs and a low-carbohydrate diet, especially for Nilotinib, and not to rush to stop the TKI because most often, EIs regress over time in order to allow good therapeutic adherence and obtain better results.

Quality of Active Pharmaceutical Ingredients Present on Algerian Soil: Control of Impurities of Ciprofloxacin, Metronidazole and Fluconazole.

INTRODUCTION: The medicine quality is defined by its aptitude to meet certain requirements declared by the regulatory authorities. Among these, impurities control which constitutes the major fear of pharmaceutical manufacturers in efficiency and safety terms. Nowadays, in many developing countries, the presence of poor quality drugs is common, for this reason, an increased control should be instituted including impurities which represent a serious public health problem threatening the efficacy and the safety medicines, because of their nocuous repercussions on health. The objective of this study is to verify that impurities in certain APIs: Ciprofloxacin, Metronidazole and Fluconazole actually collected on Algerian soil meet the impurity requirements. MATERIALS AND METHODS: An observational experimental study was carried out from 1st December 2013 to 31st December 2017, on impurities control in the APIs of Ciprofloxacin, Metronidazole and Fluconazole medicines registered in the Algerian Medicines Nomenclature and marketed in Algeria. All samples collected were analyzed to detect, quantify and evaluate impurties for rigorous control of three categories of impurties, such as: Organic related-impurities analysis by High-Pressure Liquid Chromatography with UV Detector (HPLC-UV), Elemental-impurities analysis by Inductively Coupled Plasma-Optical Emission Spectrometry (ICP-OES) and Residual Solvents-impurities analysis by Headspace Gas Chromatography with Flame Ionization Detection (HS-GC-FID). RESULTS AND DISCUSSION: 18 samples collected from 11 laboratories among 27 requested. 22% of non-conformities were detected, including 5.5% Indian origin, 5.5% Spanish origin, 5.5% French origin and 5.5% Chinese origin. These non-conformity cases are due to the high rate of degradation product-impurity for C5 sample, Cobalt-impurity and Nickel-impurity contents exceeding the required limits for C4 and M3 samples respectively, Methanol-impurity and Toluene-impurity contents exceeding the authorized limits for M2 and F3 samples respectively. CONCLUSION: This study concluded that samples non-compliance rate is high because of certain impurities detection exceeding the safety standards. So, we interpellate the health authorities to ensure the APIs impurities control before being put into the manufacturing process in order to prevent the potentially serious health problems that are difficult to control.