Unwanted Adverse Reactions Research Articles

Different therapeutic approaches in melasma: advances and limitations.

Melasma is a chronic hyperpigmentation skin disorder that is more common in the female gender. Although melasma is a multifactorial skin disorder, however, sun-exposure and genetic predisposition are considered as the main etiologic factors in melasma occurrence. Although numerous topical and systemic therapeutic agents and also non-pharmacologic procedural treatments have been considered in melasma management, however, the commonly available therapeutic options have several limitations including the lack of sufficient clinical effectiveness, risk of relapse, and high rate of unwanted adverse drug reactions. Recruitment of nanotechnology for topical drug delivery in melasma management can lead to enhanced skin penetration, targeted drug delivery to the site of action, longer deposition at the targeted area, and limit systemic absorption and therefore systemic availability and adverse drug reactions. In the current review, first of all, the etiology, pathophysiology, and severity classification of melasma have been considered. Then, various pharmacologic and procedural therapeutic options in melasma treatment have been discussed. Afterward, the usage of various types of nanoparticles for the purpose of topical drug delivery for melasma management was considered. In the end, numerous clinical studies and controlled clinical trials on the assessment of the effectiveness of these novel topical formulations in melasma management are summarized.

Influence of thioctic acid in patients with diabetes mellitus or newly diagnosed diabetes mellitus in combination with diabetic polyneuropathy after anterior septal Q wave myocardial infarction on the prevention of hypertrophy and structural myocardial remodeling

BACKGROUND: Diabetes mellitus, one of the most common chronic diseases in the world, has a significant aggravating effect on the course of myocardial infarction. Thioctic acid affects the cardiovascular risks of diabetes mellitus and has a protective effect on ischemic myocardium. Human studies to support this effect have not been widely conducted.AIM: To confirm the possibility of using thioctic acid in patients with diabetes mellitus or newly diagnosed diabetes mellitus in combination with diabetic polyneuropathy who have had anterior septal Q wave myocardial infarction to prevent hypertrophy and myocardial remodeling.MATERIALS AND METHODS: The study involved patients with myocardial infarction and type 2 diabetes mellitus, newly diagnosed diabetes mellitus and diabetic polyneuropathy. From the obtained groups, by randomization, subgroups were allocated to which thioctic acid was prescribed at a dosage of 600 mg / day orally for 3 months. To determine the comparability of the groups, a standard set of stationary studies was carried out. At the initial stage and 12 months after the start of the study, the echocardiographic parameters of myocardial hypertrophy and remodeling were monitored.RESULTS: The study involved 125 people, 5 people were excluded due to the development of unwanted adverse reactions. The formed groups were comparable in terms of initial parameters. In the main subgroups, statistically significant dynamics of LV wall hypertrophy and myocardial remodeling were not revealed. In the control subgroup of patients with diabetes mellitus, an increase in the thickness of the IVS was noted by 0.67 mm [95% CI: 0.4–0.94, p = 0.021], LVTZ by 0.8 mm [95% CI: 0.43–1 , 27, p = 0.043], LVMI at 9.2 g / m2 [95% CI: 6.15–12.24, p = 0.05], LVMI at 17.8 g. [95% CI: 11.3–24.3, p = 0.011], an increase in the prevalence of concentric myocardial remodeling by 16.7% (p = 0.026). In the control subgroup of patients with newly diagnosed diabetes mellitus, an increase in the thickness of the IVS was noted by 0.83 mm 95% [CI: 0.43–1.23, p = 0.047], LVMI by 7.9 g / m2 [95% CI: 4 , 47–11.43, p = 0.033], LVM at 16.7 gr. [95% CI: 9.75–23.65, p = 0.023], an increase in the prevalence of concentric myocardial remodeling by 16.7% (p = 0.026). In the main subgroup of patients with diabetes mellitus, a decrease in LVMM by 3.33 g was noted. [95% CI: 1.94–4.72, p = 0.024], LVMI at 4.19 g / m2 [95% CI: 2.18–6.2, p = 0.047].CONCLUSION: The use of thioctic acid on the 3rd day from antero-septal Q wave myocardial infarction in patients with type 2 diabetes, newly diagnosed diabetes mellitus, in combination with diabetic polyneuropathy, at a dosage of 600 mg / day orally, prevents hypertrophy and myocardial remodeling, and also contributes to the positive dynamics of the structure of the ejection fraction.

ARBM101 (Methanobactin SB2) Drains Excess Liver Copper via Biliary Excretion in Wilson’s Disease Rats

Excess copper causes hepatocyte death in hereditary Wilson's disease (WD). Current WD treatments by copper-binding chelators may gradually reduce copper overload; they fail, however, to bring hepatic copper close to normal physiological levels. Consequently, lifelong daily dose regimens are required to hinder disease progression. This may result in severe issues due to nonadherence or unwanted adverse drug reactions and also due to drug switching and ultimate treatment failures. This study comparatively tested bacteria-derived copper binding agents-methanobactins (MBs)-for efficient liver copper depletion in WD rats as well as their safety and effect duration. Copper chelators were tested invitro and invivo in WD rats. Metabolic cage housing allowed the accurate assessment of animal copper balances and long-term experiments related to the determination of minimal treatment phases. We found that copper-binding ARBM101 (previously known as MB-SB2) depletes WD rat liver copper dose dependently via fecal excretion down to normal physiological levels within 8 days, superseding the need for continuous treatment. Consequently, we developed a new treatment consisting of repetitive cycles, each of ∼1 week of ARBM101 applications, followed by months of in-between treatment pauses to ensure a healthy long-term survival in WD rats. ARBM101 safely and efficiently depletes excess liver copper from WD rats, thus allowing for short treatment periods as well as prolonged in-between rest periods.

Helicobacter Pylori: A Review of Current Treatment Options in Clinical Practice.

When prescribing antibiotics, infection eradication rates, local resistance rates, and cost should be among the most essential considerations. Helicobacter pylori is among the most common infections worldwide, and it can lead to burdensome sequela for the patient and the healthcare system, without appropriate treatment. Due to constantly fluctuating resistance rates, regimens must be constantly assessed to ensure effectiveness. This was a narrative review. The sources for this review are as follows: searching on PubMed, Google Scholar, Medline, and ScienceDirect; using keywords: Helicobacter pylori, Treatment Options, Clinical Practice. Multiple antibiotics are prescribed as part of the regimen to thwart high resistance rates. This can lead to unwanted adverse reactions and adherence issues, due to the amount and timing of medication administration, which also may contribute to resistance. Single-capsule combination capsules have reached the market to ease this concern, but brand-only may be problematic for patient affordability. Due to the previously mentioned factors, effectiveness and affordability must be equally considered. This review will utilize guidelines to discuss current treatment options and give cost considerations to elicit the most effective regimen for the patient.

Anti-Inflammatory Effects of Thymoquinone in Atherosclerosis: A Mini Review

Atherosclerosis poses serious health problems and increases the risk of various cardiovascular diseases, including myocardial infarction, heart failure, ischemic stroke, and peripheral arterial disease. Atherosclerosis patients require long-term medications to prevent complications, some of which are costly and may result in unwanted adverse reactions. Natural products have emerged as potential sources of bioactive compounds that provide health benefits in cardiovascular diseases. Increased inflammation and vascular remodeling have been associated with atherosclerosis pathogenesis. The molecules involved in signaling pathways are considered valuable targets for new treatment approaches. Therefore, this review aimed to summarize the available evidence of the anti-inflammatory effects of thymoquinone, the major active compound isolated from Nigella sativa L., via inflammatory signaling pathways in atherosclerosis. Specifically, nuclear factor-κB and mitogen-activated protein kinase signaling pathways were considered. Furthermore, the potential toxic effects elicited by thymoquinone were addressed. These findings suggest a potential role of thymoquinone in managing atherosclerosis, and further studies are required to ascertain its effectiveness and safety profile.

Acute conditions in dermatology: toxic reactions and their treatment

Acute severe conditions caused by the use of various drugs are of particular difficulty in dermatological practice. Toxicodermic reactions include DRESS syndrome, StevensJohnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis and erythroderma of various origins. These disorders are characterized not only by skin lesions, but also toxic reactions in internal organs, which if untreated properly can be life-threatening. The first choice drugs for such reactions are systemic glucocorticosteroids, in particular betamethasone derivatives. Our own experience and numerous studies confirm the effectiveness of such drugs. However, it should be remembered that uncontrolled or prolonged use of systemic glucocorticosteroids can aggravate the patient's condition and lead to unwanted adverse reactions.

Immunologically Inert Nanostructures as Selective Therapeutic Tools in Inflammatory Diseases.

The current therapies based on immunosuppressant or new biologic drugs often show some limitations in term of efficacy and applicability, mainly because of their inadequate targeting and of unwanted adverse reactions they generate. To overcome these inherent problems, in the last decades, innovative nanocarriers have been developed to encapsulate active molecules and offer novel promising strategies to efficiently modulate the immune system. This review provides an overview of how it is possible, exploiting the favorable features of nanocarriers, especially with regard to their immunogenicity, to improve the bioavailability of novel drugs that selectively target immune cells in the context of autoimmune disorders and inflammatory diseases. A focus is made on nanoparticles that selectively target neutrophils in inflammatory pathologies.

THE POSSIBILITY OF QUESTIONING OF TUBERCULOSIS PATIENTS IN THE CONTROL OF UNWANTED SIDE REACTIONS

In order to identify unwanted adverse reactions (ADRs) to antituberculosis drugs, using original questionnaires, a voluntary questionnaire was conducted among 40 patients with respiratory tuberculosis and 42 patients with HIV-infection and tuberculosis concomitant pathology. In both groups, most patients were treated according to IV and V chemotherapy regimens, in the group of patients with TOD – 72.5% and in the group of patients with HIV/TB – 71.4%. A total of 965 undesirable side reactions were recorded; the minimum number of undesirable side reactions in one patient is 0, the maximum is 40. In patients in the TOD group, the most frequently observed ADRs were from the central nervous system and sensory organs, the gastrointestinal tract and the musculoskeletal system. In patients in the HIV/TB group, ADRs of the central nervous system and sensory organs, the gastrointestinal tract and the immune system prevailed. In the group of patients with TOD, adverse reactions with a moderate degree of severity were most often noted, in the group of patients with HIV/TB – with a mild degree of severity. According to the severity of ADRs, significant differences were established only when comparing the total number of reactions in both groups of patients

The place and role of domperidone in the practice of a gastroenterologist. Overview of options at the present stage

Diseases of the gastrointestinal tract (GIT) occupy a significant place in the overall structure of somatic diseases worldwide. Apart from functional diseases (the incidence of functional dyspepsia (FD) in population is 20 %), the following inflammatory and destructive diseases are widespread: gastroesophageal reflux disease (GERD) in up to 40 % of the population, chronic gastritis and chronic duodenitis in 45 — 50 % of the population, peptic ulcer of the stomach and duodenum in 14 — 15 % of the population. Each of these diseases has its own features of etiopathogenesis and approaches to treatment. However, a common pathological factor contributing to the development of these nosologies is a violation of motor‑evacuation function. The administration of drugs for the normalization of peristaltic activity is a component of treatment. The range of existing drugs with prokinetic activity against the gastrointestinal tract is quite large.One of the effective and safe prokinetics registered in October 2020 in Ukraine is the domperidone preparation Doprokin (World Medicine). This drug has a proven effectiveness in the treatment of patients with FD, GERD, chronic gastritis, especially in comorbidity with Diabetes mellitus II (diabetic gastroparesis) and gastroparesis of other etiology. This is a selective dopamine antagonist, that blocks D2‑receptors in the central and peripheral nervous systems. It increases the pressure of the lower esophageal sphincter, esophageal clearance, reduces intragastric pressure, activates peristalsis of the esophagus and antrum of the stomach, increases the frequency, amplitude and duration of contractions of the duodenum, reduces the time of passage of food masses through the small intestine. The indications for domperidone administration include relief of symptoms of nausea, vomiting, heartburn, belching, early satiety, bloating. In contrast to metoclopramide, it almost does not cross the blood‑brain barrier and does not cause unwanted central adverse reactions. Doprokin is over the counter preparation. For adults, the recommended dose is 1 tablet (10 mg) 3 times a day (15 — 30 minutes before the meals). The maximal daily dose is 30 mg, maximal treatment duration should not exceed 1 week.

Targeted therapy in bronchial asthma. Benralizumab: focus on patients using systemic glucocorticosteroids

A severe course of bronchial asthma develops in 5–20% of patients with bronchial asthma. The use of key disease-modifying agents for the treatment of severe bronchial asthma (SBA) is not always effective due to the possible uncontrolled course of the disease and persistence of signs of eosinophilic airway inflammation. Therefore, the isolation of phenotypes/ endotypes is important for an individual approach to the treatment of such patients. This method permits to get better control over the disease and reduces the risks of exacerbations, airway remodelling and unwanted adverse reactions to the therapy particularly with systemic glucocorticosteroids. The use of biological therapy among other drugs can greatly contribute to the achievement of good control over management of patients with uncontrolled severe asthma. There are currently 5 registered immunobiological drugs in Russia that belong to the group of SBA phenotype-based treatment modalities: anti-IgE therapy, anti-IL-4/13 therapy, anti-IL-5 therapy and anti-IL5Rα therapy. Depending on the disease history, clinical features of bronchial asthma course, the presence of hypersensitivity to one of the year-round allergens and the levels of laboratory markers, the medical professional establishes the exact diagnosis indicating a disease phenotype (allergic BA, eosinophilic or non-allergic BA) and addresses an issue of an appropriate drug for a patient with BA. Benralizumab (Fazenra), a humanized monoclonal antibody, generates considerable interest. Benralizumab has a slightly different principle of action: it blocks not interleukin-5 itself, but the alpha subunit of the interleukin-5 receptor (IL-5Rα), triggers active apoptosis of eosinophils, reducing their level in sputum and blood. The results of clinical studies showed the efficacy of the drug, which resulted in the significant reduction of bronchial asthma exacerbations and a dose of systemic glucocorticosteroids.

Cefixime and Metals Complex Interaction: A systemic review on Drug-metals interaction

The review study work comprises of interaction studies of cefixime with different group of drugs and metals to know about the alteration in pharmacological activity of cefixime by other drugs or vice versa. Cefixime is included among the cephalosporin third generation drug class which is active against a wide range of Gram positive and Gram negative bacteria. Since the presence of different therapeutic class of drugs like cefixime may affect the bioavailability as well as pharmacokinetics of other drugs and metal in the blood or tissues, therefore in order to study the potential interaction of cefixime with different therapeutic class of drugs and metals which can show several type of toxicity or may develop drug resistance in the body is the main reason to perform this study. About 102 articles were screened from different databases related to Cefixime and its interaction for this review. This review study claims that there is a possible interaction between cefixime and other drugs& metals which are confirmed by different method like GLC, HPLC, and Disk Diffusion Method. Drug resistance and unwanted adverse drug reactions are a common thing for different underlying factors which becomes an alarming issue. That’s why this is significant.

Cefixime and Metals Complex Interaction: A systemic review on Drug-metals interaction

The review study work comprises of interaction studies of cefixime with different group of drugs and metals to know about the alteration in pharmacological activity of cefixime by other drugs or vice versa. Cefixime is included among the cephalosporin third generation drug class which is active against a wide range of Gram positive and Gram negative bacteria. Since the presence of different therapeutic class of drugs like cefixime may affect the bioavailability as well as pharmacokinetics of other drugs and metal in the blood or tissues, therefore in order to study the potential interaction of cefixime with different therapeutic class of drugs and metals which can show several type of toxicity or may develop drug resistance in the body is the main reason to perform this study. About 102 articles were screened from different databases related to Cefixime and its interaction for this review. This review study claims that there is a possible interaction between cefixime and other drugs& metals which are confirmed by different method like GLC, HPLC, and Disk Diffusion Method. Drug resistance and unwanted adverse drug reactions are a common thing for different underlying factors which becomes an alarming issue. That’s why this is significant.

<p>Potential of Nanoparticles as Permeation Enhancers and Targeted Delivery Options for Skin: Advantages and Disadvantages</p>

The topical route of administration has many advantages for the treatment of various skin disorders as well as cosmeceutical purposes. This route bypasses hepatic first-pass effect and systemic availability of many pharmaceuticals is limited to skin organelles such as hair follicles and so could avoid unwanted adverse reactions and increase the localized therapeutic effect. Despite such attributed advantages of the topical route, the most important challenge is skin barrier characteristics that should be overcome to obtain dermal or trans-dermal drug delivery. Different approaches have been recruited to overcome this barrier. In this review, different types of nanoparticles for skin permeation enhancement and targeted delivery to skin organelles are discussed. The potential mechanisms of each nanocarrier in permeation enhancement and dermal delivery are considered and finally, the most important advantages and disadvantages of each group are summarized.

Quality of Life Dilemmas in Pediatric Patients with Epilepsy Residing in Long-Term Care Facilities

AbstractChildren with chronic care or complex medical needs, such as epilepsy, depend on advocates to ensure their safety and well-being, a role typically filled by parents or extended family. Close participation to provide vital history and details is quintessential to help guide appropriate management decisions to ensure optimal neurodevelopmental outcome. However, when these vulnerable children are placed in the foster care system, their need for an advocate becomes even more paramount. Unfortunately, this can be lacking and can lead to a breakdown in their medical care. Their complex medical conditions often can be intimidating to most potential foster families and may result in placement in long-term care facilities. This, in turn, presents additional obstacles that can hinder optimal care such as lack of consistent, dedicated caretakers. This void not only impacts their outcome and medical care but also leads to excessive use of limited healthcare resources as well as unwanted adverse reactions that can be prevented if a reliable source of history is available. As a result, there is a need for dedicated resources to help provide devoted advocates for these vulnerable children.

The Anti-inflammatory Effect of Honeysuckle Flowers (Lonicera japonica Thunb., Caprifoliaceae) in Combination with Oroxylum Indicum (Oroxylum indicum Vent. Bignoniaceae)


 This study investigates the anti-inflammatory effect of the honeysuckle flower in combination with Oroxylum indicum in search of a new kind of anti-inflammatory therapy drugs with stronger anti-inflammatory effects and without unwanted adverse reactions. The study results show that a honeysuckle flower dose of 0.72 g/kg/day, Oroxylum indicum dose of 1.2 g/kg/day together with honeysuckle flower combined with Oroxylum indicum with 1:1 ratio had an acute anti-inflammatory effect on the white rat on a mouse Leg Edema Model with carrageenin and the model causing mouse peritonitis. The results also show that a honeysuckle flower dose of 1.44 g/kg/day, Oroxylum indicum the dose of 2.4 g/kg/day together with honeysuckle flower combined with Oroxylum indicum with 1:1 ratio had a chronic anti-inflammation effect on the white mouse on the model causing chronic inflammation of the granuloma. These results open up a subsequent research direction on the possibility of combining various anti-inflammatory medicinal herbs to obtain better anti-inflammatory efficacy and contribute to the promoting of the effect of the available domestic medicinal resources.
 Keywords
 Honeysuckle flowers, Oroxylum indicum, anti-inflammatory effect
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Glucocorticoid-Induced Leucine Zipper as a Druggable Target in Inflammatory Bowel Diseases.

Inflammatory bowel diseases (IBDs) are chronic inflammatory disorders with a complex pathogenesis, affecting people of all ages. They are characterized by alternating phases of clinical relapse and remission, depending on the fine balance between immune cells and the gut microbiota. The cross talk between cells of the immune system and the gut microbiota can result in either tolerance or inflammation, according to multifactorial triggers, ranging from environmental factors to genetic susceptibility. Glucocorticoid (GC) administration remains the first-line treatment for IBDs, although long-term use is limited by development of serious adverse effects. Recently, new alternative pharmacological therapies have been developed, although these are not always effective in IBD patients. There is a constant demand for effective new drug targets to guarantee total remission and improve the quality of life for IBD patients. The glucocorticoid-induced leucine zipper (GILZ) has been implicated as a promising candidate for this purpose, in view of its powerful anti-inflammatory effects that mimic those of GCs while avoiding their unwanted adverse reactions. Here we present and discuss the latest findings about the involvement of GILZ in IBDs.

ANALYSIS AND PREVENTION OF ADVERSE RESPONSES TO DRUGS USED IN DENTISTRY

Drug preparations, a substance or a mixture of substances of synthetic or natural origin, are used for the prevention, diagnosis, and treatment of various diseases. Along with the benefits, drug prepararions can also have adverse side effects, identifying the causes of which is quite problematic in the practice of a dentist because of the diversity of the clinical picture. The rational use and optimal choice of a drug among a wide range of drugs depend on the profile of its effectiveness and safety, drug interaction, individual characteristics of the patient (genetic polymorphism), and other concomitant diseases. Nowadays, the practice of a dentist is impossible to imagine without the use of drugs. Drug preparations allow doctors providing quality medical care that meets international standards, but do not forget that when prescribing a drug is extremely important to consider how rationally and necessary to use it to achieve a positive result in treatment. Therefore, the study of the prevention of the development of unwanted adverse reactions of drugs in dentistry is an important topic that requires close attention. Based on the analysis of the literature on the RSCI, Scopus, Web of Science, MedLine databases, the most commonly prescribed groups of drugs in dentistry were found to be as follows: non-steroidal anti-inflammatory drugs (NSAIDs), topically anesthetizing, antimicrobial, antiseptic, and drugs. The aim of the study: On the basis of the analysis of modern information about undesirable reactions of drugs, often used in dentistry, to optimize approaches to rational use and prevention of undesirable side effects.

Pharmacogenetic Testing of Patients With Unwanted Adverse Drug Reactions or Therapy Failure

Pharmacogenetic Testing of Patients With Unwanted Adverse Drug Reactions or Therapy Failure

Incidence and Analysis of 7Years Adverse Transfusion Reaction: A Retrospective Analysis.

Safe blood transfusion is the primary need of all the health care delivery system. Though with the advances of transfusion medicine, the incidences of transfusion risk is gradually reduced, but the adverse transfusion reaction (ATR) of non hemolytic type still prevails. The purpose of this study was to estimate the incidence and pattern of transfusion-related adverse events at our centre. The present retrospective observational study was conducted in the Department of Transfusion Medicine from April 2011 to April 2018, at a multi-organ transplant centre in South India. All the Adverse transfusion reactions were investigated in detail in the blood bank for the clerical errors, immunohematology workup and classified according to their nature with imputability assessment. A total of 140 ATR were reported out of 100,569 blood components distributed during the study period. After the analysis and workup of the reported reactions, majority of the reactions were observed in males (71%, n = 99). Most common symptom presented was Itching/Rashes in 43.6% (n = 61) ATR. Allergic reactions (51.4%, n = 72), were the most commonly encountered ATR followed by FNHTR (25.7%, n = 36). FFP transfusions (0.2%) contributed to the majority of the reactions followed by Red cell transfusion (0.15%). ATR were observed maximum in Hepato-biliary disease and liver transplantation patients (62%) followed by oncology patients (15%). The overall incidence of ATR in our study is 0.14% which is comparatively low compared to other studies due to well established hemovigilance systems. Adoption of more equipped methods & sensitive technology in various areas of blood banking will help to bring down the unwanted adverse transfusion reactions.

Detection of vaccine-like strains of lumpy skin disease virus in outbreaks in Russia in 2017.

Lumpy skin disease (LSD) has affected many regions of Russia since its first occurrence in 2015. The most devastating year for Russia was 2016, when the virus resurged following a modified stamping-out campaign, causing 313 outbreaks in 16 regions. To avoid unwanted adverse reactions following the use of live attenuated vaccines against LSD virus (LSDV), sheeppox-based vaccines were administered during vaccination campaigns. As a result, LSD was successfully contained in all Russian regions in 2017. In the same year, however, LSD emerged anew in a few regions of the Privolzhsky Federal District of Russia along the northern border of Kazakhstan, which then necessitated vaccinating cattle with a live attenuated LSDV vaccine. Although live attenuated LSDV vaccines are prohibited in Russia, several vaccine-like LSDV strains were identified in the 2017 outbreaks, including commercial farms and backyard animals exhibiting clinical signs consistent with those of field LSDV strains. Sequence alignments of three vaccine-like LSDV strains showed clear similarity to the corresponding RPO30 and GPCR gene sequences of commercial attenuated viruses. How vaccine-like strains spread into Russian cattle remains to be clarified.