Manifestations Of Adverse Events Research Articles

Comparative analysis of efficacy and safety of various anti-tuberculosis therapy regimens in patients with MDR/XDR tuberculosis

The objective: to evaluate the efficacy and safety of various anti-tuberculosis therapy regimens for multiple drug resistant (MDR) and extensive drug resistant pulmonary tuberculosis in the intensive phase of treatment lasting for 8 months minimum.Subjects and Methods. A single-center cohort prospective-retrospective clinical study was conducted, which included 166 patients aged 18 to 70 years with active pulmonary tuberculosis and proven MDR of Mycobacterium tuberculosis, who received chemotherapy according to regimens IV and V. The treatment regimen of patients in Group I (n = 96) included modern anti-tuberculosis drugs (TBdrugs) – bedaquiline, linezolid, respiratory fluoroquinolone (levofloxacin, moxifloxacin, sparfloxacin), cycloserine, pyrazinamide, and perchlozone at a dose of 8-10 mg/kg, 1 time per day after meals during the intensive phase of treatment, that was at least 8 months. Patients from Group II (n = 70) received a respiratory fluoroquinolone (levofloxacin, moxifloxacin, sparfloxacin), aminoglycoside (amikacin), cycloserine, pyrazinamide, ethambutol, and prothionamide.Results. After 3 months of treatment, symptoms of intoxication disappeared in 22 (81.5%) patients in Group I, and only 41 (61.2%) in Group II (p = 0.04; TTF). In patients of Group I versus Group II, the body temperature returned to normal within a shorter time: 2.8 and 4.3 weeks, respectively (p < 0.05). By the end of the intensive phase of treatment (8 months), sputum conversion confirmed by culture was observed more often in patients of Group I compared to Group II (85 and 80%, pχ2 = 0.003). Adverse events (AE) caused by TB drugs in Group I were observed significantly more often versus Group II: gastroenterological adverse events (pχ2 = 0.05), cardiac adverse events (pTTP = 0.05), and endocrinological adverse events (pTTP = 0.05). Neurotoxic AEs tended to develop more often in Group I (pTTP = 0.06). Ototoxic AEs were more frequently observed in Group II where the treatment regimens included aminoglycosides (pχ2 = 0.05). To maintain adequate chemotherapy regimens IV or V over long-term treatment, MDR tuberculosis patients need continuous monitoring of AEs, intravenous administration of two or three TB drugs, and timely therapy to manage manifestations of AEs.

Вакцинація від COVID-19 в Україні. Безпечність вакцин

COVID-19 is a life-threatening disease that can be asymptomatic in the form of a common ARVI, or in extremely severe forms, with serious long-term consequences. Vaccination against COVID-19 is critically important to restrain the pandemic. The purpose of the study was to analyze and systematize the data of pharmacological supervision of the use of vaccines against COVID-19. For this, methods of analysis, systematization and generalization of information were used using the databases of the State Expert Center of the Ministry of Health of Ukraine, Food and Drug Administration, World Health Organisation in the period from February 24, 2021 to October 31, 2021. Currently, such vaccines are registered and approved for use in Ukraine as AstraZeneca (Covishield, SKBio), Comirnaty / Pfizer-BioNTech, Moderna, CoronaVac / Sinovac Biotech. According to official data, the effectiveness of all these vaccines is quite high. They are especially effective in preventing severe course of disease, hospitalization, and death. Sometimes the vaccination process can be with the development of a number of side effects. Responsibility for the risks associated with the production and use of vaccines dictates the need for constant monitoring of these side effects. That is why we analyzed the data of the State Expert Center of the Ministry of Health of Ukraine about adverse events after immunization from COVID-19 in Ukraine. Thus, the analysis of adverse events reported showed that they took place in 0.018% cases of the total number of vaccine doses that were administered. In the context, for each vaccine separately, the number of adverse events reported were: Covishield – 1128 cases (0.23%), CoronaVac – 419 (0.008%), Comirnaty – 854 (0.02%), AstraZeneca – 540 (0.02%), Moderna – 393 (0.02%), respectively. It should be noted that most of the reported cases of adverse events reported in Ukraine during vaccination against COVID-19 are mild predictable reactions (88.72 – 93.38%). This result allows us to speak of a fairly high predictability of the adverse events reported after COVID-19 vaccination. This is confirmed by the data of world literature. After analyzing the presented data of the State Expert Center of the Ministry of Health of Ukraine, we found that the most of adverse events reported after COVID-19 vaccination are so-called general disorders and disorders at the injection site (fever, fatigue, chills, redness, pain and swelling at the injection site). Neurological disorders ranked second in terms of the number of adverse events reported, and musculoskeletal disorders ranked third. Adverse events reported manifestations from other organs and systems had isolated cases. After using all of the above vaccines, the percentage of adverse events reported was significantly higher in women than in men, which coincides with the data of the world literature. Conclusion. Thus, the analysis of the safety of vaccines against COVID-19, registered and authorized for use in Ukraine, shows that the risks of adverse events reported after COVID-19 vaccination are rare; the most of them are mild and predictable. At the same time, these manifestations of adverse events reported cannot be compared with the health and life risks associated with the COVID-19 disease itself. Ensuring continuous monitoring of the safety of vaccine use and identifying potential side effects will further reduce and manage the risks associated with vaccine use

Observance of adverse reactions and analysis of biosafety compliance in the rectal application of ozone therapy in COVID-19 Cuban patients with acute infection or convalescent

Context: Patients with COVID-19 present different biochemical and metabolic alterations from the acute state of infection until months later with variability of symptoms and increased toxicity of drugs related to oxidative stress according to previous studies. There are various alternatives to modulate oxidative stress, including the use of medical ozone, which rectal way requires observing both compliance with biosafety measures and adverse reactions in patients. Aims: To evaluate compliance with biosafety measures and the possible manifestations of adverse events in the rectal application of ozone therapy in patients with acute infection or convalescent of COVID-19. Methods: Descriptive, longitudinal studies in two clinical trials conducted at the Ernesto Guevara Hospital and the Salvador Allende Hospital, from May to July 2020. Rectal ozone therapy was applied to patients in two trials with a cycle of up to 20 applications according to the study. The activities were described and the performance of the professionals in the procedure was evaluated through an observation guide. Patient follow-up and surveillance for potential adverse reactions were performed. Results: 80% (28/36) of the patients reported the feeling of fullness of the intestines, without other reports, in no case treatment was required. The evaluation of the practices showed full compliance with the procedures without transmission of infection during the period. Conclusions: Compliance with good practices and biosafety in the rectal application of ozone results in the adequate performance of the protocols with benefit and safety for patients under treatment.

Bedakvilino ir delamanido vartojimas vaistams atspariai tuberkuliozei gydyti. Kokių šalutinių poveikių galima tikėtis?

Tyrimo tikslas. Ištirti, ar naujųjų medikamentų nuo tuberkuliozės (TB) – bedakvilino (BDQ) ir delamanido (DLM) vartojimas klinikinėje praktikoje yra saugus. Tyrimo metodai. Atlikta retrospektyvioji 32 vaistams atsparia (VA) TB sergančių pacientų, gydytų BDQ ir (arba) DLM nuo 2016 m. antrojo pusmečio iki 2019 m. pirmojo ketvirčio pabaigos Lietuvos sveikatos mokslų universiteto ligoninės Kauno klinikų filialo Romainių TB ligoninės Rezistentinės TB skyriuje, ligos istorijų analizė. Vertinti tiriamųjų duomenys bei naujųjų medikamentų nuo TB sukelti šalutiniai poveikiai. Rezultatai. Didžioji dalis tiriamųjų buvo santykinai jauno amžiaus (mediana – 50 metų) vyrai. 59,38 proc. pacientų buvo piktnaudžiaujantys alkoholiu. 56,3 proc. pacientų, gydytų naujaisiais vaistais nuo TB, sirgo ypač vaistams atsparia TB. Dažniausiai radiologiškai rastas abipusis plaučių pažeidimas (68,75 proc.). Pusei tiriamųjų pasireiškė bent vienas galimas šalutinis poveikis. Dažniausi galimi šalutiniai poveikiai: QTc intervalo prailgėjimas, išbėrimas, pykinimas arba vėmimas. Rečiau pasireiškė periferinė neuropatija, viduriavimas, širdies plakimo pojūtis. Dėl kliniškai reikšmingų pokyčių elektrokardiogramoje vienam pacientui nutrauktas gydymas DLM. Trimis (9,38 proc.) atvejais neabejota, jog šalutinį poveikį sukėlė BDQ arba DLM. Gydymo metu statistiškai reikšmingo ryšio tarp amžiaus, lyties bei alkoholio vartojimo ir galimų šalutinių poveikių pasireiškimo nenustatyta (p>0,05). Statistiškai reikšmingo QTc intervalo prailgėjimo ryšio su amžiumi bei lytimi taip pat nepavyko nustatyti (p>0,05), tačiau tai imtyje buvo būdinga tik vyrams. Išvados. Gydymas naujaisiais prieštuberkulioziniais vaistais yra pakankamai saugus. Siekiant nustatyti įvairių veiksnių įtaką šalutinių poveikių pasireiškimui, tikslinga atlikti tyrimą su didesne imtimi.

Data Analysis for Anti-Neoplastic Chemotherapy-Related Adverse Events Reported to the Korean Pharmacovigilance Regional Network

Background/Aims: To describe the toxicity profile of anti-neoplastic agents from real clinical settings, we analyzed spontaneously reported adverse events (AEs) using data from the adverse drug reaction (ADR) reporting system of the Korean Food and Drug Administration (KFDA). Methods: Data were extracted from the nationwide spontaneous ADR reporting system of KFDA from July 2009 to December 2010. We extracted and analyzed data related to chemotherapy and identified unlabeled ADR that were not described in the package insert of the products. Results: In total, 5,867 cases of antineoplastic agent-related AE reports were identified after excluding cases for duplication and cases assessed as ‘unlikely’ and ‘unclassifiable’, based on expert opinion. Of the patients with AEs, 52.4% were males and the median age was 56 years. In total, 460 AEs (7.8%) from 267 patients were reported as ‘serious’ AEs. The most common causative anti-cancer drug class was pyrimidine analogs (31.5%), followed by platinum compounds (19.9%), protein kinase inhibitors (10.8%), and taxanes (8.8%). The most common clinical manifestation of AEs was gastrointestinal toxicities (25.5%), followed by skin disorders (25.3%), and generalized reactions (14.3%). In total, 168 cases (2.9%) of unlabeled AEs were identified. Among these, 10 were reported as serious AEs. Conclusions: The most common causative class of antineoplastic agents was that of pyrimidine analogs. Gastrointestinal and dermatological toxicities were the most common clinical chemotherapy-related adverse events. Further investigation and

Effects of pregabalin on acute herpetic pain and postherpetic neuralgia incidence

Acute zoster pain usually disappears with regression of the rash but may be of significant intensity and prolonged duration leading to postherpetic neuralgia. We evaluated the effect of pregabalin on alleviation of acute zoster pain and onset of postherpetic neuralgia. The prospective randomized double-blind placebo-controlled study included 29 outpatients who had had acute zoster pain for a period of 7-14 days. Patients were treated for three weeks with 150-300 mg pregabalin daily or with a placebo. Pain was treated with naproxen, tramadol or oxycodone, as necessary. During the treatment we assessed pain, allodynia, hyperalgesia, severity of burning, prickling and tingling sensations, quality of sleep, physical activity, consumption of analgesics, manifestation of adverse events and postherpetic neuralgia. There were no statistically significant differences with respect to patients' demographic data, dermatomal distribution and severity of rash, use of antiviral therapy or duration of acute zoster pain. Standard statistical analyses found no significant differences between the two treatment groups in intensity of pain, allodynia, hyperalgesia, burning, prickling and tingling sensations, consumption of analgesics, or the quality of sleep and physical activity; there was also no significant difference in development of postherpetic neuralgia. However, there were statistically significant differences between the groups in the occurrence of dizziness and somnolence in relation to pregabalin. The study did not prove any statistically significant effect of pregabalin in pain relief in patients with acute zoster pain or in the onset of postherpetic neuralgia in comparison with the placebo. The use of pregabalin was related to a statistically significant increase in the appearance of adverse effects.