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1.
Sci Rep ; 14(1): 8986, 2024 04 18.
Artículo en Inglés | MEDLINE | ID: mdl-38637591

RESUMEN

Potassium-competitive acid blockers (P-CABs) provide potent acid inhibition, yet studies on P-CAB-based quadruple therapy for H. pylori eradication are limited. We theorized that integrating bismuth subsalicylate into a quadruple therapy regimen could enhance eradication rates. However, data on the efficacy of vonoprazan bismuth quadruple therapy are notably scarce. Therefore, the aim of this study was to evaluate the efficacy of vonoprazan-based bismuth quadruple therapy in areas with high clarithromycin and levofloxacin resistance. This was a prospective, single-center, randomized trial conducted to compare the efficacy of 7-day and 14-day vonoprazan-based bismuth quadruple therapy for H. pylori eradication between June 1, 2021, and March 31, 2022. Qualified patients were randomly assigned to the 7-day or 14-day regimen (1:1 ratio by computer-generated randomized list as follows: 51 patients for the 7-day regimen and 50 patients for the 14-day regimen). The regimens consisted of vonoprazan (20 mg) twice daily, bismuth subsalicylate (1024 mg) twice daily, metronidazole (400 mg) three times daily, and tetracycline (500 mg) four times daily. CYP3A4/5 genotyping and antibiotic susceptibility tests were also performed. Successful eradication was defined as 13negative C-UBTs 4 weeks after treatment. The primary endpoint was to compare the efficacy of 7-day and 14-day regimens as first-line treatments, which were assessed by intention-to-treat (ITT) and per-protocol (PP) analyses. The secondary endpoints included adverse effects. A total of 337 dyspeptic patients who underwent gastroscopy were included; 105 patients (31.1%) were diagnosed with H. pylori infection, and 101 patients were randomly assigned to each regimen. No dropouts were detected. The antibiotic resistance rate was 33.3% for clarithromycin, 29.4% for metronidazole, and 27.7% for levofloxacin. The CYP3A4 genotype was associated with 100% rapid metabolism. The H. pylori eradication rates for the 7-day and 14-day regimens were 84.4%, 95% CI 74.3-94.2 and 94%, 95% CI 87.4-100, respectively (RR difference 0.25, 95% CI 0.03-0.53, p value = 0.11). Interestingly, the 14-day regimen led to 100% eradication in the clarithromycin-resistant group. Among the patients in the 7-day regimen group, only two exhibited resistance to clarithromycin; unfortunately, neither of them achieved a cure from H. pylori infection. The incidence of adverse events was similar in both treatment groups, occurring in 29.4% (15/51) and 28% (14/50) of patients in the 7-day and 14-day regimens, respectively. No serious adverse reactions were reported. In conclusion, 14 days of vonoprazan-based bismuth quadruple therapy is highly effective for H. pylori eradication in areas with high levels of dual clarithromycin and levofloxacin resistance.


Asunto(s)
Infecciones por Helicobacter , Helicobacter pylori , Compuestos Organometálicos , Pirroles , Salicilatos , Sulfonamidas , Humanos , Claritromicina/farmacología , Bismuto/uso terapéutico , Bismuto/efectos adversos , Levofloxacino/efectos adversos , Metronidazol/efectos adversos , Estudios Prospectivos , Citocromo P-450 CYP3A , Antibacterianos/efectos adversos , Infecciones por Helicobacter/genética , Quimioterapia Combinada , Resultado del Tratamiento
2.
J Dig Dis ; 25(1): 36-43, 2024 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-38323705

RESUMEN

OBJECTIVES: We aimed to explore the efficacy and safety of tailored therapy guided by genotypic resistance in the first-line treatment of Helicobacter pylori (H. pylori) infection in treatment-naive patients. METHODS: Gastric mucosal specimens were taken during gastroscopy, and main mutations of clarithromycin- and levofloxacin-resistant genes were detected by polymerase chain reaction (PCR). Sensitive antibiotics were selected individually for treating H. pylori infection with tailored bismuth-containing quadruple therapy (BQT) consisting of esomeprazole 20 mg twice daily, bismuth potassium citrate 220 mg twice daily, amoxicillin 1 g twice daily, and clarithromycin 500 mg twice daily, or levofloxacin 500 mg once daily, or metronidazole 400 mg four times daily. Safety and patient compliance were assessed 1-3 days after eradication. Treatment outcome was evaluated by urea breath test 4-8 weeks after eradication. RESULTS: One hundred and thirty-two treatment-naive patients with H. pylori infection were included. PCR results suggested resistance rates of 47.7% and 34.9% for clarithromycin and levofloxacin, respectively, and a dual resistance rate of 18.2%. Eradication rates of tailored BQT were 87.1% and 95.8% by intention-to-treat (ITT) analysis and per-protocol (PP) analysis, respectively. There was no statistically significant difference in the efficacy of 7-day clarithromycin-containing, 7-day levofloxacin-containing, and 14-day full-dose metronidazole-containing BQT (ITT analysis: P = 0.488; PP analysis: P = 0.833). The incidence of adverse events was 19.7%, and patient compliance was 97.7%. CONCLUSION: Tailored BQT guided by genotypic resistance can achieve satisfactory efficacy, safety, and patient compliance in the first-line treatment of H. pylori infection.


Asunto(s)
Infecciones por Helicobacter , Helicobacter pylori , Humanos , Infecciones por Helicobacter/tratamiento farmacológico , Claritromicina/farmacología , Claritromicina/uso terapéutico , Levofloxacino/efectos adversos , Helicobacter pylori/genética , Bismuto/uso terapéutico , Metronidazol/uso terapéutico , Quimioterapia Combinada , Antibacterianos/efectos adversos , Amoxicilina/uso terapéutico , Resultado del Tratamiento , Reacción en Cadena de la Polimerasa
3.
Food Funct ; 15(3): 1265-1278, 2024 Feb 05.
Artículo en Inglés | MEDLINE | ID: mdl-38196314

RESUMEN

Nobiletin (NOB) exhibits significant biological activities and may be a potential dietary treatment for antibiotic-associated gut dysbiosis. In this study, mice were gavaged with 0.2 mL day-1 of 12.5 g L-1 cefuroxime (LFX) and 10 g L-1 levofloxacin (LVX) for a duration of 10 days, accompanied by 0.05% NOB to investigate the regulatory effect and potential mechanisms of NOB on antibiotic-induced intestinal microbiota disorder and intestinal barrier dysfunction. Our results indicated that dietary NOB improved the pathology of intestinal epithelial cells and the intestinal permeability by upregulating the expression of intestinal tight junction proteins (TJs) and the number of goblet cells. Furthermore, dietary NOB reduced the levels of serum lipopolysaccharide (LPS) and pro-inflammatory factors (TNF-α and IL-1ß), thereby facilitating the restoration of the intestinal mucosal barrier. Additionally, dietary NOB increased the abundance of beneficial bacteria f_Lachnospiraceae and regulated the metabolic disorders of short-chain fatty acids (SCFAs) and bile acids (BAs). Notably, NOB supplementation resulted in elevated levels of butyric acid and lithocholic acid (LCA), which contributed to the repair of the intestinal mucosal barrier function and the maintenance of intestinal homeostasis. Collectively, our results propose a healthy dietary strategy for the prevention or mitigation of antibiotic-associated gut dysbiosis by dietary NOB.


Asunto(s)
Flavonas , Microbioma Gastrointestinal , Enfermedades Intestinales , Animales , Ratones , Cefuroxima/efectos adversos , Levofloxacino/efectos adversos , Disbiosis/inducido químicamente , Enfermedades Intestinales/microbiología , Antibacterianos/efectos adversos
4.
Trials ; 25(1): 55, 2024 Jan 15.
Artículo en Inglés | MEDLINE | ID: mdl-38225650

RESUMEN

BACKGROUND: Treating Helicobacter pylori is becoming increasingly difficult with the development of bacterial resistance to many established treatment regimens. As a result, researchers are constantly looking for novel and effective treatments. This trial aims to establish the efficacy of levofloxacin-based sequential treatment regimen and concomitant levofloxacin-based regimen as empirical first-line therapy in the Syrian population. METHOD: This is an open-label, prospective, single-center, parallel, active-controlled, superiority, randomized clinical trial. The recruitment will target Helicobacter pylori-positive males and females between the ages of 18 and 65 to evaluate the efficacy of empirical first-line therapy in the Syrian population. We are planning to recruit up to 300 patients which is twice the required sample size. One hundred fifty individuals will be randomly assigned to undergo either a sequential levofloxacin-based treatment regimen or a concomitant levofloxacin-based regimen. High-dose dual therapy (proton-pump inhibitor and amoxicillin) will be the rescue therapy in the event of first-line failure. The first-line eradication rate in both groups is the primary outcome, and one of the secondary outcomes is the overall eradication rate of high-dose dual therapy in the event of first-line treatment protocol failure. Intention-to-treat analysis and per-protocol analysis will be used to evaluate the eradication rates of Helicobacter pylori for first-line treatment protocols. DISCUSSION: For the first time in the Syrian population, this randomized controlled trial will provide objective and accurate evidence about the efficacy of a sequential levofloxacin-based treatment regimen. TRIAL REGISTRATION: ClinicalTrials.gov NCT06065267 . Registered on October 3, 2023. Prospective registered. Enrollment of the first participant has not started yet.


Asunto(s)
Infecciones por Helicobacter , Helicobacter pylori , Adolescente , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Adulto Joven , Antibacterianos/efectos adversos , Protocolos Clínicos , Quimioterapia Combinada , Infecciones por Helicobacter/diagnóstico , Infecciones por Helicobacter/tratamiento farmacológico , Levofloxacino/efectos adversos , Metronidazol , Estudios Prospectivos , Inhibidores de la Bomba de Protones/uso terapéutico , Ensayos Clínicos Controlados Aleatorios como Asunto , Siria , Resultado del Tratamiento , Estudios de Equivalencia como Asunto
5.
BMC Psychiatry ; 23(1): 918, 2023 12 07.
Artículo en Inglés | MEDLINE | ID: mdl-38062399

RESUMEN

OBJECTIVE: To report a case of seizure and rapidly progressive cognitive impairment 20 min after intravenous administration of levofloxacin. A 56-year-old woman was admitted to hospital with episodic unconsciousness and unresponsiveness. About 4 days ago, she experienced a loss of consciousness, fell to the floor, and yelled for 2 min, 20 min before the first intravenous dose of levofloxacin. The patient developed symptoms of cognitive impairment after the seizure. Levofloxacin is a synthetic third generation fluoroquinolone used to treat various infectious diseases. Upon admission, the patient was conscious and unresponsive. After 11 days of symptomatic and supportive treatment, the patient was discharged from the hospital with cognition restored to baseline level and no recurrence of seizures 10 months after discharge. DISCUSSION: Epilepsy is a rare adverse reaction to levofloxacin treatment. The patient in this case had infection-related signs before the onset of the disease, and the disease progressed rapidly with fluctuating changes. After ruling out degenerative, infectious, toxic, and autoimmune causes, the patient's symptoms may be attributed to levofloxacin, and this is the first case of seizure and rapidly progressive cognitive impairment after levofloxacin injection reported in the literature. Clinicians should be aware that unexplained, rapidly progressing cognitive impairment with infection-related signs before onset may be a rare side effect of antibiotics.


Asunto(s)
Disfunción Cognitiva , Epilepsia , Femenino , Humanos , Persona de Mediana Edad , Levofloxacino/efectos adversos , Epilepsia/tratamiento farmacológico , Convulsiones , Disfunción Cognitiva/inducido químicamente
6.
F1000Res ; 12: 772, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37928175

RESUMEN

Background: This was an experimental, parallel, and randomized study to evaluate the safety of single intracameral injection of 0.6 ml 0.5% preservative-free levofloxacin eye drops on rabbit eye. Methods: In total, 24 eyes of 12 New Zealand white rabbits were divided into three groups. The first group (LFX) was treated with 0.1 ml intracameral injection of levofloxacin 0.5% eye drops of 0.6 ml preservative-free (n = 6), the second group (CRAV) was treated with 0.1 ml intracameral injection of levofloxacin 0.5% eye drops 5 ml commercially available eye drops preservative-free (n = 6), and the third group (BSS) were treated with 0.1 ml intracameral injection of balanced salt solution (n = 12). All groups received a single dose. The clinical evaluation was performed on the 1 st, 3 rd, 5 th, and 7 th day after injection. Each eye was enucleated on the 7 th day and underwent a histopathology examination. Results: The clinical scores among the three groups did not show any significant difference on days 1 st, 2 nd, 3 rd, and 7 th (p>0.05). The only ones noted in clinical scores were mild corneal opacity, mild cells, and flares in the anterior chamber. The histopathology score demonstrated no statistically significant difference between the three groups (p>0.05). Vacuolization of corneal endothelial cells was noted in all groups but was not statistically significant. Conclusions: A single intracameral injection of 0.6 ml 0.5% preservative-free levofloxacin eye drops was safe for rabbit eye, according to clinical and histopathology scores, similar to levofloxacin 0.5% eye drops in 5 ml bottle preservative free.


Asunto(s)
Endotelio Corneal , Levofloxacino , Conejos , Animales , Levofloxacino/efectos adversos , Soluciones Oftálmicas , Microscopía Electrónica de Rastreo
7.
Medicina (Kaunas) ; 59(10)2023 Oct 07.
Artículo en Inglés | MEDLINE | ID: mdl-37893502

RESUMEN

Fluoroquinolones are a commonly prescribed class of antibiotics due to their broad spectrum of antimicrobial activity, favorable pharmacokinetic properties, ability to switch from parenteral to oral administration, and global availability. After beta-lactams, they are the second most common antibiotic class associated with drug allergies. The mechanism of fluoroquinolone-induced hypersensitivity reactions has not yet been fully understood, so the true incidence of hypersensitivity reactions remains unknown. Cross-reactivity between fluoroquinolones has been the subject of conflicting and limited clinical research. Due to their similar chemical structure, some argue for close cross-reactivity within the group. However, recent studies have produced contradictory results. We present the case of a young patient who had an anaphylactic reaction to ciprofloxacin but was tolerant to levofloxacin, as determined via a skin prick test followed by a drug provocation test. Our findings support the notion that there is little cross-reactivity between fluoroquinolones. Consequently, exposure to another fluoroquinolone in a hospital setting may be beneficial, particularly for patients who lack adequate antibiotic alternatives. However, additional research on this subject is required.


Asunto(s)
Anafilaxia , Levofloxacino , Humanos , Levofloxacino/efectos adversos , Ciprofloxacina/efectos adversos , Anafilaxia/inducido químicamente , Anafilaxia/diagnóstico , Antibacterianos/efectos adversos , Fluoroquinolonas/farmacología
8.
J Med Life ; 16(7): 1032-1040, 2023 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-37900077

RESUMEN

The pathogenesis of kidney damage involves complicated interactions between vascular endothelial and tubular cell destruction. Evidence has shown that vitamin D may have anti-inflammatory effects in several models of kidney damage. In this study, we evaluated the effects of synthetic vitamin D on levofloxacin-induced renal injury in rats. Forty-two white Albino rats were divided into six groups, with each group comprising seven rats. Group I served as the control (negative control) and received intraperitoneal injections of normal saline (0.5 ml) once daily for twenty-one days. Group II and Group III were treated with a single intraperitoneal dose of Levofloxacin (50 mg/kg/day) and (100 mg/kg/day), respectively, for 14 days (positive control groups). Group IV served as an additional negative control and received oral administration of vitamin D3 (500 IU/rat/day) for twenty-one days. In Group V, rats were orally administered vitamin D3 (500 IU/rat/day) for twenty-one days, and intraperitoneal injections of Levofloxacin (50 mg/kg/day) were administered on day 8 for 14 days. Group VI received oral vitamin D3 supplementation (500 IU/rat/day) for twenty-one days, followed by intraperitoneal injections of Levofloxacin (100 mg/kg/day) on day 8 for fourteen days. Blood samples were collected to measure creatinine, urea, malondialdehyde, glutathione reductase, and superoxide dismutase levels. Compared to the positive control group, vitamin D supplementation lowered creatinine, urea, and malondialdehyde levels, while increasing glutathione reductase and superoxide dismutase levels. Urea, creatinine, and malondialdehyde levels were significantly (p<0.05) higher in rats administered LFX 50mg and 100mg compared to rats given (LFX + vitamin D). The main findings of this study show that vitamin D reduces renal dysfunction, suggesting that vitamin D has antioxidant properties and may be used to prevent renal injury.


Asunto(s)
Enfermedades Renales , Levofloxacino , Vitamina D , Animales , Ratas , Antioxidantes/farmacología , Colecalciferol/metabolismo , Creatinina , Glutatión/metabolismo , Glutatión Reductasa/metabolismo , Glutatión Reductasa/farmacología , Riñón , Levofloxacino/efectos adversos , Levofloxacino/metabolismo , Malondialdehído , Estrés Oxidativo , Superóxido Dismutasa/metabolismo , Urea/metabolismo , Urea/farmacología , Vitamina D/farmacología
9.
J Cardiovasc Pharmacol ; 82(5): 400-406, 2023 Nov 01.
Artículo en Inglés | MEDLINE | ID: mdl-37506675

RESUMEN

ABSTRACT: A correlation is already established between fluoroquinolones (FQs) use and cardiovascular events (CVEs), such as QT prolongation; however, serious events such as aortic aneurysm and valve regurgitation have also been reported with FQs. Several unstudied factors could contribute to the development of different CVEs that were not previously evaluated with FQ therapy. Therefore, we aimed to assess the incidence of different serious CVEs after completion of FQ therapy and potential associating factors. This was a retrospective case-control study of inpatients who received ciprofloxacin, levofloxacin, or moxifloxacin for ≥3 days. Patients' echocardiograms were evaluated for the development of aortic or valvular disease or worsening of an existing condition after completion of therapy. Of 373 included patients, 83 developed new valvular disease or worsening of an existing disease, where tricuspid valve regurgitation was the most common CVE (50/83; 60.2%), followed by mitral valve diseases (48/83; 57.8%). Aortic valve regurgitation occurred more commonly with moxifloxacin compared with ciprofloxacin and levofloxacin (17.8% vs. 6.7% and 10.7%, respectively; P = 0.01). Median time to CVE detection ranged 93-166 days for all FQs. The receipt of moxifloxacin and elevated baseline QT interval were associated with an increased CVEs risk (adjusted odds ratio 3.26; 95% confidence interval, 1.31-8.11 and adjusted odds ratio 1.02; 95% confidence interval, 1.00-1.04, respectively). Other factors did not show such association. The lack of association of different factors with the occurrence of CVEs indicates that all patients receiving FQ therapy, especially moxifloxacin, should be monitored during the first-year after therapy. Alternatively, other antibiotics with a better safety profile may be considered.


Asunto(s)
Fluoroquinolonas , Enfermedades de las Válvulas Cardíacas , Humanos , Fluoroquinolonas/efectos adversos , Levofloxacino/efectos adversos , Moxifloxacino/efectos adversos , Estudios de Casos y Controles , Estudios Retrospectivos , Ciprofloxacina/efectos adversos , Enfermedades de las Válvulas Cardíacas/inducido químicamente
10.
Trials ; 24(1): 413, 2023 Jun 19.
Artículo en Inglés | MEDLINE | ID: mdl-37337241

RESUMEN

BACKGROUND: New treatment strategies are required against infections caused by Helicobacter pylori, which grows increasingly resistant to antibiotics. Polymerase chain reaction-based methods for antibiotic susceptibility testing are available for detecting H. pylori-specific mutations that confer resistance to clarithromycin and levofloxacin. Several meta-analyses have compared eradication rates for susceptibility-guided versus empirical therapy for H. pylori treatment; however, all have significant limitations and high heterogeneity, and the results are contradictory. The main objective of this trial is to assess whether a sequential strategy based on molecular susceptibility testing-guided therapy for H. pylori has a better eradication rate than empirical therapy. METHODS: This trial is designed as a prospective, randomised, open-label, active-controlled and single-centre study. Men and women who are H. pylori-positive, naïve to treatment, and aged 18-65 years will be recruited. A total of 500 participants will be randomised to receive either empirical therapy or a susceptibility-guided sequential strategy. Bismuth quadruple therapy will be the empirical first-line therapy, and in case of failure, high-dose dual (proton-pump inhibitor + amoxicillin) treatment will be the rescue therapy. For the susceptibility-guided sequential strategy, regimen selection will be based on H. pylori susceptibility to clarithromycin (first-line) and levofloxacin (rescue). A first-line treatment of clarithromycin triple therapy will be selected for clarithromycin-sensitive strains. For clarithromycin resistance, a high-dose dual therapy will be selected. During the rescue treatment, a levofloxacin quadruple regimen will be selected for levofloxacin-sensitive strains, and a furazolidone quadruple regimen will be selected for others. The primary outcome is the first-line eradication rate in both groups, and the overall (including first and rescue therapies) H. pylori eradication rate in both groups is one of the secondary outcomes. The eradication rates of H. pylori will be analysed by intention-to-treat analysis, modified intention-to-treat analysis, and per-protocol analysis. DISCUSSION: This randomised controlled trial will provide objective and valid evidence about the value of polymerase chain reaction-based molecular methods for antibiotic susceptibility testing in guiding H. pylori eradication. TRIAL REGISTRATION: Clinicaltrials.gov NCT05549115. Released on 18 September 2022. First posted on 22 September 2022. Enrolment of the first participant on 20 September 2022. The study is retrospectively registered.


Asunto(s)
Infecciones por Helicobacter , Helicobacter pylori , Masculino , Humanos , Femenino , Infecciones por Helicobacter/diagnóstico , Infecciones por Helicobacter/tratamiento farmacológico , Claritromicina/efectos adversos , Helicobacter pylori/genética , Levofloxacino/efectos adversos , Estudios Prospectivos , Quimioterapia Combinada , Antibacterianos/efectos adversos , Inhibidores de la Bomba de Protones/efectos adversos , Metronidazol , Resultado del Tratamiento , Ensayos Clínicos Controlados Aleatorios como Asunto
11.
J Chemother ; 35(8): 707-711, 2023 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-37151111

RESUMEN

Levofloxacin is used as a first-line drug for the treatment of Legionella pneumonia. However, the relatively high incidence of drug-induced liver injury (DILI) remains a clinical problem. Based on the available patient data, this study aimed to identify the risk factors for DILI before levofloxacin administration. Multiple logistic regression analyses suggested that male sex (odds ratio [OR], 6.975; 95% confidence interval [CI], 1.737-28.000; p = 0.006), elevated C-reactive protein level (OR, 1.182; 95% CI, 1.089-1.283; p = 0.0006), and high haemoglobin level (OR, 1.640; 95% CI, 1.226-2.195; p = 0.001) before administration of levofloxacin were risk factors for DILI. Possible treatment with alternative drugs should be considered in male patients with elevated C-reactive protein and haemoglobin levels. Moreover, close monitoring of liver function tests when levofloxacin is administered may prevent the development and severity of DILI.


Asunto(s)
Enfermedad Hepática Crónica Inducida por Sustancias y Drogas , Levofloxacino , Humanos , Masculino , Levofloxacino/efectos adversos , Estudios Retrospectivos , Proteína C-Reactiva , Factores de Riesgo , Hemoglobinas
12.
Antimicrob Agents Chemother ; 67(6): e0037423, 2023 06 15.
Artículo en Inglés | MEDLINE | ID: mdl-37154772

RESUMEN

Results from this large, multicenter study suggest that patients with a confirmed ciprofloxacin, moxifloxacin, or levofloxacin hypersensitivity reaction are likely to tolerate other fluoroquinolones. Avoiding different fluoroquinolones in patients labeled with a ciprofloxacin, moxifloxacin, or levofloxacin allergy may not always be mandatory. This was a study of patients with a ciprofloxacin, moxifloxacin, or levofloxacin hypersensitivity reaction and a documented electronic medical record administration of a different fluoroquinolone. Numerically, the most common reaction risk occurred with a challenge to moxifloxacin (2/19; 9.5%), followed by ciprofloxacin (6/89; 6.3%), and levofloxacin (1/44; 2.2%).


Asunto(s)
Compuestos Aza , Hipersensibilidad , Quinolinas , Humanos , Fluoroquinolonas/efectos adversos , Moxifloxacino/efectos adversos , Levofloxacino/efectos adversos , Antibacterianos/efectos adversos , Ciprofloxacina , Hipersensibilidad/tratamiento farmacológico , Quinolinas/efectos adversos , Ofloxacino
14.
Int J Clin Pharmacol Ther ; 61(12): 572-574, 2023 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-37114513

RESUMEN

Quinolones can cause rhabdomyolysis, but rhabdomyolysis secondary to quinolone use is uncommon, and few reports associate rhabdomyolysis with levofloxacin use. We report a case of acute rhabdomyolysis associated with levofloxacin use. A 58-year-old Chinese woman developed myalgia and difficulty walking ~ 4 days after taking levofloxacin for a respiratory infection. Blood biochemistry revealed elevated peripheral creatine kinase and liver enzyme levels, but the patient did not develop an acute kidney injury. Her symptoms resolved after discontinuation of levofloxacin. This case report highlights the need for monitoring of blood biochemistry in patients taking levofloxacin to enable early diagnosis and treatment of potentially life-threatening myositis.


Asunto(s)
Lesión Renal Aguda , Infecciones del Sistema Respiratorio , Rabdomiólisis , Femenino , Humanos , Persona de Mediana Edad , Levofloxacino/efectos adversos , Rabdomiólisis/inducido químicamente , Rabdomiólisis/diagnóstico , Lesión Renal Aguda/inducido químicamente , Lesión Renal Aguda/diagnóstico , Lesión Renal Aguda/complicaciones
15.
Braz J Infect Dis ; 27(2): 102745, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-36750202

RESUMEN

BACKGROUND: Despite high cure rates, treatment-related mortality in children with acute lymphoblastic leukemia (ALL) remains significant. About 4% of patients die during remission induction therapy and approximately two-thirds of treatment-related deaths are due to infectious complications. METHODS: From May 2021 to June 2022, children aged one through 18 years, with a recent diagnosis of ALL, admitted to three pediatric oncology centers in Brazil, were enrolled in this multicenter, open-label, randomized, phase 3 clinical trial. Eligible patients were randomly divided into two groups, based on a 1:1 allocation ratio, to receive, or not, levofloxacin as a prophylactic agent during the induction phase. All patients were treated according to the IC-BFM 2009 chemotherapy protocol. Primary endpoints were carbapenemase-producing Enterobacteriaceae (CPE) colonization, Clostridioides difficile diarrhea, and other adverse events related to the use of levofloxacin. The secondary endpoint was febrile neutropenia during induction. The median follow-up was 289 days. RESULTS: Twenty patients were included in this trial, 10 in each group (control and levofloxacin). Mild adverse reactions related to levofloxacin were observed in three patients (30%). Three patients had Clostridioides difficile diarrhea, two in the levofloxacin group and one in the control group (p > 0.99). Only one patient presented colonization by CPE. This patient belonged to the levofloxacin group (p > 0.99). Nine patients presented febrile neutropenia, five in the control group and four in the levofloxacin intervention group (p > 0.99), one patient died due to febrile neutropenia. CONCLUSION: The use of levofloxacin was shown to be safe in the induction phase in children with de novo ALL. The use of this medication did not increase the rate of colonization by CPE nor the rate of diarrhea by C. difficile. All adverse reactions were mild and remitted either spontaneously or after switching medicine administration from oral to intravenous route.


Asunto(s)
Clostridioides difficile , Neutropenia Febril , Leucemia-Linfoma Linfoblástico de Células Precursoras , Humanos , Niño , Adolescente , Levofloxacino/efectos adversos , Profilaxis Antibiótica/métodos , Antibacterianos/efectos adversos , Brasil , Neutropenia Febril/tratamiento farmacológico , Leucemia-Linfoma Linfoblástico de Células Precursoras/tratamiento farmacológico , Leucemia-Linfoma Linfoblástico de Células Precursoras/complicaciones , Diarrea/complicaciones , Diarrea/tratamiento farmacológico
18.
Auris Nasus Larynx ; 50(4): 521-533, 2023 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-36599786

RESUMEN

OBJECTIVE: The present study aimed to evaluate the efficacy and safety of 1.5% levofloxacin (LVFX) otic solution for the treatment of patients with otitis media. METHODS: This multicenter, randomized, double-blind, parallel-group, placebo-controlled phase 3 trial was conducted at 34 institutions in Japan. A total of 202 patients with chronic suppurative otitis media (CSOM) or acute otitis media (AOM) were randomized into either the LVFX group or placebo group. A total of 6-10 drops of 1.5% otic solution of LVFX or its matching placebo were administered in the diseased ear twice daily, in the morning and evening for up to 10 days. Images corresponding to three clinical findings-purulent otorrhea, hyperemia (redness), and granulation tissue formation in the middle ear and tympanic membrane-for each diseased ear were evaluated using digital endoscopy by a blinded central independent review committee (BICRC) at each visit after treatment administration. RESULTS: In total, the data of 201 participants (LVFX group, 99; placebo group, 102) were analyzed. The proportion of patients with disappearance (improvement rate) of all three clinical findings at the end of treatment or discontinuation by the BICRC was 46.5% (46/99) in the LVFX group and 23.5% (24/102) in the placebo group, and the difference (95% confidence interval) between the groups was 22.0% (8.7, 34.2), with a significantly higher improvement rate in the LVFX group than in the placebo group (p = 0.001; Cochran-Mantel-Haenszel test), demonstrating the efficacy of LVFX. The bacterial eradication rates were 93.9% (77/82) and 12.5% (11/88) in the LVFX and placebo groups, respectively, and the rate was significantly higher in the LVFX group than in the placebo group (p < 0.001). Treatment-related adverse events (AEs) occurred in 5.1% (5/99) and 7.8% (8/102) of the patients in the LVFX and placebo groups, respectively, and no significant difference was noted in incidence rate between the groups. CONCLUSION: The clinical efficacy of 1.5% LVFX otic solution for CSOM and AOM was demonstrated by the resolution of inflammation in the middle ear and tympanic membrane as well as through the high bacterial eradication rate observed. No deaths or serious treatment-related AEs were observed. The study provided confirmation that 1.5% LVFX otic solution is a safe, well-tolerated, and effective treatment for CSOM and AOM.


Asunto(s)
Otitis Media Supurativa , Otitis Media , Humanos , Antibacterianos/efectos adversos , Levofloxacino/efectos adversos , Otitis Media/tratamiento farmacológico , Otitis Media Supurativa/tratamiento farmacológico , Oído Medio
19.
J Oncol Pharm Pract ; 29(3): 534-542, 2023 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-35075933

RESUMEN

BACKGROUND: QTc interval prolongation has been reported when combining fluoroquinolones and triazoles for chemoprophylaxis in cancer patients. Herein, we aimed to identify the prevalence and contributing factors to QTc prolongation in hematopoietic cell transplantation (HCT) recipients who received these agents during the neutropenic phase. METHODS: This is a retrospective medical chart review conducted at a university hospital in Lebanon from 2017 to 2020. It included all adult HCT inpatients on antimicrobial prophylaxis with fluoroquinolones and triazoles and whose baseline ECG monitoring done prior to chemoprophylaxis administration, then on day-3 and day-6 of therapy, were available. RESULTS: Overall, 68 HCT recipients met our inclusion criteria, of which 22% developed QTc prolongation. Based on bivariate analysis, female gender contributed to QTc prolongation (P = 0.001). There was a trend to QTc prolongation in patients with predisposing thyroid disease (P = 0.12), grade 2 vomiting and diarrhea (P = 0.16, P = 0.46, respectively), baseline hypokalemia (P = 0.18) and hypocalcemia (P = 0.3), hypomagnesemia on day-3 (P = 0.21) and day-6 hyponatremia (P = 0.36). Patients receiving two or more drugs with a known or probable risk of QTc prolongation (other than the fluoroquinolone/ triazole combination) were more prone to experience a prolonged QTc interval (P = 0.09). None of the patients that had QTc prolongation died or developed serious arrhythmias. CONCLUSION: The prevalence of QTc prolongation was 22% among HCT recipients on fluoroquinolone and triazole prophylaxis, yet we did not identify any independent risk factors for this issue. None of the patients that had QTc interval prolongation died or developed serious arrhythmias.


Asunto(s)
Trasplante de Células Madre Hematopoyéticas , Síndrome de QT Prolongado , Adulto , Humanos , Femenino , Levofloxacino/efectos adversos , Triazoles , Estudios Retrospectivos , Prevalencia , Factores de Riesgo , Síndrome de QT Prolongado/inducido químicamente , Síndrome de QT Prolongado/epidemiología , Arritmias Cardíacas , Trasplante de Células Madre Hematopoyéticas/efectos adversos , Electrocardiografía
20.
BMJ Case Rep ; 15(12)2022 Dec 22.
Artículo en Inglés | MEDLINE | ID: mdl-36549757

RESUMEN

Fluoroquinolones are commonly used antimicrobials with multiple known adverse effects, yet overdose events are rarely reported. Here, we report a case of a previously healthy middle-aged woman who unintentionally ingested 7 g of levofloxacin in one dose. Thereafter, she presented to the emergency department with hemiparesis concerning for ischaemic stroke and was administered tissue plasminogen activator. Her brain imaging showed no ischaemic injury and her symptoms resolved within 24 hours; this is consistent with a transient ischaemic attack. Our case highlights potential adverse effects of an acute overdose of levofloxacin that has not previously been well described.


Asunto(s)
Isquemia Encefálica , Sobredosis de Droga , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Accidente Vascular Cerebral Lacunar , Accidente Cerebrovascular , Persona de Mediana Edad , Femenino , Humanos , Activador de Tejido Plasminógeno/uso terapéutico , Levofloxacino/efectos adversos , Accidente Cerebrovascular/tratamiento farmacológico , Isquemia Encefálica/inducido químicamente
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