Informe diário de evidências COVID-19: busca realizada em 16 e 18 de maio de 2020 / COVID-19 daily evidence report: search conducted on May 16 and 18, 2020

O Informe Diário de Evidências é uma produção do Ministério da Saúde que tem como objetivo acompanhar diariamente as publicações científicas sobre tratamento farmacológico e vacinas para a COVID-19. Dessa forma, são realizadas buscas estruturadas em bases de dados biomédicas, referente ao dia anterior desse informe. Não são incluídos estudos pré-clínicos (in vitro, in vivo, in silico). A frequência dos estudos é demonstrada de acordo com a sua classificação metodológica (revisões sistemáticas, ensaios clínicos randomizados, coortes, entre outros). Para cada estudo é apresentado um resumo com avaliação da qualidade metodológica. Essa avaliação tem por finalidade identificar o grau de certeza/confiança ou o risco de viés de cada estudo. Para tal, são utilizadas ferramentas já validadas e consagradas na literatura científica, na área de saúde baseada em evidências. Cabe ressaltar que o documento tem caráter informativo e não representa uma recomendação oficial do Ministério da Saúde sobre a temática. Foram encontrados 22 artigos e 10 protocolos.

Avances en el tratamiento de la tuberculosis multirresistente / Advances in the treatment of multi-drug resistant tuberculosis

Resumen El tratamiento de las tuberculosis multidrogorresistentes (TBC-MDR) se basa en esquemas de fármacos con diseños muy variables, en pacientes con patrones de resistencia heterogéneos y seguimientos no estandarizados, lo que hace dificil plantear recomendaciones con fuerte nivel de evidencia. Además, sólo una minoría de estos enfermos recibe tratamiento a nivel mundial y con los actuales esquemas menos del 50% de los que logran ser tratados curan. Afortunadamente, durante los últimos años han aparecido nuevos medicamentos, (bedaquilina, delamanid y pretomanid), que están demostrando ser de real utilidad para estos pacientes en ensayos con mejor diseño y seguimiento, donde se puede establecer con mayor precisión la eficacia, toxicidad y grado de recaídas. Además, algunos fármacos ya conocidos, (fluoroquinolonas, linezolid, clofazimina) están siendo introducidos dentro de los nuevos esquemas de tratamiento.

Abstract Therapy of multi-drug resistant tuberculosis (MDR TB) is based on trials with drugs with highly variable patterns of resistance and non-standardized follow-ups that make it difficult to provide recommendations with strong levels of evidence. Also, the vast majority of MDR-TB patients fail to receive therapy and those who receive it, only achieve around 50% of good results. Fortunately new drugs have emerged (bedaquiline, delamanid, pretomanid) that are being useful for these patients with better designed trials and monitoring, in which the efficacy, toxicity and degree of relapses can be evaluated more accurately. Some drugs already known (fluorquinolones, linezolid and clofazimine) are also being introduced in new schemes of therapy.

Profilaxis con levofloxacina en pacientes neutropénicos / Levofloxacin prophylaxis in neutropenic patients

La profilaxis con fluorquinolonas ha demostrado utilidad en la prevención de infecciones en pacientes neutropénicos de alto riesgo. Nuestro objetivo fue describir y comparar las características clínicas, microbiológicas, terapéuticas y la evolución en pacientes durante el primer episodio de neutropenia febril, según hubieran o no recibido profilaxis con levofloxacina. Fue un estudio prospectivo observacional, que incluyó los episodios de internados por neutropenia febril, (febrero 1997 a noviembre 2014), y los primeros episodios en un mismo paciente en diferentes internaciones; en total fueron 946 episodios. En 821 el episodio de neutropenia febril fue de alto riesgo, y en 264 (27.9%) se administró profilaxis con levofloxacina. Este grupo estaba compuesto por mayor proporción de neutropenias febriles de alto riesgo (99.2% vs. 82.3%, p = 0.0001) y casos con trasplante de células progenitoras hematopoyéticas (67.8% vs. 29.3%, p = 0.0001) comparado con los que no recibieron profilaxis, y presentó una frecuencia similar de infecciones clínicamente documentadas pero una menor proporción de infecciones microbiológicamente documentadas (28.8% vs. 37.5%, p = 0.012). Las bacteriemias en el grupo con quimioprofilaxis fueron más frecuentemente causadas por organismos multirresistentes (OMR) (34.5% vs. 17.3%, p = 0.007) y por enterobacterias productoras de beta lactamasas de espectro extendido (19.0% vs. 3.8%, p = 0.0001). En ese grupo con profilaxis la proporción que recibió tratamiento antibiótico empírico adecuado fue menor (69.7% vs. 83.7%, p = 0.009). La evolución fue similar en ambos grupos. Sugerimos que cuando se observe un aumento en la frecuencia de infecciones por OMR en esta población se considere la interrupción de la profilaxis antibiótica con levofloxacina.

Fluorquinolone-prophylaxis has proven useful in preventing infections in high risk neutropenic patients. The objective of this study was to describe the clinical, microbiological and therapeutic characteristics, and outcome of patients in the first episode of febrile neutropenia, comparing those who received levofloxacin prophylaxis with those who didn't. It was a prospective observational study that included all the episodes of inpatients with febrile neutropenia (February 1997- November 2014), also including the first episode in a same patient in different hospitalizations. Of 946 episodes here included, 821 presented high risk febrile neutropenia. A total of 264 cases (27.9%) received levofloxacin prophylaxis. This group consisted of a higher proportion of high risk febrile neutropenia (99.2% vs. 82.3%, p = 0.0001) and patients that had received an hematopoietic stem cell transplant (67.8% vs. 29.3%, p = 0.0001) compared to those who didn't receive prophylaxis. Those who received levofloxacin prophylaxis presented a similar frequency of clinically diagnosed but a lower proportion of microbiologically documented infections (28.8% vs. 37.5%, p = 0.012) than those who didn´t receive prophylaxis. The episodes of bacteremia that occurred in the first group were more frequently caused by multidrug resistant bacteria (MDRB) (34.5% vs. 17.3%, p = 0.007) and by extended spectrum beta lactamase producing Enterobacteriaceae (19% vs. 3.8%, p = 0.0001). The group that received prophylaxis had a lower proportion of adequate empirical antibiotic treatment (69.7% vs. 83.7%, p = 0.009), with similar outcomes in both groups. We suggest that levofloxacin prophylaxis should be stopped whenever there is a rise in the frequency of MDRB infections in this population.

A case of atypical nocardia asteroides sclerouveitis resistant to fourth-generation fluoroquinolones / Um caso atípico de esclero-uveíte por Nocardia Asteroides resistente a fluorquinolona de quarta-geração

ABSTRACT We describe an unusual case of Nocardia spp scleritis in a health girl resistant to topical fourth-generation fluoroquinolones. Clinically, there was only partial response of the scleritis to initial therapy. Treatment was changed to meropenem intravenously and topical amikacin. Following several weeks of antibiotic treatment, the patient's infection resolved but her vision was reduced to no light perception. Nocardia asteroides must be considered as a possible agent in cases of necrotizing scleritis in patients without a clear source. Antibiotic sensitivity testing has a definitive role in view of the resistance to these new medications.

RESUMO Nós descrevemos um raro caso de esclerite por Nocardia spp em uma criança sadia resistente a utilização tópica de fluorquinolona de quarta-geração. Clinicamente, a paciente apresentou apenas uma resposta parcial do quadro de esclerite a terapêutica inicial. O tratamento foi então modificado para meropenem intravenoso e amicacina tópica. Após várias semanas de tratamento com antibiótico, o quadro infeccioso regrediu porém a visao da pacientes evoluiu para perda da percepção luminosa. Em casos de esclerite necrotizante em pacientes sem fatores de risco aparente é necessário considerer a Nocardia Asteroides como possível agente causador. Os testes de sensibilidade medicamentosa apresentam importância significativa em virtude do aparecimento de resistência aos novos medicamentos.

Molecular detection of clarithromycin and fluoroquinolones resistance in helicobacter pylori infection, directly applied to gastric biopsies, in an urban brazilian population

ABSTRACT Background - Antimicrobial resistance is the major factor leading to eradication failure in H. pylori treatment. Molecular tests are useful to detect genetic mutations predictive of clarithromycin and fluoroquinolones resistance. Knowledge of the local prevalence rate of resistance is important to define the best recommended treatment. Objective - To assess the prevalence of primary resistance of H. pylori to clarithromycin and fluoroquinolones, using a molecular test, in a Southeastern urban Brazilian population. Methods - A total of 72 H. pylori seropositive patients [65% female, mean age 39 (19-73) years] never treated before for this infection were studied. All patients underwent gastroscopy in addition to antrum and corpus biopsies and molecular test GenoType HelicoDR (Hain Life Science, Germany) to detect H. pylori and point mutations in genes responsible for clarithromycin and fluoroquinolone resistance. The molecular procedure was divided into three steps: DNA extraction from biopsy samples, a multiplex amplification with biotinylated primers and a reverse hybridization. The most frequent point mutations involved in resistance to the two antibiotics were evaluated. Results - Resistance to clarithromycin was detected in nine (12.5%) patients and to fluoroquinolones in eight (11.1%) patients. The point mutation A2147G was the most common (77.8%) among resistant strains to clarithromycin. In 50% of the resistant strains to fluoroquinolones, the mutant codon couldn't be identified. Conclusion - The resistance rates to clarithromycin and fluorquinolones in a large urban population in the Southeast of Brazil were acceptable, suggesting that these drugs remain appropriate options to first and second-line of H. pylori treatment. The molecular test represents an adequate diagnostic tool for monitoring H. pylori resistance.

RESUMO Contexto - A resistência aos antimicrobianos é o principal fator associado à falha terapêutica no tratamento do H. pylori. Testes moleculares são úteis na detecção das mutações genéticas associadas ao desenvolvimento de resistência à claritromicina e fluorquinolonas. O conhecimento da taxa de prevalência local de resistência é importante na definição do melhor esquema terapêutico. Objetivo - Estimar a prevalência de resistência primária do H. pylori à claritromicina e fluorquinolonas, empregando-se um teste molecular, em uma capital do Sudeste do Brasil. Métodos - Setenta e dois pacientes com sorologia positiva para H. pylori [65% mulheres, idade média 39 (19-73) anos], nunca tratados previamente para essa infecção, foram selecionados. Todos os pacientes submeteram-se à endoscopia digestiva com biópsias de antro e corpo e realização do teste molecular GenoType HelicoDR (Hain Life Science, Alemanha) para a detecção do H. pylori e das mutações pontuais dos genes responsáveis pela resistência à claritromicina e fluorquinolonas. O procedimento molecular constituía-se de três etapas: extração do DNA a partir das amostras endoscópicas, amplificação multiplex com primers biotinilados e hibridização reversa. As mutações pontuais mais frequentemente envolvidas com resistência aos dois antibióticos foram avaliadas. Resultados - Resistência à claritromicina foi detectada em nove (12,5%) pacientes e às fluorquinolonas em oito (11,1%) pacientes. A mutação pontual A2147G foi a mais comum (77,8%) entre as cepas resistentes à claritromicina. Em 50% das cepas resistentes à fluorquinolonas, o códon mutante não pôde ser identificado. Conclusão - As taxas de resistência à claritromicina (12,5%) e às fluorquinolonas (11,1%), em uma importante capital do Sudeste do Brasil, mostraram índices aceitáveis, sugerindo que essas drogas permanecem opções apropriadas para o tratamento de primeira e segunda linha do H. pylori. O teste molecular constitui uma ferramenta diagnóstica adequada para monitorar a resistência do H. pylori.

Quinolone resistance and ornithine decarboxylation activity in lactose-negative Escherichia coli

Quinolones and fluoroquinolones are widely used to treat uropathogenic Escherichia coli infections. Bacterial resistance to these antimicrobials primarily involves mutations in gyrA and parC genes. To date, no studies have examined the potential relationship between biochemical characteristics and quinolone resistance in uropathogenic E. coli strains. The present work analyzed the quinolone sensitivity and biochemical activities of fifty-eight lactose-negative uropathogenic E. coli strains. A high percentage of the isolates (48.3%) was found to be resistant to at least one of the tested quinolones, and DNA sequencing revealed quinolone resistant determining region gyrA and parC mutations in the multi-resistant isolates. Statistical analyses suggested that the lack of ornithine decarboxylase (ODC) activity is correlated with quinolone resistance. Despite the low number of isolates examined, this is the first study correlating these characteristics in lactose-negative E. coli isolates.

Gatifloxacin and iodopovidine preoperatively of phacectomy: influence on counting bacterial colonies / Gatifloxacino e iodopovidine no pré-operatório de facectomia: influência na contagem de colônias bacterianas

Objective: To analyze two methods of reducing conjunctivalmicrobiota in patients undergoing cataract surgery. Methods: A clinical trial with a convenience sample of 57 patients diagnosed with senile cataract (57 eyes) who underwent phacoemulsification with intraocular lens implantation in Recife from 2011 to 2013. Patients were divided into two groups: ATB (27 eyes) in which was instilled antibiotic eye drops (gatifloxacin 0.3%) and ASS (30 eyes) with antiseptic eye drops (iodopovidine 5%); both medications were instilled three times (one drop every 20 minutes, an hour prior to surgery). The groups were evaluated from two collections of conjunctival material: first before instilling some eye drops and the second one immediately after surgery. Gram stain, culture and sensitivity were performed. Results: Comparing the reduction in the number of bacteria found in the slides in the pre-and postoperative, there was no statistically significant difference in both groups. Conclusions: Both use of antiseptic or antibiotic, used as prophylaxis forendophthalmitis, can reduce the conjunctivalmicrobiota.

Objetivo: Analisar dois método de redução da microbiota conjuntival em indivíduos submetidos à facectomia. Métodos: Ensaio clínico, com amostra de conveniência de 57 pacientes, com diagnóstico de catarata senil (57 olhos), submetidos à facoemulsificação com implante de lente intraocular em Recife entre 2011 a 2013. Os pacientes foram alocados em dois grupos: ATB (27 olhos) no qual foi instilado colírio antibiótico (gatifloxacino a 0,3%) e ASS (30 olhos) colírio antisséptico (iodopovidine a 5%), ambas as medicações foram instiladas três vezes (uma gota a cada 20 minutos, uma hora previamente à cirurgia). Os grupos foram avaliados a partir de duas coletas de material conjuntival: a primeira antes de instilar algum colírio e a segunda imediatamente após a cirurgia. Foi realizada bacterioscopia, cultura e antibiograma. Resultados: Comparando-se a redução no número de bactérias encontrado nas lâminas no pré e pós-operatório, não se verificou diferença estatística significativa nos dois grupos. Conclusão: Tanto o uso do antisséptico como do antibiótico usados como profiláticos para a endoftalmite reduzem a microbiota conjuntival.

Efficiency of Moxifloxacin in the Treatment of Helicobacter pylori Infection

No abstract available.

Antibiotic prophylaxis with intravenous ceftriaxone and fluoroquinolone reduces infectious complications after transrectal ultrasound-guided prostatic biopsy

PURPOSE: To assess the rates of infectious complications before and after the change of prophylactic antibiotic regimens in prostate needle biopsy. MATERIALS AND METHODS: The records of 5,577 patients who underwent prostate needle biopsy at Asan Medical Center between August 2005 and July 2012 were retrospectively reviewed. Group 1 (n=1,743) included patients treated between 2005 and 2009 with fluoroquinolone for 3 days, group 2 (n=2,723) included those treated between 2009 and 2012 with ceftriaxone once before the biopsy and fluoroquinolone before biopsy and continue therapy for 3 days, and group 3 (n=1,111) received the same treatment for more than 7 days after the biopsy. Univariable and multivariable logistic regression models addressed risk factors associated with infectious complication after prostate needle biopsy. RESULTS: Infectious complication after prostate needle biopsy developed in 18 (group 1), seven (group 2), and two patients (group 3) (p=0.001). In group 1, seven patients with infectious complication had positive blood cultures and harbored fluoroquinolone-resistant Escherichia coli, four had ceftriaxone susceptible isolates, and three had extended spectrum beta-lactamase-positive E. coli. Two patients in group 1 required intensive care because of septic shock. In multivariable analysis, the patients with combination of fluoroquinolone and ceftriaxone had significantly lower infectious complication rate than the fluoroquinolon alone (p=0.003). CONCLUSIONS: Antibiotic prophylaxis with ceftriaxone and fluoroquinolone before prostate needle biopsy decreased the risk of potentially serious infectious complications.

Queratitis por Lasiodiplodia theobromae: comunicación de un caso y revisión de la literatura / Keratitis by Lasiodiplodia theobromae: a case report and literature review

We report a case of mycotic keratitis caused by Lasiodiplodia theobromae in a 60-year-old man with a history of ocular trauma with vegetable matter. Ophthalmological assessment with slit-lamp and microbiological evaluation of the corneal ulcer by conventional microbiological techniques were performed. Mycology study of the corneal scraping showed the presence of fungal filaments and the isolate was identified as Lasiodiplodia theobromae. Patient was treated with natamycin 5% and fluconazole 0.2% for 37 days. The infection was controlled but the corneal scars required a cornea transplant. This is the first case of keratitis by Lasiodiplodia theobromae in Paraguay. Difficulties in the management of these cases, which often requires surgical procedures, are discussed.

Se presenta un caso clínico de queratitis causada por Lasiodiplodia theobromae en un agricultor de 60 años de edad, con antecedentes de un trauma ocular con un vegetal. Se realizó un examen oftalmológico con lámpara de hendidura y estudio microbiológico de la úlcera corneal por técnicas microbiológicas convencionales. El examen micológico del raspado corneal reveló la presencia de hifas septadas y el cultivo fue identificado como Lasiodiplodia theobromae. El paciente fue tratado con natamicina al 5% y fluconazol al 0,2% durante 37 días. La infección fue controlada, sin embargo, el paciente quedó con cicatrices corneales y con necesidad de trasplante. Es el primer caso de queratitis por Lasiodiplodia theobromae en Paraguay. Se discute la dificultad de manejo de estos casos que a menudo requieren procedimientos quirúrgicos y trasplante de córnea.

The Efficacy of Moxifloxacin-Containing Triple Therapy after Standard Triple, Sequential, or Concomitant Therapy Failure for Helicobacter pylori Eradication in Korea

BACKGROUND/AIMS: Retreatment after initial treatment failure for Helicobacter pylori is very challenging. The purpose of this study was to evaluate the efficacies of moxifloxacin-containing triple and bismuth-containing quadruple therapy. METHODS: A total of 151 patients, who failed initial H. pylori treatment, were included in this retrospective cohort study. The initial regimens were standard triple, sequential, or concomitant therapy, and the efficacies of the two following second-line treatments were evaluated: 7-day moxifloxacin-containing triple therapy (rabeprazole 20 mg twice a day, amoxicillin 1,000 mg twice a day, and moxifloxacin 400 mg once daily) and 7-day bismuth-containing quadruple therapy (rabeprazole 20 mg twice a day, tetracycline 500 mg 4 times a day, metronidazole 500 mg 3 times a day, and tripotassium dicitrate bismuthate 300 mg 4 times a day). RESULTS: The overall eradication rates after moxifloxacin-containing triple therapy and bismuth-containing quadruple therapy were 69/110 (62.7%) and 32/41 (78%), respectively. Comparison of the two regimens was performed in the patients who failed standard triple therapy, and the results revealed eradication rates of 14/28 (50%) and 32/41 (78%), respectively (p=0.015). The frequency of noncompliance was not different between the two groups, and there were fewer adverse effects in the moxifloxacin-containing triple therapy group (2.8% vs 7.3%, p=0.204 and 25.7% vs 43.9%, p=0.031, respectively). CONCLUSIONS: Moxifloxacin-containing triple therapy, a recommended second-line treatment for initial concomitant or sequential therapy failure, had insufficient efficacy.

Epithelial Wound Healing after Cataract Surgery Comparing Two Different Topical Fluoroquinolones

PURPOSE: To compare the epithelial wound healing response of two preservative-free fluoroquinolones, moxifloxacin and levofloxacin, in patients who underwent cataract surgery. MATERIALS AND METHODS: In this prospective, evaluator-masked, randomized clinical trial, 59 eyes of 50 patients who underwent cataract surgery were enrolled. Patients were randomized to receive moxifloxacin 0.5% (n=32 eyes) or levofloxacin 0.5% (n=27 eyes). All patients instilled moxifloxacin or levofloxain four times daily for 1 week prior to surgery and 2 weeks after surgery. The epithelial wound healing status in the corneal incision site was scanned with a raster scan mode of fourier-domain optical coherence tomography (FD-OCT). The number of eyes showing epithelial defect images and average number of corneal epithelial defect cuts per eye were compared between groups. All patients were evaluated on postoperative days 1, 2, 3, and 10. RESULTS: On postoperative days 1, 2, and 3, the number of eyes showing epithelial defects in FD-OCT was not statistically different (all p>0.05). The average number of corneal epithelial defect cuts was also not statistically different between the two groups (all p>0.05). No eyes showed epithelial defects on postoperative day 10 in either group. CONCLUSION: There were no differences on epithelial wound healing comparing these two different fluoroquinolones at the incision site of cataract surgery.

Febrile Urinary Tract Infection After Prostate Biopsy and Quinolone Resistance

PURPOSE: Complications after prostate biopsy have increased and various causes have been reported. Growing evidence of increasing quinolone resistance is of particular concern. In the current retrospective study, we evaluated the incidence of infectious complications after prostate biopsy and identified the risk factors. MATERIALS AND METHODS: The study population included 1,195 patients who underwent a prostate biopsy between January 2007 and December 2012 at Chung-Ang University Hospital. Cases of febrile UTI that occurred within 7 days were investigated. Clinical information included age, prostate-specific antigen, prostate volume, hypertension, diabetes, body mass index, and biopsy done in the quinolone-resistance era. Patients received quinolone (250 mg intravenously) before and after the procedure, and quinolone (250 mg) was orally administered twice daily for 3 days. We used univariate and multivariate analysis to investigate the predictive factors for febrile UTI. RESULTS: Febrile UTI developed in 39 cases (3.1%). Core numbers increased from 2007 (8 cores) to 2012 (12 cores) and quinolone-resistant bacteria began to appear in 2010 (quinolone-resistance era). In the univariate analysis, core number> or =12 (p=0.024), body mass index (BMI)>25 kg/m2 (p=0.004), and biopsy done in the quinolone-resistance era (p=0.014) were significant factors. However, in the multivariate analysis adjusted for core number, the results were not significant, with the exception of BMI>25 kg/m2 (p=0.011) and biopsy during the quinolone-resistance era (p=0.035), which were significantly associated with febrile UTI. CONCLUSIONS: Quinolone resistance is the main cause of postbiopsy infections in our center. We suggest that further evaluation is required to validate similar trends. Novel strategies to find alternative prophylactic agents are also necessary.

The efficacy of moxifloxacin-based triple therapy in treatment of Helicobacter pylori infection: a systematic review and meta-analysis of randomized clinical trials

Recent evidence shows that moxifloxacin could exert an antimicrobial effect against Helicobacter pylori in both in vitro and in vivo models. To systematically evaluate whether moxifloxacin-containing triple therapy could improve eradication rates and reduce side effects in first-line or second-line anti-H. pylori treatment, eligible articles were identified by searches of electronic databases. We included all randomized trials comparing moxifloxacin-based triple therapy with standard triple or quadruple therapy during H. pylori eradication treatment. Statistical analysis was performed with Review Manager 5.0.10. Subanalysis/sensitivity analysis was also performed. We identified seven randomized trials (n=1263). Pooled H. pylori eradication rates were 79.03% (95%CI: 75.73-82.07) and 68.33% (95%CI: 64.44-72.04) for patients with moxifloxacin-based triple therapy or with standard triple or quadruple therapy, respectively (intention-to-treat analysis). The odds ratio (OR) was 1.82 (95%CI: 1.17-2.81), the occurrence of total side effects was 15.23% (95%CI: 12.58-18.20) and 27.17% (95%CI: 23.64-30.92) for groups with or without moxifloxacin, and the summary OR was 0.45 (95%CI: 0.26-0.77). In subgroup analyses, we noted that the second-line eradication rate in the moxifloxacin group was significantly higher than that in the quadruple therapy group (73.33 vs 60.17%, OR: 1.78, 95%CI: 1.16-2.73, P<0.001). However, there was no difference in first-line eradication treatment. Findings from this meta-analysis suggest that moxifloxacin-based triple therapy is more effective and better tolerated than standard triple or quadruple therapy. Therefore, a moxifloxacin-based triple regimen should be used in the second-line treatment of H. pylori infection.

Efficacy and Safety of Intracameral Moxoft Eye Drops (Moxifloxacin Ophthalmic Solution 0.5%) for Endophthalmitis Prophylaxis in Cataract Surgery.

Objective: To evaluate the efficacy and safety of intracameral Moxoft eye drops (Moxifloxacin ophthalmic solution 0.5%) administered at the conclusion of phacoemulsification cataract surgery for the purpose of endophthalmitis prophylaxis. Design: Open label, multicentre, prospective. Setting: Three ophthalmologists across India. Methods: A total of 134 outpatients of either sex undergoing phacoemulsification with no ocular pathology other than cataract and meeting all inclusion/exclusion criteria were enrolled in the study. All patients received preoperatively 1 drop of Moxoft eye drops (Moxifloxacin ophthalmic solution 0.5%) topically every 15 minutes atleast 4 times one hour prior to surgery. 0.1 ml moxifloxacin solution was aspirated into the tuberculin syringe and injected into the capsular bag under the capsulorhexis edge after completion of the Phacoemulsification and IOL implantation. Post-operative treatment was as per standard protocol. Patients were assessed pre-operatively and on day 1, day 7 & day 30 after surgery for ocular symptom scores for pain in eyes, ocular discharge, hazy cornea, conjunctival hyperemia, and hypopyon and chemosis. Anterior chamber (AC) reaction was graded (if present) on all the visits with fixed slit-lamp settings and on 5-point rating scale for AC flare and cells in AC. Global assessment was done for efficacy and tolerability at the end of therapy on a 3-point scale. Result: Thirteen patients were excluded from the analysis due to insufficient data and an intentionto- treat analysis was done for efficacy on 121 patients. There was significant reduction in scores of pain in eyes, conjunctival hyperemia, mean AC flare, mean AC cells (p<0.0001 for all) and ocular discharge (p=0.018). Hypopyon and/or corneal endothelial cell damage was observed in none of the patients. Therapy was rated good to excellent on efficacy and tolerability parameters with no reporting of a poor rating. Conclusion: Moxoft eye drops (Moxifloxacin ophthalmic solution 0.5%) is safe for use by intracameral administration with no corneal decompensation. Tolerability and post-operative results were found to be excellent.

Clinical Effects of Gemifloxacin on the Delay of Tuberculosis Treatment

Although gemifloxacin has low in vitro activity against Mycobacterium tuberculosis, the effect of gemifloxacin on the delay of tuberculosis (TB) treatment has not been validated in a clinical setting. The study group included patients with culture-confirmed pulmonary TB who initially received gemifloxacin for suspected community-acquired pneumonia (CAP). Two control groups contained patients treated with other fluoroquinolones or nonfluoroquinolone antibiotics. Sixteen cases were treated with gemifloxacin for suspected CAP before TB diagnosis. Sixteen and 32 patients were treated with other fluoroquinolones and nonfluoroquinolones, respectively. The median period from the initiation of antibiotics to the administration of anti-TB medication was nine days in the gemifloxacin group, which was significantly different from the other fluoroquinolones group (35 days). The median times for the nonfluoroquinolone group and the gemifloxacin group were not significantly different. There were no significant differences between the gemifloxacin and other fluoroquinolone group in terms of symptomatic and radiographic improvements. However, the frequency of radiographic improvement in the other fluoroquinolones group tended to be higher than in the gemifloxacin group. Gemifloxacin might be the preferred fluoroquinolone for treating CAP, to alleviate any concerns about delaying TB treatment.

Safety and Efficacy of Balofox (Balofloxacin) in the Treatment of Uncomplicated Urinary Tract Infections in Adults (BUTA Study).

Objective: To evaluate the safety and efficacy of Balofox (Balofloxacin) in the treatment of Uncomplicated Urinary Tract Infections in Adults. Design: Open, prospective, noncomparative, observational, multi-center, post-marketing study. Setting: 248 physicians across India in clinical and hospital settings. Patients: A total of 3511 patients of either sex above 18 years of age with laboratory and/or clinical diagnosis of urinary tract infection were administered Balofox (Balofloxacin) orally two times daily for 5-7 days. Respiratory system abnormalities, cardiovascular abnormalities, nervous system abnormalities and abdominal symptoms were seen in 554 patients. Body temperature, abdominal pain and burning during micturation were recorded at baseline and then on days 2, 3, 4, 5 and 6. Global assessment was done by physician independently at the end of therapy on a 4-point Likert scale. Results: Of the 8063 patients enrolled in the study with, 6977 patients had urinary tract infection, but data of 3466 patients was excluded from analysis due to insufficient data and an intention-to-treat analysis done for efficacy on 3511 patients. The body temperature reduced from 102.12°F at baseline to 99.03°F on day 3 (p<0.0001), and upto 97.72 on day 6 (p<0.0001). The scores for abdominal pain and burning during micturation also significantly (p<0.05) reduced on days 2, 3, 5, & 6 from baseline. The commonly reported adverse events were nausea (5.95%), headache (1.85%), vomiting (1.77%), vertigo and giddiness (1.62%), hyperacidity (1.05%). For global assessment of response to therapy, more than 95% doctors reported the response to therapy as good. More than 90% of doctors reported the tolerability of the drug to be good. Conclusion: Balofox is safe and effective in the management of uncomplicated urinary tract infection in adults.

Effectiveness of enrofloxacin for the treatment of experimentally-induced bovine anaplasmosis / Eficácia da enrofloxacina no tratamento da anaplasmose bovina experimental

Four groups of six Holstein calves were inoculated with 3.6 × 10(7) erythrocytes parasitized with Anaplasma marginale. The criteria for treatment of calves were increasing A. marginale rickettsemia and 30% reduction of baseline packed cell volume (PCV) of each animal. Group 1 (G1) received 7.5 mg.kg-1 of enrofloxacin in a single dose; Group 2 (G2) 7.5 mg.kg-1 of enrofloxacin twice every three days; Group 3 (G3) 20 mg.kg-1 of long-acting oxytetracycline in a single dose; and Group 4 (G4) a single dose of PBS. Physical examinations, blood smears and PCV were performed daily. On day treatment, G1, G2 and G3 animals had a mean rickettsemia of 17, 23 and 12%, respectively. At 2 days after treatment (DAT) G1 and G2 animals showed a significant reduction of rickettsemia (p < 0.05) compared to G3. G3 animals had high rates of rickettsemia in the first 2 DAT and a slow decrease until stabilization on 9 DAT. The mean PCV in G1 and G2 increased and stabilized after 7 and 8 DAT, respectively. PCV stabilization was achieved in G3 at 13 DAT. Both enrofloxacin and oxytetracycline were effective for the treatment of anaplasmosis, but enrofloxacin was faster reduction of rickettsemia and PCV recuperation (p < 0.05) compared to oxytetracycline.

Quatro grupos de seis bezerros da raça Holandesa foram inoculados com 3,6 × 10(7) eritrócitos parasitados com Anaplasma marginale. Os critérios para o tratamento dos bezerros foram aumento da rickettsemia do A. marginale e redução de 30% do valor basal de volume globular (VG) de cada animal. O Grupo 1 (G1) recebeu 7,5 mg.kg-1 de enrofloxacina em dose única; o Grupo 2 (G2), 7,5 mg.kg-1 de enrofloxacina duas vezes a cada três dias; o Grupo 3 (G3), 20 mg.kg-1 de oxitetraciclina de longa ação em dose única; e o Grupo 4 (G4) uma única dose de PBS. Exames físicos, esfregaço sanguíneo e VG foram realizadas diariamente. No dia do tratamento, os animais G1, G2 e G3 apresentaram rickettsemia média de 17, 23 e 12%, respectivamente. Nos primeiros 2 dias após o tratamento (DAT) os animais do G1 e G2 mostraram uma redução significativa de rickettsemia (p < 0,05) em relação ao G3. Animais do G3 tiveram altas taxas de rickettsemia nos 2 DAT e uma diminuição lenta até à estabilização em 9 de DAT. O VG médio no G1 e G2 aumentou e estabilizou após 7 e 8 DAT, respectivamente. A estabilização do VG do G3 foi aos 13 DAT. A enrofloxacina e a oxitetraciclina foram efetivas no tratamento da anaplasmose, mas a enrofloxacina apresentou redução da rickettsemia e recuperação do VG (p < 0,05) mais rápida em comparação com oxitetraciclina.