Linear mixed models are commonly used in the clinical pharmaceutical studies to analyze repeated measures such as the crossover study data of bioequivalence studies. In these models, random effects describe the correlation between repeated outcomes and variance-covariance matrix explain within-subject variabilities. Bioequivalence analysis verifies whether a 90% confidence interval for geometric mean ratio of Cmax and AUC between reference drug and test drug is included in the bioequivalence margin [0.8, 1.25] performed using linear mixed models with period, sequence and treatment effects as fixed and sequence nested subject effects as random. A Levofloxacin study is referred to for an example of real data analysis.
Kim, Hyung-Suk;Lim, So-Young;Pyon, Jai-Kyong;Mun, Goo-Hyun;Bang, Sa-Ik;Oh, Kap-Sung
Archives of Plastic Surgery
/
v.38
no.4
/
pp.516-518
/
2011
Purpose: The prevalence of antibiotic-resistant Streptococcus pneumoniae meningitis has increased worldwide. There are some reports about postoperative antibiotic-resistant Streptococcus pneumoniae infection after craniofacial surgery, but, there is no report in Korea. We present a report on the treatment of postoperative multidrug-resistant Streptococcus pneumoniae (MRSP) meningitis and sepsis after craniofacial surgery based on our experience. Methods: The patient was a 7-year-old boy with Crouzon's disease who was treated by fronto-orbital bar advancement. Intraoperatively, frontal sinus opening was seen during osteotomy which was covered with forehead galeopericranial flap. MRSP meningitis was diagnosed after the surgery, he was treated with intravenous vancomycin, meropenem, and levofloxacin. Results: The patient was treated successfully after 3 weeks of intravenous antibiotics treatment. During the 8 month follow-up period, there was no neurologic sequelae. Conclusion: Postoperative infection after craniofacial surgery is an important phenomenon that needs immediate recognition. Prevention, early diagnosis, and treatment immediate after onset are important as countermeasures against postoperative drug-resistant bacterial infection. To prevent adverse outcome and reoperation, proper antibiotics treatment should be performed.
Maraki, Sofia;Mavromanolaki, Viktoria Eirini;Stafylaki, Dimitra;Hamilos, George;Samonis, George
Infection and chemotherapy
/
v.50
no.4
/
pp.328-339
/
2018
Background: Pneumococcal disease is a major cause of morbidity and mortality worldwide, especially in patients with comorbidities and advanced age. This study evaluated trends in epidemiology of adult pneumococcal disease in Crete, Greece, by identifying serotype distribution and antimicrobial resistance of consecutive Streptococcus pneumoniae strains isolated from adults during an 8-year time period (2009-2016) and the indirect effect of the infant pneumococcal higher-valent conjugate vaccines 10-valent pneumococcal conjugate vaccine (PCV10) and 13-valent pneumococcal conjugate vaccine (PCV13). Materials and Methods: Antimicrobial susceptibility was performed by E-test and serotyping by Quellung reaction. Multidrug resistance (MDR) was defined as non-susceptibility to penicillin (PNSP) combined with resistance to ${\geq}2$ non-${\beta}$-lactam antimicrobials. Results: A total of 135 S. pneumoniae strains were isolated from adults during the study period. Twenty-one serotypes were identified with 17F, 15A, 3, 19A, and 11A, being the most common. The coverage rates of PCV10, and PCV13 were 17.8% and 37.8%, respectively. PCV13 serotypes decreased significantly from 68.4% in 2009 to 8.3% in 2016 (P = 0.002). The most important emerging non-PCV13 serotypes were 17F, 15A, and 11A, with 15A being strongly associated with antimicrobial resistance and MDR. Among all study isolates, penicillin-resistant and MDR strains represented 7.4% and 14.1%, respectively. Predominant PNSP serotypes were 19A (21.7%), 11A (17.4%), and 15A (17.4%). Erythromycin, clindamycin, tetracycline, trimethoprim-sulfamethoxazole, and levofloxacin resistant rates were 30.4%, 15.6%, 16.3%, 16.3%, and 1.5%, respectively. Conclusion: Although pneumococcal disease continues to be a health burden in adults in Crete, our study reveals a herd protection effect of the infant pneumococcal higher-valent conjugate vaccination. Surveillance of changes in serotype distribution and antimicrobial resistance among pneumococcal isolates are necessary to guide optimal prevention and treatment strategies.
Background: Effective treatment of fluoroquinolone-resistant multidrug-resistant tuberculosis (FQr-MDR-TB) is difficult because of the limited number of available core anti-TB drugs and high rates of resistance to anti-TB drugs other than FQs. However, few studies have examined anti-TB drugs that are effective in treating patients with FQr-MDR-TB in a real-world setting. Methods: The impact of anti-TB drug use on treatment outcomes in patients with pulmonary FQr-MDR-TB was retrospectively evaluated using a nationwide integrated TB database (Korean Tuberculosis and Post-Tuberculosis). Data from 2011 to 2017 were included. Results: The study population consisted of 1,082 patients with FQr-MDR-TB. The overall treatment outcomes were as follows: treatment success (69.7%), death (13.7%), lost to follow-up or not evaluated (12.8%), and treatment failure (3.9%). On a propensity-score-matched multivariate logistic regression analysis, the use of bedaquiline (BDQ), linezolid (LZD), levofloxacin (LFX), cycloserine (CS), ethambutol (EMB), pyrazinamide, kanamycin (KM), prothionamide (PTO), and para-aminosalicylic acid against susceptible strains increased the treatment success rate (vs. unfavorable outcomes). The use of LFX, CS, EMB, and PTO against susceptible strains decreased the mortality (vs. treatment success). Conclusion: A therapeutic regimen guided by drug-susceptibility testing can improve the treatment of patients with pulmonary FQr-MDR-TB. In addition to core anti-TB drugs, such as BDQ and LZD, treatment of susceptible strains with later-generation FQs and KM may be beneficial for FQr-MDR-TB patients with limited treatment options.
Maryam Salah Ud Din;Umar Farooq Gohar;Hamid Mukhtar;Ibrar Khan;John Morris;Soisuda Pornpukdeewattana;Salvatore Massa
Microbiology and Biotechnology Letters
/
v.51
no.4
/
pp.432-440
/
2023
Irrational and injudicious use of antibiotics, easy availability of them as over-the-counter drugs in economically developing countries, and unavailability of regulatory policies governing antimicrobial use in agriculture, animals, and humans, has led to the development of multi-drug resistance (MDR) bacteria. The use of medicinal plants can be considered as an alternative, with a consequent impact on microbial resistance. We tested extracts of Piper longum fruits as new natural products as agents for reversing the resistance to antibiotics. Six crude extracts of P. longum fruits were utilized against a clinical isolate of multidrug-resistant Staphylococcus aureus.The antibiotic susceptibility testing disc method was used in the antibiotic resistance reversal analysis. Apart from cefoxitin and erythromycin, all other antibiotics used (lincosamides [clindamycin], quinolones [levofloxacin and ciprofloxacin], and aminoglycosides [amikacin and gentamicin]) were enhanced by P. longum extracts. The extracts that showed the greatest synergy with the antibiotics were EAPL (ethyl acetate [extract of] P. longum), n-BPL (n-butanol [extract of] P. longum), and MPL (methanolic [extract of] P. longum The results of this study suggest that P. longum extracts have the ability to increase the effectiveness of different classes of antibiotics and reverse their resistance. However, future studies are needed to elucidate the molecular mechanisms behind the synergy between antibiotic and phytocompound(s) and identify the active biomolecules of P. longum responsible for the synergy in S. aureus.
Alaa Mohammed;Mohammed Kadhom;Marwa Fadhil;Alhamzah D. Hameed;Ahmed Imad;Ahmed Alamiery;Muna Bufaroosha;Rahimi M. Yusop;Ali Jawad;Emad Yousif
Analytical Science and Technology
/
v.37
no.4
/
pp.251-260
/
2024
As polymers became very important in our lives, their negative impact on general health and the environment raised a serious issue. Here, enhancing their life term is presented as a compromise solution between the need and harm. In the study, six PVC films, the plain and five filled with improvers, underwent radiation exposure for 300 hours at room temperature to investigate their photodegradation rates. The modified films were embedded with organotin(IV) complex derivatives (Ph3SnL, Ph2SnL2, Bu3SnL, Bu2SnL2, and Me2SnL2 (where L is levofloxacin)), and their effectiveness was evaluated. The PVC films were compared before and after exposure to various tests including UV-Vis spectroscopy, gel content analysis, theoretical calculations, and EDX microscopy. Findings indicated that the presence of organotin(IV) complex derivatives, particularly Ph3SnL, notably decreased UV light absorbance and the amount of gel content in PVC sheets in comparison to untreated PVC. Furthermore, EDX analysis showed that the PVC-Ph3SnL blend exposed to radiation exhibited the highest chlorine content, reaching 30 %. This blend demonstrated superior efficacy in stabilizing the polymeric materials.
Jeon, Bong-Hee;Kim, Miok;Kim, Jeong Hong;Shin, Sang Yop;Lee, Jaechun
Tuberculosis and Respiratory Diseases
/
v.66
no.5
/
pp.358-364
/
2009
Background: The appropriate empirical antimicrobial choice in the treatment of community-acquired pneumonia (CAP) should be advocated by community-based information on the etiologic pathogens, their susceptibility to antimicrobials, clinical characteristics and outcomes. Jeju is a geographically isolated and identical region in Korea. However, there is no regional reference on adult CAP available. This study investigated the etiologic agents and clinical outcomes of adult patients diagnosed with CAP in Jeju, Korea, to help guide the empirical antimicrobial choice. Methods: A prospective observational study for one year in a referral hospital in Jeju, Korea. Patients diagnosed with CAP were enrolled with their clinical characteristics. Microbiological evaluations to identify the etiologic agents in the adult patients with CAP were performed with blood culture, expectorated sputum smear and culture, antibody tests for mycoplasma, chlamydophila, and antigen tests for legionella and pneumococcus. The clinical outcomes of the initial empirical treatment were analyzed. Results: Two hundred and three patients with mean age of 64 and 79 females were enrolled. Ten microbials from 90 cases (44.3%) were isolated and multiple isolates were confirmed in 30. Among the microbial isolates, S. pneumoniae (36.3%) was the most common, followed by M. pneumoniae (23.0%), C. pneumoniae (17.0%), S. aureus (9.6%) and P. aeruginosa (5.9%). The initial treatment failure (23.8%) was related to the isolation of polymicrobial pathogens, elevated inflammatory markers, and the presence of pleural effusion. Among the 30 isolates of S. pneumoniae, 16 (53.3%) were not susceptible to penicillin, and 19 isolates (63.3%) to erythromycin and clarithromycin. However, 29 isolates (96.7%) were susceptible to levofloxacin and ceftriaxone. Conclusion: S. pneumoniae, M. pneumoniae, S. aureus, and P. aeruginosa are frequent etiologic agents of adult CAP in Jeju, Korea. The clinical characteristics and antibiotic resistance should be considered when determining the initial empirical antimicrobial choice. Respiratory quinolone or ceftriaxone is recommended as an empirical antimicrobiotic in the treatment of adult CAP in Jeju, Korea.
Jo, Yun Ju;Lee, Eun Jeong;Choi, Kyong Min;Eun, Young Min;Yoo, Hwang Jae;Kim, Cheol Hong;Lee, Hyun Hee;Kim, Pyung Kil
Pediatric Infection and Vaccine
/
v.17
no.1
/
pp.30-35
/
2010
Purpose : We investigated the causative organism and its antibiotic susceptibility of community acquired urinary tract infection (UTI) in children at a secondary hospital to test the adequacy of the current guidelines. Methods : Children diagnosed with UTI at the Department of Pediatrics, Kwandong University MyMyongji Hospital by pyuria and bacterial growth of greater than $1.0{\times}10^5CFU/mL$ on clean catch midstream urine from January 2005 to December 2008 were studied retrospectively. The epidemiologic data, causative organism, and the antibiotic susceptibility were analyzed. Results : Sixty two children were diagnosed with sixty four cases of UTI's. Two bacteria were isolated in one case and thus data on 65 urine cultures were analyzed. The male:female ratio was 1.6:1 and 78.1% were less than 12 months of age. Escherichia coli was the predominant cause consisting of 53 cases (82.8%) of the cases. K. pneumoniae (5), Enterobacter (4), Enterococcus (1), $\beta$-streptococcus (1), Diphtheroides (1) were isolated. The antibiotic resistance of E. coli were as follows; ampicillin 69.8%, cefotaxime 1.9%, gentamicin 15.1%, amikacin 0.0%, levofloxacin 1.9%, and trimethoprim/sulfamethoxazole 26.4 %. Only one case of the E. coli was extended spectrum $\beta$-lactamase (ESBL) positive. Conclusion : Compared to prior reports from other tertiary hospitals in Korea, E. coli was the predominant cause in childhood UTI and the rate of ESBL positivity was low. The antibiotic resistance was also different compared to prior reports. We conclude that a difference in the cause and antibiotic resistance of childhood UTI exists between centers and this should be taken into consideration when prescribing antibiotics for childhood UTIs.
Kim, Joon-Woo;Kim, Jong-Gu;Jang, Hyo-Sang;Cho, Hyeon-Seo;Takao, Yuji;Arizono, Koji
Journal of Environmental Science International
/
v.18
no.3
/
pp.245-254
/
2009
In recent years, environmental pollution by phannaceuticals and personal care products (PPCPs) in the aquatic environment is of great concern worldwide. Recent studies have been reported to occur in a variety of environmental organisms such as surface, drinking and ground water, soils, sediments and hospitals. The purpose of this study was to evaluate the occurrence and environmental behavior of fourteen human PPCPs in surface waters of Mankyung River in South Korea. We were conducted to field survey for water quality and PPCPs analysis at November, 2006. PPCPs were analyzed by liquid chromatograph coupled with a tandem mass spectrometer (HPLC-MS/MS). The concentration of COD was measured to be 2.37$\sim$19.71 mg/L, which was belong to 4$\sim$5 grade in water quality criteria of lake. Station 2 that there is no pollution in upper stream, was appeared to lower concentration. The concentration of TN and TP, that is cause matter of eutrophication, were found to be 7.78$\sim$35.42 mg/L and 0.08$\sim$0.95 mg/L, respectively, which were exceeding 5 grade in Lake water quality criteria. The 11 kind of PPCPs compounds except levofloxacin and triclosan were detected to Mankyung river. PPCPs concentrations of STP(Sewer Treatment Plant) effluents and aquatic environment in Mankyung river have been detected in the range from dozens of ng/L to hundreds of ${\mu}g/L$ that by order of atenolol, carbamazepine, propranolol, Ibuprofen, erythromycin, ifenprodil, clarithromycin, mefenamic acid, fluconazole, indomethacin, disopyramide. PPCPs concentration of Station 1 and 5, which was influenced by Jeonju STP and Wanju STP, was detected high values. Station 2 that there is no pollution, showed lower values. Station 3 which joined Gosan stream and Jeonju stream and station 4 which influenced by stock wastewater was detected to low values.
Helicobacter pylori as the second most common cause of gastric cancer in the world infects approximately half of the developed countries population and 80% of the population living in developing countries. Integrons as genetic reservoirs play major roles in dissemination of antimicrobial resistance genes. To the best of our knowledge, this is the first study to report carriage of class 1 and 2 integrons and associated gene cassettes in H. pylori isolates from Iran. This cross-sectional study was conducted in Tehran among 110 patients with H. pylori infection. Antimicrobial susceptibility testing (AST) for H. pylori strains were assessed by the micro broth dilution method. Class 1 and 2 integrons were detected using PCR. In order to determine gene cassettes, amplified fragments were subjected to DNA sequencing of both amplicon strands. The prevalence of resistance to clarithromycin, metronidazole, clarithromycin, tetracycline, amoxicillin, rifampin, and levofloxacin were 68.2% (n=75), 25.5% (n=28), 24.5% (n=27), 19.1% (n=21), 18.2% (n=20) and 16.4% (n=18), respectively. Frequency of multidrug resistance among H. pylori isolates was 12.7%. Class 2 integron was detected in 50 (45.5%) and class 1 integron in 10 (9.1%) H. pylori isolates. The most predominant gene cassette arrays in class 2 integron-bearing H. pylori were included sat-era-aadA1, dfrA1-sat2-aadA1, blaoxa2 and, aadB whereas common gene cassette arrays in class 1 integron were aadB-aadA1-cmlA6, aacA4, blaoxa2, and catB3. The high frequency of class 2 integron and multidrug resistance in the present study should be considered as a warning for clinicians that continuous surveillance is necessary to prevent the further spread of resistant isolates.
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