Impact of broad-spectrum antimicrobial treatment on the ecology of intestinal flora

Background

Suppression of intestinal flora by broad-spectrum antimicrobial agents facilitated risk of colonization or infection with resistant pathogen. We aimed to investigate the changes in bowel carriage of target resistant microorganisms (TRO) among patients treated with three different classes of Pseudomonas-sparing broad-spectrum antimicrobial agents (ertapenem, moxifloxacin and flomoxef) with anaerobic coverage. Risk factors for developing colonization of TRO were also analyzed.

莫西沙星治疗老年慢性阻塞性肺疾病急性下呼吸道感染临床评价

目的评价莫西沙星治疗老年慢性阻塞性肺疾病（COPD）合并急性下呼吸道细菌性感染的临床疗效和安全性.方法将65例老年COPD伴急性下呼吸道细菌性感染患者分成两组,莫西沙星组32例,采用莫西沙星0.4 g每日1次,静脉滴注;左氧氟沙星组33例,给予左氧氟沙星0.5 g每日1次,静脉滴注,两组疗程均为7～10 d.结果莫西沙星组治愈率为68.8%,有效率为90.6%,细菌清除率为91.2%;左氧氟沙星组治愈率为60.6%,有效率为87.9%,细菌清除率为90.3%,两组比较差异无显著性（P＞0.05）.结论莫西沙星治疗老年COPD伴急性下呼吸道细菌性感染疗效确切、使用安全.     

利福布丁联合莫西沙星方案治疗耐多药结核病的疗效分析

目的：评价利福布丁联合莫西沙星方案治疗耐多药结核病（MDR-TB）的临床疗效。方法选取经药物敏感性试验确诊的90例肺 MDR-TB 患者,随机分为联合用药组（A 组）和常规治疗组（B 组）,每组各45例。B 组常规使用含莫西沙星方案（6ZKmMfxCsPto ／18Z MfxCsPto）,A 组在此基础上加用利福布丁口服。观察并比较2组患者在治疗后3、6、12、18个月痰液培养结核杆菌阴转率、肺部病灶吸收情况及不良反应的发生率。结果治疗12、18个月后,A 组的痰结核杆菌培养阴转率均高于 B 组（P 均＜0．05）。A 组患者肺部病灶吸收情况优于 B 组（P ＜0．05）。治疗期间2组患者的不良反应均经对症治疗后好转,2组不良反应发生率比较差异无统计学意义（P ＞0．05）。结论采用利福布丁与莫西沙星联合用药方案治疗 MDR-TB 可有效促进痰结核杆菌培养阴转、肺部病灶吸收,且安全性良好。     

莫西沙星联合头孢氨苄治疗老年患者下呼吸道细菌感染的临床疗效

目的探讨莫西沙星联合头孢氨苄治疗老年患者下呼吸道细菌感染的临床疗效及安全性,为临床治疗提供依据。方法收集2013年3月-2014年3月接受治疗的老年下呼吸道细菌感染患者100例,按照随机数字表格法分为观察组与对照组,每组各50例,其中观察组给予莫西沙星联合头孢氨苄治疗,对照组给予头孢氨苄治疗,比较两组患者的临床疗效及不良反应的发生,数据采用SPSS17.0统计软件进行处理。结果下呼吸道感染老年患者共检出病原菌103株,其中革兰阴性菌64株、革兰阳性菌20株、真菌19株,分别占62.1%、19.4%、18.5%;观察组患者治疗总有效率为92.0%,明显高于对照组的72.0%,两组比较差异有统计学意义(P<0.05);两组患者在体温恢复、咳嗽消失、肺部啰音消失、白细胞计数恢复等临床症状、体征消失时间比较,差异有统计学意义(P<0.05);不良反应发生观察组有4例、对照组有5例,两组不良反应发生比较,差异无统计学意义。结论莫西沙星联合头孢氨苄治疗老年患者呼吸道感染的效果明显,不良反应小,可将其作为治疗老年呼吸道感染重要方法。     

Dose optimization of moxifloxacin and linezolid against tuberculosis using mathematical modeling and simulation

Introduction

There is an urgent need for new anti-tuberculosis (TB) drugs and optimization of current TB treatment. Moxifloxacin and linezolid are valuable options for the treatment of drug-resistant TB; however, it is crucial to find a dose at which these drugs not only show high efficacy but also suppress the development of further drug resistance.

阿夫唑嗪联合莫西沙星治疗慢性前列腺炎

【摘要】 目的 探讨阿夫唑嗪联合莫西沙星治疗慢性前列腺炎的临床疗效。 方法 选取2018年2月～2019年2月我院收治的103例慢性前列腺炎患者，采用抽签法分为三组，即阿夫唑嗪组（n=34)，莫西沙星组(n=34)，联合组(n=35)。阿夫唑嗪组给予阿夫唑嗪治疗，莫西沙星组给予莫西沙星治疗，联合组给予阿夫唑嗪联合莫西沙星治疗。比较三组临床疗效、巨噬细胞集落刺激因子（M-CSF）、血清胰石蛋白（PSP）、神经生长因子(NGF)、白细胞介素4（IL-4）、白细胞介素8（IL-8）、肿瘤坏死因子（TNF-α）、最大尿流率（MFR）、平均尿流率（AFR）变化情况及并发症发生情况。 结果 治疗后，联合组临床疗效总有效率均显著高于阿夫唑嗪组、莫西沙星组（P＜0.05）；治疗前，联合组和单药组血清M-CSF、PSP、NGF、IL-4、IL-8、TNF-α水平对比均无显著差异（P＞0.05）；治疗后，三组血清M-CSF、PSP、NGF、IL-4、IL-8、TNF-α〖JP〗均随着时间的推移而下降，且联合组均显著低于阿夫唑嗪组、莫西沙星组（P＜0.05）；治疗前，联合组和单药组排尿情况水平对比无显著差异（P＞0.05）；治疗后，三组MFR、AFR均随着时间的推移而升高，且联合组显著高于阿夫唑嗪组、莫西沙星组（P＜0.05）；联合组并发症发生率与阿夫唑嗪组、莫西沙星组比较，差异无统计学意义（P＞0.05）。 结论 阿夫唑嗪联合莫西沙星治疗慢性前列腺炎疗效显著，可有效改善患者排尿功能，降低炎症反应，且并发症较少,有利于患者康复。     

The emergence of Clostridium difficile PCR ribotype 078 in piglets in the Czech Republic clusters with Clostridium difficile PCR ribotype 078 isolates from Germany,Japan and Taiwan

Clostridium difficile is a major nosocomial pathogen in humans with an increasing incidence in the community. The “one-health” approach of research is needed to investigate possible reservoirs of C. difficile and route of its transmission. The objective of this study is to investigate the occurrence of C. difficile in pigs in the Czech Republic with characterisation of the isolates to determine their genetic relatedness to C. difficile isolates from European and Asian pigs. A total of 198 pig faeces samples from 23 farms were investigated and of those 57 samples (55 piglets, 2 sows) from 11 farms were confirmed as C. difficile positive. The majority of C. difficile isolates belonged to the sequence type 11 and clade 5. The predominant ribotypes were 078 (n = 23), 078-variant (n = 5), 033 (n = 10) followed by RTs 150 (n = 7), 011 (n = 5), 045 (n = 4), 126, 014, 002 (n = 1, each). All isolates were susceptible to metronidazole, vancomycin and tetracycline. Isolates of RTs 150 and 078-variant were moxifloxacin resistant (MIC≥32 mg/L) and carried the amino acid substitution Thr82Ile in the GyrA. A multi-locus variable number tandem-repeats analysis (MLVA) revealed a clonal relatedness of isolates within individual farms and in C. difficile RT078 isolates between two Czech farms. Czech C. difficile RT078 isolates clustered with German C. difficile RT078 isolates and Czech C. difficile 078-variant isolates clustered with C. difficile RT078 isolates from Japan and Taiwan. This study found an emergence of C. difficile RT078 in Czech piglets that was related genetically to C. difficile RT078 isolates from Germany, Japan and Taiwan.     

Comparison of azithromycin and moxifloxacin against bacterial isolates causing conjunctivitis

ABSTRACT

Objective: To examine in vitro resistance to azithromycin and moxifloxacin in bacterial conjunctivitis isolates.

Methods: MIC₉₀s (Minimum Inhibitory Concentration) and resistance rates to azithromycin and moxifloxacin were determined based upon microtiter broth dilution and/or antimicrobial gradient test strips in a multicenter phase III study and confirmed externally.

Results: The most common isolates collected from bacterial conjunctivitis patients in the phase III study were Haemophilus influenzae (40.6%), followed by Staphylococcus epidermidis (19.3 %), Propionibacterium acnes (17.3%), Streptococcus pneumoniae (16.8%), and Staphylococcus aureus (0.06%). MIC₉₀s for all of these organisms were well below established resistance breakpoints for moxifloxacin, indicating no bacterial resistance. On the other hand, the MIC₉₀ for H. influenzae was 3-fold higher than the resistance breakpoint for azithromycin, ≥ 128-fold higher for S. epidermidis, 16-fold higher for S. pneumoniae and ≥ 128-fold higher for S. aureus, indicating moderate to very high bacterial resistance to azithromycin.

Conclusions: Resistance to azithromycin is more common than resistance to moxifloxacin in clinical isolates causing bacterial conjunctivitis.     

Assay sensitivity in “Hybrid thorough QT/QTc (TQT)” study

A concurrent positive control should be included in a thorough QTc clinical trial to validate the study according to ICH E14 guidance. Some pharmaceutical companies have started to use “hybrid TQT” study to meet ICH E14 regulatory requirements since the release of ICH E14 Q&A (R3). The “hybrid TQT” study includes the same treatment arms (therapeutic and/or supratherapeutic dose of investigational drug, placebo, and positive control) with sample size less than traditional TQT studies, but use concentration-QTc (C-QTc) analysis as primary analysis and assay sensitivity analysis. To better understand the statistical characteristics of assay sensitivity with a commonly used positive control – Moxifloxacin - in “hybrid TQT” studies, we examined the original and subsampled moxifloxacin and placebo data from more than a hundred of TQT studies submitted to FDA. The assay sensitivity results are quite consistent between classical E14 analysis and C-QTc analysis using the original datasets. Performance of assay sensitivity in “hybrid TQT” studies using subsampled data depends on number of moxifloxacin subjects, study design (crossover design and parallel design), and C-QTc model. The results presented here can aid the design of future “hybrid TQT” studies.     

莫西沙星片联合青霉素经验性治疗非重症社区获得性肺炎的疗效观察

目的:观察莫西沙星片联合青霉素经验性治疗非重症社区获得性肺炎的疗效及安全性。方法:137例门诊非重症社区获得性肺炎患者随机分组,试验组69例,给予莫西沙星片400 mg、qd、口服,联合青霉素480万单位、静脉滴注、bid,疗程6 d;对照组68例,给予莫西沙星氯化钠注射液400 mg、静脉滴注、qd,联合青霉素480万单位、静脉滴注、bid,疗程6 d。观察两组患者的疗效和不良反应。结果:试验组与对照组的治愈率分别为56.52%、60.29%(χ2=0.125,P>0.05),有效率分别为91.30%、94.12%(χ2=0.213,P>0.05)。结论:莫西沙星片联合青霉素经验性治疗门诊非重症社区获得性肺炎是一种既有效又经济的治疗方案。