<strong>Background:</strong><span><span><span style="font-family:""><span style="font-family:Verdana;"> Group B </span><i><span style="f...<strong>Background:</strong><span><span><span style="font-family:""><span style="font-family:Verdana;"> Group B </span><i><span style="font-family:Verdana;">Streptococcus </span></i><span style="font-family:Verdana;">(GBS) is a major cause of bacterial infections in the perinatal period, of which colonization prevalence among Northern-Nigerian pregnant women is scarce. We attempted to determine </span></span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">1</span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">) its prevalence</span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">,</span></span></span><span><span><span style="font-family:""> </span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">2</span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">) risk factors for GBS colonization and </span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">3</span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">) drugs-susceptibility.</span></span></span><span><span><span style="font-family:""> </span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><b><span style="font-family:Verdana;">Methodology:</span></b></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;"> This cross-sectional study involved 185 pregnant women between 35</span></span></span><span><span><span style="font-family:""> </span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">-</span></span></span><span><span><span style="font-family:""> </span></span></span><span><span><span style="font-family:""><span style="font-family:Verdana;">37 weeks of gestation at tertiary health center of Sokoto, Nigeria. </span><span style="font-family:Verdana;">Vaginal/rectal swabs were collected, were cultured for GBS and tested for drug-</span><span style="font-family:Verdana;">susceptibilities. The study was conducted between December, 2017 and April, </span><span style="font-family:Verdana;">2018.</span></span></span></span><span><span><span style="font-family:""> </span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><b><span style="font-family:Verdana;">Results:</span></b></span></span><span><span><span style="font-family:""> <a name="_Toc14800008"></a><span style="font-family:Verdana;">One hundred and eighty five (185) pregnant women participated </span></span></span></span><span><span><span><span style="font-family:""><span style="font-family:Verdana;">in this study. GBS vaginal-colonization-rate was 3.8% (7/185). A significance relationship was observed between GBS-colonization and socio-economic class, as 57.10% (4/7) of the GBS positive women were of low-socio economic class (</span><i><span style="font-family:Verdana;">p</span></i><span style="font-family:Verdana;"> 0.035). No associations were observed between GBS-colonization and the followings: maternal age, parity, poor obstetric outcome-history. All the 7 GBS positive cultures were sensitive to Clindamycin. One was sensitive to both Clindamycin and Ceftriaxone. None was sensitive to Penicillin. </span><b><span style="font-family:Verdana;">Conclusion</span></b></span></span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><b><span style="font-family:Verdana;">:</span></b></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;"> The prevalence of GBS colonization was low in this area. Maternal socio-economic class is found to be a risk of GBS-colonization.</span></span></span>展开更多
目的:评价产科胎膜早破(PROM)患者B族链球菌(GBS)感染预防药物临床路径(以下简称“临床药径”)的应用效果。方法:针对某院产科PROM患者GBS感染的抗菌药物预防性使用中存在的问题,制定了PROM患者GBS感染预防临床药径,分为足月PROM、≥34 ...目的:评价产科胎膜早破(PROM)患者B族链球菌(GBS)感染预防药物临床路径(以下简称“临床药径”)的应用效果。方法:针对某院产科PROM患者GBS感染的抗菌药物预防性使用中存在的问题,制定了PROM患者GBS感染预防临床药径,分为足月PROM、≥34 w未足月PROM(PPROM)、<34 w PPROM,“医药护”三师联动对PROM患者GBS感染预防进行管理。对比临床药径实施前后PROM患者GBS感染预防抗菌药物使用的合理性、抗菌药物使用强度、药物经济学(住院时间、抗菌药物费用)等指标。结果:临床药径实施后PROM患者GBS感染预防用药的药物选择、给药时机、疗程合理率均有显著升高(P<0.05)。足月PROM、≥34 w PPROM患者的用药疗程均较前显著缩短(P<0.05)。足月PROM平均住院时间缩短0.7 d,平均抗菌药物费用下降8.86元/人,与实施前比较,差异有统计学意义(P<0.05)。抗菌药物使用强度呈明显下降趋势,最低下降至9.78DDD。结论:建立产科PROM患者GBS感染预防临床药径切实可行,有效降低了医疗成本、住院天数及抗菌药物使用强度,在保障围产期PROM患者母婴安全中发挥积极作用。展开更多
2020年,国家药品监督管理局颁布了《模型引导的药物研发技术指导原则》等技术指南,为建模与模拟技术在新药研发中的应用提供了技术指导。2022年7月,为了解国内新药研发企业在模型引导的药物研发(model-informed drug development,MIDD)...2020年,国家药品监督管理局颁布了《模型引导的药物研发技术指导原则》等技术指南,为建模与模拟技术在新药研发中的应用提供了技术指导。2022年7月,为了解国内新药研发企业在模型引导的药物研发(model-informed drug development,MIDD)方面的实践情况,药品审评中心对制药工业界在新药研发中应用MIDD的实践能力进行了问卷调查。本文主要针对收集到的企业反馈数据,分析MIDD技术在国内制药工业界的实践情况,并对当前仍存在的部分问题进行简要讨论。展开更多
文摘<strong>Background:</strong><span><span><span style="font-family:""><span style="font-family:Verdana;"> Group B </span><i><span style="font-family:Verdana;">Streptococcus </span></i><span style="font-family:Verdana;">(GBS) is a major cause of bacterial infections in the perinatal period, of which colonization prevalence among Northern-Nigerian pregnant women is scarce. We attempted to determine </span></span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">1</span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">) its prevalence</span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">,</span></span></span><span><span><span style="font-family:""> </span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">2</span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">) risk factors for GBS colonization and </span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">3</span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">) drugs-susceptibility.</span></span></span><span><span><span style="font-family:""> </span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><b><span style="font-family:Verdana;">Methodology:</span></b></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;"> This cross-sectional study involved 185 pregnant women between 35</span></span></span><span><span><span style="font-family:""> </span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">-</span></span></span><span><span><span style="font-family:""> </span></span></span><span><span><span style="font-family:""><span style="font-family:Verdana;">37 weeks of gestation at tertiary health center of Sokoto, Nigeria. </span><span style="font-family:Verdana;">Vaginal/rectal swabs were collected, were cultured for GBS and tested for drug-</span><span style="font-family:Verdana;">susceptibilities. The study was conducted between December, 2017 and April, </span><span style="font-family:Verdana;">2018.</span></span></span></span><span><span><span style="font-family:""> </span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><b><span style="font-family:Verdana;">Results:</span></b></span></span><span><span><span style="font-family:""> <a name="_Toc14800008"></a><span style="font-family:Verdana;">One hundred and eighty five (185) pregnant women participated </span></span></span></span><span><span><span><span style="font-family:""><span style="font-family:Verdana;">in this study. GBS vaginal-colonization-rate was 3.8% (7/185). A significance relationship was observed between GBS-colonization and socio-economic class, as 57.10% (4/7) of the GBS positive women were of low-socio economic class (</span><i><span style="font-family:Verdana;">p</span></i><span style="font-family:Verdana;"> 0.035). No associations were observed between GBS-colonization and the followings: maternal age, parity, poor obstetric outcome-history. All the 7 GBS positive cultures were sensitive to Clindamycin. One was sensitive to both Clindamycin and Ceftriaxone. None was sensitive to Penicillin. </span><b><span style="font-family:Verdana;">Conclusion</span></b></span></span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><b><span style="font-family:Verdana;">:</span></b></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;"> The prevalence of GBS colonization was low in this area. Maternal socio-economic class is found to be a risk of GBS-colonization.</span></span></span>
文摘目的:评价产科胎膜早破(PROM)患者B族链球菌(GBS)感染预防药物临床路径(以下简称“临床药径”)的应用效果。方法:针对某院产科PROM患者GBS感染的抗菌药物预防性使用中存在的问题,制定了PROM患者GBS感染预防临床药径,分为足月PROM、≥34 w未足月PROM(PPROM)、<34 w PPROM,“医药护”三师联动对PROM患者GBS感染预防进行管理。对比临床药径实施前后PROM患者GBS感染预防抗菌药物使用的合理性、抗菌药物使用强度、药物经济学(住院时间、抗菌药物费用)等指标。结果:临床药径实施后PROM患者GBS感染预防用药的药物选择、给药时机、疗程合理率均有显著升高(P<0.05)。足月PROM、≥34 w PPROM患者的用药疗程均较前显著缩短(P<0.05)。足月PROM平均住院时间缩短0.7 d,平均抗菌药物费用下降8.86元/人,与实施前比较,差异有统计学意义(P<0.05)。抗菌药物使用强度呈明显下降趋势,最低下降至9.78DDD。结论:建立产科PROM患者GBS感染预防临床药径切实可行,有效降低了医疗成本、住院天数及抗菌药物使用强度,在保障围产期PROM患者母婴安全中发挥积极作用。
文摘2020年,国家药品监督管理局颁布了《模型引导的药物研发技术指导原则》等技术指南,为建模与模拟技术在新药研发中的应用提供了技术指导。2022年7月,为了解国内新药研发企业在模型引导的药物研发(model-informed drug development,MIDD)方面的实践情况,药品审评中心对制药工业界在新药研发中应用MIDD的实践能力进行了问卷调查。本文主要针对收集到的企业反馈数据,分析MIDD技术在国内制药工业界的实践情况,并对当前仍存在的部分问题进行简要讨论。