To develop near-infrared （NIR） reflectance spectroscopic methods for the quantitative analysis of cefoperazone sodium/ sulbactam sodium from different manufacturers for injection powder medicaments. Various powders ...To develop near-infrared （NIR） reflectance spectroscopic methods for the quantitative analysis of cefoperazone sodium/ sulbactam sodium from different manufacturers for injection powder medicaments. Various powders of cefoperazone sodium/ sulbactam sodium were directly analyzed by non-destructive NIR reflectance spectroscopy using the spectrometer EQUINOX55. Two quantitative methods via integrating sphere （IS） and fiberoptic probe （FOP） models were explored from 6 batches of commercial samples and 42 batches of laboratory samples at a content ranging from 30% to 70% for cefoperazone and 60% to 20% for sulbactam. The root mean square errors of cross validation （RMSECV） and the root mean square errors of prediction （RMSEP） of IS were 1.79% and 2.85%, respectively, for cefoperazone sodium, and were 1.86% and 3.08%, respectively, for sulbactam sodium; and those of FOP were 2.93% and 2.92%, respectively, for cefoperazone sodium, and were 2.23% and 3.01%, respectively, for sulbactam sodium. Based on the ICH guidelines and Ref. 12, the quantitative models were then evaluated in terms of specificity, linearity, accuracy, precision, robustness and model transferability. The non-destructive quantitative NIR methods used in this study are applicable for rapid analysis of injectable powdered drugs from different manufacturers.展开更多
目的探究肾功能亢进(augmented renal clearance,ARC)对重症监护病房(intensive care unit,ICU)老年患者注射用头孢哌酮舒巴坦钠应用疗效的预测价值,为相关临床诊治工作提供理论参考。方法选取2020年1月-2021年12月临沂市人民医院重症...目的探究肾功能亢进(augmented renal clearance,ARC)对重症监护病房(intensive care unit,ICU)老年患者注射用头孢哌酮舒巴坦钠应用疗效的预测价值,为相关临床诊治工作提供理论参考。方法选取2020年1月-2021年12月临沂市人民医院重症医学科收治的老年患者528例,根据是否发生ARC将其分为ARC组(n=106)和非ARC组(n=422)。收集两组一般临床资料、注射用头孢哌酮舒巴坦钠稳态谷浓度(用药前半小时采集患者的血液进行稳态谷浓度检测)及注射用头孢哌酮舒巴坦钠应用疗效,并进行对比。采用单因素及多因素Logistic回归分析筛选重症老年患者注射用头孢哌酮舒巴坦钠应用疗效的相关影响因素,采用受试者工作特征曲线评估各项影响因素对重症老年患者注射用头孢哌酮舒巴坦钠应用疗效的预测价值。结果本研究ARC发生率为20.1%。两组性别、体质量指数、总蛋白、白蛋白、球蛋白、白球比、谷丙转氨酶、总胆红素、尿酸等差异均无统计学意义(P>0.05)。与非ARC组比较,ARC组年龄较小、尿素氮水平较低、肌酐水平较低、肌酐清除率水平较高、肾小球滤过率水平较高,差异均有统计学意义(P<0.05)。两组注射用头孢哌酮舒巴坦钠稳态谷浓度及临床结局差异均有统计学意义(P<0.05)。与非ARC组比较,ARC组住院天数较长、死亡人数占比较高,差异均有统计学意义(P<0.05)。多因素Logistic回归分析显示,ARC、年龄、尿素氮、肌酐、肌酐清除率、肾小球滤过率均是影响注射用头孢哌酮舒巴坦钠应用疗效的独立危险因素(P<0.05)。绘制受试者工作特征曲线显示,ARC预测ICU老年患者注射用头孢哌酮舒巴坦钠应用疗效的曲线下面积为0.828,敏感度89.69%,特异度78.28%。结论ARC对ICU老年患者注射用头孢哌酮舒巴坦钠应用疗效具有良好的预测价值。展开更多
目的:观察头孢哌酮钠舒巴坦钠联合参麦注射液治疗老年卒中相关性肺炎(SAP)的疗效和安全性。方法:选择2016年3月-2017年3月达州市中心医院收治的84例SAP患者,按随机数字表法分为对照组(42例)和观察组(42例)。在常规治疗的基础上,对照组...目的:观察头孢哌酮钠舒巴坦钠联合参麦注射液治疗老年卒中相关性肺炎(SAP)的疗效和安全性。方法:选择2016年3月-2017年3月达州市中心医院收治的84例SAP患者,按随机数字表法分为对照组(42例)和观察组(42例)。在常规治疗的基础上,对照组患者给予注射用头孢哌酮钠舒巴坦钠3 g,加入5%葡萄糖注射液100 m L,静脉滴注,每日2次;并依据病原学检查及药敏试验结果选择合适的抗菌药物。观察组患者在对照组治疗的基础上给予参麦注射液100 m L,加入5%葡萄糖注射液250 m L中,静脉滴注,每日1次。两组患者均连续治疗2周。观察两组患者的临床疗效,治疗前后T淋巴细胞亚群(CD4^+、CD8^+、CD4^+/CD8^+)、炎症标志物[血清肿瘤坏死因子α(TNF-α)、超敏C反应蛋白(hs-CRP)、降钙素原(PCT)]水平、住院时间,并记录不良反应发生情况。结果:观察组患者总有效率(95.24%)和显效率(47.62%)均显著高于对照组的83.33%和23.81%,住院时间[(15.24±3.53)d]显著短于对照组[(18.43±4.21)d],差异均有统计学意义(P<0.05)。治疗后,两组患者CD4^+、CD4^+/CD8^+水平均显著高于同组治疗前,且观察组显著高于对照组;两组患者CD8^+、TNF-α、hs-CRP、PCT水平均显著低于同组治疗前,且观察组显著低于对照组,差异均有统计学意义(P<0.05)。两组患者不良反应总发生率比较,差异均无统计学意义(P>0.05)。结论:在常规治疗的基础上,头孢哌酮钠舒巴坦钠联合参麦注射液治疗SAP疗效显著,可有效改善患者免疫功能,降低机体炎症水平,缩短住院时间,且未增加不良反应的发生。展开更多
基金National Key Technologies R&D Program Foundation of China (Grant No. 2006BAK04A11)
文摘To develop near-infrared （NIR） reflectance spectroscopic methods for the quantitative analysis of cefoperazone sodium/ sulbactam sodium from different manufacturers for injection powder medicaments. Various powders of cefoperazone sodium/ sulbactam sodium were directly analyzed by non-destructive NIR reflectance spectroscopy using the spectrometer EQUINOX55. Two quantitative methods via integrating sphere （IS） and fiberoptic probe （FOP） models were explored from 6 batches of commercial samples and 42 batches of laboratory samples at a content ranging from 30% to 70% for cefoperazone and 60% to 20% for sulbactam. The root mean square errors of cross validation （RMSECV） and the root mean square errors of prediction （RMSEP） of IS were 1.79% and 2.85%, respectively, for cefoperazone sodium, and were 1.86% and 3.08%, respectively, for sulbactam sodium; and those of FOP were 2.93% and 2.92%, respectively, for cefoperazone sodium, and were 2.23% and 3.01%, respectively, for sulbactam sodium. Based on the ICH guidelines and Ref. 12, the quantitative models were then evaluated in terms of specificity, linearity, accuracy, precision, robustness and model transferability. The non-destructive quantitative NIR methods used in this study are applicable for rapid analysis of injectable powdered drugs from different manufacturers.
文摘目的探究肾功能亢进(augmented renal clearance,ARC)对重症监护病房(intensive care unit,ICU)老年患者注射用头孢哌酮舒巴坦钠应用疗效的预测价值,为相关临床诊治工作提供理论参考。方法选取2020年1月-2021年12月临沂市人民医院重症医学科收治的老年患者528例,根据是否发生ARC将其分为ARC组(n=106)和非ARC组(n=422)。收集两组一般临床资料、注射用头孢哌酮舒巴坦钠稳态谷浓度(用药前半小时采集患者的血液进行稳态谷浓度检测)及注射用头孢哌酮舒巴坦钠应用疗效,并进行对比。采用单因素及多因素Logistic回归分析筛选重症老年患者注射用头孢哌酮舒巴坦钠应用疗效的相关影响因素,采用受试者工作特征曲线评估各项影响因素对重症老年患者注射用头孢哌酮舒巴坦钠应用疗效的预测价值。结果本研究ARC发生率为20.1%。两组性别、体质量指数、总蛋白、白蛋白、球蛋白、白球比、谷丙转氨酶、总胆红素、尿酸等差异均无统计学意义(P>0.05)。与非ARC组比较,ARC组年龄较小、尿素氮水平较低、肌酐水平较低、肌酐清除率水平较高、肾小球滤过率水平较高,差异均有统计学意义(P<0.05)。两组注射用头孢哌酮舒巴坦钠稳态谷浓度及临床结局差异均有统计学意义(P<0.05)。与非ARC组比较,ARC组住院天数较长、死亡人数占比较高,差异均有统计学意义(P<0.05)。多因素Logistic回归分析显示,ARC、年龄、尿素氮、肌酐、肌酐清除率、肾小球滤过率均是影响注射用头孢哌酮舒巴坦钠应用疗效的独立危险因素(P<0.05)。绘制受试者工作特征曲线显示,ARC预测ICU老年患者注射用头孢哌酮舒巴坦钠应用疗效的曲线下面积为0.828,敏感度89.69%,特异度78.28%。结论ARC对ICU老年患者注射用头孢哌酮舒巴坦钠应用疗效具有良好的预测价值。
文摘目的:观察头孢哌酮钠舒巴坦钠联合参麦注射液治疗老年卒中相关性肺炎(SAP)的疗效和安全性。方法:选择2016年3月-2017年3月达州市中心医院收治的84例SAP患者,按随机数字表法分为对照组(42例)和观察组(42例)。在常规治疗的基础上,对照组患者给予注射用头孢哌酮钠舒巴坦钠3 g,加入5%葡萄糖注射液100 m L,静脉滴注,每日2次;并依据病原学检查及药敏试验结果选择合适的抗菌药物。观察组患者在对照组治疗的基础上给予参麦注射液100 m L,加入5%葡萄糖注射液250 m L中,静脉滴注,每日1次。两组患者均连续治疗2周。观察两组患者的临床疗效,治疗前后T淋巴细胞亚群(CD4^+、CD8^+、CD4^+/CD8^+)、炎症标志物[血清肿瘤坏死因子α(TNF-α)、超敏C反应蛋白(hs-CRP)、降钙素原(PCT)]水平、住院时间,并记录不良反应发生情况。结果:观察组患者总有效率(95.24%)和显效率(47.62%)均显著高于对照组的83.33%和23.81%,住院时间[(15.24±3.53)d]显著短于对照组[(18.43±4.21)d],差异均有统计学意义(P<0.05)。治疗后,两组患者CD4^+、CD4^+/CD8^+水平均显著高于同组治疗前,且观察组显著高于对照组;两组患者CD8^+、TNF-α、hs-CRP、PCT水平均显著低于同组治疗前,且观察组显著低于对照组,差异均有统计学意义(P<0.05)。两组患者不良反应总发生率比较,差异均无统计学意义(P>0.05)。结论:在常规治疗的基础上,头孢哌酮钠舒巴坦钠联合参麦注射液治疗SAP疗效显著,可有效改善患者免疫功能,降低机体炎症水平,缩短住院时间,且未增加不良反应的发生。
