AIM: To investigate whether adding ecabet sodium to the standard triple therapy for H pylori infection improve eradication rate. METHODS: Two hundred and fifty-seven H pylori-infected patients were randomly assigned t...AIM: To investigate whether adding ecabet sodium to the standard triple therapy for H pylori infection improve eradication rate. METHODS: Two hundred and fifty-seven H pylori-infected patients were randomly assigned to standard triple therapy (group A, n = 129) or triple therapy plus ecabet sodium (group B, n = 128). Successful eradication was defined as a negative 13C-urea breath test 6-8 wk after completion of treatment. RESULTS: After completion of therapy, 194/257 patients showed negative 13C-urea breath test results. According to intention-to-treat analysis, the infection was eradicated in 93/129 (72.1%) patients in group A and 101/128 (78.9%) in group B (P = 0.204). Per-protocol analysis showed successful eradication in 93/118 (78.8%) patients from group A and 101/114 (88.6%) from group B (P = 0.044). There were no significant differences in the side effects experienced by the patients in the two treatment groups. CONCLUSION: Our results suggest that the addition of ecabet sodium improves the efficacy of the standard triple therapy for H pylori.展开更多
为了定量测定依卡倍特钠中潜在遗传毒性杂质依卡倍特磺酸乙酯(杂质Ⅰ),参考文献方法合成依卡倍特磺酸乙酯。采用高分辨质谱、结合二级质谱与核磁共振确定其相对分子质量及化学结构。采用Thermo C18色谱柱,以5 mmol/L乙酸铵溶液(甲酸调p ...为了定量测定依卡倍特钠中潜在遗传毒性杂质依卡倍特磺酸乙酯(杂质Ⅰ),参考文献方法合成依卡倍特磺酸乙酯。采用高分辨质谱、结合二级质谱与核磁共振确定其相对分子质量及化学结构。采用Thermo C18色谱柱,以5 mmol/L乙酸铵溶液(甲酸调p H至3.0)为流动相A;乙腈为流动相B,按照梯度:0 min 50%B,4 min 50%B,12 min 80%B,16 min 80%B,16.1 min 50%B,20 min 50%B进行洗脱,柱温40℃;采用电喷雾负离子化-MS/MS选择反应监测。杂质Ⅰ的线性质量浓度范围为4~150 ng/m L,且线性关系良好(r=0.999);最低定量限为4 ng/m L;杂质Ⅰ的进样精密度、重复性和加标回收率良好,耐用性良好。方法操作简便,灵敏度高,可用于依卡倍特钠原料药中潜在遗传毒性杂质依卡倍特磺酸乙酯的含量测定。展开更多
基金An unrestricted grant by JEIL Pharm.Co.,Ltd.,Korea
文摘AIM: To investigate whether adding ecabet sodium to the standard triple therapy for H pylori infection improve eradication rate. METHODS: Two hundred and fifty-seven H pylori-infected patients were randomly assigned to standard triple therapy (group A, n = 129) or triple therapy plus ecabet sodium (group B, n = 128). Successful eradication was defined as a negative 13C-urea breath test 6-8 wk after completion of treatment. RESULTS: After completion of therapy, 194/257 patients showed negative 13C-urea breath test results. According to intention-to-treat analysis, the infection was eradicated in 93/129 (72.1%) patients in group A and 101/128 (78.9%) in group B (P = 0.204). Per-protocol analysis showed successful eradication in 93/118 (78.8%) patients from group A and 101/114 (88.6%) from group B (P = 0.044). There were no significant differences in the side effects experienced by the patients in the two treatment groups. CONCLUSION: Our results suggest that the addition of ecabet sodium improves the efficacy of the standard triple therapy for H pylori.
文摘为了定量测定依卡倍特钠中潜在遗传毒性杂质依卡倍特磺酸乙酯(杂质Ⅰ),参考文献方法合成依卡倍特磺酸乙酯。采用高分辨质谱、结合二级质谱与核磁共振确定其相对分子质量及化学结构。采用Thermo C18色谱柱,以5 mmol/L乙酸铵溶液(甲酸调p H至3.0)为流动相A;乙腈为流动相B,按照梯度:0 min 50%B,4 min 50%B,12 min 80%B,16 min 80%B,16.1 min 50%B,20 min 50%B进行洗脱,柱温40℃;采用电喷雾负离子化-MS/MS选择反应监测。杂质Ⅰ的线性质量浓度范围为4~150 ng/m L,且线性关系良好(r=0.999);最低定量限为4 ng/m L;杂质Ⅰ的进样精密度、重复性和加标回收率良好,耐用性良好。方法操作简便,灵敏度高,可用于依卡倍特钠原料药中潜在遗传毒性杂质依卡倍特磺酸乙酯的含量测定。
