Recent pharmacokinetic studies have demonstrated that gastric acid suppression(AS)reduces exposure of gefitinib.However,the clinical significance of this drug-drug interaction(DDI)has not been determined.We,therefore,...Recent pharmacokinetic studies have demonstrated that gastric acid suppression(AS)reduces exposure of gefitinib.However,the clinical significance of this drug-drug interaction(DDI)has not been determined.We,therefore,evaluated it in this real-world study.A total of 200 NSCLC patients who received gefitinib from 2016 to 2018 at Fudan University Shanghai Cancer Center(FUSCC)were randomly selected.The patients were divided into two groups according to whether AS was used.The clinical characteristics of the patients were collected,and the efficacy and safety of gefitinib were compared between the two groups.We showed that 188 patients were considered eligible for this retrospective analysis,49 received AS(AS user group),while 139 patients did not(AS non-user group).Objective response rate(ORR)and disease control rate(DCR)in the AS user group versus AS non-user group were 69.4%versus 73.4%(P=0.591)and 89.8%versus 90.6%(P=0.486),respectively,while the progression-free survival(PFS)were 9.7 versus 12.2 months(P=0.0644).No significant difference in ORR,DCR or PFS was observed between the two groups.Further study showed that the PFS was related to the time of co-administration,and the patients receiving over 50%AS prescription overlap with gefitinib was significantly less compared with the other people(8.4 vs 12.6 months,P=0.0004).The frequencies of rash(8.2%vs 15.1%,P=0.281),diarrhea(4.1%vs 6.5%,P=0.539)and elevated ALT or AST level(6.1%vs 10.1%,P=0.407)were similar for both groups.Therefore,concomitant use of AS and gefitinib might affect the efficacy of gefitinib,which should be avoided if possible.展开更多
目的评估在静配中心应用密闭式药物配制和转运系统(closed-system drug transfer device,CSTD)对细胞毒性药物在工作环境中污染残留量的影响。方法利用环磷酰胺为示例药物,通过WIPE采样法和高效液相色谱法定量检测复旦大学附属肿瘤医院...目的评估在静配中心应用密闭式药物配制和转运系统(closed-system drug transfer device,CSTD)对细胞毒性药物在工作环境中污染残留量的影响。方法利用环磷酰胺为示例药物,通过WIPE采样法和高效液相色谱法定量检测复旦大学附属肿瘤医院静配中心配制舱内环境中环磷酰胺残留量。在常规配制方法配药的一个工作日配药结束时清理前、清理后以及连续应用3周CSTD进行配药工作后,分别进行3批采样。采样位置包括3个生物安全柜(BSC)操作台面、转运小推车、出舱台等19个位置。比较3批样本中环磷酰胺的残留量。结果常规配药清理去污前各监测点中位值为1.30(IRQ:0.24,2.60)ng/cm^2,去污后中位值为0.22(IRQ:0.08,0.53)ng/cm^2,前后比较差异有统计学意义(P<0.001)。CSTD系统配药后,各监测点中位值为0.06(0.02,0.88)ng/cm^2,明显低于常规方法去污前(P<0.001),也低于常规方法去污后,但差异无统计学意义(P=0.299)。结论应用CSTD可有效减少细胞毒性药物在配制转运过程中的渗漏污染,从而显著减少相关医务人员的毒性药物职业暴露。展开更多
文摘Recent pharmacokinetic studies have demonstrated that gastric acid suppression(AS)reduces exposure of gefitinib.However,the clinical significance of this drug-drug interaction(DDI)has not been determined.We,therefore,evaluated it in this real-world study.A total of 200 NSCLC patients who received gefitinib from 2016 to 2018 at Fudan University Shanghai Cancer Center(FUSCC)were randomly selected.The patients were divided into two groups according to whether AS was used.The clinical characteristics of the patients were collected,and the efficacy and safety of gefitinib were compared between the two groups.We showed that 188 patients were considered eligible for this retrospective analysis,49 received AS(AS user group),while 139 patients did not(AS non-user group).Objective response rate(ORR)and disease control rate(DCR)in the AS user group versus AS non-user group were 69.4%versus 73.4%(P=0.591)and 89.8%versus 90.6%(P=0.486),respectively,while the progression-free survival(PFS)were 9.7 versus 12.2 months(P=0.0644).No significant difference in ORR,DCR or PFS was observed between the two groups.Further study showed that the PFS was related to the time of co-administration,and the patients receiving over 50%AS prescription overlap with gefitinib was significantly less compared with the other people(8.4 vs 12.6 months,P=0.0004).The frequencies of rash(8.2%vs 15.1%,P=0.281),diarrhea(4.1%vs 6.5%,P=0.539)and elevated ALT or AST level(6.1%vs 10.1%,P=0.407)were similar for both groups.Therefore,concomitant use of AS and gefitinib might affect the efficacy of gefitinib,which should be avoided if possible.
文摘目的评估在静配中心应用密闭式药物配制和转运系统(closed-system drug transfer device,CSTD)对细胞毒性药物在工作环境中污染残留量的影响。方法利用环磷酰胺为示例药物,通过WIPE采样法和高效液相色谱法定量检测复旦大学附属肿瘤医院静配中心配制舱内环境中环磷酰胺残留量。在常规配制方法配药的一个工作日配药结束时清理前、清理后以及连续应用3周CSTD进行配药工作后,分别进行3批采样。采样位置包括3个生物安全柜(BSC)操作台面、转运小推车、出舱台等19个位置。比较3批样本中环磷酰胺的残留量。结果常规配药清理去污前各监测点中位值为1.30(IRQ:0.24,2.60)ng/cm^2,去污后中位值为0.22(IRQ:0.08,0.53)ng/cm^2,前后比较差异有统计学意义(P<0.001)。CSTD系统配药后,各监测点中位值为0.06(0.02,0.88)ng/cm^2,明显低于常规方法去污前(P<0.001),也低于常规方法去污后,但差异无统计学意义(P=0.299)。结论应用CSTD可有效减少细胞毒性药物在配制转运过程中的渗漏污染,从而显著减少相关医务人员的毒性药物职业暴露。
