治疗窗窄药片5种分剂量准确性研究

目的了解5种治疗窗窄药片分剂量的准确性,为临床合理用药提供参考。方法应用药片切割器、剪刀、刀片对5种药片分剂量成2等份及4等份。结果 5种治疗窗窄药片中,硬度最大和最小的药片分别为氨茶碱、地高辛;直径最大和最小的药片分别为卡马西平、地高辛;厚度最大和最小的药片分别为卡马西平、地高辛。地高辛（切）、苯妥英钠（切）FW1/2和FW1/4与TW1/2和TW1/4比较差异有统计学意义（P〈0.05）;地高辛（剪）、氨茶碱（剪）、华法林钠（剪）、苯妥英钠（剪）FW1/4与TW1/4比较差异有统计学意义（P〈0.05和P〈0.01）;华法林钠（刀）FW1/2和FW1/4与TW1/2和TW1/4比较差异有统计学意义（P〈0.01）。5种药片用3种工具分剂量至少有5片超出质量差异15%,均不符合欧洲药典标准。分剂量成2等份时,应用剪刀超出平均质量15%的药片数均较其他2种方法多;分剂量成4等份时,3种方法超出平均质量15%的药片数均较分剂量成2等份时多。结论 5种治疗窗窄药片应用3种工具分剂量准确性较差,临床用药应引起足够的注意。需要调整给药剂量时,可考虑用液体制剂分剂量。

Accuracy research on divided dose of 5 narrow therapeutic-window tablets

Objective To explore the accuracy of divided dose of 5 narrow therapeutic-window tablets,in order to provide reference for clinical drug use.Methods 5 tablets were splitted to half or quarter with 3 different methods:splitting device,scissor and surgical knife.Results Of the 5 tablets,the most and least hardest drug respectively were aminophylline and digoxin;The longest and shortest diameter drug respectively were carbamazepine and digoxin,which were also with the biggest and smallest thickness respectively.There were statistical significance between FW1/2,FW1/4 and TW1/2,TW1/4 of digoxin(splitting) and phenytoinum(splitting),respectively(P<0.05).There were statistical significance between FW1/4 and TW1/4 of digoxin(scissor),aminophylline(scissor),warfarin sodium (scissor) and phenytoinum(scissor),respectively(P<0.05,P<0.01). There were statistical significance between FW1/2,FW1/4 and TW1/2,TW1/4 of warfarin sodium (knife) respectively(P<0.01).Of 5 tablets,at least 5 tablets of the divided dose were above 15% of the quality variety,which did not conform to EDQM.When divided into half,the number of tablets divided by scissor 15% above average quality was more than the other 2 methods;When divided into quarter,the number of tablets divided by the 3 above methods 15% above the average quality,were respectively more than divided into half.Conclusion Dose accuracy when dividing 5 narrow therapeutic-window tablets is so poor that it is should be paid attention to.When adjusting dose is need,liquid preparation may be a good choice.