两种塞来昔布胶囊在健康受试者中不良事件的比较

Comparison of Adverse Events of Two Celecoxib Capsules in Healthy Subjects

目的比较受试制剂与参比制剂塞来昔布胶囊0.2 g在健康受试者生物等效性试验中不良事件的发生情况。方法入组2018年7—10月84例健康受试者通过在空腹或餐后状态下口服受试制剂或参比制剂塞来昔布胶囊0.2 g生物等效性试验的观察,收集并对比分析两种胶囊引发的不良事件。结果在空腹与餐后两组参与者中,83例服用受试制剂的健康受试者发生不良事件9例,其中空腹组5例,餐后组4例,占10.8%;82例服用参比制剂的健康受试者发生不良事件12例,其中空腹组5例,餐后组7例,占14.6%。两者相比,差异无统计学意义(χ^(2)=0.000、0.916,P>0.05)。以上不良事件均为可预期、轻中度、一过性、可耐受,未见有其他临床意义的症状、体征。结论受试制剂和参比制剂塞来昔布胶囊0.2 g安全性较高,但药物本身不良反应较多,服药后应关注其不良反应。

Objective To compare the occurrence of adverse events between the test preparation and the reference preparation celecoxib capsule 0.2 g in the bioequivalence test of healthy subjects.Methods A total of 84 healthy subjects were enrolled from July to October 2018,and the adverse events caused by the two capsules were collected and analyzed by observing 0.2 g bioequivalence test of the test preparation or reference preparation crecoxib capsule orally in fasting or postpranal state.Results In the fasting and postprandial two groups of participants,83 healthy subjects who took the test preparation had 9 adverse events,including 5 in the fasting group and 4 in the postprandial group,accounting for 10.8%;there were 12 cases of adverse events in 82 healthy subjects taking the reference preparation,including 5 cases in the fasting group and 7 cases in the postprandial group,accounting for 14.6%.Compared with the two groups,the difference was not statistically significant(χ^(2)=0.000,0.916,P>0.05).The above adverse events were all predictable,mild to moderate,transient,tolerable,and no other clinically significant symptoms or signs were seen.Conclusion The test preparation and the reference preparation celecoxib capsule 0.2 g are safer,but the drug itself has many adverse reactions,and attention should be paid to the adverse reactions after taking the drug.