新型灌肠操作在美沙拉秦灌肠剂临床试验健康受试者中的应用效果  

Application effect of a new enema administration operation clinical trial of mesalazine enema in healthy subjects

作　　者：余姝彦 曹艳佩 杨晓莉 朱茉莉 徐婕 戎兰 郁继诚[1] 唐兴雨 曹国英[1] 吴菊芳 张菁[1] 梁虹 王晶晶[1] YU Shuyan;CAO Yanpei;YANG Xiaoli;ZHU Moli;XU Jie;RONG Lan;YU Jicheng;TANG Xingyu;CAO Guoying;WU Jufang;ZHANG Jing;LIANG Hong;WANG Jingjing(PhaseⅠUnit,Huashan Hospital,Fudan University,Shanghai 200040,China;Nursing Department,Huashan Hospital,Fudan University,Shanghai 200040,China;Digestive System Department,Huashan Hospital,Fudan University,Shanghai 200040,China)

机构地区：[1]复旦大学附属华山医院Ⅰ期临床研究中心,上海200040 [2]复旦大学附属华山医院护理部,上海200040 [3]复旦大学附属华山医院消化科,上海200040

出　　处：《中国临床药学杂志》2023年第4期263-266,共4页Chinese Journal of Clinical Pharmacy

基　　金：复旦大学-复星护理科研基金(编号FNF202162)。

摘　　要：目的 评估新型灌肠操作对美沙拉秦灌肠剂直肠给药的舒适度、安全性及效果。方法 在1项评价中国健康受试者单次和多次给予美沙拉秦灌肠液(颇得斯安灌肠液)的药动学和安全性的开放研究中纳入11例健康受试者,接受每日1次美沙拉秦灌肠剂(1g·100mL^(-1))直肠给药,连续给药7 d。采用数字疼痛分级法对受试者灌肠时/后的舒适度(疼痛评分)进行评价。通过体格检查、生命体征和实验室检查等评估灌肠操作的安全性。通过给药后药液保留时间、纸尿裤质量变化和药物血浆平均暴露量变化评估灌肠操作的给药效果。结果 11例受试者灌肠给药后疼痛评分为(0.73±0.55)分,最高2分,最低0分。所有受试者均完成临床试验,未发现与灌肠操作有关的不良事件。所有受试者保留药液均超过8 h,给药后纸尿裤质量增加低于6.5 g。第1、5和7天给药后药物血浆暴露量(AUC_(0-24h))基本一致。结论 新型灌肠操作在健康受试者接受每日1次、连续7 d美沙拉秦灌肠液(1 g·100 mL^(-1))直肠给药中舒适度、安全性及效果良好,可应用于临床灌肠给药。AIM To evaluate the comfort,safety and effect of the new rectal administration operation in the clinical trial of mesalazine enema.METHODS An open-label,single and multiple dose study investigating pharmacokinetics and safety of PENTASA■ Enema in healthy Chinese subjects was conducted.A total of 11 healthy subjects were rectal administered mesalazine enema(1 g·100 mL^(-1)) once daily for 7 consecutive days.Subjects' comfort assessment(pain level) during/after mesalazine enema administration was measured by Numeric Rating Scale.The safety after rectal administration was evaluated by physical examination,vital signs and laboratory examination,etc.The effect after enema administration was evaluated by drug retention time,diaper weight change and average mesalazine plasma exposure.RESULTS The mean pain score of 11 subjects after enema administration was(0.73 ±0.55) points,with the highest of 2points,the lowest 0 point.All subjects completed the clinical trial with no adverse events related with the enema operation.All subjects got a drug retention time of more than 8 h,and diaper weight gain was less than 6.5 g after administration.There was no significant difference in drug plasma exposure(AUC_(0-24h)) on day 1,5 and 7 of administration.CONCLUSION Healthy subjects who received rectal administration of mesalazine enema(1 g·100 mL^(-1)) once daily for 7 consecutive days have good comfort,safety and effect.The new enema operation provides a scientific basis and standard for clinical enema administration.

关 键 词：美沙拉秦 灌肠剂 临床试验 灌肠操作 

分 类 号：R969[医药卫生—药理学]