李家泰 吕媛 王普玉 陈绍鹏 北京医科大学临床药理研究中心临床药理研究所，北京100034 中国新药与临床杂志 1999 0 18 3


    关键词：青霉素V；片剂；细菌感染；临床试用药物；药物毒性； 药物副反应报告系统；药物监测；多中心研究；售后产品监测 期刊 zgxyylczz 0 论著 fur -->


    

摘要 目的 ：评价10374例细菌性感染病人不做皮试口服青霉素V的安全性及有效性。方法 ：青霉素V250～500mg,po,tid,疗程5d。结果 ：参加疗效评定9063例，显效率42.18%(3823/9063例)，总有效率81.18%(7357/9063例)。1930例病人用药前后做细菌培养,1163例阳性，共培养出致病菌1163株，治疗后细菌清除960株(82.55%)。不良反应发生率0.74%(76/10311例)，44例因不良反应在治疗中被迫停药，主要为胃肠道反应。过敏反应发生率低，仅为0.18%。但没有一例病人出现过敏性休克。1538例病人用药 前后做了肝、肾功能检查：2例ALT升高，发生率为0.13%(2/1538)。结论：不做皮试口服青霉素V治疗细菌感染是安全有效的。

Safetyevaluation of po phenoxymethy-lpenicillin t ablets in 10374 patients:a multicenter study

LI Jia-Tai,L Yuan,WANG Pu-Yu,CHEN Shao-Peng,WANG Peng

    (The Clinical Pharmacology Research Center,Institute of Clinical Ph armacology,Beijing Medical University,BEIJING 100034 )

ABSTRACT AIM:Total 10374 patients with bacterial infections enrolled the study^* to evaluate the safety and efficacy of penicillin V witho ut skintest.METHODS : Thedosage wasgiven 250-500mg,po,tid for5d.RESULTS : Showed 9063 patients were evaluated forthe efficacy.The effective rate was 42.18%(3823/9063 patients) and theclinical efficacy rate was 81.18%(7 357/9063 patients).Total 1163pathogens were isolated from 1930 patients prior to treatment.960isolates were eradicated and the bacterial clearance rate was 82.55%at the end of therapy. 10311 of all were evaluated for thesafety.The in cidence of clinical adversedrug reactions(ADRs) was 0.74% (76/10311).Fo rty-four patie ntsdiscontinued the therapydue toADRs.Most of them weregastrointestinal rea ction.Allergic reaction waslower,only 0.18%.No one occurred the allergic sho ck.One thousand,fivehundred and thirty-eight patients were examined the liver and renalfunction prior to treatment and at the end of therapy.The ALT level of2 patients was elevated,ADRs rates was 0.13%(2/1536).CONCLUSION :Orally administed penicillin V in bacterial infe ctions as safe andeffective without skin test.

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