对10374例青霉素V片剂安全性评价的多中心研究

Safety evaluation of po phenoxymethy_ lpenicillin tablets in 10374 patients: a multicenter study

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。

AIM: Total 10374 patients with bacterial infections enrolled the study* to evaluate the safety and efficacy of penicillin V without skin test. METHODS: The dosage was given 250_500 mg, po , tid for 5 d. RESULTS: Showed 9063 patients were evaluated for the efficacy. The effective rate was 42.18%(3823/9063 patients) and the clinical efficacy rate was 81.18%(7357/9063 patients). Total 1163 pathogens were isolated from 1930 patients prior to treatment. 960 isolates were eradicated and the bacterial clearance rate was 82.55% at the end of therapy. 10311 of all were evaluated for the safety. The incidence of clinical adverse drug reactions(ADRs) was 0.74% (76/10311). Forty_four patients discontinued the therapy due to ADRs. Most of them were gastrointestinal reaction. Allergic reaction was lower, only 0.18%. No one occurred the allergic shock. One thousand, five hundred and thirty_eight patients were examined the liver and renal function prior to treatment and at the end of therapy. The ALT level of 2 patients was elevated, ADRs rates was 0.13%(2/1536). CONCLUSION: Orally administed penicillin V in bacterial infections as safe and effective without skin test.