摘要
目的评估去甲万古霉素(norvancomycin,万迅)治疗革兰阳性球菌感染的安全性。方法采用前瞻性方法进行多中心临床开放试验。结果在北京20家医院用去甲万古霉素治疗革兰阳性球菌感染者418例,可供评价不良反应者415例,男性234例,女性181例;平均年龄为(57．5±18．8)岁(14-95岁)。全组平均用药(8．5±4．6)d,平均用药量为(10．8±5．7)g。本组药物相关性不良反应发生率为10．1％(42／415),其中耳肾不良反应发生率3．4％(14／ 415):包括轻度肾损害6例、头晕1例、耳鸣2例、听力下降5例(3例为高龄者)。其他不良反应有皮疹、皮肤瘙痒、药物热、胃肠道反应和血清ALT轻度增高等,停药或加用抗过敏药后好转。1例化脓性骨髓炎患者于静滴去甲万古霉素第4天出现头痛、眩晕、呼吸困难和低血压等症状,经停药和应用异丙嗪及强的松龙后症状很快缓解;推测可能为去甲万古霉素相关过敏反应或为本品剂量依赖性H1介导的非免疫性组织胺反应。因此,本品必须缓慢静脉滴注。结论去甲万古霉素是治疗重症革兰阳性球菌感染的较为安全的国产糖肽类抗生素。
Objective To evaluate the safety of norvancomycin for treatment Gram - positive bacterial infections including methicillin resistant staphylococci （MRS） and entrococci infections . Methods A prospective, open, multicentre clinical trial to evaluate the safety of norvancomycin administration. Results 418 patients in Beijing areas were received norvancomycin 400mg infusion q8h/q6h or 800mg ql2h for treatment of Gram - positive bacterial infections. Of them, 415 patients （ 224 males, 181 females） with mean age （57.5 ±18.8）years were available to assess adverse reaction. Mean duration of treatment was （8.5 ±4.6）days, mean dosage （ 10.8 ±5.7）days. The total ADR rate was 10. 1% （42/415）. The rate of ototoxicity and nephrotoxicity was 3.4% （ 14/415 ）, nephrotxicity was mild and included 5 elevated serum BUN and/or creatinine levels, I proteinuia, when drug stopped, renal ruction returm to baseline. Ototoxicity including I case with dizziness, 2 with tinnitus, 5 with hearing loss （3/5 with vertigo） ; most symptoms were return to baseline except 1 with hearing loss audiometrically when withdrew drug. Other AE were skin rash, itching, drug fever, mild elevated serum ALT level and GI symp- tom et al. while drug stopped and antianaphylaxis added, AE symptom disappeared. But only one patients withsevere suppurative osteomyelitis developed anaphylactoid symptoms such as headache, vertigo, short of breath and hypotension during norvancomycin infusion on 4th day. After stopping drug and phenergan/predisolong administration, above symptoms resolved rapidly. It was true allergy to noevancomycin or the drug caused dose dependent HZ mediated nonimmune histamin reaction. It must not be mistakenly given as a bolus and must extending the infusion time. Conclusion Results showed that norvancomycin is more safety domestic glycopeptide for treatment severe gram positive bacterial infections
出处
《临床药物治疗杂志》
2005年第5期47-49,共3页
Clinical Medication Journal
