摘要
受卫生部委托,对山东省医科院药物研究所研制的卡铂(Carboplatin)进行了Ⅰ期临床试验。共18例恶性肿瘤患者,以100mg/m^2为初试剂量,分别递增至200,300,400,500mg/m^2。试验结果,卡铂对血液系统影响较明显,在剂量达400mg/m^2时,出现较多Ⅰ度以上(按WHO分级)毒性,白细胞及血小板多在用药1—2周下降至最低点,持续2—4周恢复,中国人最大耐受剂量(MTD)相当于500mg/m^2,推荐Ⅰ期试验剂量为400mg/m^2iV,每3—4周一次,卡铂还有胃肠道反应,多可耐受,不需治疗。卡铂不需作水化治疗,肾毒性较轻微而短暂。人体药动学研究另文报告。
As signed by the ministry of Health Drug Administration, Phase I clinical study of Ca-rboplatin manufacfured by Shangdong Institute of Medical sciences was carried out. 18 cases of proven malignant patients were treated. Initial dose was 100mg/m2 and escalate to 200. 300, 400. 500mg/m 2 gradually. It was found that hematologic toxicity was main and dose limiting side effects, WHO grade II toxicity were common at 400mg/m2 , the Chinese human MTD was found to be 500mg/m 2 and the recommanded phase II study dosage was 400mg/m 2 every 3-4 weeks. Mild and tolerable G-I reactions were also encountered. Renal toxicity was very mild and transient without forced hydration.
出处
《癌症》
SCIE
CAS
CSCD
北大核心
1990年第6期449-451,共3页
Chinese Journal of Cancer
