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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。
Commissioned by the Ministry of Health, a Phase I clinical trial was conducted on carboplatin developed by the Institute of Pharmacy of Shandong Provincial Academy of Medical Sciences. A total of 18 patients with malignant tumors were treated with 100 mg/m~2 as initial reagents, which were increased to 200,300,400,500 mg/m~2, respectively. The results of the test showed that carboplatin had a significant impact on the blood system. At a dose of 400 mg/m 2 , more than 1 degree (by WHO grade) toxicity appeared. White blood cells and platelets mostly fell to the lowest point within 1-2 weeks of drug use. For 2-4 weeks recovery, the Chinese maximum tolerated dose (MTD) is equivalent to 500mg/m~2, and the recommended phase I trial dose is 400mg/m~2iV. Once every 3-4 weeks, carboplatin has gastrointestinal tract. The response is more tolerable and requires no treatment. Carboplatin does not require hydration treatment and nephrotoxicity is mild and transient. Pharmacokinetic studies in humans were reported elsewhere.