依立替康治疗未曾接受治疗的晚期食管和胃腺癌患者的II期临床试验

Chemotherapy options for esophagogastric adenocarcinoma remain limited. Irinotecan has demonstrated broad activity in a variety of epithelial malignancies. Forty-six patients with previously untreated, measurable, unresectable, or metastatic esophagogastric adenocarcinoma were enrolled. Patients received irinotecan (125 mg/m2 intravenously over 90 min weekly) for 4 consecutive weeks followed by a 2-week rest. Forty-three patients received at least one treatment and were evaluable for response and toxicity. One complete and five partial responses were observed, for an overall response rate of 14%(95%CI, 4-24%). Median survival for all 43 patients was 6.4 months (95%CI, 4.6-8.2 months). Grade 3 to 4 toxicity included 10 patients (23%) with neutropenia, 13 patients (30%) with late diarrhea, 6 patients (14%) with vomiting, and 6 patients (14%) with fatigue. We conclude that although single-agent irinotecan is an active agent for esophagogastric adenocarcinoma, the schedule utilized in this trial is associated with moderate toxicity. When used as a single-agent, a triweekly schedule may be preferable for this patient population.

系列问答81——我国新药临床试验分为几期？

我国新药临床试验过去分为3期，但近年已和国际接轨分为4期。1999年5月1日施行的《新药审批办法》第十二条规定”新药的临床试验分为Ⅰ、Ⅱ、Ⅲ、Ⅳ期”，其内容如下：

普卢利沙星片治疗呼吸和泌尿系统急性感染的有效性和安全性研究

目的：评价国产普卢利沙星片治疗呼吸系统和泌尿系统急性细菌感染的安全性和有效性。方法：采用多中心、随机、双盲双模拟、阳性药平行对照试验设计，以左氧氟沙星为对照药，普卢利沙星组264mg，左氧氟沙星组200mg，每日两次，疗程5—14天，视病情和病种而异。结果：本研究共纳入265例，普卢利沙星组132例，左氧氟沙星组133例。疗程结束时，两系统感染的FAS分析，对照组和试验组痊愈率分别为67．67％和73．48％，总有效率对照组和试验组分别为89．47％和90．91％。PP分析与FAS分析结果一致。对照组细菌清除率为94．06％（95／101）；试验组细菌清除率为95．96％（95／99）。两组以上比较均无统计学差异。两组的不良反应发生率分别为5．26％（7／133）和3．79％（5／132），包括恶心、头痛、腹胀、腹泻等，其程度均为轻度，疗程结束后均消失或恢复正常。两组不良反应比较差异无统计学意义。结论：国产普卢利沙星片同左氧氟沙星相比，其治疗急性呼吸道和泌尿道感染的安全性和有效性相当。