[Phase III clinical trial of elemenum emulsion in the management of malignant pleural and peritoneal effusions].
From July 1994 to June 1995, a prospective multicenter phase III clinical trial was conducted to evaluate the efficacy of Injectio Emulsioni Elemeni in the management of malignant effusions. Four hundred and eighty-four patients, including 313 with pleural effusion and 171 with peritoneal effusion, were evaluable. The drug was administered in 0.5% emulsion, with a dosage of 200 mg/m2 for intrapleural injection once every week for 1-2 weeks and 300-400 mg/m2 for intraperitoneal injection once or twice every week for 2 weeks. The response rates were 77.6% in patients with malignant pleural effusion, 66.1% in patients with peritoneal effusion. There were no bone marrow, liver, cardiac and renal toxicities; while fever, local pain and gastro-intestinal reaction were the major adverse effects. It is concluded that Elemenum emulsion is one of the active agents in the management of malignant effusions.
Wang
J
J
Cancer Institute (Hospital), Chinese Academy of Medical Sciences, Beijing.
Zhang
H
H
Sun
Y
Y
D000293:Adolescent; D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects / Q000627:therapeutic use*; D001202:Ascitic Fluid / Q000188:drug therapy*; D005260:Female; D005334:Fever / Q000139:chemically induced; D006801:Humans; D007274:Injections, Intraperitoneal; D008297:Male; D008875:Middle Aged; D009822:Oils, Volatile / Q000009:adverse effects / Q000627:therapeutic use*; D016066:Pleural Effusion, Malignant / Q000188:drug therapy*; D011446:Prospective Studies; D012717:Sesquiterpenes
D000972:Antineoplastic Agents, Phytogenic; D009822:Oils, Volatile; D012717:Sesquiterpenes; C038905:elemene