[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.