揽香烯乳治疗晚期恶性肿瘤的Ⅱ期临床试用结果

RESULTS OF PHASE II CLINICAL TRIALS OF ELEMENUM EMULSION IN THE MANAGEMENT OF ADVANCED MALIGNANCIES

对299例晚期恶性胸腔积液、腹腔积液、浅表肿瘤及子宫颈癌患者用揽香烯乳进行了国内多中心前瞻性Ⅱ期临床研究。治疗恶性胸腔积液按200mg/m^2,腹腔积液按400mg/m^2,注射1～2次/周。治疗局部浅表病灶包括皮肤结节及子宫颈癌,则采用局部注射,25～50mg/次,1次/d,连用5～10d。结果表明,该制剂对恶性胸腔积液的疗效为74.8％,对恶性腹腔积液的疗效为75.0％;接受局部注射的患者,有效率为63.5％。本品无骨髓毒性,但有可被大多数患者耐受的胃肠道反应、发热和局部疼痛。

Injectio Emulsioni Elemeni is an active fraction containing mainly β -elemen isolated from the roots of Curcuma wenyujin, YH Chen et C Ling. A prospective multi-centre phase II trial was conducted from October 1992 to May 1993 in 299 cases of advanced malignancies with malignant pleural or peritoneal effusions, superficial nodules, and cervical carcinoma. The drug was administered in 5% emulsion (5 or 10ml per ampule) , and the dosage was 200mg/m2 for intra-pleural injection or 400mg/m2 for intra-peritoneal injection once or twice every week, while 25-50mg daily for 5 to 10 days for local infiltration in superficial lesions such as skin nodules and cervical carcinoma. The response rates were 74. 8% in patients with malignant pleural effusion, 75.0% in patients with peritoneal effusion, and 63. 5% in patients received local injections. There was no apparent bone marrow toxicity, while the gastro-intestinal reactions, fever, and local pain were tolerated well by the majority of patients.