Balfour J A, Goa K L
Adis International Limited, Auckland, New Zealand.
Drugs. 1997 Aug;54(2):273-98. doi: 10.2165/00003495-199754020-00008.
Dolasetron (dolasetron mesilate) is a pseudopelletierine-derived 5-HT3 antagonist which has recently become available for clinical use. It is rapidly converted in vivo to its active major metabolite, hydrodolasetron, which appears to be largely responsible for its pharmacological activity. In clinical trials, single intravenous or oral doses of dolasetron were effective in preventing acute chemotherapy-induced nausea and vomiting (CINV). Intravenous doses of 1.8 mg/kg achieved complete suppression of vomiting in approximately 50% of patients receiving highly emetogenic cisplatin-containing chemotherapy and in approximately 60 to 80% of patients receiving moderately emetogenic chemotherapy. In the latter setting, oral doses of 200 mg achieved similar response rates. In comparative studies, intravenous dolasetron 1.8 mg/kg was as effective as intravenous granisetron 3 mg or ondansetron 32 mg after highly emetogenic chemotherapy, and oral dolasetron 200 mg was equivalent to multiple oral doses of ondansetron (3 or 4 doses of 8 mg) after moderately emetogenic chemotherapy. Dolasetron 1.8 mg/kg was superior to metoclopramide in preventing emesis induced by high dose cisplatin or by moderately emetogenic chemotherapy in high risk subgroups. Dolasetron has also shown efficacy in preventing radiotherapy-induced nausea and vomiting (RINV) in preliminary studies. Single intravenous or oral dolasetron doses ranging from 12.5 to 100 mg and 25 to 200 mg, respectively, were significantly more effective than placebo in preventing postoperative nausea and vomiting (PONV) in female surgical patients. A 50 mg intravenous dose was as effective in preventing PONV as ondansetron 4 mg in a mixed-gender group. Intravenously administered dolasetron was also effective in treating established PONV, although complete suppression of vomiting was achieved in < 40% of patients. Dolasetron has a tolerability profile characteristic of this class of compounds, with headache, dizziness and diarrhoea being the most commonly occurring adverse events in clinical trials. Diarrhoea is not thought to be related to dolasetron administration, being experienced mostly by patients receiving chemotherapy. Dolasetron and other 5-HT3 receptor antagonists have been associated with minor changes in ECG intervals, but these generally do not appear to be clinically important. Thus, available evidence suggests that dolasetron will provide an alternative to other 5-HT3 receptor antagonists for the management of CINV and PONV. Further studies are required to determine whether it offers any advantages over other agents in these settings and to determine the optimum dosage for preventing RINV.
多拉司琼(甲磺酸多拉司琼)是一种源自假石榴碱的5-羟色胺3(5-HT3)拮抗剂,最近已可供临床使用。它在体内迅速转化为其活性主要代谢产物氢多拉司琼,其似乎在很大程度上负责其药理活性。在临床试验中,单次静脉注射或口服多拉司琼对预防急性化疗引起的恶心和呕吐(CINV)有效。静脉注射剂量为1.8mg/kg时,在接受含高致吐性顺铂化疗的患者中约50%实现了呕吐的完全抑制,在接受中度致吐性化疗的患者中约60%至80%实现了呕吐的完全抑制。在后一种情况下,口服剂量200mg达到了相似的有效率。在比较研究中,高致吐性化疗后,静脉注射1.8mg/kg多拉司琼与静脉注射3mg格拉司琼或32mg昂丹司琼效果相同,中度致吐性化疗后,口服200mg多拉司琼与多次口服昂丹司琼(3或4剂8mg)效果相当。在预防高剂量顺铂或中度致吐性化疗在高风险亚组中引起的呕吐方面,1.8mg/kg多拉司琼优于甲氧氯普胺。在初步研究中,多拉司琼在预防放疗引起的恶心和呕吐(RINV)方面也显示出疗效。单次静脉注射或口服多拉司琼剂量分别为12.5至100mg和25至200mg时,在预防女性外科手术患者术后恶心和呕吐(PONV)方面明显比安慰剂更有效。在一个混合性别组中,50mg静脉注射剂量在预防PONV方面与4mg昂丹司琼效果相同。静脉注射多拉司琼在治疗已发生的PONV方面也有效,尽管在<40%的患者中实现了呕吐的完全抑制。多拉司琼具有这类化合物的耐受性特征,头痛、头晕和腹泻是临床试验中最常出现的不良事件。腹泻被认为与多拉司琼的给药无关,主要发生在接受化疗的患者中。多拉司琼和其他5-HT3受体拮抗剂与心电图间期的轻微变化有关,但这些变化通常在临床上似乎并不重要。因此,现有证据表明,多拉司琼将为管理CINV和PONV提供一种替代其他5-HT3受体拮抗剂的药物。需要进一步研究以确定它在这些情况下是否比其他药物具有任何优势,并确定预防RINV的最佳剂量。