Adis, a Wolters Kluwer Business, Mairangi Bay, North Shore, Auckland, New Zealand.
Drugs. 2010 Aug 20;70(12):1593-601. doi: 10.2165/11295960-000000000-00000.
Dexlansoprazole modified release (dexlansoprazole MR) is an orally administered delayed-release formulation of the R-enantiomer of the proton pump inhibitor lansoprazole that is effective in improving the healing of all grades of erosive oesophagitis, maintaining the healing of erosive oesophagitis and in the treatment of symptomatic non-erosive reflux disease (NERD). In two large, identical, 8-week, randomized, double-blind, multicentre phase III trials, dexlansoprazole MR 60 mg once daily achieved complete healing in >or=92% of patients with all grades of erosive oesophagitis (primary endpoint) and was noninferior to lansoprazole 30 mg once daily using life-table analysis. Moreover, in a randomized, double-blind, multicentre phase III trial in patients with healed erosive oesophagitis, dexlansoprazole MR 30 mg once daily was significantly more effective than placebo in maintaining healing following 6 months' treatment (primary endpoint). In addition, the proportion of 24-hour heartburn-free days (primary endpoint) was significantly greater in recipients of dexlansoprazole MR 30 mg once daily than in recipients of placebo following 4 weeks' treatment in a large, randomized, double-blind, multicentre phase III trial in patients with NERD. Dexlansoprazole MR 30 or 60 mg once daily was generally well tolerated in a pooled analysis of clinical trials of up to 12 months' duration.
多库兰索拉唑（dexlansoprazole MR）是质子泵抑制剂兰索拉唑的 R-对映异构体的口服延迟释放制剂，能有效改善所有级别糜烂性食管炎的愈合，维持糜烂性食管炎的愈合，并治疗有症状的非糜烂性反流病（NERD）。在两项大型、相同的、为期 8 周、随机、双盲、多中心 III 期临床试验中，多库兰索拉唑 MR 60mg 每日 1 次治疗所有级别的糜烂性食管炎患者的愈合率超过 92%（主要终点），使用生命表分析，与兰索拉唑 30mg 每日 1 次相比非劣效。此外，在一项已愈合糜烂性食管炎患者的随机、双盲、多中心 III 期试验中，多库兰索拉唑 MR 30mg 每日 1 次治疗 6 个月后维持愈合的疗效显著优于安慰剂（主要终点）。此外，在一项为期 4 周、有症状的 NERD 患者的大型、随机、双盲、多中心 III 期临床试验中，与安慰剂组相比，多库兰索拉唑 MR 30mg 每日 1 次组的 24 小时烧心无发作天数（主要终点）比例显著更高。在长达 12 个月的临床试验汇总分析中，多库兰索拉唑 MR 30 或 60mg 每日 1 次的总体耐受性良好。
