Avner D L, Movva R, Nelson K J, McFarland M, Berry W, Erfling W
Graduate Hospital, Philadelphia, Pennsylvania, USA.
Am J Gastroenterol. 1995 Aug;90(8):1289-94.
A multicenter, double-blind study was conducted in 268 patients to compare the safety and efficacy of 15, 30, and 60 mg of lansoprazole and placebo in the treatment of gastric ulcer.
The study included an 8-wk treatment period to assess healing and a 6-month posttreatment period to evaluate ulcer recurrence. Endoscopies were performed, GI symptoms and antacid use were assessed, and safety evaluations were conducted, including serum gastrin and biopsies of the lesions and the greater curvature of the stomach.
At week 4, healing rates were significantly higher with lansoprazole 15 and 30 mg (64.6 and 58.1%, respectively) compared with placebo (37.5%). By week 8, healing rates were 76.7% with placebo, 92.2% with 15 mg of lansoprazole, 96.8% with 30 mg, and 93.2% with 60 mg of lansoprazole (p < 0.05). The drug was well tolerated, with no significant differences from placebo in the incidence of adverse events. Fasting serum gastrin increased in all lansoprazole groups, reaching a plateau by week 2 and returning to baseline levels by month 1 posttreatment. No significant increase in Grimelius-positive cells or inflammation was evident. All but two patients had normal gastric morphology evaluated by Solcia classification.
Lansoprazole, 15, 30, and 60 mg, administered once daily before eating, healed gastric ulcers to an approximately equal degree, and all were significantly better than placebo.
对268例患者进行了一项多中心、双盲研究，以比较15毫克、30毫克和60毫克兰索拉唑及安慰剂治疗胃溃疡的安全性和疗效。
该研究包括一个为期8周的治疗期以评估愈合情况，以及一个为期6个月的治疗后期以评估溃疡复发情况。进行了内镜检查，评估了胃肠道症状和抗酸剂的使用情况，并进行了安全性评估，包括血清胃泌素以及病变和胃大弯处的活检。
在第4周时，15毫克和30毫克兰索拉唑组的愈合率（分别为64.6%和58.1%）显著高于安慰剂组（37.5%）。到第8周时，安慰剂组的愈合率为76.7%，15毫克兰索拉唑组为92.2%，30毫克组为96.8%，60毫克兰索拉唑组为93.2%（p<0.05）。该药物耐受性良好，不良事件发生率与安慰剂无显著差异。所有兰索拉唑组的空腹血清胃泌素均升高，在第2周达到平台期，并在治疗后第1个月恢复到基线水平。Grimelius阳性细胞或炎症无明显显著增加。除两名患者外，所有患者经Solcia分类评估胃形态均正常。
每天饭前服用一次的15毫克、30毫克和60毫克兰索拉唑使胃溃疡愈合程度大致相同，且均显著优于安慰剂。
