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兰索拉唑针剂治疗十二指肠球部溃疡出血的多中心临床研究 被引量:11

Intravenous iansoprazole in treating duodenal ulcer bleeding: a multi-center clinical trial
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摘要 目的探讨兰索拉唑针剂治疗十二指肠球部溃疡出血的临床效果及安全性。方法采用多中心、随机、阳性药物、平行对照研究。将2005年4月-11月收集的216例经胃镜证实的十二指肠球部溃疡出血患者随机分为两组,试验组110例给予兰索拉唑(商品名:奥维加)30mg、对照组106例给予奥美拉唑钠(商品名:洛赛克)40mg静脉滴注,每12h 1次,连续5d。结果共有212例患者可供疗效评价及安全性评价。试验组的临床显效率为73.39%,总有效率为95.41%,对照组的临床显效率为81.55%,总有效率为95.15%,两组间差异无统计学意义(P〉0.05)。止血时间试验组为(31.90±18.58)h,对照组为(28.00±18.31)h;止血率试验组为98.17%,对照组为99.03%,两组间差异均无统计学意义(P〉0.05)。两组不良反应主要为白细胞减少、转氨酶轻度升高和皮疹(P〉0.05)。结论兰索拉唑针剂是治疗十二指肠球部溃疡出血有效且安全的药物。 Objective To assess the efficacy and safety of intravenous infusion of lansoprazole in treating duodenal ulcer bleeding. Methods A multi-center, randomized, parallel-controlled, and positive-drug contrast clinical trial was conducted in 216 patients with endoscopic proved duodenal ulcer bleeding. The patients were randomly divided into lansoprazole group (n = 110) and control group (n=106). Patients in lansoprazole group were intravenously received lansoprazole (Allwell) of 30 mg twice daily for 5 days, while those in control group were intravenously received omeprazole sodium (Losec) of 40 mg twice daily for 5 days. Results There were 212 cases qualified for analysis of efficacy and safety. The effective rate and response rate were 73. 39% and 95.41% in lansoprazole group respectively, while they were 81. 55% and 95. 15% in control group, respectively (P〉0. 05). Haemostatic time and haemostatic rate were (31. 90 ± 18. 58) h and 98. 17% in lansoprazole group respectively, while they were (28.00±18.31) h and 99. 03% in control group, respectively (P〉0.05). The major adverse events were leucopenia, slight elevated transaminase and rach (P〉0.05 ). Conclusion Intravenous lansoprazole is a safe and effective drug for treatment of duodenal ulcer bleeding.
出处 《中华消化杂志》 CAS CSCD 北大核心 2009年第5期338-340,共3页 Chinese Journal of Digestion
关键词 十二指肠球部溃疡 出血 兰索拉唑 Duodenal ulcer Bleeding Lansoprazole
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参考文献4

  • 1Bustamante M, Stollman N. The efficacy of proton pump inhibitors in acute ulcer bleeding: a qualitative review. J Clin Gastroenterol, 2000, 30:7-13.
  • 2Freston JW, Pilmer BL, Chiu YL, et al. Evaluation of the pharmacokinetics and pharmacodynamics of intravenous lansoprazole. Aliment Pharmacol Ther, 2004,19:1111-1122.
  • 3Freston JW. Therapeutic choices in reflux disease: defining the criteria for selecting a proton pump inhibitor. Am J Med, 2004, 117(suppl 5A) : 14S-22S.
  • 4Metz DC, Amer F, Hunt B, et al. Lansoprazole regimens that sustain intragastric pH > 6.0: an evaluation of intermittent oral and continuous intravenous infusion dosages. Aliment Pharmaeol Ther, 2006, 23: 985-995.

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