Bochenek W J, Mack M E, Fraga P D, Metz D C
Clinical Research and Development, Wyeth Research, Collegeville, PA, USA.
Aliment Pharmacol Ther. 2004 Nov 15;20(10):1105-14. doi: 10.1111/j.1365-2036.2004.02233.x.
Effective symptom control is a primary concern of most heartburn suffers.
To compare the safety and efficacy of pantoprazole, placebo and the H2 antagonist nizatidine in relieving symptoms in patients with erosive oesophagitis.
Data from two randomized, double-blind studies were pooled. Patients received pantoprazole 10, 20 or 40 mg, or placebo daily (study 1, n = 603), or pantoprazole 20 or 40 mg daily or 150-mg nizatidine b.d. (study 2, n = 243) for either 4 or 8 weeks. Endoscopy was performed at baseline, week 4 and week 8. Persistent absence of symptoms was defined as the first day that no symptoms were reported by the patient on that day or any subsequent study day.
A significantly higher percentage (P < 0.05) of pantoprazole patients reported elimination of all symptoms by week 8. Daytime heartburn, night-time heartburn and regurgitation were significantly better controlled with pantoprazole (with a dose-response at most time-points). Absence of symptoms was a powerful predictor of healing; presence of symptoms correlated poorly.
Pantoprazole is more effective than placebo or nizatidine for controlling heartburn and acid regurgitation in patients with erosive oesophagitis. Relief of GERD symptoms is highly predictive of healing of erosive oesophagitis at 4 and 8 weeks.
有效控制症状是大多数胃灼热患者首要关注的问题。
比较泮托拉唑、安慰剂和H2拮抗剂尼扎替丁缓解糜烂性食管炎患者症状的安全性和有效性。
汇总两项随机、双盲研究的数据。患者每日接受10、20或40mg泮托拉唑或安慰剂（研究1，n = 603），或每日接受20或40mg泮托拉唑或150mg尼扎替丁每日两次（研究2，n = 243），疗程为4周或8周。在基线、第4周和第8周进行内镜检查。持续无症状定义为患者在当天或随后任何研究日未报告症状的第一天。
到第8周时，报告所有症状消除的泮托拉唑患者比例显著更高（P < 0.05）。泮托拉唑能更好地控制白天胃灼热、夜间胃灼热和反流（在大多数时间点呈剂量反应关系）。无症状是愈合的有力预测指标；症状的存在与愈合的相关性较差。
在控制糜烂性食管炎患者的胃灼热和胃酸反流方面，泮托拉唑比安慰剂或尼扎替丁更有效。GERD症状的缓解高度预测糜烂性食管炎在4周和8周时的愈合情况。
