Paré Pierre, Armstrong David, Pericak Dan, Pyzyk Myron
Hôpital St-Sacrement, Division of Gastroenterology, 1050, Chemin Ste-Foy, Québec G1S 4L8, Canada.
J Clin Gastroenterol. 2003 Aug;37(2):132-8. doi: 10.1097/00004836-200308000-00008.
Health-related quality of life (HRQoL) is impaired in untreated patients with gastroesophageal reflux disease (GERD). In the absence of an objective marker such as erosions, assessment of treatment efficacy can be based on symptoms and HRQoL.
To evaluate changes in HRQoL during treatment with pantoprazole or nizatidine in patients with GERD.
This was a prospective, randomized, double blind Canadian multicenter study. Patients with GERD, characterized by heartburn that had occurred 4 or more times per week for at least 6 months, were treated for 28 days with either pantoprazole 40 mg once daily or nizatidine 150 mg twice daily. HRQoL assessment was performed before endoscopy (baseline) and on days 7 and 28 after treatment. HRQoL was assessed using 4 domains of the SF-36, the SF-12 summary scales and the gastrointestinal system rating scale (GSRS).
A total of 208 patients (n = 106 pantoprazole treatment group, n = 102 nizatidine treatment group) was available for intention-to-treat analysis. Baseline HRQoL scores were comparable between the 2 treatment groups. After 7 days, treatment with pantoprazole led to a statistically significant greater improvement in HRQoL in 2 SF-36 domains: bodily pain (pantoprazole versus nizatidine, P = 0.0088) and vitality (pantoprazole versus nizatidine, P = 0.0137), and in the GSRS reflux score (pantoprazole versus nizatidine, P = 0.0078). After 28 days of treatment, the changes in scores relative to baseline were still greater with pantoprazole than with nizatidine. The improvement in the 4 SF-36 domains and the GSRS reflux score achieved by pantoprazole after 7 days were also significantly greater than those achieved by nizatidine after 28 days.
HRQoL improves more rapidly and to a greater degree following treatment with pantoprazole than nizatidine. Control of heartburn strongly predicts HRQoL improvement during the acute treatment of GERD. Our data support the approach to use pantoprazole instead of nizatidine as the initial therapy for patients with heartburn in a primary care practice setting.
未经治疗的胃食管反流病（GERD）患者的健康相关生活质量（HRQoL）受损。在缺乏诸如糜烂等客观标志物的情况下，治疗效果的评估可基于症状和HRQoL。
评估GERD患者使用泮托拉唑或尼扎替丁治疗期间HRQoL的变化。
这是一项前瞻性、随机、双盲的加拿大多中心研究。以每周至少发生4次烧心且持续至少6个月为特征的GERD患者，接受为期28天的治疗，其中一组每天一次服用40mg泮托拉唑，另一组每天两次服用150mg尼扎替丁。在内镜检查前（基线）以及治疗后的第7天和第28天进行HRQoL评估。使用SF-36的4个领域、SF-12总结量表和胃肠道系统评定量表（GSRS）对HRQoL进行评估。
共有208例患者（泮托拉唑治疗组n = 106，尼扎替丁治疗组n = 102）可进行意向性分析。两个治疗组的基线HRQoL评分相当。7天后，泮托拉唑治疗使HRQoL在SF-36的2个领域有统计学意义的更大改善：躯体疼痛（泮托拉唑与尼扎替丁相比，P = 0.0088）和活力（泮托拉唑与尼扎替丁相比，P = 0.0137），以及GSRS反流评分（泮托拉唑与尼扎替丁相比，P = 0.0078）。治疗28天后，泮托拉唑相对于基线的评分变化仍大于尼扎替丁。泮托拉唑在7天后实现的4个SF-36领域和GSRS反流评分的改善也显著大于尼扎替丁在28天后实现的改善。
与尼扎替丁相比，泮托拉唑治疗后HRQoL改善更快且程度更大。烧心的控制强烈预测GERD急性治疗期间HRQoL的改善。我们的数据支持在初级保健实践环境中，将泮托拉唑而非尼扎替丁用作烧心患者初始治疗的方法。
