van Leen M W F, van der Eijk I, Schols J M G A
Avoord Zorg & Wonen, Etten-Leur, The Netherlands.
Age Ageing. 2007 Jul;36(4):414-8. doi: 10.1093/ageing/afm049. Epub 2007 May 30.
The objectives of this study were to (i) survey the risk factors for NSAID gastropathy in outpatients (elderly patients in the community), compared to those living in old people's homes or nursing homes, (ii) study the prescription of medication prophylaxis during use of NSAIDs conform the current national guidelines and (iii) survey the influence on gastrointestinal symptoms and safety of pantoprazole 20 mg as prophylaxis for NSAID gastropathy.
Patients over 65 years of age, using an NSAID without prophylaxis or newly starting NSAID treatment were included in the study. Pantoprazole 20 mg was prescribed as prophylaxis. Patients using an NSAID with prophylaxis being a proton pump inhibitor at the first visit were registered for epidemiological reasons. Demographic data, risk factors, gastrointestinal complaints, and adverse events were collected at t = 0, t = 2 weeks, t = 3 months and t = 6 months. Differences between groups were analysed with Chi-square tests and Mann-Whitney U tests; changes in time in GI symptoms were tested using Wilcoxon signed ranks tests and McNemar tests.
One hundred eighty one general practitioners (treating outpatients and patients in old people's homes)and five nursing home physicians participated in the study and a total of 615 patients were included (522 patients treated by general practitioners (GP) and 93 patients in nursing homes). Four hundred thirty two patients were using NSAIDs without prophylaxis or started using an NSAID at the first visit; 269 (62.1%) and 163 (37.9%) patients respectively. 65.3% of the outpatients (224 out of 343) did not receive indicated prophylaxis, versus 76.2% (16 out of 21) in old people's homes and 42.6% in nursing homes (29 out of 69) (P < 0.001). Patients in nursing homes had more risk factors for gastrointestinal complications (2.94 +/- 1.3 versus 1.77 +/- 0.9) than outpatients. More patients using an NSAID prior to the study complained of gastrointestinal symptoms compared to new users (P < 0.001). This seems to indicate that NSAIDs caused these symptoms. After 2 weeks of treatment with pantoprazole, there was no statistical difference between the two groups. Moreover, both groups showed improvement in complaints (P < 0.001). Only nine patients in the study population (3.1%) reported mild adverse events (e.g. nausea, headache) with an average of 1.1 adverse events per patient. Five patients (1% of the included population) died during the study period, but there was no relation to the NSAID or pantoprazole.
Patients in nursing homes had more risk factors for NSAID gastropathy than patients in old people's homes or outpatients (>65 years). Although in nursing homes co-prescription of prophylaxis during NSAID use is more common, in general the Dutch guidelines on adequate NSAID use are still not fully implemented at this moment. The results also showed that pantoprazole was effective in diminishing gastrointestinal complaints, as well as preventing symptomatic NSAID gastropathy. Moreover, pantoprazole showed to be a safe and well-tolerated drug in our treatment group.
本研究的目的是：（i）调查门诊患者（社区老年患者）与住在养老院或护理院的患者相比，非甾体抗炎药相关性胃病的危险因素；（ii）研究非甾体抗炎药使用期间药物预防的处方是否符合现行国家指南；（iii）调查20mg泮托拉唑作为非甾体抗炎药相关性胃病预防用药对胃肠道症状和安全性的影响。
纳入65岁以上正在使用非甾体抗炎药但未进行预防或刚开始使用非甾体抗炎药治疗的患者。处方20mg泮托拉唑作为预防用药。因流行病学原因，将首次就诊时使用质子泵抑制剂进行预防的正在使用非甾体抗炎药的患者纳入研究。在t = 0、t = 2周、t = 3个月和t = 6个月时收集人口统计学数据、危险因素、胃肠道症状和不良事件。组间差异采用卡方检验和曼-惠特尼U检验进行分析；胃肠道症状随时间的变化采用威尔科克森符号秩检验和麦克尼马尔检验进行测试。
181名全科医生（治疗门诊患者和养老院患者）和5名护理院医生参与了该研究，共纳入615名患者（522名由全科医生治疗，93名在护理院）。432名患者正在使用非甾体抗炎药但未进行预防或在首次就诊时开始使用非甾体抗炎药；分别为269名（62.1%）和163名（37.9%）患者。65.3%的门诊患者（343名中的224名）未接受适当的预防，而养老院为76.2%（21名中的16名），护理院为42.6%（69名中的29名）（P < 0.001）。护理院患者胃肠道并发症的危险因素比门诊患者更多（2.94±1.3对1.77±0.9）。与新使用者相比，研究前使用非甾体抗炎药的患者更多抱怨胃肠道症状（P < 0.001）。这似乎表明非甾体抗炎药导致了这些症状。泮托拉唑治疗2周后，两组之间无统计学差异。此外，两组的症状均有改善（P < 0.001）。研究人群中只有9名患者（3.1%）报告了轻度不良事件（如恶心、头痛），平均每名患者1.1次不良事件。5名患者（纳入人群的1%）在研究期间死亡，但与非甾体抗炎药或泮托拉唑无关。
护理院患者非甾体抗炎药相关性胃病的危险因素比养老院患者或门诊患者（>65岁）更多。虽然在护理院中，非甾体抗炎药使用期间联合预防用药更为常见，但总体而言，荷兰关于适当使用非甾体抗炎药的指南目前仍未得到充分实施。结果还表明，泮托拉唑在减轻胃肠道症状以及预防有症状的非甾体抗炎药相关性胃病方面是有效的。此外，在我们的治疗组中，泮托拉唑显示出是一种安全且耐受性良好的药物。
