Dalby Vårdcentral, Dalby, Sweden.
Clin Drug Investig. 2011;31(3):181-9. doi: 10.2165/11586330-000000000-00000.
Despite the high prevalence of gastro-oesophageal reflux disease (GORD) and the documented impact of GORD symptoms on individual health-related quality of life (HR-QOL) and on socioeconomic factors, structured management of GORD has had a low priority in Swedish routine primary health care.
The primary objective of this study (IMPROVE) was to evaluate the effects of a structured follow-up and management regimen for primary-care GORD patients with symptomatic breakthrough despite standard proton pump inhibitor (PPI) treatment. Patients received either an increased dose of current PPI treatment or were switched to the more effective acid inhibitor esomeprazole.
GORD patients with symptomatic breakthrough despite standard PPI treatment were identified through medical records and by a postal survey using the GERD Impact Scale (GIS) questionnaire. Patients rated the severity and frequency of GORD symptoms, general health status (EuroQol Group 5-Dimension Self-Report Questionnaire) and the impact of GORD symptoms on work productivity (Work Productivity and Activity Impairment) before and 4 weeks following randomization to open-label treatment with either increased acid suppressive therapy or an adjusted, higher dosage of the PPI previously used. The patients' valuation, in monetary terms, of the treatment they received pre-study versus the treatment given during the study was documented through willingness-to-pay (WTP) questions.
Following more effective acid suppression, 66.3% of the study population experienced complete relief of heartburn, with no difference between the groups; HR-QOL was restored to a level comparable to that of a normal Swedish population and ability to work efficiently was significantly improved. Access to a better acid suppressive treatment was highly valuable to the patients in terms of WTP.
An improved GORD management strategy including structured follow-up of treatment given and initiation of more effective acid inhibitor therapy when symptoms persist will be of great benefit to GORD patients. [ClinicalTrials.gov Identifier: NCT00272701].
尽管胃食管反流病（GORD）的患病率很高，且 GORD 症状对个体健康相关生活质量（HR-QOL）和社会经济因素的影响已得到证实，但在瑞典常规初级保健中，GORD 的结构化管理一直没有得到高度重视。
本研究（IMPROVE）的主要目的是评估对接受标准质子泵抑制剂（PPI）治疗后仍有症状性突破性 GORD 患者进行结构化随访和管理方案的效果。患者接受当前 PPI 治疗剂量增加或换用更有效的酸抑制剂埃索美拉唑。
通过病历和使用 GERD 影响量表（GIS）问卷进行的邮寄调查，确定接受标准 PPI 治疗后仍有症状性突破性 GORD 的患者。患者在随机分组接受开放标签治疗之前和之后 4 周，使用 GIS 问卷评估 GORD 症状的严重程度和频率、一般健康状况（EuroQol Group 5-Dimension Self-Report Questionnaire）和 GORD 症状对工作效率的影响（工作效率和活动障碍），并记录他们对研究前接受的治疗和研究期间接受的治疗的货币价值评估（通过意愿支付（WTP）问题）。
在接受更有效的抑酸治疗后，研究人群中有 66.3%的患者完全缓解烧心症状，两组之间无差异；HR-QOL 恢复到与正常瑞典人群相当的水平，工作效率显著提高。从 WTP 的角度来看，患者对获得更好的抑酸治疗的途径非常重视。
改善 GORD 管理策略，包括对已给予的治疗进行结构化随访，以及在症状持续存在时启动更有效的酸抑制剂治疗，将使 GORD 患者受益。[临床试验注册号：NCT00272701]。
