■多通道腔内阻抗-pH监测(MII-pH)的经验性治疗已用于胃食管反流引起的慢性咳嗽(GERC)的初始治疗。然而,基于胃食管反流病问卷(GerdQ)的算法有可能实现简单的,结构化,和GERC患者的有效治疗方法。
■本研究比较了基于GerdQ(新的结构化途径,NSP)在MII-pH检查后进行医学治疗(普通临床路径,OCP)在GERC的管理中。
■对于NSP,我们调整了GerdQ评分以建立治疗算法的基础。对于OCP,使用MII-pH检查结果确定治疗。
■使用非劣效性(NI)假设来评估NSP与OCP。
■总的来说,基于NSP和OCP的治疗算法对GERC具有相似的疗效[NI分析:95%置信区间(CI),-4.97至17.73,p=0.009;优势分析:p=0.420]。此外,在第8周,NSP组的咳嗽症状评分和咳嗽阈值改善快于OCP组(p<0.05)。在使用GerdQ和GerdQ影响量表(GIS)得分的亚组分析中,低可能性GERC(GerdQ<8)患者更有可能从OCP获益(NI分析:95%CI,-19.73~18.02,p=0.213).另一方面,在高可能性和低反流影响GERC患者中(GerdQ>8和GIS<4),NSP组不劣于OCP的标准治疗(NI分析:95%CI,-8.85至28.21%,p=0.04;优势分析:p=0.339),这表明GerdQ和GIS指导的GERC患者的诊断和管理可以替代MII-pH管理,尤其是在医疗资源减少的环境中。
■在初级保健环境中处理GERC患者时应考虑使用GerdQ算法。
■本研究在中国临床试验注册中心(ChiCTR-ODT-12001899)注册。
Empiric therapy with multichannel intraluminal impedance-pH monitoring (MII-pH) has been used for the initial treatment of gastroesophageal reflux-induced chronic cough (GERC). However, an algorithm based on the gastroesophageal reflux disease questionnaire (GerdQ) has the potential to achieve a simple, structured, and effective treatment approach for patients with GERC.
This study compared the efficacy of anti-reflux therapy based on GerdQ (new structured pathway, NSP) with medical treatment after MII-pH examination (ordinary clinical pathway, OCP) in the management of GERC.
For the NSP, we adapted the GerdQ score to establish the basis for a treatment algorithm. For the OCP, treatment was determined using the MII-pH examination results.
The non-inferiority (NI) hypothesis was used to evaluate NSP versus OCP.
Overall, the NSP and OCP-based therapeutic algorithms have similar efficacy for GERC [NI analysis: 95% confidence interval (CI), -4.97 to 17.73, p = 0.009; superiority analysis: p = 0.420]. Moreover, the cough symptom scores and cough threshold improved faster in the NSP group than in the OCP group at week 8 (p < 0.05). In the subgroup analyses using the GerdQ and GerdQ impact scale (GIS) scores, patients with low-likelihood GERC (GerdQ < 8) were more likely to benefit from OCP (NI analysis: 95% CI, -19.73 to 18.02, p = 0.213). On the other hand, in patients with high-likelihood and low-reflux impact GERC patients (GerdQ > 8 and GIS < 4), the NSP arm was not inferior to the standard treatment of OCP (NI analysis: 95% CI, -8.85 to 28.21%, p = 0.04; superiority analysis: p = 0.339), indicating that GerdQ- and GIS-guided diagnosis and management of patients with GERC could be an alternative to MII-pH management, especially in settings with reduced medical resources.
The use of the GerdQ algorithm should be considered when handling patients with GERC in the primary care setting.
This research was registered in the Chinese Clinical Trials Registry (ChiCTR-ODT-12001899).