Department of Pulmonary and Critical Care Medicine, Tongji Hospital, School of Medicine, Tongji University, Shanghai, China.
Department of Pulmonary and Critical Care Medicine, Tongji Hospital, Tongji University School of Medicine, No. 389 Xincun Road, Shanghai 200065, China.
Ther Adv Respir Dis. 2024 Jan-Dec;18:17534666231220817. doi: 10.1177/17534666231220817.
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 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, = 0.009; superiority analysis: = 0.420]. Moreover, the cough symptom scores and cough threshold improved faster in the NSP group than in the OCP group at week 8 ( < 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, = 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%, = 0.04; superiority analysis: = 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).
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)的算法有可能为 GERC 患者实现简单、结构化和有效的治疗方法。
本研究比较了基于 GerdQ 的反流治疗(新的结构化途径,NSP)与 MII-pH 检查后(普通临床途径,OCP)的药物治疗在 GERC 管理中的疗效。
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 检查结果来确定治疗。
使用非劣效性(NI)假设来评估 NSP 与 OCP。
总体而言,基于 NSP 和 OCP 的治疗算法对 GERC 的疗效相似[NI 分析:95%置信区间(CI),-4.97 至 17.73,=0.009;优势分析:=0.420]。此外,在第 8 周时,NSP 组的咳嗽症状评分和咳嗽阈值改善速度快于 OCP 组(<0.05)。在使用 GerdQ 和 GerdQ 影响量表(GIS)评分的亚组分析中,低可能性 GERC(GerdQ<8)患者更有可能从 OCP 中受益(NI 分析:95%CI,-19.73 至 18.02,=0.213)。另一方面,在高可能性和低反流影响 GERC 患者(GerdQ>8 和 GIS<4)中,NSP 组与标准 OCP 治疗无差异(NI 分析:95%CI,-8.85 至 28.21%,=0.04;优势分析:=0.339),表明 GerdQ 和 GIS 指导的 GERC 患者诊断和管理可以替代 MII-pH 管理,特别是在医疗资源减少的情况下。
在基层医疗机构处理 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。