Dipartimento di Medicina, Chirurgia e Farmacia, University of Sassari, Sassari, Italy.
Department of Medicine, Baylor College of Medicine, Houston, Texas, USA.
Helicobacter. 2024 Jul-Aug;29(4):e13112. doi: 10.1111/hel.13112.
Helicobacter pylori infections have become resistant to many previously highly effective antimicrobial regimens resulting in clarithromycin, metronidazole, or fluoroquinolone-containing therapies becoming unsuccessful. Pretreatment susceptibility testing is only widely available in the United States but is still rarely done. Here, we propose a framework to monitor H. pylori eradication in small clinical settings by routinely assessing the effectiveness of therapy.
Because of the small sample size in individual practice's, we assume an acceptable cure rate of ≥80% (preferred cure rate ≥85%) in adherent patients, with a dichotomous outcome (cured vs. failed) and consecutive patient enrollment. To obtain results (feedback) in a timely manner, for individual practices, cure rates can be estimated after 10 patients. Large practices which acquire patients more rapidly can delay analysis until a total of 104 H. pylori-infected patients, assuming a baseline cure rate of at least 85% with the preferred regimen.
We show how data from individual practices can be utilized to improve the effectiveness of H. pylori treatment decisions. The method consists of recording and accumulating the confirmation of cure data for successive small groups of patients. These data are then analyzed as binary outcomes (pass-fail) and serve as the basis for studying and improving the effectiveness of H. pylori treatment decisions.
A simple actuarial method can serve outpatient clinics to ensure a reliable test-to-cure method and avoid futile Hp regimens.
幽门螺杆菌感染对许多以前高度有效的抗菌方案产生了耐药性，导致包含克拉霉素、甲硝唑或氟喹诺酮类药物的治疗方案失败。尽管在 美国，治疗前药敏检测已广泛应用，但实际上仍很少进行。在此，我们提出了一个框架，通过常规评估治疗效果，在小型临床环境中监测幽门螺杆菌的清除。
由于个体实践中样本量较小，我们假设在坚持治疗的患者中，可接受的治愈率≥80%（首选治愈率≥85%），采用二项结果（治愈与失败）和连续患者入组。为了及时获得结果（反馈），对于个体实践，可以在 10 名患者后估计治愈率。对于获得患者更快的大型实践，可以延迟分析，直到总共 104 例幽门螺杆菌感染患者，假设首选方案的基线治愈率至少为 85%。
我们展示了如何利用个体实践的数据来提高幽门螺杆菌治疗决策的有效性。该方法包括记录和积累连续小批患者的治愈确认数据。然后，将这些数据作为二项结果（通过/失败）进行分析，并作为研究和提高幽门螺杆菌治疗决策有效性的基础。
一种简单的计算方法可以为门诊诊所服务，以确保可靠的检测-治愈方法，并避免无效的 Hp 方案。
