Dore Maria Pina, Saba Francesco, Zanni Lucia, Rocca Anna, Piroddu Jessica, Gutierrez Giuseppe, Pes Giovanni Mario
Dipartimento di Medicina, Chirurgia e Farmacia, Clinica Medica, University of Sassari, Viale San Pietro 8, 07100 Sassari, Italy.
Department of Medicine, Baylor College of Medicine, One Baylor Plaza Blvd, Houston, TX 77030, USA.
J Clin Med. 2023 Jan 15;12(2):681. doi: 10.3390/jcm12020681.
Earlier studies have shown that a modified low-dose bismuth quadruple therapy given for 10 to 14 days is highly effective for the treatment of infection in Sardinia. However, bismuth is not universally available.
We aimed to investigate the efficacy of a simplified low-dose 10-day quadruple therapy containing a galenic formulation of bismuth salicylate for infection.
Adult patients positive for infection were assigned to a quadruple therapy containing a galenic formulation of bismuth salicylate (200 mg) plus tetracycline 500 mg, metronidazole 500 mg and rabeprazole 20 mg, given twice a day with the midday and evening meals for 10 days. A negative stool antigen test or 13C-Urea Breath Test defined successful eradication. Compliance and adverse events were recorded 30-40 days after the end of treatment.
In this open-label pilot study, 42 patients were enrolled (mean age 54.1 ± 12.0 years; 64% female). Among the study participants, 35 were naïve to treatment. The treatment regimen was completed by 41 patients, with an overall success rate of 95.1%. More specifically, the eradication rate was 95.1% PP; 95% confidence interval (CI) = 86.6-100 and 92.9% by ITT; 95%CI = 85.1-100%, respectively. For naïve patients, the cure rate was 97.1%. Compliance was excellent. Side effects were absent or mild overall.
The modified low-dose 10-day quadruple therapy provided high eradication rates of infection, despite the replacement of colloidal bismuth subcitrate with bismuth salicylate. In regions where bismuth is unavailable in the market, the galenic formulation should be a valid option.
早期研究表明，改良的低剂量铋剂四联疗法治疗10至14天对撒丁岛幽门螺杆菌感染非常有效。然而，铋剂并非普遍可用。
我们旨在研究一种简化的含低剂量水杨酸铋制剂的10天四联疗法对幽门螺杆菌感染的疗效。
幽门螺杆菌感染阳性的成年患者被分配接受含200毫克水杨酸铋制剂加500毫克四环素、500毫克甲硝唑和20毫克雷贝拉唑的四联疗法，每天两次，与午餐和晚餐同时服用，持续10天。粪便抗原检测阴性或13C尿素呼气试验确定根除成功。在治疗结束后30至40天记录依从性和不良事件。
在这项开放标签的试点研究中，纳入了42例患者（平均年龄54.1±12.0岁；64%为女性）。在研究参与者中，35例为初次接受幽门螺杆菌治疗。41例患者完成了治疗方案，总体成功率为95.1%。更具体地说，按符合方案分析的根除率为95.1%；95%置信区间（CI）=86.6-100，意向性分析的根除率为92.9%；95%CI=85.1-100%。对于初次治疗的患者，治愈率为97.1%。依从性良好。总体副作用不存在或轻微。
尽管用含水杨酸铋制剂替代了次枸橼酸铋胶体，但改良的低剂量10天四联疗法仍提供了较高的幽门螺杆菌根除率。在市场上无法获得铋剂的地区，含水杨酸铋制剂应是一个有效的选择。
