Department of Internal Medicine, Holy Family Hospital, Faculty of Medicine in the Galilee, Bar-Ilan University, Nazareth, Israel.
Aliment Pharmacol Ther. 2012 Aug;36(3):231-8. doi: 10.1111/j.1365-2036.2012.05161.x. Epub 2012 May 31.
The eradication rate of Helicobacter pylori with standard treatments are decreasing worldwide.
To determine whether adding simvastatin as adjuvant to triple regimen in patients with H. pylori infection will improve the eradication rate.
We conducted a double-blind, placebo-controlled, randomised clinical trial comparing a 7-day, triple eradication regimen consisting of two antibiotics (clarithromycin 500 mg and amoxicillin 1 g, all twice per day) plus a proton pump inhibitor (omeprazole 20 mg twice daily) supplemented with simvastatin 20 mg (CAO + S) or a comparable placebo (CAO + P). Both the simvastatin and the placebo were taken orally twice daily for 1 week in 113 patients with H. pylori infection. The presence of H. pylori was determined by positive rapid urease test and histology. Eradication was confirmed by ¹³C-urea breath test at least 1 month after treatment. Adverse effects were assessed by questionnaire.
A total of 113 patients underwent randomisation. Intention-to-treat analysis (ITT; n = 113) eradication rates were: CAO + S (86%; 95% CI: 78-92%), CAO + P (69%; 95% CI: 64-74%). Per protocol analysis (PP; n = 108) eradication rates were: CAO + S (91%; 95% CI: 84-94%), CAO + P (72%; 95% CI: 65-78%). Eradication rates were higher with CAO + S than CAO + P in PP and ITT (P = 0.03, P = 0.04 respectively). No differences were demonstrated between the two groups concerning compliance or adverse effects.
In this randomised clinical trial simvastatin as adjuvant to standard therapy improves significantly the H. pylori eradication rate.
全球范围内，标准治疗方案根除幽门螺杆菌的成功率正在下降。
确定在幽门螺杆菌感染患者中，三联疗法中添加辛伐他汀作为辅助药物是否会提高根除率。
我们进行了一项双盲、安慰剂对照、随机临床试验，比较了一种 7 天的三联根除方案，该方案由两种抗生素（克拉霉素 500mg 和阿莫西林 1g，均每日两次）加质子泵抑制剂（奥美拉唑 20mg，每日两次）加辛伐他汀 20mg（CAO+S）或相当的安慰剂（CAO+P）组成。113 例幽门螺杆菌感染患者接受了为期 1 周的辛伐他汀或安慰剂口服治疗，每日两次。幽门螺杆菌的存在通过快速尿素酶试验和组织学检查确定。治疗后至少 1 个月，通过¹³C-尿素呼气试验确认根除。通过问卷评估不良反应。
共有 113 例患者接受了随机分组。意向治疗分析（ITT；n=113）的根除率为：CAO+S（86%；95%CI：78-92%），CAO+P（69%；95%CI：64-74%）。按方案分析（PP；n=108）的根除率为：CAO+S（91%；95%CI：84-94%），CAO+P（72%；95%CI：65-78%）。PP 和 ITT 中，CAO+S 的根除率均高于 CAO+P（P=0.03，P=0.04）。两组在依从性或不良反应方面无差异。
在这项随机临床试验中，辛伐他汀作为标准治疗的辅助药物可显著提高幽门螺杆菌的根除率。
