铋剂、埃索美拉唑、甲硝唑和米诺环素或四环素作为幽门螺杆菌根除的一线方案：一项随机对照试验。
Bismuth, esomeprazole, metronidazole, and minocycline or tetracycline as a first-line regimen for Helicobacter pylori eradication: A randomized controlled trial.
机构信息
Department of Gastroenterology, Peking University Third Hospital, Beijing 100191, China.
Digestive Disease Research Center of Peking University, Beijing 100191, China.
出版信息
Chin Med J (Engl). 2023 Apr 20;136(8):933-940. doi: 10.1097/CM9.0000000000002629. Epub 2023 Apr 3.
BACKGROUND
Given the general unavailability, common adverse effects, and complicated administration of tetracycline, the clinical application of classic bismuth quadruple therapy (BQT) is greatly limited. Whether minocycline can replace tetracycline for Helicobacter pylori ( H . pylori ) eradication is unknown. We aimed to compare the eradication rate, safety, and compliance between minocycline- and tetracycline-containing BQT as first-line regimens.
METHODS
This randomized controlled trial was conducted on 434 naïve patients with H . pylori infection. The participants were randomly assigned to 14-day minocycline-containing BQT group (bismuth potassium citrate 110 mg q.i.d., esomeprazole 20 mg b.i.d., metronidazole 400 mg q.i.d., and minocycline 100 mg b.i.d.) and tetracycline-containing BQT group (bismuth potassium citrate/esomeprazole/metronidazole with doses same as above and tetracycline 500 mg q.i.d.). Safety and compliance were assessed within 3 days after eradication. Urea breath test was performed at 4-8 weeks after eradication to evaluate outcome. We used a noninferiority test to compare the eradication rates of the two groups. The intergroup differences were evaluated using Pearson chi-squared or Fisher's exact test for categorical variables and Student's t -test for continuous variables.
RESULTS
As for the eradication rates of minocycline- and tetracycline-containing BQT, the results of both intention-to-treat (ITT) and per-protocol (PP) analyses showed that the difference rate of lower limit of 95% confidence interval (CI) was >-10.0% (ITT analysis: 181/217 [83.4%] vs . 180/217 [82.9%], with a rate difference of 0.5% [-6.9% to 7.9%]; PP analysis: 177/193 [91.7%] vs . 176/191 [92.1%], with a rate difference of -0.4% [-5.6% to 6.4%]). Except for dizziness more common (35/215 [16.3%] vs . 13/214 [6.1%], P = 0.001) in minocycline-containing therapy groups, the incidences of adverse events (75/215 [34.9%] vs . 88/214 [41.1%]) and compliance (195/215 [90.7%] vs . 192/214 [89.7%]) were similar between the two groups.
CONCLUSION
The eradication efficacy of minocycline-containing BQT was noninferior to tetracycline-containing BQT as first-line regimen for H . pylori eradication with similar safety and compliance.
TRIAL REGISTRATION
ClinicalTrials.gov, ChiCTR 1900023646.
背景
鉴于四环素的普遍不可用、常见的不良反应和复杂的给药方式，经典铋四联疗法（BQT）的临床应用受到了极大限制。米诺环素能否替代四环素用于幽门螺杆菌（H. pylori ）的根除尚不清楚。我们旨在比较米诺环素和四环素含 BQT 作为一线方案的根除率、安全性和依从性。
方法
这项随机对照试验在 434 例 H. pylori 感染的初治患者中进行。参与者被随机分配到 14 天的米诺环素含 BQT 组（枸橼酸铋钾 110 mg，每日 4 次，艾司奥美拉唑 20 mg，每日 2 次，甲硝唑 400 mg，每日 4 次，米诺环素 100 mg，每日 2 次）和四环素含 BQT 组（枸橼酸铋钾/艾司奥美拉唑/甲硝唑剂量与上述相同，加用四环素 500 mg，每日 4 次）。在根除后 3 天内评估安全性和依从性。在根除后 4-8 周进行尿素呼气试验以评估结果。我们使用非劣效性检验比较两组的根除率。使用 Pearson 卡方检验或 Fisher 确切检验比较分类变量，使用 Student's t 检验比较连续变量。
结果
在米诺环素和四环素含 BQT 的根除率方面，意向治疗（ITT）和符合方案（PP）分析的结果均显示下限 95%置信区间（CI）差值率> -10.0%（ITT 分析：181/217 [83.4%] 与 180/217 [82.9%]，差值率为 0.5% [-6.9%至 7.9%]；PP 分析：177/193 [91.7%] 与 176/191 [92.1%]，差值率为 -0.4% [-5.6%至 6.4%]）。除米诺环素组更常见头晕（35/215 [16.3%] 与 13/214 [6.1%]，P = 0.001）外，两组不良反应发生率（75/215 [34.9%] 与 88/214 [41.1%]）和依从性（195/215 [90.7%] 与 192/214 [89.7%]）相似。
结论
米诺环素含 BQT 作为 H. pylori 根除的一线方案，其根除效果不劣于四环素含 BQT，且安全性和依从性相似。
试验注册
ClinicalTrials.gov，ChiCTR1900023646。
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