Songür Yildiran, Senol Altuğ, Balkarli Ayşe, Baştürk Abdülkadir, Cerçi Süreyya
Department of Internal Medicine, Süleyman Demirel University School of Medicine, Isparta, Turkey.
Am J Med Sci. 2009 Jul;338(1):50-3. doi: 10.1097/MAJ.0b013e31819c7320.
Our aim was to compare lansoprazole-tetracycline-metranidazole (LTM) as first-line treatment with the classical lansoprazole-amoxicillin-clarithromycin (LAC) and bismuth-containing quadruple treatments.
This prospective, single-center, randomized study included 464 consecutive Helicobacter pylori-positive patients with dyspeptic symptoms. A total of 415 patients completed the study. The patients were allocated into 4 study groups using random sampling numbers as follows-LAC group: lansoprazole 30 mg twice daily, amoxicillin 1000 mg twice daily, and clarithromycin 500 mg twice daily for 14 days; BLTM group: bismuth subcitrate 300 mg 4 times a day, lansoprazole 30 mg twice daily, tetracycline 500 mg 4 times a day, and metronidazole 500 mg twice daily for 10 days; RBLTM group: ranitidine bismuth citrate 400 mg twice daily, lansoprazole 30 mg twice daily, tetracycline 500 mg 4 times a day, and metronidazole 500 mg twice daily for 10 days; and LTM group: lansoprazole 30 mg twice daily, tetracycline 500 mg 4 times a day, and metronidazole 500 mg twice daily for 10 days.
The per protocol H. pylori eradication rate in LAC, BLTM, RBLTM, and LTM groups were 37 of 104 (35.6%), 56 of 102 (54.9%), 67 of 104 (64.4%), and 63 of 105 (60%), respectively. The intention-to-treat eradication rate was 37 of 113 (32.7%) in LAC, 56 of 119 (47.1%) in BLTM, 67 of 117 (57.3%) in RBLTM, and 63 of 115 (54.8%) in LTM group. The BLTM, RBLTM, and LTM treatment groups achieved a significantly better eradication rate than the LAC treatment group (P < 0.001). There was not any significant statistical difference between the groups of BLTM, RBLTM, and LTM.
LTM treatment group achieved a significantly better eradication rate than the LAC treatment group. The success ratio of LTM therapy is comparable with quadruple bismuth-based treatments.
我们的目的是比较兰索拉唑-四环素-甲硝唑(LTM)作为一线治疗方案与传统的兰索拉唑-阿莫西林-克拉霉素(LAC)及含铋四联疗法。
这项前瞻性、单中心、随机研究纳入了464例连续的有消化不良症状的幽门螺杆菌阳性患者。共有415例患者完成了研究。使用随机抽样数字将患者分为4个研究组,如下所示:LAC组:兰索拉唑30毫克,每日2次;阿莫西林1000毫克,每日2次;克拉霉素500毫克,每日2次,疗程14天;BLTM组:枸橼酸铋300毫克,每日4次;兰索拉唑30毫克,每日2次;四环素500毫克,每日4次;甲硝唑500毫克,每日2次,疗程10天;RBLTM组:枸橼酸铋雷尼替丁400毫克,每日2次;兰索拉唑30毫克,每日2次;四环素500毫克,每日4次;甲硝唑500毫克,每日2次,疗程10天;LTM组:兰索拉唑30毫克,每日2次;四环素500毫克,每日4次;甲硝唑500毫克,每日2次,疗程10天。
按方案分析,LAC组、BLTM组、RBLTM组和LTM组的幽门螺杆菌根除率分别为104例中的37例(35.6%)、102例中的56例(54.9%)、104例中的67例(64.4%)和105例中的63例(60%)。意向性分析的根除率在LAC组为113例中的37例(32.7%),BLTM组为119例中的56例(47.1%),RBLTM组为117例中的67例(57.3%),LTM组为115例中的63例(54.8%)。BLTM组、RBLTM组和LTM治疗组的根除率显著高于LAC治疗组(P<0.001)。BLTM组、RBLTM组和LTM组之间无显著统计学差异。
LTM治疗组的根除率显著高于LAC治疗组。LTM疗法的成功率与含铋四联疗法相当。