Bujanda L, Sánchez A, Iriondo C, Santos A, Cosme A, Muñoz C
Servicio de Digestivo, Hospital San Eloy, Baracaldo, Vizcaya.
An Med Interna. 2001 Jul;18(7):361-3.
To compare the efficacy of ranitidine bismuth citrate (RB) combined with two antibiotics during seven days in comparison with OCA-7 for treatment of Helicobacter pylori.
In a randomized clinical trial 200, consecutive patients infected by Helicobacter pylori were studied prospectively. One of two regimens was given for 7 days; OCA-7 (omeprazole 20 mg b.i.d., amoxycillin 1 gr b.i.d., clarithromycin 500 mg b.i.d.) or RBCA (RB 400 b.i.d., amoxicillin 1 gr b.i.d., clarithromycin 500 mg b.i.d.). Eradication was defined as a negative breath test one month after therapy.
112 male and 88 female with a mean age of 48 years (range 18-82). 100 patients were randomized to OCA-7 and 100 patients to RBCA-7. Overall 186 patients completed the treatment. Intention to-treat eradication was in the group OCA-7 of 72% and 73% in group RBCA-7. Per-protocol eradication was in the group OCA-7 of 78% and 77% in group RBCA-7 (p = 0.3). Five patients in the group OCA-7 and nine in the group RBCA-7, had side effects, three of these patients did not complete therapy by diarrhea.
RB with two antibiotics is as effective and safe as OCA-7 for the eradication of Helicobacter pylori.
比较枸橼酸铋雷尼替丁（RB）联合两种抗生素治疗7天与OCA - 7治疗幽门螺杆菌的疗效。
在一项随机临床试验中，对200例连续的幽门螺杆菌感染患者进行前瞻性研究。给予两种治疗方案之一，为期7天；OCA - 7（奥美拉唑20毫克，每日两次，阿莫西林1克，每日两次，克拉霉素500毫克，每日两次）或RBCA（RB 400毫克，每日两次，阿莫西林1克，每日两次，克拉霉素500毫克，每日两次）。根除定义为治疗后1个月呼气试验阴性。
112例男性和88例女性，平均年龄48岁（范围18 - 82岁）。100例患者随机分为OCA - 7组，100例患者分为RBCA - 7组。总体上186例患者完成了治疗。意向性分析的根除率在OCA - 7组为72%，在RBCA - 7组为73%。符合方案分析的根除率在OCA - 7组为78%，在RBCA - 7组为77%（p = 0.3）。OCA - 7组有5例患者，RBCA - 7组有9例患者出现副作用，其中3例患者因腹泻未完成治疗。
RB联合两种抗生素在根除幽门螺杆菌方面与OCA - 7一样有效且安全。
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