10天、14天序贯疗法与铋剂四联在幽门螺杆菌补救治疗中的效果观察
发布时间：2019-03-28 12:27
【摘要】：目的：观察10天、14天序贯疗法及10天铋剂四联疗法三种方案作为幽门螺杆菌（H.Pylori)）根除失败后二线补救治疗方案的根除效果、患者的症状改善情况、药物的安全性及副反应，并对三组治疗方案进行成本-效果分析，进而为临床上寻找一种对Hp安全、有效的、价格相对低廉且患者容易接受的补救治疗方法。 方法：通过门诊胃镜检查诊断为慢性胃炎或消化性溃疡的患者，且所有患者既往经过正规抗Hp治疗，本次复诊时14C尿素呼气试验Hp仍为阳性的患者91例。随机分为三组。A组（n＝30例，男18，女12）铋剂四联疗法：雷贝拉唑10mg bid+胶体果较铋0.15g tid+阿莫西林克拉维酸钾(0.457g bid)+左氧氟沙星0.2g bid，疗程10天；B组（n＝30例，男17，女13）10d序贯疗法：前5d雷贝拉唑10mgbid+阿莫西林克拉维酸钾(0.457g bid)，后5d雷贝拉唑10mg+替硝唑0.5g+左氧氟沙星0.2g，bid；C组（n＝31例，男19，女12）14d序贯疗法：前7天雷贝拉唑10mgbid+阿莫西林克拉维酸钾(0.457g bid)，后7天雷贝拉唑10mg+替硝唑（0.5g bid）+左氧氟沙星（0.2g bid）。随访患者服药期间的不良反应和症状缓解情况，复诊时间为抗生素停用最少1月， PPI至少14天后行14C-尿素呼气试验（Urea BreanthTest，UBT）检测Hp的根除情况。 结果：本实验共有91例患者，三组各失访1例，，治疗期间患者无因严重的不良反应（ADR）而退出实验。10天铋剂四联组、10天序贯疗法组和14天序贯方案组分别为30例、30例和31例。三组方案的Hp根除率按意向治疗分析（ITT）根除率分别为73.3%、76.7%和80.6%；完成治疗分析（PP）根除率分别为75.9%、79.3%和83.3%；三组方案的Hp根除率差异用统计学解释无显著性意义(P0.05)。三种不同治疗方法的症状缓解率和不良反应发生率也无显著性差异（P0.05）；成本-效果分析显示，每增加1%的根除率，10天序贯疗法比10天铋剂四联疗法的成本低33.5元，10天序贯疗法比14天序贯疗法的成本低14.13元。 结论：10日序贯疗法、14日序贯疗法、10天铋剂四联疗法对Hp的补救治疗中，序贯14天方案的根除率相对较高，但三种方案间的差异还不能用统计学解释（P＞0.05）。可能是因为本研究样本含量小，以及局限在来我院就诊的患者、及本地区对抗生素的耐药情况等因素，还需要大样本、多中心、随机的实验来证明。三组补救治疗方案的临床症状缓解率及不良反应的发生率并没有显著差异。三组方案的不良反应发生率无统计学差异（P＞0.05），提示三种方案有较好的安全性。10日序贯疗法作为Hp的二线补救治疗方案根除率高、更经济，易于被广大患者接受，值得在临床上推广。
[Abstract]:Objective: to observe the efficacy of 10-day, 14-day sequential therapy and 10-day bismuth tetra-therapy as second-line remedial therapy after the failure of Helicobacter pylori (H.Pylori) eradication, and improve the symptoms of the patients. The safety and side effects of the drug were analyzed, and the cost-effectiveness analysis was carried out to find a safe, effective, low-cost and easy-to-accept remedy for Hp. Methods: 91 patients with chronic gastritis or peptic ulcer diagnosed by out-patient gastroscopy were treated with regular anti-Hp therapy. The 14C urea breath test (Hp) was still positive in 91 patients at the time of re-diagnosis. Group A (n = 30, M 18, F 12) were randomly divided into three groups: group A (n = 30, M 18, F 12): Rabeprazole 10mg bid colloid fruit was treated with 0.2 g bid, of levofloxacin compared with bismuth 0.15g tid amoxicillin clavulanate potassium (0.457g bid,); Group B (n = 30, male 17, F 13) received 10-day sequential therapy: Rabeprazole 10mgbid, amoxicillin-clavulanate potassium (0.457g bid),) 5 days later, 10mg tinidazole 0.5g levofloxacin 0.2g, bid; Group C (n = 31, M 19, F 12) 14 days sequential therapy: Rabeprazole 10mgbid amoxicillin clavulanate potassium (0.457g bid),) 7 days after lameprazole 10mg tinidazole (0.5g bid) levofloxacin (0.2g bid).) The adverse reactions and symptom relief during the treatment were followed up. The duration of re-diagnosis was at least 1 month after antibiotic discontinuation. The eradication of Hp was detected by 14C-urea breath test (Urea BreanthTest,UBT) after at least 14 days of PPI. Results: there were 91 patients in this experiment, one in each of the three groups, and there were no serious side effects such as (ADR) during the treatment, 30 patients in the 10-day bismuth quadruple group, 10-day sequential therapy group and 14-day sequential therapy group were 30 cases, respectively, and there were 30 cases in the 10-day sequential therapy group and in the 14-day sequential therapy group, respectively. 30 cases and 31 cases. The Hp eradication rate of the three groups was 73.3%, 76.7% and 80.6% respectively according to the intention-to-treat analysis, and the (PP) eradication rate of the complete treatment analysis was 75.9%, 79.3% and 83.3%, respectively. There was no significant difference in Hp eradication rate among the three groups (P0.05). There was no significant difference in symptom remission rate and adverse reaction rate among the three different treatment methods (P0.05). Cost-effectiveness analysis showed that for every 1% increase in eradication rate, the cost of 10-day sequential therapy was 33.5 yuan lower than that of 10-day bismuth quadruple therapy, and 10-day sequential therapy was 14.13 yuan lower than that of 14-day sequential therapy. Conclusion: among the 10-day sequential therapy, 14-day sequential therapy and 10-day bismuth quadruple therapy, the eradication rate of sequential 14-day regimen for Hp was relatively high, but the differences among the three regimens could not be explained statistically (P > 0.05). This study may be due to the small sample size, limited to our hospital patients, as well as the region's antibiotic resistance and other factors, but also need large samples, multicenter, randomized trials to prove. There was no significant difference in the remission rate of clinical symptoms and the incidence of adverse reactions among the three groups. There was no statistical difference in the incidence of adverse reactions among the three groups (P > 0.05), suggesting that the three regimens had better safety. 10-day sequential therapy as a second-line remedial therapy for Hp had high eradication rate, more economical, and easy to be accepted by the majority of patients. It is worth popularizing in clinic.
【学位授予单位】：延安大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R573
本文编号：2448865
[Abstract]:Objective: to observe the efficacy of 10-day, 14-day sequential therapy and 10-day bismuth tetra-therapy as second-line remedial therapy after the failure of Helicobacter pylori (H.Pylori) eradication, and improve the symptoms of the patients. The safety and side effects of the drug were analyzed, and the cost-effectiveness analysis was carried out to find a safe, effective, low-cost and easy-to-accept remedy for Hp. Methods: 91 patients with chronic gastritis or peptic ulcer diagnosed by out-patient gastroscopy were treated with regular anti-Hp therapy. The 14C urea breath test (Hp) was still positive in 91 patients at the time of re-diagnosis. Group A (n = 30, M 18, F 12) were randomly divided into three groups: group A (n = 30, M 18, F 12): Rabeprazole 10mg bid colloid fruit was treated with 0.2 g bid, of levofloxacin compared with bismuth 0.15g tid amoxicillin clavulanate potassium (0.457g bid,); Group B (n = 30, male 17, F 13) received 10-day sequential therapy: Rabeprazole 10mgbid, amoxicillin-clavulanate potassium (0.457g bid),) 5 days later, 10mg tinidazole 0.5g levofloxacin 0.2g, bid; Group C (n = 31, M 19, F 12) 14 days sequential therapy: Rabeprazole 10mgbid amoxicillin clavulanate potassium (0.457g bid),) 7 days after lameprazole 10mg tinidazole (0.5g bid) levofloxacin (0.2g bid).) The adverse reactions and symptom relief during the treatment were followed up. The duration of re-diagnosis was at least 1 month after antibiotic discontinuation. The eradication of Hp was detected by 14C-urea breath test (Urea BreanthTest,UBT) after at least 14 days of PPI. Results: there were 91 patients in this experiment, one in each of the three groups, and there were no serious side effects such as (ADR) during the treatment, 30 patients in the 10-day bismuth quadruple group, 10-day sequential therapy group and 14-day sequential therapy group were 30 cases, respectively, and there were 30 cases in the 10-day sequential therapy group and in the 14-day sequential therapy group, respectively. 30 cases and 31 cases. The Hp eradication rate of the three groups was 73.3%, 76.7% and 80.6% respectively according to the intention-to-treat analysis, and the (PP) eradication rate of the complete treatment analysis was 75.9%, 79.3% and 83.3%, respectively. There was no significant difference in Hp eradication rate among the three groups (P0.05). There was no significant difference in symptom remission rate and adverse reaction rate among the three different treatment methods (P0.05). Cost-effectiveness analysis showed that for every 1% increase in eradication rate, the cost of 10-day sequential therapy was 33.5 yuan lower than that of 10-day bismuth quadruple therapy, and 10-day sequential therapy was 14.13 yuan lower than that of 14-day sequential therapy. Conclusion: among the 10-day sequential therapy, 14-day sequential therapy and 10-day bismuth quadruple therapy, the eradication rate of sequential 14-day regimen for Hp was relatively high, but the differences among the three regimens could not be explained statistically (P > 0.05). This study may be due to the small sample size, limited to our hospital patients, as well as the region's antibiotic resistance and other factors, but also need large samples, multicenter, randomized trials to prove. There was no significant difference in the remission rate of clinical symptoms and the incidence of adverse reactions among the three groups. There was no statistical difference in the incidence of adverse reactions among the three groups (P > 0.05), suggesting that the three regimens had better safety. 10-day sequential therapy as a second-line remedial therapy for Hp had high eradication rate, more economical, and easy to be accepted by the majority of patients. It is worth popularizing in clinic.
【学位授予单位】：延安大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R573
【参考文献】
相关期刊论文 前1条
1 洪卫康;;左氧氟沙星序贯与铋剂四联抗幽门螺杆菌的随机对照研究[J];中外医疗;2013年36期
本文编号：2448865
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