铋剂四联疗法联合不同药物对幽门螺杆菌感染的疗效

The effect of bismuth-based quadruple therapy combined with different drugs in the treatment of Helicobacter pylori infection

目的分析铋剂四联疗法联合不同药物对幽门螺杆菌感染的疗效。方法入选患者依据治疗方案不同进行分组,其中A组患者采用铋剂四联方案(1种PPI+1种铋剂+2种抗生素)进行治疗,B组患者采用铋剂四联+思联康治疗,C组患者采用铋剂四联+荆花胃康治疗。3组患者均于根除治疗结束停药1个月后复查13C呼气试验以评估疗效。对各方案的H.pylori根除率进行评比,并分析其临床疗效和成本-效益情况。结果按ITT集分析时,C组与A组患者根除率比较差异无统计学意义(χ^2=3.642,P=0.056),B组与A组和C组患者比较差异无统计学意义(χ^2=3.209、0.130,P>0.05)。按PP集分析时,C组患者根除率最高,A组患者根除率最低,B、C组与A组患者比较差异有统计学意义(χ^2=4.620、4.419,P<0.05),B、C两组根除率比较差异无统计学意义(χ^2=0.062,P>0.05)。A组、B组和C组患者不良反应发生率按PP集计算分别为50.0%、7.9%和26.7%,3组患者不良反应发生率两两比较差异均有统计学意义(均P<0.05)。成本-效益分析结果显示B组患者的成本-效果比值最小。结论综合有效性、安全性及成本-效益比分析,铋剂四联+思联康方案具有H.pylori根除率高,患者不良反应发生率低,成本效益比低的优势,提示此方案为本研究的最佳方案,值得临床推广应用。

Objective To explore the effect of bismuth-based quadruple therapy combined with different drugs in the treatment of Helicobacter pylori infection. Methods Patients were divided into different groups according to different treatment options. The patients in group A were treated with bismuth-based quadruple therapy(1 PPI + 1 bismuth-based agent + 2 antibiotics), those in group B with bismuth-based quadruple therapy and Si Lian Kang, while those in group C with bismuth-based quadruple therapy and Jing-Hua Wei Kang. All the patients received 13C-exhalation test for evaluation of efficacy one month after withdrawal of eradication medication. The H. pylori eradication rate in each group was evaluated, and the clinical effect and cost-effectiveness were analyzed and compared among groups. Results ITT analysis showed that the eradication rates had no significant difference between group C and group A(χ^2=3.642, P=0.056). There were no significant differences between group B and group A and between group B and C(χ^2=3.209, 0.130;P>0.05). PP analysis showed that the eradication rate was the highest in group C, and the lowest in group A. There were significant differences between group B and C and between group B and A(χ^2=4.620, 4.419;P<0.05). There was no significant difference in eradication rate between group B and C(χ^2=0.062, P>0.05). According to the PP analysis, the incidence of adverse reactions in groups A, B and C were 50.0%, 7.9% and 26.7%, respectively. There were statistically significant differences in the incidence of adverse reactions among the three groups(P<0.05). The cost-benefit analysis showed that the cost-benefit ratio in group B was the lowest. Conclusion Taking efficacy, safety and cost-benefit ratio into consideration, bismuth-based quadruple therapy combined with Si Lian Kang has the advantages of high eradication rate, low adverse reaction rate and low cost-benefit ratio. It is the best treatment option in this study and is worthy to be recommended for clinical practice.