幽门螺杆菌感染初治患者铋剂四联方案联合益生菌治疗的疗效及卫生经济学分析  

Efficacy and cost-effectiveness analysis of probiotics in initial Helicobacter pylori eradication therapy

作　　者：张越溪[1] 邹小青 吴作艳[1] Zhang Yuexi;Zou Xiaoqing;Wu Zuoyan(Department of Gastroenterology,Beijing Sixth Municipal Hospital,Beijing 100007,China;School of Population Medicine and Public Health,Chinese Academy of Medical Sciences&Peking Union Medical College,Beijing100730,China)

机构地区：[1]北京市第六医院消化内科,北京100007 [2]中国医学科学院、北京协和医学院群医学及公共卫生学院,北京100730

出　　处：《中华全科医师杂志》2023年第7期722-727,共6页Chinese Journal of General Practitioners

摘　　要：目的评价在幽门螺杆菌感染初治患者根除治疗中,铋剂四联方案联合口服益生菌治疗的疗效,并进行成本效果分析。方法该研究采用前瞻性随机对照方法,选取2020年1月1日至2021年8月31日在北京市第六医院消化内科及内镜中心就诊经13C-呼气试验确诊为幽门螺杆菌感染的初治患者267例,随机分为试验组及对照组。两组均给予口服包含阿莫西林及克拉霉素的铋剂四联方案根除幽门螺杆菌治疗,试验组另加服双歧杆菌四联活菌片联合治疗。两组疗程均为14 d,停药4~12周后复查13C-呼气试验,观察两组幽门螺杆菌根除及不良反应发生率,并采用成本效果分析对两种治疗方案的经济性进行评价。结果两组根除率比较,试验组高于对照组,意向性(ITT)分析结果为80.6%(108/134)比68.4%(91/133)(χ^(2)=5.213,P=0.022),符合方案集(PP)分析结果为83.1%(108/130)比72.2%(91/126)(χ^(2)=4.356,P=0.037)。试验组不良反应发生率低于对照组[8.2%(11/134)比18.8%(25/133),χ^(2)=6.415,P=0.011]。成本效果分析结果显示,与对照组相比,试验组的增量成本效果比为1010.49元;敏感分析结果显示,试验组方案的有效率对结果的影响较大,对照组方案的有效率和双歧杆菌四联活菌片的成本次之;当意愿支付值为2500.00元时,联合益生菌组具有成本效果优势的概率为91.2%。结论在幽门螺杆菌感染初治患者群中,相比单纯铋剂四联根除方案,联合益生菌的治疗方案可提高根除率,同时降低不良反应发生率,效果确切、安全,是一种经济有效的治疗方案。ObjectiveTo analyze the efficacy and cost-effectiveness of probiotics in initial Helicobacter pylori(H.pylori)eradication therapy.MethodsA total of 267 patients with positive H.pylori infection were randomly assigned to two groups,the control group(n=133)received a 14-day bismuth agent quadruple therapy and the study group(n=144)received conventional quadruple therapy plus probiotics from January 2020 to August 2021.Eradication status was assessed 4-12 weeks after treatment.The H.pylori eradication rate,adverse reactions,and cost-effectiveness were compared between the two groups.ResultsThe H.pylori eradication rate was higher in study group than that in the control group in intention-to-treat(ITT)(80.6%(108/134),95%CI:73.8%-87.4%vs.68.4%(91/133),95%CI:60.4%-76.4%,P=0.022)and per-protocol(83.1%(108/130),95%CI:76.5%-89.6%vs.72.2%(91/126),95%CI:64.3%-80.2%,P=0.037).The incidence of adverse effects in the study group was lower than that in the control group(8.2%(11/134)vs.18.8%(25/133),χ^(2)=6.415,P=0.011).Cost-effectiveness analysis showed that compared with the control group,the incremental cost-effectiveness ratio(ICER)of the study group was 1010.49 yuan.The single factor sensitivity analysis showed that the H.pylori eradication rate of the study group had a greater impact on the results,followed by that of the control group and the cost of bifidobacterium quadruplex viable tablets.The probability sensitivity analysis showed that when the willingness to pay value(WTP)was 2500 yuan,the probability that the probiotics combined with the bismuth agent quadruple therapy group was more cost-effective than the simple bismuth agent quadruple therapy group was 91.2%.ConclusionAs initial Helicobacter pylori treatment,probiotics combined with the bismuth agent quadruple scheme has a higher eradication rate and a lower incidence of adverse events than the bismuth agent quadruple scheme.

关 键 词：幽门螺杆菌 益生菌 根除治疗 成本效果分析 

分 类 号：R573[医药卫生—消化系统]