清热健脾法治疗幽门螺杆菌初治失败的临床研究:基于倾向性评分匹配研究

Clinical research on the treatment of primary failure of Hp with heat-clearing and spleen-invigorating method:a matching study based on propensity score

目的探讨清热健脾法治疗Hp初治失败患者的临床疗效与安全性。方法回顾性分析2021年1月-2022年12月本院155例Hp初治失败患者的临床资料,根据治疗方案分为中药组66例和西药组89例。采用Python 3.70进行倾向性评分匹配(PSM),按1∶1比例均衡治疗前易混杂因素,最终2组各有66例配对成功。中药组予以一清胶囊+健脾丸,4周为1个疗程;西药组予四联抗Hp补救方案,2周为1个疗程。2组均治疗1个疗程。采用14 C呼气试验检测Hp并计算其清除率;从餐后饱胀不适、早饱感、中上腹痛、中上腹烧灼感4个方面进行功能性消化不良(FD)总体症状评分;观察治疗期间的不良反应,评价临床疗效。结果治疗后,中药组Hp清除率为75.76%(50/66)、西药组为83.33%(55/66),2组均较同组治疗前明显好转,但组间比较差异无统计学意义(χ^(2)=1.16,P=0.281)。中药组治疗后餐后饱胀不适[1(0,2)分比4(2,4)分,Z=-6.85]、早饱感[2(0,2)分比4(4,6)分,Z=-8.02]、中上腹痛[2(2,4)分比4(4,6)分,Z=-4.48]积分低于西药组(P<0.01)。中药组总有效率为75.76%(50/66)、西药组为69.70%(46/66),2组比较差异无统计学意义(χ^(2)=2.00,P=0.573)。2组治疗期间未发生不良反应。结论清热健脾法治疗Hp初治失败患者,其Hp清除率与临床总有效率与西药相当,可有效改善Hp初治失败患者的临床症状。

Objective To investigate the clinical efficacy and safety of heat-clearing and spleen-invigorating method in the treatment of Helicobacter pylori(Hp)initial treatment failure population.Methods The clinical data of 155 patients with initial Hp failure in our hospital from January 2021 to December 2022 were retrospectively analyzed.According to the treatment plan,they were divided into TCM group(66 cases)and Western medicine group(89 cases).Python 3.70 was used for bias score matching(PSM)to obtain samples with balanced covariates between groups.Finally 66 pair of cases were successfully matched according to the propensity score and the 1:1 matching principle.The TCM group was given Yiqing Capsule+Jianpi Pills(4 weeks)as a course of treatment.The Western medicine group was given four anti-Hp remedial regimen,2 weeks for 1 course.2 groups were treated for 1 course.Hp was detected by 14C breath test and its clearance rate was calculated.The overall symptoms of functional dyspepsia(FD)were evaluated from four aspects:postprandial fullness,early satiety,middle and upper abdominal pain,and middle and upper abdominal burning sensation.The adverse reactions during treatment were observed and the clinical efficacy was evaluated.Results After treatment,the Hp clearance rate was 75.76%(50/66)in the TCM group and 83.33%(55/66)in the Western medicine group,which was significantly improved compared with that before treatment,without statistical significance(χ^(2)=1.16,P=0.281).After treatment,the scores of fullness and discomfort after meal[1(0,2)vs.(2,4),Z=-6.85],early satiety[2(0,2)vs.4(4,6),Z=-8.02],middle and upper abdominal pain[2(2,4)vs.4(4,6),Z=-4.48]in the TCM group were lower than those in Western medicine group(P<0.01).The total effective rate was 75.76%(50/66)in the TCM group and 69.70%(46/66)in the Western medicine group,without statistical significance(χ^(2)=2.00,P=0.573).No adverse reactions occurred in the 2 groups during treatment.Conclusion In terms of heat-clearing and spleen-invigorating method for Hp initially failed patients,its Hp clearance rate and clinical total effective rate are comparable to Western medicine,and can effectively improve the clinical symptoms of patients with Hp initial treatment failure.