健脾祛湿解毒通络方联合补救四联疗法治疗难治性幽门螺杆菌感染的临床疗效观察

Clinical observation of Jianpi Qushi Jiedu Tongluo Decoction combined with remedial quadruple therapy in the treatment of refractory Helicobacter pylori infection

目的观察健脾祛湿解毒通络方联合补救四联疗法治疗难治性幽门螺杆菌感染(refractory Helicobacter pylori infection,RHPI)的临床疗效和安全性。方法将诊断为RHPI的患者按照1:2的比例随机分为治疗组和对照组,最终纳入治疗组23例,对照组46例。对照组予标准补救四联疗法治疗,疗程14 d;治疗组在对照组用药方案的基础上,联合健脾祛湿解毒通络方进行治疗,补救四联疗法疗程10 d(纳入后第1~10天服用),中药疗程14 d(纳入后第11~24天服用)。观察停药8周后幽门螺杆菌(Helicobacter pylori,HP)根除率,停药后和停药8周后的中医症状积分、中医疗效,治疗期间不良反应发生率,对疗效进行评估。结果治疗组HP根除率为91.3%(21/23),高于对照组的82.6%(38/46),但两组间差异无统计学意义(P>0.05)。停药后,治疗组在改善大便溏泻、症状总积分方面优于对照组(P<0.05);停药8周后,治疗组在上腹胀满、上腹疼痛、嗳气、反酸烧心、口干口苦、大便溏泻等单项症状积分和症状总积分方面的改善效果优于对照组(P<0.05);中医疗效方面,治疗组在停药及停药8周后的疗效均优于对照组(P<0.05)。安全性方面,治疗组不良反应发生率为4.3%,对照组为17.4%,治疗组低于对照组,但组间差异无统计学意义(P>0.05)。结论健脾祛湿解毒通络方联合补救四联疗法是治疗RHPI的有效方案,在减少抗生素用量的同时,可维持HP根除率与补救四联疗法相当,且能明显改善患者的临床症状。

Objective To observe the clinical efficacy and safety of Jianpi Qushi Jiedu Tongluo Decoction combined with remedial quadruple therapy in the treatment of refractory Helicobacter pylori infection(RHPI).Methods Patients diagnosed with RHPI were randomly divided into the treatment group and the control group in the 1:2 ratio,with 23 patients in the treatment group and 46 patients in the control group.The remedial quadruple therapy was used in the control group for 14 days;the treatment group was treated with remedial quadruple therapy combined with Jianpi Qushi Jiedu Tongluo Decoction,with a course of remedial quadruple therapy for 10 days(taken on the 1st-10th day after inclusion),and a course of Traditional Chinese Medicine(TCM)for 14 days(taken on the 11th-24th day after inclusion).To observe the eradication rate of Helicobacter pylori(H.pylori)8 weeks after drug discontinuation,the TCM symptom score and TCM efficacy after drug discontinuation and 8 weeks after drug discontinuation,and the incidence of adverse reactions during the treatment period.Results The H.pylori eradication rate of the treatment group was 91.3%(21/23),which was better than that of the control group(82.6%,38/46)(P>0.05).After stopping the medication,the treatment group was better than the control group in improving loose stools and total symptom scores;after stopping the medication for 8 weeks,the treatment group was better than the control group in improving epigastric distension,epigastric pain,belching,acid reflux and heartburn,dry mouth and bitter taste,loose stools and total symptom scores(P<0.05);as for the efficacy of TCM,the efficacy of the treatment group was better after stopping the medication and 8 weeks after stopping the medication(P<0.05).In terms of adverse reactions,the incidence rate of adverse reactions in the treatment group was 4.3%lower than the rate of adverse reactions in the control group,which was 17.4%(P>0.05).Conclusion Jianpi Qushi Jiedu Tongluo Decoction combined with remedial quadruple therapy is an effective regimen for the treatment of RHPI,which reduces the amount of antibiotics while maintaining the H.pylori eradication rate comparable to that of the remedial quadruple therapy,and significantly improves the clinical symptoms.