蒲翘异功汤联合四联疗法治疗脾胃虚寒证幽门螺杆菌相关性胃溃疡临床研究

目的:观察蒲翘异功汤联合常规含铋剂四联疗法治疗脾胃虚寒证幽门螺杆菌(Hp)感染相关性胃溃疡的临床疗效。方法:选择符合纳入标准与排除标准的消化科患者60例,将其按随机数字表法分为2组各30例,对照组予四联疗法治疗14天,后予序贯服用予艾司奥美拉唑镁肠溶片治疗6周;观察组在对照组治疗方案的基础上加用蒲翘异功汤治疗。2组均治疗8周评价疗效。疗程结束后观察临床疗效指标及安全性指标。对胃镜下治愈并根除Hp的患者随访4个月,评价其远期疗效。结果:治疗后,2组Hp感染情况比较,观察组总有效率93.33%;对照组总有效率90.00%,差异无统计学意义(P>0.05)。治疗结束4个月后,观察组复发率10.71%,对照组37.04%,2组比较,差异有统计学意义(P<0.05)。胃溃疡疗效观察组痊愈率46.67%,总有效率93.33%;对照组痊愈率33.33%,总有效率76.67%。2组比较,差异有统计学意义(P<0.05)。治疗结束4个月后溃疡复发情况进行比较,观察组溃疡痊愈14例中,复发1例,复发率7.14%;对照组痊愈10例中,复发4例,复发率40.00%。差异有统计学意义(P<0.05)。治疗后,2组环氧合酶2(COX-2)、中间核转录因子(NF-кBp65)和三叶因子(TFF3)免疫组化表达阳性率比较,差异均有统计学意义(P<0.05)。2组各项中医症状积分较治疗前均有下降,差异均有统计学意义(P<0.05)。治疗后,观察组胃脘疼痛、得食痛减、四肢乏力、肢冷畏寒、纳呆食少症状积分分别与对照组比较,差异均有统计学意义(P<0.05)。在研究过程中,2组间的安全性指标均未见明显异常,无不良反应,治疗前后心、肝、肾功能,血、小便、大便常规检查及心电图检查均无明显异常。结论:蒲翘异功汤联合常规含铋剂四联疗法治疗脾胃虚寒证Hp相关性胃溃疡,其Hp清除率与单纯含铋剂四联疗法治疗虽无明显变化,但能降低Hp感染的远期复发率,不同程度改善脾胃虚寒证Hp相关性胃溃疡患者的中医症状,提高胃溃疡治愈率,降低胃溃疡远期复发率,有效降低COX-2、NF-кBp65、TFF3肿瘤风险因子表达水平,且临床安全性高。

Clinical Study on Puqiao Yigong Tang Combined with Quadruple Therapy for Helicobacter Pylori-Associated Gastric Ulcer with Spleen-Stomach Deficiency Cold Syndrome

Objective:To observe the clinical effect of Puqiao Yigong tang combined with routine quadruple therapy containing bismuth agent for Helicobacter pylori(Hp)-associated gastric ulcer with spleen-stomach deficiency cold syndrome.Methods:A total of 60 cases of patients who met inclusion criteria and exclusion criteria in the Digestive Department were selected,and divided into two groups according to the random number table method,30 cases in each group.The control group was treated with quadruple therapy for 14 days,and the sequential treatment of oral administration of esomeprazole magnesium enteric-coated tablets for 6 weeks.The observation group was additionally given Puqiao Yigong tang based on the treatment of the control group.Both groups were treated for 8 weeks,and the curative effect was evaluated.After treatment,the indexes of clinical effect and safety indexes were observed.Patients who had Hp cured and eradicated under gastroscopy were followed up for four months.The long-term curative effect was evaluated.Results:After treatment,the total effective rate was 93.33%in the observation group,and 90.00%in the control group;there was no significant difference being found in the comparison of Hp infection between the two groups(P>0.05).Four months after treatment,the recurrence rate was 10.71%in the observation group,and 37.04%in the control group,the difference being significant(P<0.05).The healing rate of gastric ulcer was 46.67%in the observation group,and 33.33%in the control group;the total effective rate was 93.33%in the observation group,and 76.67%in the control group,the difference being significant(P<0.05).Four months after treatment,with the recurrence rate being 7.14%,there was 1 recurrence case in the 14 patients of the observation group that recovered from ulcer;with the recurrence rate being 40.00%,there were 4 recurrence cases in the 10 patients of the control group that recovered;the comparison of the recurrence of ulcer between the two groups showed significance in the difference(P<0.05).After treatment,when compared the positive rate of immunohistochemical expressions of cyclooxygenase-2(COX-2),nuclear-factor kappa B p65(NF-κBp65),and trefoil factor(TFF3),there was significance in differences(P<0.05).In the two groups,each Chinese medicine symptom score was decreased when compared with that before treatment,differences being significant(P<0.05).After treatment,when compared symptom scores of stomach duct pain,relief of pain due to food intake,lack of strength in limbs,cold limbs and fear of cold,torpid intake and lack of appetite between the two groups,there was significance in differences(P<0.05).During the study,there was no obvious abnormality in safety indexes of the two groups,and no adverse reactions;blood routine,urine routine,stool routine,the heart,liver,and kidney function,and electrocardiogram examination in both groups were normal before and after treatment.Conclusion:In the treatment of Hp-associated gastric ulcer with spleen-stomach deficiency cold syndrome,the comparison of the eradication rate of Hp showed no obvious difference between the therapy of Puqiao Yigong tang combined with routine quadruple therapy containing bismuth agent and simple quadruple therapy containing bismuth agent.But the combination therapy can decrease the long-term recurrence rate of Hp infection and gastric ulcer,improve Chinese symptoms of the disease with various degrees,increase the healing rate of gastric ulcer,and effectively reduce expression levels of tumor risk factors including COX-2,NF-κBp65,and TFF3,with high clinical safety.