中药序贯联合铋剂四联方案治疗幽门螺杆菌相关性十二指肠溃疡疗效观察

目的观察中药序贯联合铋剂四联方案治疗幽门螺杆菌相关性十二指肠溃疡的临床疗效。方法选择2016年3月—2018年3月在山东中医药大学附属医院治疗的60例幽门螺杆菌相关性十二指肠溃疡湿热中阻证患者(溃疡活动期),按随机对照原则分为试验组和对照组各30例。治疗过程共分为除菌期(14 d)、除菌后期(28 d),共连续观察42 d。对照组除菌期采用铋剂四联疗法(阿莫西林胶囊+克拉霉素缓释片+泮托拉唑肠溶胶囊+胶体果胶铋胶囊)治疗,除菌后期继续服用泮托拉唑肠溶胶囊。试验组在对照组基础上,除菌期第1周和第2周分别加服胃疡1号方和胃疡2号方,除菌后期加服胃疡3号方。观察2组治疗后中医症状评分变化,统计中医症状疗效;停药后1周内复查胃镜,评估胃镜疗效;1个月后复查幽门螺杆菌根除情况,评估总体疗效;6个月后再次进行幽门螺杆菌及胃镜检测,统计2组溃疡和幽门螺杆菌复发情况;记录2组治疗过程中不良反应发生情况。结果2组治疗后各中医症状积分及总分均显著降低(P均<0.05),且试验组胃脘疼痛、痞胀不适、口苦口黏、纳呆恶心、身重肢倦积分及总分均明显低于对照组(P均<0.05)。试验组中医症状总显效率、胃镜疗效总显效率、幽门螺杆菌根除率、总体疗效总显效率分别为90.0%(27/30),96.7%(29/30)、96.7%(29/30)、93.3%(28/30),对照组分别为66.7%(20/30)、86.7%(26/30)、86.7%(26/30)、63.3%(19/30),试验组均明显高于对照组(P均<0.05)。试验组溃疡及幽门螺杆菌复发率分别为3.3%(1/30)、6.9%(2/29),对照组分别为13.3%(4/30)、11.5%(3/26),试验组均明显低于对照组(P均<0.05)。2组在治疗过程中均无不良反应发生。结论中药序贯联合铋剂四联方案治疗幽门螺杆菌相关性十二指肠溃疡近、远期疗效均显著。

Observation on the efficacy of quadruple regimen with sequential Chinese medicine combined with bismuth on Helicobacter pylori-associated duodenal ulcer

Objective It is to observe the clinical efficacy of on Helicobacter pylori-associated duodenal ulcer.Methods Sixty patients with Helicobacter pylori-associated duodenal ulcer of syndrome of dampness and heat mid-obstruction(ulcer active phase)treated in the Affiliated Hospital of Shandong University of Traditional Chinese Medicine from March 2016 to March 2018 were selected and divided into experimental group and control group according to randomized controlled principles,30 cases in each group.The treatment process was divided into sterilization period(14d)and post-sterilization period(28d),totally treated for 42 days.The control group was treated with bismuth quadruple therapy(amoxicillin capsules+clarithromycin sustained-release tablets+pantoprazole enteric-coated capsules+colloidal pectin bismuth capsules)during the sterilization period,and pantoprazole was continued during the post-sterilization period.On the basis of the control group,the experimental group was respectively treated with Weiyang No.1 and Weiyang No.2 during the first and second weeks of the sterilization period,and Weiyang No.3 was added in the post-sterilization period.The changes of TCM symptom scores after treatment were observed in the two groups,and the efficacy of TCM symptoms were evaluated;the reexamination of gastroscopy was performed within 1 week after drug withdrawal to evaluate the efficacy of gastroscopy;the eradication of Helicobacter pylori after 1 month was reviewed,and the overall efficacy was evaluated.In 6 months later,the detection of Helicobacter pylori and gastroscopy were performed again to calculate the recurrence of ulcers and Helicobacter pylori in the two groups.The adverse events during the treatment of the two groups were recorded.Results After treatment,the scores of TCM symptoms and total scores in the two groups were significantly reduced(P<0.05),and the scores of gastric pain,bloating discomfort,bitter taste,poor appetite and nausea,heavy body and limb fatigue and total scores in the experimental group were significantly lover than those in the control group(P<0.05).The total marked effective rate of TCM symptoms,total marked effective rate of gastroscopy,total eradication rate of Helicobacter pylori,and total effective rate of overall efficacy in the experimental group were 90.0%(27/30),96.7%(29/30),96.7%(29/30),and 93.3%(28/30)respectively,those in the control group were 66.7%(20/30),86.7%(26/30),86.7%(26/30),63.3%(19/30),respectively,the rates in the experiment group were significantly higher than those in the control group(P<0.05).The recurrence rates of ulcer and Helicobacter pylori in the experimental group were 3.3%(1/30)and 6.9%(2/29),respectively,which were significantly lower than those 13.3%(4/30)and 11.5%(3/26)in the control group(all P<0.05).No adverse reactions occurred in the two groups during the treatment.Conclusion Quadruple regimen with sequential Chinese medicine combined with bismuth has significant short-term and long-term effects on Helicobacter pylori-associated duodenal ulcer.