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目的观察连芙胃和口服液结合三联疗法治疗幽门螺杆菌感染的临床疗效。方法将180例幽门螺杆菌感染者随机分为治疗A组(A组)、治疗B组(B组)、对照组(C组),每组60例。C组予标准三联疗法(奥美拉唑+阿莫西林+克拉霉素),A组予常规剂量连芙胃和口服液加三联疗法,B组予高剂量连芙胃和口服液加三联疗法。各组疗程均为7天,观察Hp根除率、临床疗效及不良反应发生情况。结果 1最终完成试验者172例,A组59例,B组57例,C组56例。2全分析集(FAS)中,A组、B组、C组Hp根除率分别为80.00%、80.70%和71.67%;组间Hp根除率比较,差异无统计学意义(P>0.05)。符合方案分析集(PPS)中,A组、B组、C组Hp根除率分别为81.36%、80.70%和76.79%;组间Hp根除率比较,差异无统计学意义(P>0.05)。3全分析集(FAS)中,A组、B组、C组临床疗效分别为91.67%、91.23%和70.00%;组间临床疗效比较,差异有统计学意义(P<0.05);A组、B组分别与C组比较,临床疗效差异有统计学意义(P<0.05)。符合方案分析集(PPS)中,A组、B组、C组临床疗效分别为93.22%、91.23%和75.00%;组间临床疗效比较,差异有统计学意义(P<0.05);A组、B组分别与C组比较,临床疗效差异有统计学意义(P<0.05)。4试验中共出现21例不良反应,其中A组3例,B组6例,C组12例;组间不良反应发生率比较,差异有统计学意义(P<0.05);A组、B组分别与C组比较,差异有统计学意义(P<0.05);A组与B组比较,差异有统计学意义(P<0.05)。结论连芙胃和口服液结合三联疗法治疗幽门螺杆菌感染的疗效满意,且不良反应较少,但不推荐高剂量应用连芙胃和口服液。
Objective To observe the clinical efficacy of Lian Fu Wei and oral liquid combined with triple therapy in the treatment of Helicobacter pylori infection. Methods 180 cases of Helicobacter pylori infection were randomly divided into treatment group A (group A), treatment group B (group B) and control group (group C), 60 cases in each group. C group to standard triple therapy (omeprazole + amoxicillin + clarithromycin), A group to conventional doses of Fu Fu stomach and oral solution plus triple therapy, B group to high-dose Fu Fu stomach and oral solution plus triple therapy . Each course of treatment was 7 days, observed Hp eradication rate, clinical efficacy and adverse reactions. Results 1 The final trial of 172 patients, A group of 59 cases, B group 57 cases, C group 56 cases. In the whole analysis set (FAS), the Hp eradication rates in group A, group B and group C were 80.00%, 80.70% and 71.67%, respectively. There was no significant difference in Hp eradication rates between groups (P> 0.05). According to the protocol analysis set (PPS), the Hp eradication rates in group A, group B and group C were 81.36%, 80.70% and 76.79%, respectively. There was no significant difference in Hp eradication rates between groups (P> 0.05). The clinical efficacy of group A, group B and group C was 91.67%, 91.23% and 70.00%, respectively. There was significant difference between the two groups (P <0.05) The difference of clinical curative effect between group B and group C was statistically significant (P <0.05). In the PPS group, the clinical efficacy of group A, group B and group C was 93.22%, 91.23% and 75.00% respectively. There was significant difference between the two groups in clinical curative effect (P <0.05) The difference of clinical curative effect between group B and group C was statistically significant (P <0.05). There were 21 adverse reactions in 4 trials, including 3 cases in group A, 6 cases in group B and 12 cases in group C. The incidence of adverse reactions was significantly different between groups (P <0.05) Compared with group C, the difference was statistically significant (P <0.05). The difference between group A and group B was statistically significant (P <0.05). Conclusion Lian Fu Wei and oral liquid combined with triple therapy for the treatment of Helicobacter pylori infection with satisfactory results, and fewer adverse reactions, but not recommended for high-dose Lian Fu Wei and oral solution.