Combination of “Lianfu Weihe Oral Solution” and triple therapy for helicobacter pylori infection:a randomized controlled trial

XIANG Yi-jin; LIN Jiang; ZHU Mei-ping; LI Yi-meng; CHEN Chang-zhou; ZHANG Wen

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Combination of “Lianfu Weihe Oral Solution” and triple therapy for helicobacter pylori infection:a randomized controlled trial

更新时间：2022-08-31

- Combination of “Lianfu Weihe Oral Solution” and triple therapy for helicobacter pylori infection:a randomized controlled trial
- Shanghai Journal of Traditional Chinese Medicine Vol. 49, Issue 2, Pages: 34-37(2015)
- 作者机构：
  
  1. 上海中医药大学附属曙光医院脾胃病科,上海,200021
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XIANG Yi-jin, LIN Jiang, ZHU Mei-ping, et al. Combination of “Lianfu Weihe Oral Solution” and triple therapy for helicobacter pylori infection:a randomized controlled trial. [J]. Shanghai Journal of Traditional Chinese Medicine 49(2):34-37(2015)
DOI：

XIANG Yi-jin, LIN Jiang, ZHU Mei-ping, et al. Combination of “Lianfu Weihe Oral Solution” and triple therapy for helicobacter pylori infection:a randomized controlled trial. [J]. Shanghai Journal of Traditional Chinese Medicine 49(2):34-37(2015) DOI：

摘要

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。

Abstract

Objective:To observe the clinical efficacy of “Lianfu Weihe Oral Solution” (LFWH) and triple therapy for the treatment of helicobacter pylori infection Methods: One hundred and eighty cases with helicobacter pylori infection were randomized into treatment A group, treatment B group, and control C group, with 60 cases in each group. Group C was treated with triple therapy (Omeprazole, amoxicillin and clarithromycin); group A was treated with normal dose of LFWH and triple therapy; group B was treated with high dose of LFWH and triple therapy, with the course of 7 days. The Hp eradication rate, clinical efficacy and adverse reactions were observed Results: ① Finally 172 cases fulfilled the trial, fifty-nine cases in group A, 57 in group B and 56 in group C. ② Full analysis set (FAS) showed that the Hp eradication rates of group A, B and C were 80%, 80.7% and 71.7% respectively; no significant difference was found among the groups (P＞0.05). Meanwhile, Protocol analysis set (PPS) showed that the Hp eradication rates of group A, B and C were 81.36%, 80.70% and 76.79% respectively; no significant difference was found among them (P＞0.05). ③ Full analysis set (FAS) showed that the clinical efficacy of the group A, B and C were 91.67%, 91.23% and 70.00% respectively; no significant difference was found among them (P＜0.05), but with significant difference between group A and C, and between group B and C (P＜0.05). PPS showed that the clinical efficiency of group A, B and C were 93.22%, 91.23% and 75.00% respectively; with significant difference among them (P＜0.05), as well as between group A and C, and between group B and C (P＜0.05). ④ Total of 21 cases of adverse reactions appeared in the trial, with 3 cases in the group A, 6 cases in the group B and 12 cases in the group C; with significant difference in occurrence rate of adverse reactions among them (P＜0.05), as well as between any two groups (P＜0.05) Conclusion: Combined LFWH and triple therapy can achieve satisfaction effects on the treatment of helicobacter pylori infection, and less adverse reactions. But high dose of “Lianfu Weihe Oral Solution” does not recommend.

关键词

幽门螺杆菌连芙胃和口服液三联疗法根除率不良反应

Keywords

Helicobacter pylori“Lianfu Weihe Oral Solution” (LFWH)triple therapyeradication rateadverse reaction

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