Cheng H, Hu F L, Sheng J Q, An H J, Xu L, Liu F X, Li Y, Hao Q, Zheng P Y, Lu G F, Cao Z Q, Wang Y P
Department of Gastroenterology, Peking University First Hospital, Beijing 100034, China.
Zhonghua Yi Xue Za Zhi. 2016 Nov 1;96(40):3206-3212. doi: 10.3760/cma.j.issn.0376-2491.2016.40.002.
To explore the efficacy of Jinhuaweikang capsules plus furazolidone-based triple or quadruple therapy as the rescue treatment for (.) infection. This is a prospective randomized controlled multicenter clinical trial. Patients with chronic gastritis from . infection in whom eradication treatment failed were recruited from 6 hospitals. All patients were divided into 4 groups using stratified randomization: group A1 (PAFJ), receiving pantoprazole 40 mg+ amoxicillin 1 000 mg+ furazolidone 100 mg+ Jinghuaweikang 3 capsules, twice a day for 10 d (d1-10); group A2, PAFJ therapy as in group A1, followed by Jinghuaweikang 3 capsules twice a day for 18 d (d11-28); group B1 (PAFB), receiving pantoprazole 40 mg+ amoxicillin 1 000 mg+ furazolidone 100 mg+ bismuth potassium citrate 220 mg, twice a day for 10 d (d1-10); group B2, PAFB therapy as in group B1, followed by Jinghuaweikang 3 capsules twice a day for 18 d (d11-28). At least 28 days after the end of treatment, all patients underwent C urea breath test for assessment of . eradication. A total of 357 patients, 145 males and 212 females, were recruited, including 90 in group A1, 88 in group A2, 89 in group B1, and 90 in group B2. The eradication rates of . in groups A1 and A2 were 76.1%(67/88)and 79.6%(70/88) in per-protocol (PP) analysis, 74.4%(67/90) and 79.6%(70/88)in intention-to-treat (ITT) analysis; the rates in groups B1 and B2 were as 85.9%(73/85) and 92.1%(81/88) in PP analysis, 82.0%(73/89) and 90.0%(81/90)in ITT analysis. There were statistically significant differences in PP eradication rates among the 4 groups (=0.020); there was statistically significant difference between groups A1 and B2, and also between groups A2 and B2 (=0.003, 0.020), but not between groups A1/A2 and B1 (>0.05), nor between groups B1 and B2 (>0.05). No statistically significant differences in ITT eradication rates were found among the 4 groups (>0.05). The improvement of belching and poor appetite for patients in groups A2 and B2 was better than those in groups A1 and B1. The efficacy of Jinghuaweikang capsules plus furazolidone-based quadruple therapy is superior to combination with furazolidone-based triple therapy as the rescue treatment of . and superior to bismuth-containing quadruple therapy. Extending administration of Jinghuaweikang capsules to 28 days may better improve symptoms of indigestion.
探讨荆花胃康胶囊联合基于呋喃唑酮的三联或四联疗法作为（.）感染挽救治疗的疗效。这是一项前瞻性随机对照多中心临床试验。从6家医院招募根除治疗失败的（.）感染所致慢性胃炎患者。采用分层随机化将所有患者分为4组：A1组（PAFJ），口服泮托拉唑40mg +阿莫西林1000mg +呋喃唑酮100mg +荆花胃康3粒胶囊，每日2次，共10天（第1 - 10天）；A2组，采用与A1组相同的PAFJ疗法，随后口服荆花胃康3粒胶囊，每日2次，共18天（第11 - 28天）；B1组（PAFB），口服泮托拉唑40mg +阿莫西林1000mg +呋喃唑酮100mg +枸橼酸铋钾220mg，每日2次，共10天（第1 - 10天）；B2组，采用与B1组相同的PAFB疗法，随后口服荆花胃康3粒胶囊，每日2次，共18天（第11 - 28天）。治疗结束后至少28天，所有患者接受C尿素呼气试验以评估（.）根除情况。共招募357例患者，男性145例，女性212例，其中A1组90例，A2组88例，B1组89例，B2组90例。按符合方案（PP）分析，A1组和A2组（.）根除率分别为76.1%（67/88）和79.6%（70/88），意向性分析（ITT）中分别为74.4%（67/90）和79.6%（70/88）；B1组和B2组PP分析中根除率分别为85.9%（73/85）和92.1%（81/88），ITT分析中分别为82.0%（73/89）和90.0%（81/90）。4组间PP根除率差异有统计学意义（=0.020）；A1组与B2组、A2组与B2组间差异有统计学意义（=0.003，0.020），但A1/A2组与B1组间差异无统计学意义（>0.05），B1组与B2组间差异无统计学意义（>0.05）。4组间ITT根除率差异无统计学意义（>0.05）。A2组和B2组患者嗳气和食欲不振的改善情况优于A1组和B1组。荆花胃康胶囊联合基于呋喃唑酮的四联疗法作为（.）感染的挽救治疗疗效优于联合基于呋喃唑酮的三联疗法，且优于含铋四联疗法。将荆花胃康胶囊服用时间延长至28天可能更好地改善消化不良症状。
