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荆花胃康胶丸联合基于质子泵抑制剂的三联疗法治疗幽门螺杆菌感染的慢性萎缩性胃炎:一项多中心、随机、对照临床研究

[Jinghuaweikang gelatin pearls plus proton pump inhibitor-based triple regimen in the treatment of chronic atrophic gastritis with Helicobacter pylori infection: a multicenter, randomized, controlled clinical study].

作者信息

Wang Ting-ting, Zhang Yue-miao, Zhang Xue-zhi, Cheng Hong, Hu Fu-lian, Han Hai-xiao, Chen Xiao-wei, Li Jun-xiang, Lai Yao-liang, Liu Yong

机构信息

Department of Integrated Traditional & Western Medicine, Beijing University First Hospital, Beijing 100034, China.

Email:

出版信息

Zhonghua Yi Xue Za Zhi. 2013 Nov 26;93(44):3491-5.

PMID:24521887
Abstract

OBJECTIVE

To observe the efficacy of Jinghuaweikang gelatin pearls plus proton pump inhibitor (PPI)-based triple regimen in the treatment of chronic atrophic gastritis (CAG) patients with Helicobacter pylori (H.pylori) infection.

METHODS

For this multicenter, randomized, controlled clinical study, 90 patients of endoscopically confirmed CAG with positive H.pylori ((13)C or (14)C-urea breath test (UBT) or rapid urease test) were enrolled. There were 46 males and 44 females with an age range of (54 ± 10) years. None of them had H.pylori eradication background. They were randomly divided into 2 groups, Group LACJ (n = 45) received lansoprazole 30 mg+amoxicillin 1000 mg+clarithromycin 500 mg + jinghuaweikang gelatin pearls 240 mg, twice daily, for 10 days (d1-10) plus another 14 days (d11-24) only with jinghuaweikang gelatin pearls 240 mg, twice daily. Group LACB (n = 45) had standard quadruple regimen treatment: lansoprazole 30 mg+amoxicillin 1000 mg+clarithromycin 500 mg+bismuth potassium citrate 220 mg, twice daily for 10 days (d1-10). The status of H.pylori was detected by (13)C-UBT at least 28 days after therapy.

RESULTS

The eradication rates in Groups LACJ and LACB were as follows: per-protocol (PP): 70.5% (31/44) and 83.3% (35/42), intention-to-treat (ITT): 68.9% (31/45) and 77.8% (35/45) (both P > 0.05). The symptomatic improvements of bloating in upper abdomen, belching and epigastric pain after treatment in both groups. And those in Group LACJ was higher than those of Group LACB, but no statistical difference existed between two groups (all P > 0.05).

CONCLUSIONS

The efficacy of LACJ for the treatment of CAG patients with H.pylori infection is similar to LACB. And the symptomatic improvement of patients is better than LACB.

摘要

目的

观察荆花胃康胶丸联合基于质子泵抑制剂(PPI)的三联疗法治疗幽门螺杆菌(H.pylori)感染的慢性萎缩性胃炎(CAG)患者的疗效。

方法

在这项多中心、随机、对照临床研究中,纳入90例经内镜确诊为CAG且H.pylori阳性((13)C或(14)C-尿素呼气试验(UBT)或快速尿素酶试验)的患者。其中男性46例,女性44例,年龄范围为(54±10)岁。他们均无H.pylori根除史。将他们随机分为2组,LACJ组(n = 45)接受兰索拉唑30 mg+阿莫西林1000 mg+克拉霉素500 mg+荆花胃康胶丸240 mg,每日2次,共10天(第1 - 10天),之后仅服用荆花胃康胶丸240 mg,每日2次,持续14天(第11 - 24天)。LACB组(n = 45)采用标准四联疗法:兰索拉唑30 mg+阿莫西林1000 mg+克拉霉素500 mg+枸橼酸铋钾220 mg,每日2次,共10天(第1 - 10天)。治疗后至少28天通过(13)C-UBT检测H.pylori状态。

结果

LACJ组和LACB组的根除率如下:符合方案集(PP):70.5%(31/44)和83.3%(35/42),意向性分析集(ITT):68.9%(31/45)和77.8%(35/45)(均P>0.05)。两组治疗后上腹部腹胀、嗳气和上腹痛的症状均有改善。且LACJ组改善情况高于LACB组,但两组间无统计学差异(均P>0.05)。

结论

LACJ治疗H.pylori感染的CAG患者的疗效与LACB相似。且患者症状改善情况优于LACB。

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