根除幽门螺杆菌治疗新疆维吾尔自治区维吾尔族幽门螺杆菌胃炎伴消化不良的临床研究

Clinical study on H.pylori eradication in the treatment of Xinjiang Uygur Helicobacter pylori gastritis with dyspepsia

目的研究不同剂量埃索美拉唑四联方案治疗维吾尔族幽门螺杆菌(H.pylori)的效果。方法选取喀什地区第二人民医院2015年8月至2016年5月诊治的H.pylori阳性的维吾尔族浅表性胃炎患者248例为研究对象,按照随机数表法将其分为单剂量组(82例)、标准剂量组(83例)及大剂量组(83例)。单剂量组患者给予埃索美拉唑肠溶片(40 mg,1次/天)联合阿莫西林胶囊、克拉霉素缓释片及胃铋镁颗粒治疗;标准剂量组患者给予埃索美拉唑肠溶片(20 mg,2次/天)联合阿莫西林胶囊、克拉霉素缓释片及胃铋镁颗粒治疗;大剂量组患者给予埃索美拉唑肠溶片(40 mg,2次/天)联合阿莫西林胶囊、克拉霉素缓释片及胃铋镁颗粒治疗。三组患者疗程均为14天。比较三组患者治疗后H.pylori根除率、临床疗效、症状积分及药物不良反应发生情况。结果意向处理分析(intentionto-treat analysis,ITT)显示,单剂量组、标准剂量组及大剂量组患者H.pylori根除率分别为74.39%(61/82)、81.92%(68/83)及89.16%(74/83)。符合方案集分析(per-protocol analysis,PP)显示,单剂量组、标准剂量组及大剂量组患者H.pylori根除率分别为79.22%(61/77)、87.18%(68/78)及96.10%(74/77),三组间两两比较均有显著差异(P<0.05)。H.pylori根除治疗4周后,单剂量组患者上腹痛、上腹烧灼感、上腹胀、恶心呕吐症状积分及总积分较入组时均明显降低(P<0.05);标准剂量组和大剂量组患者的各项消化不良症状积分和症状总积分较入组时均显著降低(P<0.01),且均明显低于单剂量组(P<0.01);大剂量组患者上腹痛、上腹烧灼感、上腹胀症状积分及总积分较标准剂量组明显降低(P<0.01)。H.pylori根除治疗4周后,单剂量组、标准剂量组及大剂量组患者的总有效率分别为45.5%、75.6%及87.0%,三组间两两比较差异均具有显著性(P<0.05)。三组患者不良反应发生率比较均无显著差异(P>0.05)。结论根除H.pylori治疗可明显改善新疆维吾尔自治区维吾尔族患者H.pylori胃炎伴消化不良症状,以大剂量埃索美拉唑为基础的四联方案可提高维吾尔族患者H.pylori根除率和H.pylori胃炎伴消化不良症状的临床疗效,且安全性高。

Objective To observe the curative effect of quadruple regime based on different doses of Esom- eprazole in the treatment of H.pylori infection in Uygur population. Method A total of 248 Uygur patients diagnosed with H.pylori positive and superficial gastritis in Kashgar Prefecture Second People＇s Hospital had been recruited from August 2015 to May 2016. According to the method of random number table, the patients were divided into single-dose group （82 cases）, standard-dose group （83 cases） and high-dose group （83 cases）.Single-dose group patients were treated with Esomeprazole 40 mg, once a day, combined with Amoxicillin and Clarithromycin, compound bismuth and magnesium granules as well. Standard-dose group patients were treated with Esomeprazole 20 mg, twice a day, combined with Amoxicillin and Clarithromycin as well as compound bismuth and magnesium granules. High-dose group patients were treated with Esomeprazole 40 mg, twice a day, combined with Amoxicillin and Clarithromycin as well as compound bismuth and magnesium granules. The treatment course of the three groups was 14 days. The H.pylori eradication rate, clinical efficacy, symptom score and adverse drug reaction were evaluated and compared among the three groups before and after treatment. Result ITT analysis showed that the eradication rates of H.pylori in single- dose group, standard-dose group and high-dose group were respectively 74.39% （61/82）, 81.92% （68/83） and 89.16% （74/83）. PP analysis showed that H.pylori eradication rates of single-dose group, standard-dose group and high-dose group were 79.22% （61/77）, 87.18% （68/78） and 96.10% （74/77） respectively. There were statistically significant differences among the three groups （P 〈 0.05）. After 4 weeks of eradication therapy, the symptoms score included epigastric pain, epigastric burning, abdominal distention, nausea and vomiting and total symptom score of the single-dose group significantly decreased compared with before treatment （P 〈 0.05）. In the standard-dose group and high-dose group various dyspepsia symptom score and the total symptoms score significantly lower than before treatment （P 〈 0.01）. After treatment, various dyspepsia symptom scores and the total symptom score of standard-dose group and high-dose group compared with the single-dose group significantly decreased （P 〈 0.01）. Compared with the standard-dose group, upper abdominal pain, epigastric burning, abdominal distention symptom score and total score of high-dose group decreased significantly （P 〈 0.01）. After 4 weeks of treatment, the total efficacy rate of single-dose group, standard-dose group and high-dose group were 45.5%, 75.6% and 87.0% respectively. There were statistically significant differences among the three groups （P 〈 0.05）. The incidences of adverse drug reactions among the three groups had no statistically significant differences （P 〉 0.05）. Conclusion H.pylori eradication therapy can significantly improve the dyspeptic symptoms of Uygur H.pylori gastritis. The quadruple therapy based on high dose of Esomeprazole can improve the H.pylori eradication rate and clinical curative effect of H.pylori gastritis with dyspepsia as well as high safety in Uygur population.