辛伐他汀和PPI联用对Barrett食管的预防效果及其安全性分析

Study of the preventive effect of simvastatins combined with PPI on Barrett esophagus and its safety

目的:探讨辛伐他汀和质子泵抑制剂(PPI)联用对Barrett食管的预防效果及安全性。方法:以无Barrett食管的胃食管反流患者248例为研究对象,按数字随机法分为试验组和参照组各124例。参照组常规采用PPI治疗,试验组在参照组的基础上加用辛伐他汀20 mg·d^(-1),共治疗1年,治疗期间每3个月复查1次Barrett食管发生情况,比较两组治疗前后症状积分、疗效、Barrett食管发生率及消化道反应、头痛、咽炎、皮疹、肌痛等不良反应和并发症发生情况。结果:试验组和参照组治疗前后症状积分、疗效比较差异均无统计学意义(P>0.05)。两组治疗半年和1年的症状积分均较治疗前降低(P<0.05)。试验组Barrett食管发生率明显低于参照组(P<0.05)。两组不良反应和并发症的总发生率比较差异均无统计学意义(P>0.05)。结论:辛伐他汀和PPI联用治疗胃食管反流对其Barrett食管的预防效果良好且不会增加不良反应和并发症的发生,是预防胃食管反流患者Barrett食管发生的安全有效方法。

Objective： To explore the effect of simvastatin combined with proton pump inhibitor（ PPI） in the prevention of Barrett esophagus and its safety.Methods： Two hundred and forty-eight patients with gastroesophageal reflux without Barrett esophagus were selected as the research subjects and divided into experiment group（ n = 124）and control group（ n = 124） by the digital random method.The control group received routine PPI treatment,while the experiment group received simvastatin 20 mg·d-1treatment in addition to PPI treatment.Both of the 2 groups were treated for 1 year.Occurrence of Barrett esophagus was examined every 3 months during the treatment.Symptom score,curative effect,incidence of Barrett esophagus and digestive tract reaction,headache,pharyngitis,skin rashes,muscle pain and other adverse reactions and complications of the two groups were compared before and after treatment.Results： No statistically significant differences of the symptom score and curative effectiveness exist between the experiment group and the control group before and after treatment（ P 〉 0.05）.Symptom score of the two groups after treatment for six months and 1 year was lower than that before the treatment（ P 〈 0.05）.The incidence of Barrett esophagus in the experiment group was obviously lower than that of the control group（ P 〈0.05）.There were no statistically significant differences in the total prevalence of gastrointestinal reaction,headache,pharyngitis,skin rashes,muscle pain and other adverse reactions and complications between the two groups（ P 〉 0.05）.Conclusion： Combined treatment of simvastatin with PPI for gastroesophageal reflux can effectively prevent the occurrence of Barrett esophagus without increasing adverse reactions and complications,which is a safe and effective method to prevent Barrett esophagus in patients with gastroesophageal reflux.