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目的:系统评价铝碳酸镁联合奥美拉唑对比奥美拉唑治疗胃溃疡的疗效和安全性,为临床治疗提供循证参考。方法:计算机检索 PubMed、Embase、Medline、Cochrane 图书馆、中国知网、维普网和万方数据,检索时限均为自建库起至2018年8月,收集铝碳酸镁联合奥美拉唑(试验组)对比单用奥美拉唑(对照组)治疗胃溃疡的随机对照试验(RCT),对符合纳入标准的文献进行资料提取,并采用Cochrane系统评价员手册5.0.1进行质量评价后,采用Rev Man 5.3统计学软件对有效率、不良反应发生率、胃溃疡出血复发率、临床症状改善所需时间、住院时间进行Meta分析。结果:共纳入16项RCT,合计1 802例患者。Meta分析结果显示,试验组患者有效率[RR=1.24,95%CI(1.19,1.29),P<0.001]显著高于对照组,胃溃疡出血复发率[RR=0.27,95%CI(0.17,0.45),P<0.001]、临床症状改善所需时间[MD=-2.04,95%CI(-2.25,-1.83),P<0.001]、住院时间[MD=-4.25,95%CI(-4.55, -3.95),P<0.001]均显著低于(短于)对照组,差异均有统计学意义;两组患者不良反应发生率比较,差异无统计学意义[RR=0.68,95%CI(0.46,1.02),P=0.06]。结论:与单用奥美拉唑相比,铝碳酸镁联合奥美拉唑可显著提高胃溃疡患者的临床治疗有效率,降低其胃溃疡出血复发率、缩短其临床症状改善所需时间以及住院时间,且不会增加不良反应发生率。
OBJECTIVE: To systematically evaluate the efficacy and safety of hydrotalcite combined with omeprazole for gastric ulcer, and to provide evidence-based reference for clinical treatment. METHODS: Retrieved from PubMed, Embase, Medline, the Cochrane library, CNKI, VIP and Wanfang database, randomized controlled trials (RCTs) about hydrotalcite combined with omeprazole (trial group) versus omeprazole alone (control group) for gastric ulcer during the database establishment to Aug. 2018. After data extraction of included literatures met inclusion criteria, and quality evaluation with Cochrane evaluator manual 5.0.1, Meta-analysis was performed for response rate, the incidence of ADR, recurrence rate of gastric ulcer bleeding, needed time of clinical symptom improvement and hospitalization stays by using Rev Man 5.3 statistical software. RESULTS: A total of 16 RCTs, involving 1 802 patients were included. The results of Meta-analysis showed that response rate [RR=1.24, 95%CI(1.19,1.29), P<0.001] of trial group was significantly higher than that of control group; recurrence rate of gastric ulcer [RR=0.27,95%CI(0.17,0.45),P<0.001], clinical symptom improvement time [MD=-2.04,95%CI(-2.25, -1.83),P<0.001] and hospitalization time [MD=-4.25,95%CI(-4.55,-3.95),P<0.001] of trial group were significantly lower or shorter than those of control group, with statistical significance. There was no statistical significance in the incidence of ADR [RR=0.68,95%CI(0.46,1.02),P=0.06] between 2 groups. CONCLUSIONS: Compared with omeprazole alone, hydrotalcite combined with omeprazole for gastric ulcer can obviously increase the clinical response rate, decrease the recurrence rate of gastric ulcer and shorten the needed time of clinical symptom improvement and hospitalization time, but do not increase the incidence of ADR.
铝碳酸镁奥美拉唑胃溃疡疗效安全性Meta分析
HydrotalciteOmeprazoleGastric ulcerEfficacySafetyMeta-analysis
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