艾普拉唑治疗消化性溃疡出血患者的临床研究

Clinical trial of eprazole in the treatment of patients with peptic ulcer bleeding

目的比较艾普拉唑注射剂和奥美拉唑注射剂治疗消化性溃疡出血的临床疗效及安全性。方法将消化性溃疡出血患者随机分成对照组和试验组。对照组给予奥美拉唑钠每次40 mg,静脉滴注,q12 h(30 min内滴完),治疗3 d;试验组给予艾普拉唑钠,第1天于60 min内静脉滴注20 mg,第2~3天30 min内静脉滴注10 mg,每天1次。2组患者均治疗3 d。比较2组患者的临床疗效、临床症状、血清学指标,以及药物不良反应的发生情况。结果试验组入组67例,脱落7例,最终60例纳入分析;对照组入组59例,脱落9例,最终50例纳入分析。治疗后,试验组和对照组的总有效率分别为93.33%(56例/60例)和86.00(43例/50例),差异无统计学意义(P>0.05)。治疗后,试验组和对照组的便血次数分别为(0.15±0.04)和(0.22±0.05)time·d^(-1),呕血次数分别为(0.37±0.13)和(0.52±0.16)time·d^(-1),胃泌素17水平分别为(13.40±6.30)和(17.90±4.77)pmol·L^(-1),超氧化物歧化酶水平分别为(108.63±12.05)和(98.25±13.70)μmol·L^(-1),血管内皮生长因子水平分别为(476.38±42.53)和(449.61±38.87)pg·mL^(-1),前列环素I2水平分别为(85.08±22.96)和(105.34±23.22)ng·L^(-1),血栓素A2水平分别为(78.25±19.54)和(86.75±20.65)ng·L^(-1),差异均有统计学意义(均P<0.05)。试验组发生的药物不良反应有口干、腹泻、便秘、皮疹,对照组发生的药物不良反应有便秘、口干和皮疹。试验组和对照组的总药物不良反应发生率分别为10.00%和8.00%,差异无统计学意义(P>0.05)。结论艾普拉唑注射剂和奥美拉唑注射剂治疗消化性溃疡出血的临床疗效和安全性相近,但前者能更有效地改善患者的临床症状和血清学指标。

Objective To compare the clinical efficacy and safety of eprazole injection and omeprazole injection in the treatment of patients with peptic ulcer bleeding.Methods The patients with peptic ulcer bleeding were randomly divided into control group and treatment group.Control group was given omeprazole sodium 40 mg each time,intravenous infusion,q12 h(within 30 min),treated for 3 days.Treatment group was given iprrazole sodium,20 mg intravenously within 60 minutes on the first day,and 10 mg intravenously within 30 minutes on the second to third day,once a day.Two groups were treated for 3 days.The clinical efficacy,clinical symptoms,serological indexes and adverse drug reactions were compared between two groups.Results In treatment group,67 cases were enrolled,7 cases dropped out,and 60 cases were included in the analysis.In control group,59cases were enrolled,9 cases dropped out,and 50 cases were included in the analysis.After treatment,the total effective rates of treatment and control groups were 93.33%(56 cases/60 cases)and 86.00(43 cases/50 cases)without significant difference(P>0.05).After treatment,the number of hematochezia in the treatment and control groups was(0.15±0.04)and(0.22±0.05)time·d^(-1),the number of hematemesis was(0.37±0.13)and(0.52±0.16)time·d^(-1),gastrin 17 levels were(13.40±6.30)and(17.90±4.77)pmol·L^(-1),superoxide dismutase levels were(108.63±12.05)and(98.25±13.70)μmol·L^(-1),vascular endothelial growth factor levels were(476.38±42.53)and(449.61±38.87)pg·m L^(-1),prostacycline I_2levels were(85.08±22.96)and(105.34±23.33)ng·L^(-1),thromboxane A2 levels were(78.25±19.54)and(86.75±20.65)ng·L^(-1),and the differences were statistically significant(all P<0.05).The adverse drug reactions of treatment group were dry mouth,diarrhea,constipation and rash,while the those in control group were constipation,dry mouth and rash.The total incidences of adverse drug reaction in the treatment group and control groups were 10.00%and 8.00%,without significant difference(P>0.05).Conclusion The clinical efficacy and safety of eprazole injection and omeprazole injection in the treatment of peptic ulcer bleeding are similar,but the former is more effective in improving the patients’clinical symptoms and serological indicators.