奥美拉唑联合凝血酶治疗上消化道非静脉曲张出血患者的临床研究

Clinical trial of omeprazole combined with thrombin in the treatment of patients with upper gastrointestinal non-varicose hemorrhage

目的观察奥美拉唑注射剂联合凝血酶冻干粉治疗上消化道非静脉曲张出血患者的止血效果及安全性。方法将上消化道非静脉曲张出血患者随机分为对照组和试验组。对照组静脉滴注奥美拉唑40 mg,qd;试验组在对照组治疗的基础上,联合口服凝血酶冻干粉2000 U,bid。2组患者均治疗7 d。比较2组患者的止血效果、临床疗效和药物不良反应的发生情况。比较2组患者治疗前后凝血功能和血小板参数。结果试验过程中共脱落3例,最终试验组和对照组分别纳入44例。治疗后,试验组和对照组的总有效率分为93.18%和77.27%,差异有统计学意义(P<0.05)。治疗后,试验组和对照组的出血量分别为(224.57±23.08)和(283.54±29.35)mL,输血量分别为(136.89±14.37)和(154.37±16.24)mL,止血时间分别为(2.30±0.24)和(2.54±0.26)d,纤维蛋白原水平分别为(2.01±0.22)和(2.53±0.28)g·L^(-1),凝血酶原时间水平分别为(9.66±1.02)和(12.32±1.35)s,凝血酶时间水平分别为(13.87±1.44)和(15.96±1.63)s,活化部分凝血活酶时间水平分别为(35.97±3.68)和(30.85±3.12)s,血小板比容水平分别为(0.26±0.03)%和(0.16±0.02)%,血小板计数水平分别为(191.84±20.03)×10^(9)和(167.84±17.42)×10^(9)·L^(-1),血小板体积水平分别为(8.49±0.92)和(6.77±0.71)fL,差异均有统计学意义(均P<0.05)。试验组和对照组的总药物不良反应率分别为11.36%和13.64%,差异无统计学意义(P>0.05)。结论奥美拉唑注射剂联合凝血酶冻干粉治疗上消化道非静脉曲张出血患者具有良好的止血效果,其作用机制可能与改善凝血功能和血小板有关。

Objective To observe the hemostatic effect and safety of omeprazole injection combined with lyophilizing thrombin powder in the treatment of upper gastrointestinal non-varicose hemorrhage.Methods Patients with upper gastrointestinal non-varicose hemorrhage were enrolled and randomly divided into control group and treatment group.The patients in control group were treated with intravenous infection of omeprazole(40 mg),while patients in treatment group were additionally treated with lyophilizing thrombin powder(2000 U).All were treated for 7 d.The hemostatic effect,clinical curative effect and occurrence of adverse reactions,coagulation indexes and platelet parameters before and after treatment were compared between the two groups.Results There were 3 cases lost during the trial,and there were 44 cases in treatment group and 44 cases in control group,respectively.After treatment,the total effective rates of the treatment group and the control group were 93.18%and 77.27%,respectively,and the difference was statistically significant(P<0.05).After treatment,the amount of bleeding in the treatment group and the control group were(224.57±23.08)and(283.54±29.35)mL,the amount of blood transfusion were(136.89±14.37)and(154.37±16.24)mL,the hemostasis time were(2.30±0.24)and(2.54±0.26)d,the fibrinogen levels were(2.01±0.22)and(2.53±0.28)g·L^(-1),and the prothrombin time levels were(9.66±1.02)and(12.32±1.35)s,respectively.The levels of thrombin time were(13.87±1.44)and(15.96±1.63)s,the levels of activated partial thromboplastin time were(35.97±3.68)and(30.85±3.12)s,the levels of platelet specific volume were(0.26±0.03)%and(0.16±0.02)%,and the levels of platelet count were(191.84±20.03)×10^(9) and(167.84±17.42)×10^(9)·L^(-1),respectively.The platelet volume levels were(8.49±0.92)and(6.77±0.71)fL,respectively,and the differences were statistically significant(all P<0.05).The total adverse drug reaction rates of the treatment group and the control group were 11.36%and 13.64%,respectively,and the difference was not statistically significant(P>0.05).Conclusion The hemostatic effect of omeprazole injection combined with lyophilizing thrombin powder is good in patients with upper gastrointestinal non-varicose hemorrhage,and the mechanism of action may be related to improving coagulation function and platelet.