摘要
目的:与善宁对照,评价国产醋酸奥曲肽注射液治疗肝硬化门静脉高压食管胃底静脉曲张急性出血的疗效和安全性.方法:采用随机、双盲、多中心、阳性药物平行对照的方法治疗肝硬化食管胃底静脉曲张急性出血.在基础治疗(禁食、输液、输血、对症处理)的基础上,试验组70例将试验药醋酸奥曲肽注射液溶于生理盐水中,以50mg/h的速度连续滴注48h.对照组66例同样用善宁治疗并评估和比较其疗效及安全性.结果:治疗第1,2天和停药后24h,两组呕血次数和呕血量、黑便次数和黑便量也均显著减少,组内比较均有显著的统计学差异(P<0.05),而组间比较无统计学差异(P>0.05).两组治疗后生命体征如心率、收缩压、舒张压以及患者的恶心、头晕、心悸、出汗、口渴症状均明显改善(P<0.05),但是组间相比没有显著性差异(P>0.05).两组患者治疗后的不良反应分别为1.43%和1.52%,也无显著性差异(P>0.05).治疗后试验组总有效率为97.1%,与对照组的92.4%相似(P=0.2223).结论:奥曲肽治疗肝硬化门静脉高压食管胃底静脉曲张出血的疗效和安全性与善宁相当.
AIM： To evaluate curative effect and safety of acetic octreotide in the treatment of esophageal varices bleeding （EVB） in comparison with octreotide （Sandostatin）
METHODS： EVB patients were randomly and doubleblinded assigned into acetic octreotide group （n = 70） and Sandostatin group （n = 66）. Both kinds of drugs were dissolved in normal saline and then given to the patients at the rate of 50 μg/h for 48 h. The amount of bleeding and vital signs of all the patients were observed and comparatively analyzed.
RESULTS： The frequencies and amount of hematemesis, the excreted frequencies and amount of black feces were significantly different before and after treatment with both kinds of drugs （P 〈0.05）, but there was no marked difference between the two groups （P 〉0.05）. The vital signs such as heart rate, systolic and diastolic blood pressure as well as symptoms of nausea, swirling, heart-throb, sweatiness, and thirst were notably improved after treatment （P 〈0.05）, but there was still no obvious difference between the two groups （P 〉0.05）. Adverse drug reaction was not significantly different between the two groups （1.43% vs 1.52%, P 〉0.05）. The total effective rates in acetic octreotide and Sandostatin group were 97.14% and 92.42%, respectively （P 〉0.05）.
CONCLUSION： Acetic octreotide is safe and effective in the treatment of EVB, and its effect is not significantly different from Sandostatin＇s.
出处
《世界华人消化杂志》
CAS
北大核心
2005年第21期2570-2573,共4页
World Chinese Journal of Digestology
