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一项预防食管静脉曲张破裂出血的随机对照临床研究 被引量:2

A Randomized Controlled Clinical Trial in the Prevention of Esophageal Variceal Bleeding
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摘要 目的:比较普萘洛尔单用及与哌唑嗪联合应用降低门脉高压、预防食管静脉曲张破裂出血的疗效及安全性。方法:53例肝硬化伴中度以上食管静脉曲张(内镜检查证实)的连续入院患者随机化分组后分别接受普萘洛尔联合哌唑嗪(试验组)或单用普萘洛尔(对照组)治疗,随访直至终点事件出现;治疗前和随访第3个月时行心肝核素显影比值(H/L)测定。结果:试验组(27例)和对照组(26例)的平均随访期为13个月。用药后,试验组患者的H/L值显著下降(P=0.01)。对于有出血史的患者,试验组用药后H/L值明显下降(P=0.01),下降的绝对差值及相对比例均明显优于对照组(P=0.02);试验组H/L值下降> 20%的患者比例亦显著高于对照组(P=0.04)。两组患者的平均无出血时间无明显差异(P=0.42);但Kaplen-Meier曲线显示,在90~237天左右,试验组患者的累积未出血率高于对照组(90.5%比71.3%)。10例患者因药物不良反应而停药,其中试验组7例,对照组3例。结论:对于既往有出血史的患者,普萘洛尔与哌唑嗪联合应用在第3个月时可使门静脉压力较基础值明显下降;H/L的下降幅度和药物有效率均明显优于普萘洛尔单用。 Background/Aims: To assess the efficacy and safety of propranolol combined with prazosin compared with propranolol alone in decreasing the portal pressure and in the prevention of esophageal variceal bleeding. Methods: Fifty-three patients diagnosed as cirrhosis with moderate or severe esophageal varices proven by endoscopy were consecutively enrolled and randomly assigned to two groups: treatment group (propranolol plus prazosin) and control group (propranolol alone) after baseline heart-liver ratio of radioisotopic imaging (H/L) measurement. They were followed up until the endpoints and H/L was repeated at the third month. Results: Patients (27 in treatment group and 26 in control group) were followed up for 13 months. Treatment with propranolol plus prazosin caused a marked reduction in H/L (P=0.01). In treatment group, propranolol plus prazosin caused a significantly lower H/L value in patients with a previous bleeding history (P=0.01), both the absolute and relative reductions were significantly greater as compared with the control group (P=0.02), and treatment group had a greater responding rate (the reduction rate of H/L>20%) than the control group (P= 0.04). No difference was found in the average bleeding-free interval between the two groups (P=0.42). Kaplan-Meier curve demonstrated that in the day of 90th to 237th, the cumulative rate of bleeding-free interval in the treatment group was longer than that in the control group (90.5% vs 71.3%). 10 patients withdrew from the trial because of drug-related adverse effects (7 in treatment group and 3 in control group). Conclusions: Combination of propranolol with prazosin caused a significantly greater reduction in the portal pressure on the third month and the reduction in H/L and responding rate were greater in the treatment group than in the control group in patients with a previous bleeding episode. The use of propranolol plus prazosin treatment may be limited by its side effects. Patients with a history of ascites were predisposed to sodium and water retention.
出处 《胃肠病学》 2001年第2期90-93,共4页 Chinese Journal of Gastroenterology
关键词 普萘洛尔 哌唑嗪 食管胃静脉曲线 出血 预防 控制 放射性核素显像 Propranolol Prazosin Esophageal and Gastric Varices Hemorrhage/prevention & control Radionuclide Imaging
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