一项预防食管静脉曲张破裂出血的随机对照临床研究  

A Randomized Controlled Clinical Trial in the Prevention of Esophageal Variceal Bleeding

作　　者：蒋晓渠[1] 王吉耀[1] 陈世耀 朱畴文 

机构地区：[1]复旦大学附属中山医院消化内科

出　　处：《胃肠病学》2001年第2期90-93,共4页Chinese Journal of Gastroenterology

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 wa

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 

分 类 号：R571.3[医药卫生—消化系统]