Pulanić R, Vrhovac B, Jokić N, Rosandić-Pilas M, Salamon V, Opacić M, Rustemović N, Korać B, Vucelić B
Department of Internal Medicine, University Hospital Rebro, Zagreb, Croatia, Yugoslavia.
Int J Clin Pharmacol Ther Toxicol. 1991 Sep;29(9):347-51.
The present trial was carried out to determine the usefulness of H2-receptor antagonist drug therapy for the prevention of esophageal bleeding and esophageal varices in patients who underwent sclerotherapy. According to randomization, out of the 58 patients, 28 received, along with the usual standard therapy, ranitidine and 30 received placebo. Ranitidine, 50 mg, was administered intravenously over a period of 3 days every 8 hours, and then 150 mg of ranitidine was given per os in the evening for one month. For improvement of hemostasis and during the elective sclerotherapies, 1% polidocanol was used as the sclerosant. During each puncture, 2 ml was injected. Injections were paravasal and intravasal. After sclerotherapy, endoscopic examinations were carried out on the third day and one month later. Necrosis was noted in 42% of the patients and esophageal mucosal inflammation in 26%. Esophageal ulcers did not occur. There was no statistically significant difference between the two groups in terms of age, sex ratio, cause of liver cirrhosis, and the Child's classification. The size of the esophageal varices had no effect on the development of esophageal mucosal changes in correlation with the quantity of sclerosant. The comparison of the two groups of patients, sclerosed for hemorrhage and sclerosed electively, showed no statistically significant difference regarding esophageal mucosal changes. No differences between the ranitidine and placebo groups of patients were observed in this indication. It can be concluded that esophageal mucosal changes probably arise as a consequence of the sclerosant, its concentration, quantity and mode of application.(ABSTRACT TRUNCATED AT 250 WORDS)
本试验旨在确定H2受体拮抗剂药物治疗对接受硬化疗法的患者预防食管出血和食管静脉曲张的有效性。根据随机分组,58例患者中,28例在接受常规标准治疗的同时服用雷尼替丁,30例服用安慰剂。雷尼替丁50毫克,每8小时静脉注射3天,然后每晚口服150毫克雷尼替丁,持续1个月。为改善止血效果并在择期硬化治疗期间,使用1%聚多卡醇作为硬化剂。每次穿刺时注射2毫升。注射部位为血管旁和血管内。硬化治疗后,在第3天和1个月后进行内镜检查。42%的患者出现坏死,26%的患者出现食管黏膜炎症。未发生食管溃疡。两组在年龄、性别比例、肝硬化病因和Child分级方面无统计学显著差异。食管静脉曲张的大小与硬化剂用量相关,但对食管黏膜变化的发展无影响。对因出血而接受硬化治疗和择期接受硬化治疗的两组患者进行比较,在食管黏膜变化方面无统计学显著差异。在该指标上,雷尼替丁组和安慰剂组患者之间未观察到差异。可以得出结论,食管黏膜变化可能是硬化剂及其浓度、用量和应用方式的结果。(摘要截断于250字)