Strauss E, Ribeiro M F, Albano A, Honain N Z, Maffei R A, Caly W R
Clinic of Gastroenterology, Hospital Heliópolis, São Paulo, Brazil.
J Gastroenterol Hepatol. 1999 Mar;14(3):225-30. doi: 10.1046/j.1440-1746.1999.01799.x.
In order to evaluate the prophylactic impact of sclerotherapy of small varices in patients with cirrhosis and no endoscopic signs suggesting risk of haemorrhage, a randomized clinical trial was performed.
Seventy-one hospitalized patients met the inclusion criteria of diagnosis of cirrhosis with no previous bleeding and small varices. Due to exclusion criteria of: gastroduodenal ulcers (n = 5), diverticulosis (n = 1), hepatic insufficiency (n = 10), hepatocellular carcinoma (n = 4), death before randomization (n = 6), age over 70 (n = 1) and denial of consent to participate in the study (n = 1), 43 patients could be randomized, 21 for sclerotherapy and 22 for the control group. Two patients (one in each group) were lost to follow up, and another patient, although not lost, refused sclerotherapy after randomization. Ethanolamine oleate was used as the sclerosing agent. All patients were followed up for a mean time of 60 months, initially every 2 months for the first 2 years and clinical and endoscopic controls were performed each 6-12 months thereafter.
During the first 2 years clinical assessment showed that there were five bleedings in the sclerotherapy group and none in the control group, but mortality was similar in both groups. Long-term follow up continued to show a higher prevalence of bleeding in the sclerotherapy group but that mortality was not different from the control group.
为评估硬化疗法对肝硬化且无内镜下出血风险迹象患者小静脉曲张的预防作用，开展了一项随机临床试验。
71例住院患者符合肝硬化诊断且既往无出血及小静脉曲张的纳入标准。因存在以下排除标准：胃十二指肠溃疡（n = 5）、憩室病（n = 1）、肝功能不全（n = 10）、肝细胞癌（n = 4）、随机分组前死亡（n = 6）、年龄超过70岁（n = 1）及拒绝参与研究（n = 1），43例患者可进行随机分组，21例接受硬化疗法，22例作为对照组。2例患者（每组各1例）失访，另1例患者虽未失访，但随机分组后拒绝硬化疗法。油酸乙醇胺用作硬化剂。所有患者平均随访60个月，最初2年每2个月随访1次，此后每6 - 12个月进行临床及内镜检查。
在最初2年的临床评估中，硬化疗法组有5例出血，对照组无出血，但两组死亡率相似。长期随访结果显示，硬化疗法组出血发生率仍较高，但死亡率与对照组无差异。
