Gail M H, You W C, Chang Y S, Zhang L, Blot W J, Brown L M, Groves F D, Heinrich J P, Hu J, Jin M L, Li J Y, Liu W D, Ma J L, Mark S D, Rabkin C S, Fraumeni J F, Xu G W
Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, Maryland 20892, USA.
Control Clin Trials. 1998 Aug;19(4):352-69. doi: 10.1016/s0197-2456(98)00016-6.
In the fall of 1995, 3411 subjects in 13 rural villages in Linqu County, Shandong Province, China, began participating in a blinded, randomized 23 factorial trial to determine whether interventions can reduce the prevalence of dysplasia and other precancerous gastric lesions. One intervention is treatment for infection by Helicobacter pylori with amoxicillin and omeprazole. A second is dietary supplementation with capsules containing vitamin C, vitamin E, and selenium. A third is dietary supplementation with capsules containing steam-distilled garlic oil and Kyolic aged garlic extract. Investigators will evaluate histopathologic endpoints after gastroscopies with biopsies from seven standard sites in 1999. Initial data from pill counts and sampled blood levels of vitamin E, vitamin C, and S-allylcysteine indicate excellent compliance. Subjects have tolerated all interventions well, although 3.1% of those assigned to amoxicillin and omeprazole developed rashes, compared to 0.3% to those in the control group. Preliminary breath tests demonstrate substantial reductions in gastric urease activity, an indication of infection by Helicobacter pylori, among those assigned to amoxicillin and omeprazole.
1995年秋，中国山东省临朐县13个乡村的3411名受试者开始参与一项双盲、随机2×3析因试验，以确定干预措施是否能够降低发育异常及其他胃癌前病变的发生率。一种干预措施是用阿莫西林和奥美拉唑治疗幽门螺杆菌感染。第二种是补充含有维生素C、维生素E和硒的胶囊。第三种是补充含有蒸馏蒜油和卡尤力克陈年大蒜提取物的胶囊。研究人员将在1999年对七个标准部位进行胃镜活检后评估组织病理学终点。药丸计数以及维生素E、维生素C和S-烯丙基半胱氨酸血样水平的初步数据表明受试者的依从性良好。尽管分配到阿莫西林和奥美拉唑组的受试者中有3.1%出现皮疹，而对照组为0.3%，但所有受试者对所有干预措施耐受性良好。初步呼气试验表明，分配到阿莫西林和奥美拉唑组的受试者胃脲酶活性大幅降低，这表明幽门螺杆菌感染有所减少。
