增生平治疗食管上皮增生的Ⅲ期临床观察

Results of phase Ⅲ clinical trial of Zeng Sheng ping in the treatment of patients with esophageal epithelial hyperplasia

目的 采用多中心、单盲随机分组和安慰剂对照方法 ,观察增生平对食管癌高发区食管上皮增生患者的治疗作用。方法 选择食管癌高发地区河北磁县现场 40～ 6 5岁居民 ,先进行食管细胞学检查 ,对筛选出的食管上皮增生患者 ,再进行食管镜活检病理确诊。根据患者性别、年龄及食管病变的级别 (轻、中、重度 )进行分层随机分组。 44 9例食管上皮增生的患者随机分为两组 :治疗组 30 0例 ,口服增生平每次 8片 ,每天 2次 ,共服 6个月 ;对照组 149例 ,口服安慰剂每次 8片 ,每天 2次 ,共服6个月。为确保试验的准确性 ,两组药品中均加入适量核黄素作为指示剂 ,并定期测定患者的尿样本。结果 99%的患者均定期服药 ,在治疗组可评价疗效的 30 0例患者中 ,好转者 193例 (6 4 3 % ) ;而对照组 149例中 ,好转者仅为 34例 (2 2 .8% ) ,两组差异有极显著性 (χ2 =6 8.6 7,P <0 .0 0 1)。治疗组中病变加重者 10例 (3 .3% ) ,对照组 37例 (2 4.8% ) ,差异有极显著性 (χ2 =49.0 9,P <0 .0 0 1)。

Objective Through a multi center randomized, single blinded and placebo controlled trial to evaluate the therapentic effect of Zeng Sheng ping (ZSP) on esophageal epithelial hyperplasia in a population with high risk of esophageal cancer.Methods The residents between 40 and 65 years of age in Ci County of Hebei Province were screened by balloon cytological examinations of the esophagus. Patients with esophageal epithelial hyperplasia were further confirmed by biopsy with esophagoscopy. They were randomly stratified into different arms according to sex, age and the grade of hyperplastic lesions. A total of 449 with esophageal epithelial hyperplasia were eligible and randomized into ZSP group and placebo group. In ZSP group, 300 patients received oral ZSP 8 tablets, twice a day for 6 months. There were 149 patients, in the placebo group. To ensure the accuracy of the trial, riboflavin was added into ZSP and placebo group as an indicator of compliance and urine samples were periodically examined.Results After 6 months of treatment, the response rate was 64.4%(193/300) in ZSP group and 22.8% (34/149) in the placebo group. There was a statistically significant difference between the two groups( P < 0.001). In addition, the frequency of disease progression in ZSP group was 3.3%(10/300) while that in the placebo group was 24.8% ( P <0.001).Conclusion ZSP is an effective drug in the treatment of esophageal epithelial hyperplasia. Adverse effects are mild and well tolerated by the patients.