[Results of phase III clinical trial of zeng sheng-ping in the treatment of patients with esophageal epithelial hyperplasia].
摘要
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.