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| Randomized Double-Blind Clinical Trial of Moluodan (摩罗丹) for the Treatment of Chronic Atrophic Gastritis with Dysplasia |
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| KeyWord:gastric epithelial dysplasia, chronic atrophic gastritis, Moluodan, folic acid, randomized clinical trial |
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| Abstract: |
| Objective: To assess the efficacy and safety of Moluodan (摩罗丹) in treating dysplasia in chronic atrophic gastritis (CAG) patients. Methods: This was a multi-centered, double-blind, randomized controlled trial. The total of 196 subjects were assigned to receive either Moluodan or folic acid in a 2:1 ratio by blocked randomization. Mucosa marking targeting biopsy (MTB) was used to insure the accuracy and consistency between baseline and after 6-month treatment. Primary outcomes were histological score, response rate of pathological lesions and dysplasia disappearance rate. Secondary endpoints included gastroscopic findings, clinical symptom and patient reported outcome (PRO) instrument. Results: Dysplasia score decreased in Moluodan group (P=0.002), significance was found between groups (P=0.045). Dysplasia disappearance rates were 24.6% and 15.2% in Moluodan and folic acid groups respectively, no significant differences were found (P=0.127). The response rate of atrophy and intestinal metaplasia were 34.6% and 23.0% in Moluodan group, 24.3% and 13.6% in folic acid group. Moluodan could improve erythema (P=0.044), and bile reflux (P=0.059), no significance between groups. Moluodan was better than folic acid in improving epigastric pain, epigastric suffocation, belching and decreased appetite (P<0.05), with symptom disappearance rates of 37% to 83%. Conclusions: Moluodan improved dysplasia score in histopathology, and erythema and bile reflux score in endoscopy, and superior to folic acid in improving epigastric pain, epigastric suffocation, belching and decreased appetite. |
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