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为了比较兰索拉唑每日15mg与30mg两种剂量口服治疗十二指肠溃疡的效果及安全性,对109例经内镜证实活动性十二指肠溃疡随机分成15mg组(51例)和30mg组(58例)。剂量分别为每日15mg和30mg,疗程2~4周。于疗程结束后重复胃镜检查,2周溃疡愈合率15mg组为70.6%;30mg组为89.7%,30mg组明显高于15mg组(P<0.05)。4周溃疡愈合率15mg和30mg组分别为96.1%和98.3%,两组比较无明显差异(P>0.05)。3d,7d,14d的疼痛累积缓解率15mg组分别为55.4%(22/39);82.1%(32/39);92.3%(36/39);30mg组分别为68.8%(33/48);91.7%(44/48);100%(48/48)。两组比较无明显差异(P>0.05)。治疗中两组均未发生明显药物不良反应以及实验室指标的异常。研究结果表明兰索拉唑每日15mg,30mg均为中国人十二指肠溃疡病安全有效范围,而30mg更能促进溃疡的愈合。
In order to compare the efficacy and safety of oral lansoprazole 15mg and 30mg two doses of oral treatment of duodenal ulcer, 109 cases of active duodenal ulcer confirmed by endoscopy were randomly divided into 15mg group (n = 51) and 30mg group (58 cases). Dosages were 15mg and 30mg daily, course of treatment for 2 to 4 weeks. Gastroscopy was repeated at the end of the course of treatment. The healing rate of ulcer in 2 weeks was 70.6% in 15mg group, 89.7% in 30mg group and 15mg in 30mg group (P <0.05). The rate of ulcer healing in 4-week group was 96.1% and 98.3% in 15mg and 30mg groups, respectively. There was no significant difference between the two groups (P> 0.05). The cumulative pain relief rates of 15 mg, 45 mg and 45 mg respectively on the 3rd, 7th and 14th days in the 15 mg group were 82.1% (32/39) and 92.3% (36/39), respectively. 8% (33/48); 91.7% (44/48); 100% (48/48). There was no significant difference between the two groups (P> 0.05). No significant adverse drug reactions and laboratory abnormalities were observed in both groups. The results show that lansoprazole daily 15mg, 30mg are safe and effective range of Chinese duodenal ulcer disease, and 30mg can promote ulcer healing.