摘要
目的:评价口服冬凌草滴丸和冬凌草片治疗复发性口腔溃疡(RAU)的临床疗效。方法:选择132例口腔溃疡患者。采用多中心、随机、双盲双模拟、以冬凌草片做阳性对照,试验组65例,每天口服960mg冬凌草滴丸和冬凌草片模拟剂,共5d,对照组67例,每天口服1 000mg冬凌草片和冬凌草滴丸模拟剂,共5d,实验前制定统一的实验方案和诊断标准,对口腔溃疡各临床症状分级量化指标,于治疗前后观察总积分和各临床症状积分的变化,并做治疗前后2组自身比较和2组间对照比较,对2组的临床疗效比较分析。结果:冬凌草滴丸和冬凌草片治疗前后自身比较,总积分和各临床症状积分都有明显的降低,差异有极显著性(P<0.01),2组对口腔溃疡各临床症状都有明显疗效;冬凌草滴丸和冬凌草片2组间有效性比较,冬凌草滴丸的总有效率为81.54%,对照组冬凌草片的总有效率为80.60%,2组间差异无显著性(P>0.05)。结论:冬凌草滴丸和冬凌草片治疗口腔溃疡都有明显的疗效,这2种剂型比较,疗效相当,差异无显著性。
OBJECTIVE To evaluate and compare the effect of systemically administered Rabdosia rubescens drop pill and Rabdosia rubescens tablet for the treatment of recurrent aphthous ulcer （RAU）. METHODS A multi-center, randomized, double-blind, double-simulation, positive-controlled parallel group trial was adopted, 132 patients showing clinical signs of RAU were involved in. The subjects were randomly divided into two treatment groups： experimental group （n = 65）, 960 mg Rabdosia rubescens drop pill and simulation agent of Rabdosia rubescen tablet/day for 5 days; and controls （n = 67）, 1 000 mg Rabdosia rubescens tablet and simulation agent of Rabdosia rubescens drop pill/day for 5 days. Before experiment, the unified experimental program and standard of diagnosis were set out by expert group. The clinical symptoms were graded and quanti- fied. The scores of clinical signs of RAU were assessed at baseline and on the 6th day post-treatment, the therapeutic efficacy was compared between the two groups and in each group itself before and after the treatment. RESULTS Two groups were demonstrated statistically significant reductions in the scores of clinical signs of RAU （P〈0. 01 ） and total scores （P〈0. 01）. The effective rate of Rabdosia rubescens drop pill was 81.54% in test group and 80. 60% in control group respectively. There were no significant differences between two groups （P：〉0. 05）. CONCLUSION The restllts presented in this study suggest that Rabdosia rubescens shows great promise as a treatment modality in RAU. There were obvious effect in two groups, and the therapeutic effect of two dosage form for the treatment of RAU is similar.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2010年第21期1848-1851,共4页
Chinese Journal of Hospital Pharmacy
关键词
冬凌草滴丸
冬凌草片
复发性口腔溃疡
Rabdosia rubescens drop pill, Rabdosia rubescens tablet, recurrent aphthous ulcer（RAU）
