自拟中药汤剂联合西药治疗口腔白斑疗效分析及不良反应观察

Self-Made Decoction Combined with Western Medicine of Oral leukoplakia and Adverse Reactions

目的:探讨自拟中药汤剂联合西药治疗口腔白斑的临床疗效及对其治疗后不良反应观察,为临床诊断治疗提供依据。方法:2012年5月—2014年1月期间就诊的口腔白斑患者96例,按照随机数字表法将其随机分为对照组(n=48)与治疗组(n=48)。两组患者均给予局部维生素AD滴剂。对照组给予西药进行治疗,治疗组在西药治疗基础上结合自拟中药汤剂进行治疗;两组均以10d为1个疗程,3个疗程观察疗效、补体C3和免疫球蛋白(IgA、IgM及IgG)的变化及不良反应。结果:治疗组总有效率(91.67%)显著高于对照组(72.92%),且有显著性差异(P<0.05);两组治疗前各组间C3、IgA、IgM、IgG变化差异无统计学意义(P>0.05);治疗组治疗后IgA、IgM、IgG变化与对照组治疗后具有显著性差异(P<0.05),而C3变化差异无统计学意义(P>0.05);两组患者不良反应率对比无显著性差异(P>0.05)。结论:自拟中药汤剂联合西药治疗口腔白斑疗效明显,且无明显不良反应发生,具有重要临床研究价值。

Objective：To investigate self-made decoction combined with western medicine and clinical efficacy of oral leukoplakia and adverse reactions to provide the basis for clinical diagnosis and treatment.Methods：In May 2012-January 2014,96 cases,according to the random number table,were randomly divided into control group（n = 48） and treatment group（n = 48）.Two groups＇ patients were treated with topical vitamin AD drops.Control group was given medicine for treatment and the treatment group combined the decoction on the basis of western medicine.10d was as a course.After three treatment courses,efficacy,complement C3 and immunoglobulins（IgA,IgM and IgG） changes and adverse reactions were observed.Results：The total effective rate（91.67%） in treatment group was significantly higher than that of control group（72.92%） and there was a significant difference（P 〈0.05）.Before and after treatment in each group,C3,IgA,IgM and IgG changes had no significant difference（P〉0.05）.After treatment,IgA,IgM and IgG changes in treatment and control group had significant difference（P〈 0.05） whereas no significant difference in C3change（P 〈 0.05）.However,there was no significant difference（P 〉 0.05） in two groups about adverse reaction rates.Conclusion：Self-made decoction combined with western medicine of oral leukoplakia has obvious effect and no significant adverse events,with important clinical research value.