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对照观察了口疮灵冲剂与复合维生素Ｂ、灭滴灵、金霉素甘油（外擦）对复发性口疮（脾胃阴虚型）２２０例的临床疗效，结果表明：治疗组总有效率为９２％，显效率为６９．２３％，３个月内未复发率为６３．３３％，半年内未复发率为３０．０％；对照组总有效率为５５．５６％，显效率为３１．１１％，３个月、半年内未复发率分别为１６．６７％和３．３３％。两组比较，有高度统计学意义。并且治疗组对脾胃阴虚的中医证候（疼痛、口干唇燥、知饥不欲食、大便干涩，舌苔薄黄或少或乏津等）有明显改善作用（Ｐ＜０．０１），提示口疮灵冲剂是一种疗效好、具有开发应用前景的治疗复发性口疮的新型纯中药制剂。
The curative effect of KouShiLing granule and compound vitamin B, metronidazole and chlortetracycline glycerol (external rubbing) on 220 cases of recurrent aphthous (spleen and stomach yin deficiency) were observed and compared. The results showed that the total effective rate was 92% , Markedly effective rate was 69.23%, 3-month non-recurrence rate was 63.33%, half-year non-recurrence rate was 30.0%; control group, the total effective rate was 55.56%, markedly effective rate was 31.11 %, 3 months, six months without recurrence rates were 16.67% and 3.33%. The two groups have a high degree of statistical significance. And the treatment group had obvious improvement on TCM syndrome of spleen-stomach yin deficiency (pain, dry lips and lips, hungry, dry stools, thin yellow or less furong, etc.) (P <0.01) Suggest that Kushenling granule is a new type of pure traditional Chinese medicine preparation with good curative effect and promising application in the treatment of recurrent aphthous ulcer.