开喉剑喷雾剂(儿童型)治疗小儿急性咽炎和急性扁桃体炎的用法用量探讨

Usage and Dosage of Kaihoujian Throat Spray (for Children) in Treatment of Acute Pharyngitis and Acute Tonsillitis

目的:明确开喉剑喷雾剂(儿童型)治疗动物急性咽炎和急性扁桃体炎的有效剂量范围,为指导临床用法用量提供依据。方法:取幼龄SD大鼠160只,白兔96只,ICR小鼠160只按体质量等级随机分为16组,分别为正常组、模型组、阿莫西林组或利巴韦林、复方一枝黄花组及开喉剑喷雾剂(儿童型)不同给药剂量组;开喉剑喷雾剂(儿童型)不同给药剂量组,分别设置2喷/次,4次/日; 4喷/次,4次/日; 6喷/次,4次/日; 8喷/次,4次/日; 2喷/次,6次/日; 4喷/次,6次/日; 6喷/次,6次/日; 8喷/次,6次/日; 2喷/次,8次/日; 4喷/次,8次/日; 6喷/次,8次/日; 8喷/次,8次/日;共12个给药组。除正常组外,其余各组采用5%氨水咽部喷雾致大鼠急性咽炎、乙型溶血性链球菌感染致家兔急性咽炎和急性扁桃体炎、腺病毒感染致小鼠急性咽炎3种动物模型,通过咽部病变评分及病理检测评价开喉剑喷雾剂(儿童型)的最佳用法用量。结果:与正常组比较,各实验中模型组动物肉眼及病理观察评分均有显著升高(P <0. 01);与模型组比较,开喉剑喷雾剂(儿童型)各给药组均可不同程度减轻大、小鼠咽部病变,减轻家兔咽部组织和扁桃体组织病变,在4～8喷/次,6次/日以及2～6喷/次,8次/日剂量范围内疗效显著,与模型对照组比较有显著性差异。结论:开喉剑喷雾剂(儿童型)治疗急性咽炎和急性扁桃体炎的不同年龄小儿推荐用量为1～3岁:2喷/次,6～8次/日; 4～6岁:3～6喷/次,6～8次/日; 7-12岁:5～8喷/次,6～8次/日。

Objective:To explore the effective dose range of Kaihoujian throat spray(for children)in treating acute pharyngitis and acute tonsillitis,in order to provide the reference for the usage and dosage in clinic.Method:A total of 160 juvenile SD rats were divided into 16 groups according to the body mass grade,namely normal group,model group,amoxicillin or ribavirin group,compound Yizhi Huanghua group and different doses of Kaihoujian(for children)groups.The different doses of Kaihoujian(for children)groups were divided into 12 treatment groups based on 2 sprays/time,4 times/day,4 sprays/time,4 times/day,6 sprays/time,4 times/day,8 sprays/time,4 times/day,2 sprays/time,6 times/day,4 sprays/time,6 times/day,6 sprays/time,6 times/day,8 sprays/time,6 times/day,2 sprays/time,8 times/day,4 sprays/time,8 times/day,6 sprays/time,8 times/day,and 8 sprays/time,8 times/day.Except for normal group,all of the remaining groups were included in three animal models,namely 5%ammonia-induced acute pharyngitis in rat,B type streptococcus haemolyticusinduced acute pharyngitis and tonsillitis in rabbit,and adenovirus-induced acute pharyngitis in mice.Then the optimal usage and dosage of Kaihoujian throat spray(for children)were evaluated based on pharyngeal lesion score and htoxylin eosin(HE)staining.Result:There were significant differences in pharyngeal and tonsil lesions between the model group and the normal group(P<0.01).All of the 12 treatment groups could alleviate pharyngeal and tonsil lesions in three animal models,and the best dose range with significant potency were 4~8 sprays/times,6 times/day and 2~6 sprays/times,8 times/day(P<0.05,P<0.01).Conclusion:The clinical usage and dosage of Kaihoujian throat spray(for children)in treating acute pharyngitis and tonsillitis were suggested to be 2 sprays/times,6~8 times/day for 1~3 year-old children;3~6 sprays/times,6~8 times/day for 4~6 year-old children and 5~8 sprays/times,6~8 times/day for 7~12 year-old children.