小儿通便口腔速溶散对儿童功能性便秘(FC)临床疗效观察

Clinical Curative Observation of Children Tongbian Oral Instant Powder for Children with Functional Constipation(FC)

目的:观察“小儿通便口腔速溶散”对儿童功能性便秘的疗效、安全性及患儿服药接受度并作出客观评价。方法:将90例患儿随机分为治疗组、中药对照组、安慰剂对照组3组,每组各30例。治疗组使用“小儿通便口腔速溶散”治疗,中药组采用小儿通便汤治疗,安慰剂组采用安慰剂干预,比较3组的临床疗效。结果:治疗组(86.6%)与中药组(90%)相比,两组治疗效果相当,评分相近,均优于安慰剂组(26.6%)(P<0.05);在症状对比中,治疗组与中药组对改善大便性状,减缓排便费力及减轻排便腹胀均有疗效(P<0.05),且与治疗时间呈正相关,但3组对减少单次排便时间均无明显效果(P>0.05);在改善排便频率方面,中药组效果优于治疗组及对照组(P<0.05);在药物接受程度上,治疗组(80%)与安慰剂(76.7%)组明显高于中药组(46.3%)。结论:“小儿通便口腔速溶散”对儿童功能性便秘疗效确切,能明显改善患儿大便性状,缓解排便费力,能明显减轻患儿的腹胀情况,较好解决了儿童服用中药口感差的问题,能有效提高治疗依从性,受到患儿及家属欢迎,具有临床推广价值。

Objective:To observe the efficacy,safety and drug acceptability of Children Tongbian Oral Instant Powder on functional constipation(FC)in children and make an objective evaluation.Methods:90children were randomly divided into three groups:treatment group,traditional Chinese medicine controlled group and placebo controlled group.Each group had 30cases.The treatment group was treated with Children Tongbian Oral Instant Powder.The traditional Chinese medicine group was treated with Children Tongbian Oral Instant Powder,and the placebo group was treated with placebo.The clinical efficacy of the three groups was compared.Results:The treatment group(86.6%)compared with the traditional Chinese medicine group(90%),two groups of curative effect,score,were superior to placebo(26.6%)(P<0.05),symptoms in comparison,the treatment group and the Chinese traditional medicine group to improve the defecate character,slow,defecate and reduce abdominal distention defecate had curative effect(P<0.05),and positively correlated with treatment time,but three groups had no obvious effect to reduce single defecation time(P>0.05),in terms of the defecation frequency,the effect of the traditional Chinese medicine group was better than the treatment group and the controlled group(P<0.05),but on the drug acceptance,the treatment group(80%)and the placebo group(76.7%)were significantly higher than the traditional Chinese medicine group(46.3%).Conclusion:Children Tongbian Oral Instant Powder has definite curative effect on children with functional constipation.It can obviously soften the stool of children,relieve the labor of defecation,reduce the abdominal distension of children,and accord with the taste of children.It also effectively improves the adaptability of treatment and is well loved by children.It has clinical popularization value.