归芪通便汤及耳穴治疗儿童功能性便秘的临床研究
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摘要
目的通过观察归芪通便汤、耳穴贴压及基础治疗对儿童功能性便秘的临床疗效及安全性,探讨归芪通便汤、耳穴贴压治疗儿童功能性便秘的作用机理及治疗优势,为儿童功能性便秘的治疗寻找可行、有效的方法。
     方法本研究入选75例合格病例作为受试对象,按照随机原则分为三组:中药组26例,予口服归芪通便汤并进行基础治疗;耳穴组25例,予耳穴贴压并进行基础治疗;对照组24例,予基础治疗。疗程2周,观察三组患儿治疗前后诸症积分变化情况,将起效时间、近期疗效,停药二个月后远期疗效进行对比。
     结果1.起效时间比较:中药组平均起效时间为2.65±1.02天,耳穴组平均起效时间为2.10±0.96天,对照组平均起效时间为3.46±0.93天,经统计学分析,三组间起效时间有差异(P<0.05)。2.总疗效分析:按照临床疗效评定标准,中药组近期总有效率为96.15%,耳穴组近期总有效率为92.00%,对照组近期总有效率为29.17%,经统计学分析,中药组与耳穴组间近期总疗效有差异(P<0.05)。中药组及耳穴组与对照组间近期总疗效有显著性差异(P<0.01)。二月后随诊,中药组远期总有效率为79.17%,耳穴组远期总有效率为57.14%,对照组远期总有效率为52.63%,经统计学分析,中药组与耳穴组间远期总疗效有差异(P<0.05)。中药组与对照组间远期总疗效有显著性差异(P<0.01)。耳穴组与对照组间远期总疗效无差异(P >0.05)。3.症状积分比较:按照症状分级及评分标准,疗程结束后,中药组与耳穴组主要临床症状均有显著好转,积分下降,经统计学分析,与对照组相比有显著性差异(P<0.01);中药组、耳穴组在改善患儿临床症状方面无差异(P >0.05)。4.安全性观察指标方面,三组患儿在治疗期间,均未发生明显不良反应。
     结论本次临床观察表明,归芪通便汤、耳穴贴压法均能明显改善患儿的临床症状,是治疗儿童功能性便秘的有效方法。耳穴贴压法起效快,归芪通便汤远期疗效好,说明了中医药治疗儿童功能性便秘有一定优势和特点,同时为儿童功能性便秘的治疗开辟了新的途径。
Objective Through the investigatation of the clinical efficacy and security of Guiqi decoction for laxativation、ear auricular pressure treatment and foundation therapy in the treatment for children with functional constipation(FC), to explore the mechanism and advantage of FC and find a feasible and effective method for the treatment of FC.
     Methods Seventy-five children with FC were enrolled in this study and divided randomly into three group: Twenty-six cases were treated with Guiqi decoction for laxativation and foundation therapy as traditional Chinese medicine (TCM) group, Twenty-five cases were treated with ear auricular pressure and foundation therapy as ear auricular group, Twenty-four cases were treated only with foundation therapy as control group . By two weeks treatment course, observe the integral changes of primary clinical symptoms and signs before and after treatment. Compare the onset time, the recent efficacy and the long-term efficacy after 2 months.
     Results 1. The comparison of the onset time : By means of statistics analysis , there was a statistics difference (P<0.05) among the three groups. 2.The comparison of the total efficiency : In accordance with the standards of clinical assessment, the recently total efficiency of TCM group is 96.15%, the recently total efficiency of ear auricular group is 92.00%,for the control group is 29.17%, there were significant statistics differences among the three groups (P<0.01) by means of statistics analysis. Two month later, the long-term efficiency of TCM group is 79.17%, the long-term efficiency of ear auricular group is 57.14%, for the control group is 52.63%, there were statistics differences among the three groups (P<0.05) by means of statistics analysis. 3. The comparison of the symptom scores: After the treatment, the principal clinical symptoms and signs of TCM group and ear auricular group were significantly improved and the integral declined in accordance with the standard of symptom score and grade. Compared with the control group, there were significant statistics differences ( P<0.01) by means of statistics analysis, there were no statistics difference about TCM group and ear auricular group in improving the clinical symptoms and signs(P>0.05).4. Safety of indicators, there were no significant adverse reactions among the three groups in the treatment.
     Conclusions The clinical observation indicated that Guiqi decoction for laxativation and ear auricular pressure treatment can significantly improve the clinical symptoms and signs, they are all effective ways to children with FC. Ear auricular pressure treatment works fast and Guiqi decoction for laxativation and ear auricular pressure treatment have good long-term results. It states that TCM have some advantages and characteristics on treating children with FC and opened a new avenues for the treatment of children with FC at the same time.
引文
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