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| 小儿开胃增食颗粒治疗小儿厌食脾失健运证的Ⅲ期临床试验 |
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赵越郡1, 马融2, 胡思源2, 魏小维2, 吕玉霞3, 丁樱4, 周盈5, 何平6
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1.天津中医药大学, 天津 300193;2.天津中医药大学第一附属医院儿科, 天津 300193;3.黑龙江中医药大学附属第一医院, 哈尔滨 150088;4.河南中医学院第一附属医院, 郑州 450003;5.新疆维吾尔自治区中医医院, 乌鲁木齐 830000;6.云南省中医医院, 昆明 650021
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| 摘要: |
| [目的]以健身消导颗粒为对照,进一步验证小儿开胃增食颗粒治疗小儿厌食脾失健运证的有效性。[方法]分层区组随机、双盲双模拟、阳性药平行对照、多中心的临床研究的方法,将入选451例患者分为2组,试验组338例,脱落16例,剔除4例;对照组113例,脱落2例,剔除1例。两组分别应用小儿开胃增食颗粒和健身消导颗粒,疗程均为14 d。[结果]小儿开胃增食颗粒治疗小儿厌食脾失健运证疾病疗效的总有效率为95.28%,对照组为92.73%,两组比较,差异无统计学意义(P>0.05)。非劣效检验结果显示,试验组疗效非劣于对照组。两组证候疗效的总有效率,试验组为98.43%,对照组为97.27%,两组比较,差异无统计学意义(P>0.05)。[结论]小儿开胃增食颗粒治疗小儿厌食脾失健运证安全、有效。 |
| 关键词: 小儿开胃增食颗粒 健身消导颗粒 小儿厌食症 |
| DOI：10.11656/j.issn.1672-1519.2012.01.10 |
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| 基金项目:国家十二五重大新药创制—儿科中药新药临床评价研究技术平台规范化建设(2011ZX09302-00603) |
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| Clinical research of Xiaoer Kaiwei Zengshi granula on anorexia with dysfunction of spleen transportation in infanti |
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ZHAO Yue-jun1, MA Rong2, HU Si-yuan2, WEI Xiao-wei2, LV Yu-xia3, DING Ying4, ZHOU Ying5, HE Ping6
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1.Tianjin University of TCM, Tianjin 300193, China;2.The First Affiliated Hospital of Tianjin University of TCM, Tianjin 300193, China;3.The First Affiliated Hospital of Heilongjiang University of TCM, Haerbin 150088, China;4.The First Affiliated Hospital of Henan University of TCM, Zhengzhou 450003, China;5.TCM Hospital of Xinjiang Weiwuer Municipality, Wulumuqi 830000, China;6.TCM Hospital of Yunnan, Kunming, 650021, China
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| Abstract: |
| [Objective] To study the effect and safety of Xiaoer Kaiwei Zengshi granule in treating infantile anorexia with dysfunction of spleen transportation taking Jianshen Xiaodao granule as the control drug.[Methods] Randomized,positive-drug,parallel-controlled,doubled-blind,double-dummy,multi-center trial methods were designed in the clinical study.The test choose 451 children.338 cases were in treatment group,among them 16 removed,4 excluded;113 cases in control group,2 removed,1 excluded.[Results] The total effective rate of treatment group was 95.28% and that of the control group was 92.73%.There weren't obviously different in treatment group and control group(P<0.05).The test showed that the drug in trial group was not inferior than that of the control group.The syndrome total effective rate of treatment group was 98.43% and that of control group was 97.27% without significant difference between the control and the treatment group(P<0.05).[Conclusion] Xiaoer Kaiwei Zengshi granule is safe and effective on infantile anorexia with dysfunction of spleen transportation. |
| Key words: Xiaoer Kaiwei Zengshi granule Jianshen Xiaodao granule infantile anorexia |
