摘要
观察宝儿康散治疗脾虚湿困型小儿腹泻病的临床疗效,将小儿腹泻病分为急性(层一)和慢性迁延性(层二)2层,然后分别采用随机、双盲双模拟、阳性药平行对照并进行剂量探索的方法:将入组层一的340例小儿急性腹泻病患者随机分为3组:高剂量组112例,低剂量组113例,阳性药对照组115例,疗程3 d,比较3组患者的临床疗效,并对宝儿康散临床应用的安全性进行评价;将入组层二的167例小儿慢性迁延性腹泻患者随机分为3组:高剂量组56例,低剂量组55例,阳性药对照组56例,疗程5 d,比较3组患者的临床疗效,同时对宝儿康散临床应用的安全性进行评价。结果发现,高、低剂量组治疗小儿急性和慢性迁延性腹泻病的愈显率和有效率显著高于阳性药对照组(P<0.05,P<0.01)。对于中医脾虚湿困证的治疗,高、低剂量组的愈显率和有效率显著高于阳性药对照组(P<0.05,P<0.01);其中试验组对大便稀溏、便次增多、食欲不振的愈显率和有效率显著优于阳性药对照组(P<0.05,P<0.01)。高、低剂量组和阳性药对照组在试验期间均未发生不良事件,一般体检指标均未发现异常。结果表明宝儿康散治疗小儿急性腹泻病和小儿慢性迁延性腹泻病(脾虚湿困证)疗效显著,且临床应用安全。
The study aims to observe the clinical efficacy of Baoerkang san on spleen-deficiency and dampness-obstructing diarrhea in children. Children diarrhea divided into acute diarrhea （group Ⅰ ） and chronic persistent diarrhea （group Ⅱ ）. A randomized, double-blind, positive control test was conducted for dose finding. The 340 cases with acute diarrhea in group Ⅰ were divided into three groups： the high dose group （112 patients）, the low dose group （113 patients） and the positive control group （115 patients）, which were treated for 3 days. Their clinical efficacies were compared to evaluate the clinical safety of Baoerkang san. The 167 patients with chronic persistent diarrhea in group Ⅱ were divided into the high dose group （56 patients）, the low dose group （55 patients） and the control group （56 patients）, which were treated for 5 days. Their clinical efficacy were compared to evaluate the clinical safety of Baoerkang san. According to the results, the cure rate and the effective rate of acute diarrhea and chronic persistent diarrhea in the high dose group and the low dose group were significantly higher than that of the positive control group （P 〈0. 05, P 〈0. 01 ）. In the treatment of spleen-deficiency and dampness-obstructing diarrhea with traditional Chinese medicines, the cure rate and the effective rate of acute diarrhea and chronic persistent diarrhea in the high dose group and the low dose group were significantly higher than that of the positive control group （P 〈0. 05, P 〈0. 01 ）. During the test, all of the three groups did not suffer any adverse event, with no any ab- normality in general physical indexes. In conclusion, Baoerkang san shows a significant efficacy in treating acute diarrhea and chronic persistent diarrhea （spleen-deficiency and dampness-obstructing） and safe clinical application.
出处
《中国中药杂志》
CAS
CSCD
北大核心
2015年第8期1605-1609,共5页
China Journal of Chinese Materia Medica
关键词
宝儿康散
腹泻
脾虚湿困证
疗效
Baoerkang san
diarrhea
spleen-deficiency and dampness-obstructing
efficacy
作者简介
[通信作者]张丽学，学士，主治医师，主要从事儿科临床研究，E—mail：zqzhlx@126．com
