【作者】 罗菲；

【导师】 许华；

【作者基本信息】 广州中医药大学 ， 中医儿科学， 2012， 博士

【摘要】 目的：从总有效率、止泻时间及临床证候改善情况等角度着眼,客观规范地评价中药苍苓散治疗小儿湿热型轮状病毒肠炎的疗效,并观察苍苓散对肠道粘膜免疫及肠道菌群的影响,探讨其治疗轮状病毒肠炎的作用机制,为进一步开发疗效显著、安全可靠地复方新药提供理论和实验依据。方法：1.临床研究采用前瞻性的随机对照临床研究方法,研究的目标人群为6个月～2岁轮状病毒肠炎患儿,采用中心随机化分配系统分为中药苍苓散组和思密达组,分配比例1：1,治疗组口服中药苍苓散(药物由广州中医药大学第一附属医院中药房提供),每日一剂,3天为一疗程；对照组予以思密达口服,<1岁,1/3包,每天3次；6月～1岁,1/3包,每天3次；-2岁,1/2包,每天3次,3天为一疗程。观察两组患儿临床症状、总有效率等。2.实验研究分别采用酶联免疫双抗体夹心法检测轮状病毒肠炎患儿治疗前后粪便中SIgA含量,以及采用实时荧光定量PCR (FQ-PCR)技术检测轮状病毒肠炎患儿治疗前后粪便双歧杆菌、乳酸杆菌及大肠杆菌含量。结果：1.治疗后苍苓散组的总有效率为96.16%,思密达组总有效率为79.17%,二者比较具有显著性差异(P<0.05),苍苓散组优于思密达组；2.苍苓散组、思密达组止泻时间分别为2.53±1.35天、4.37±1.68天,两者的止泻时间比较有显著性差异(P<0.05),苍苓散组优于思密达组；3.苍苓散组、思密达组腹胀消失时间分别为3.16±1.54天、5.42±1.93天。两者比较有显著性差异(P<0.05),苍苓散组优于思密达组；4.苍苓散组、思密达组饮食恢复时间分别为3.47±1.52天、5.86±1.81天。两者比较有显著性差异(P<0.05),苍苓散组优于思密达组；5.治疗后两组腹泻患儿粪便标本中的SIgA含量数值均较治疗前增加,与治疗前相比,有显著性差异(P<O.05)；治疗后两组SIgA含量数值比较无显著性差异。苍苓散组与健康对照组(20例)比较有显著性差异。6.对双歧杆菌、乳酸杆菌、大肠杆菌分别分析,两组治疗前、后组间差异无统计学意义(P>0.05)；治疗前、后差值的组间差异无统计学意义(P>0.05)；治疗前、后组内差异均无统计学意义(P>0.05)。7.对乳酸菌与大肠杆菌比值、双歧杆菌与大肠杆菌比值分别分析,两组治疗前、后组间差异无统计学意义(P>0.05)；治疗前、后差值的组间差异无统计学意义(P>0.05)；治疗前、后组内差异均无统计学意义(P<0.05)。8SIgA分别与双歧杆菌、大肠杆菌、乳酸杆菌进行相关分析,治疗前后SIgA含量与双歧杆菌、大肠杆菌之间无显著相关关系(P>0.05),治疗前后SIgA含量与乳酸杆菌之间有显著相关关系(P<0.05)结论1.本次研究结果提示苍苓散治疗轮状病毒肠炎湿热证临床疗效可靠,苍苓散能迅速起到止泻,消除腹胀,改善患儿食欲,缩短病程,减少住院时间；2.治疗三天,苍苓散可能具有促进轮状病毒感染急性期肠粘膜SIgA分泌作用；苍苓散早期治疗机制可能并非直接通过调节肠道菌群而起作用,可能存在其他作用靶点。也可能与标本采集时间节点的选取有关；3.在轮状病毒肠炎中乳酸杆菌可能对SIgA的分泌具有刺激作用。更多还原

【Abstract】 ObjectiveA randomized control clinical study of Chinese medicine in infantile rotavirus diarrhea treatment was conducted to evaluate objectively and standardized the effect of cang ling powder on infantile heat-dampness rotavirus diarrhea in terms of clinical syndrome appearance and so on.And observed the effect of Cang Ling powder on mucosal immunity and microecological regulation. to further analyzes the pathogenesis of HRV diarrhea and the possible targets of Cang Ling Powder, to provide scientific basis for the clinical treatment for Human rotavirus (HRV) diarrhea by traditional chinese medicine.MethodsThe clinical study was designed as a prospective, randomized, control trial in target population of6-month to2-year-old infants with HRV diarrhea, who were allocated into Cang Ling Powder group, and smectite group in proportion of1:1with randomizatal method. Clinical symptoms observation and detection of the change of SIgA and microecological regulation in stool between pre/post-treatment and follow-up.Results1. Clinical study of infantile heat-dampness HRV diarrhea1.1Post-treatment total effective rates of Cang Ling Powder group was96.16%and Post-treatment total effective rates of Dioctahedral smectite group is79.17%, there were significant differences when compared the two treatments. Post-treatment total effective rates of Cang Ling Powder group was superior to Dioctahedral smectite group.1.2The antidiarrheal time of Cang Ling Powder group and Dioctahedral smectite group was2.53±1.35days and4.37±1.68days respectively.there was significant difference between the antidiarrheal times of two treatments revealed by statistics analysis. The antidiarrheal time of Cang Ling Powder group was superior to Dioctahedral smectite group.1.3The appetite recovery time of Cang Ling Powder group and Dioctahedral smectite group was3.47±1.52days and5.86±1.81days respectively. there was significant difference between the antidiarrheal times of two treatments revealed by statistics analysis. The appetite recovery time of Cang Ling Powder group was superior to Dioctahedral smectite group.1.4The abdominal distension recovery time of Cang Ling Powder group and Dioctahedral smectite group was3.16±1.54days and5.42±1.93days respectively.there was significant difference between the antidiarrheal times of two treatments revealed by statistics analysis. The abdominal distension recovery time of Cang Ling Powder group was superior to Dioctahedral smectite group.2. Experimental study of infantile heat-dampness HRV diarrhea2.1Content of SIgA were detected in100infants with HRV diarrhea, and the results showed significant difference were revealed between the content of SIgA post-treatment stool specimens of infants in the two groups and that pre-treatment stool specimens; But there was no significant difference of the SIgA content about post-treatment stool specimens in two groups(cangling powder group and smectite group)(P>0.05);There were significant differere between the content of SIgA post-treatment stool specimens of infants in the two groups (cangling powder group and healthy group) specimens.2.2To analyse the content of bifidobacteria, there was no difference in the two groups of both post-treatment stool specimens and pre-treatment stool specimens(P>0.05).2.3To analyse the content of lactobacilli, there was no difference in the two groups of both post-treatment stool specimens and pre-treatment stool specimens(P>0.05).2.4To analyse the content of escherichia coli, there was no difference in the two groups of both post-treatment stool specimens and pre-treatment stool specimens(P>0.05).2.5To analyse the ratio of and escherichia coli, there was no difference in the two groups of both post-treatment stool specimens and pre-treatment stool specimens(P>0.05).2.6To analyse the ratio of lactobacilli and escherichia coli, there was no difference in the two groups of both post-treatment stool specimens and pre-treatment stool specimens(P>0.05).2.7To analyse the content of SIgA and bifidobacteria, there was no correlatons in the two groups of both post-treatment stool specimens and pre-treatment stool specimens(P>0.05).2.8To analyse the content of SIgA and lactobacilli, there was significant correlatons in the two groups of both post-treatment stool specimens and pre-treatment stool specimens(P<0.05).2.9To analyse the content of SIgA and escherichia coli, there was no correlatons in the two groups of both post-treatment stool specimens and pre-treatment stool specimens(P>0.05).Conlusion(1)The study reveal the Cang Ling powder had good effect on HRV diarrhea, it could relieve diarrhea, recover appetite and abdominal distension;So it could decline the course of diarrhea.(2) Through three days, Cang Ling Powder could elevate the content of SIgA in heat-dampness HRV diarrhea infant, there was no significant difference in two groups;Cang Ling Powder had no effect on the bacterial flora content of heat-dampness HRV diarrhea infant, maybe in the forepart of HRV diarrhea, Cang Ling Powder worked throngh other track; or it was limited by the time of collecting stool specimens.(3)Lactobacilli maybe can stimulate the secretion of SIgA更多还原