【作者】 刘佳； 钟赣生； 柳海艳； 高源； 刘云翔； 王茜；

【Author】 LIU Jia;ZHONG Gan-sheng;LIU Hai-yan;GAO Yuan;LIU Yun-xiang;WANG Xi;College of Preclinical Medicine,Beijing University of Chinese Medicine;Traditional Chinese Medicine Department,Hebei University of Traditional Chinese Medicine;

【机构】 北京中医药大学基础医学院方药系； 河北中医学院；

【摘要】 目的:对十八反中海藻甘草反药组合临床同用研究文献中所涉及的不良事件及两者同用情况进行整理统计分析。方法:按照特定检索条件,在指定的中、英文数据库中,按照特定的纳入、排除标准系统检索临床文献记载使用十八反中海藻甘草反药组合的研究文献,对检索到的临床研究文献按涉及"不良事件"及文中给出的反药同用理论依据情况进行简单分类,对分类后共三大类七种情况的临床研究文献进行整理分析以其来探讨临床两者同用的安全性情况。结果:共检索到海藻甘草组合同用的临床研究文献1002篇,其中Ⅰ类有852篇文献,这些文献文中未提及是否有不良事件也未给出反药同用理论依据,说明应用者可能是没有意识到运用了反药或是其他原因;Ⅱ类共80篇,文献中未提及是否有不良事件但是文中给出了反药同用的理论依据;Ⅲ类38篇文献中明确提及无不良事件并且给出反药同用理论依据;Ⅳ-1类仅有2篇文中明确指出不良事件并非由反药同用引起并且给出反药同用理论依据;Ⅳ-2类仅3篇文中未提及不良事件是否由反药同用引起但文中给出反药同用理论依据,综合可见Ⅱ、Ⅲ、Ⅳ-1和Ⅳ-2类文献中均给出反药同用的理论依据阐述,说明治疗者明知是反药仍继续应用,且认为反药同用效果优于甘两药单独使用,尤其是Ⅲ和Ⅳ-1这两类提及反药同用安全或是无不良事件的就更能说明两者可同用这一点。最后Ⅳ-3类共27篇文献,文中既未提及不良事件是否由反药同用引起也未给出反药同用理论依据,本类文章文中未提及反药同用情况,可能是没有意识到运用了反药或是其他原因,所以也无法主观上判断反药同用是否能产生不良事件。综合上述可见在检索到的1002篇文章中Ⅱ、Ⅲ、Ⅳ-1、Ⅳ-2类共12%(123/1002)的文章中给出反药组合同用效优的理论依据,说明治疗者认为反药组合可同用且效果优于两药物单一使用;Ⅲ、Ⅳ-1类共4%(40/1002)的文献文中治疗者认为两者可同用且安全有效。结论:从临床检索文献数来看,有部分医家临床运用海藻甘草反药组合同用治疗一些特定疾病,如乳腺囊性增生病等,且有医家文献中记载两者可同用且安全有效,但是由于文献提及不良事件观察的研究以及作者明确说明反药同用理论的研究均太少,海藻甘草反药组合同用的安全性尚不能确定。更多还原

【Abstract】 Objective:to analyze the adverse events and anti-drug using situation of clinical literature which haizao and gancao using together.Methods:Searching the clinical literature which haizao and gancao using together,then to analyze the adverse events of them in order to investigate the situation of haizao and gancao using together.Results:Though the searching,we got 1002 cases clinical literature,of which 12%(123/1002)gives anti-drug group contracts with excellent efficiency theory,which illustrate the two herbs can be used together;4%(40/1002) can be considered with the use of both effective and safe.Among the 1002 cases,class 1 has 852 cases,which are not given adverse events and the theory evidence;class 2 has 80 cases,which are not given adverse events but given the theory evidence;class 3 has38 cases,which are mentioned no happened adverse events in cases and given the theory evidence;class Ⅳ-1 has 2 cases,which are mentioned the adverse events is not caused by the anti-drugs in cases and given the theory evidence;class Ⅳ-2 has 3 cases,which are not mentioned the adverse events whether is caused by the anti-drugs in cases and given the theory evidence;cIassⅣ-3 has 27 cases,which are not mentioned the adverse events whether is caused by the anti-drugs in cases and no given the theory evidence.In a word,the class 2,classⅢ,classⅣ-1,class Ⅳ-2 are all given the theory evidence to consider the gancao and haizao can be used together;also the class Ⅲ class Ⅳ-l’s cases consider the two herbs can be used together safe and effective.Conclusion:From the number retrieved clinical literature,indeed doctors in clinical use haizao and gancao together to treat some special diseases,such as cystic hyperplasia,etc.And also some doctors believe the two herbs can be used together effective and safety.But because of adverse events observed in the literature mentioned studies and the author explicitly anti-drug use were too theoretical studies,if haizao and gancao can be used together effective and safety is still not sure.更多还原