摘要
目的六种含鱼腥草的注射制剂与鱼腥草注射液存在本质不同,其药物成分和药理作用更复杂多样,本文分析其临床用药情况、不良反应/不良事件(ADR/AE)涉及系统和表现等,评价其安全性和有效性,为后续更全面深入的研究提供参考依据。方法计算机检索MEDLINE、EMbase、e Cochrane Library(检索时间均为1998～2010.12.31)、CNKI(1979～2010.12.31)、CBM(1978～2010.12.31)和VIP(1989～2010.12.31),查找相关病例报告、系列病例观察、横断面研究、临床对照研究,按纳入排除标准选择文献和提取数据,分析ADR/AE发生原因、规律。如数据可行,作有效性Meta分析。结果①ADR/AE:纳入132篇文献,共118例出现ADR/AE。新鱼腥草素钠注射液:共59篇文献,93例出现ADR/AE,主要表现为注射部位疼痛(41例)、皮疹(19例)、过敏性休克(11例)、其他输液或过敏反应(21例)。鱼金注射液:共69篇,25例出现ADR/AE,表现为皮疹(12例)、过敏性休克(4例)、注射部位疼痛(3例)、其他输液或过敏反应(6例)。②疗效分析:各有1篇横断面研究和RCT分别报道了新鱼腥草钠注射液和鱼金注射液的临床疗效,认为疗效较好。但因资料有限,不足以判定其有效性。结论目前检索到的6种含鱼腥草注射制剂的临床应用研究较少,且存在严重临床不合理用药情况,多数ADR/AE病例与不合理用药有关,其中非适应症和擅自改变给药方式是最多的两种情况。含鱼腥草的注射制剂的安全性和有效性分析评价证据不足,需要开展设计更严谨,符合用药规范的大样本临床试验来支撑深入分析研究。
Objective To analyze the clinical application,ADR/AE involved systems and manifestations of the six injections containing Houttuynia cordata which are much complicated in their ingredients and pharmacological actions compared with the Houttuynia cordata Injection,and to assess their safety and efficacy,so as to provide references for further deep research.Methods Such databases as MEDLINE（1998 to December 31,2010）,EMBASE（1998 to December 31,2010）,The Cochrane Library（1998 to December 31,2010）,CNKI（1979 to December 31,2010）,CBM（1978 to December 31,2010）,and VIP（1989 to December 31,2010） were searched to retrieve the case report,series of cases observation,cross-sectional study,and clinical control study.The studies were included according to the inclusive and exclusive criteria,and the data was abstracted to analyze the reason and regularity of ADR/AE.Meta-analyses for efficacy were conducted when the data was feasible.Results a） About ADR/AE： Among the included 132 studies,118 cases were reported with the ADR/AE.There were 59 studies about the New Houttuyfonate sodium injection,93 cases with ADR/AE mainly manifested as pain in injection site（41 cases）,rash（19 cases）,anaphylactic shock（11 cases） and other infusion or allergic reactions（21 cases）.There were 69 studies about the Yu Jin injection,25 cases with ADR/AE manifested as rash（12 cases）,anaphylactic shock（four cases）,pain in injection site（three cases）,and other infusion or allergic reactions（six cases）;and b） The good efficacy of the New Houttuyfonate sodium injection and the Yu Jin injection was reported in one cross-sectional study and one RCT respectively,but the limited data was not enough to properly judge the efficacy.Conclusion There are few of clinical studies about these six injections containing Houttuynia cordata,and the irrational use in clinic is serious.Most of the ADR/AE cases are related to irrational use,such as,non-indication use,and arbitrarily change of administration method.The proof for analyzing and evaluating the safety and efficacy of injections containing Houtturnia cordata is insufficient,so strict clinical trials with large sample size are required to support further research.
出处
《中国循证医学杂志》
CSCD
2011年第7期799-804,共6页
Chinese Journal of Evidence-based Medicine
