本文關(guān)鍵詞：中藥注射劑臨床使用合理性與安全性再評(píng)價(jià)方法學(xué)探討，由筆耕文化傳播整理發(fā)布。

中藥注射劑臨床使用合理性與安全性再評(píng)價(jià)方法學(xué)探討

Analysis of rational clinical uses of traditional Chinese medicine injections and factors influencing adverse drug reactions

[1] [2] [3] [4] [5] [6] [7] [8] [9]

SUN Shi-guang , LI Zi-feng, XIE Yan-ming , LIU Jian, LU Yan, SONG Yi-fei , HAN Ying-hua , LIU Li-da , PENG Ting-ting （ 1. Second Affiliated Hospital of Shandong Unive

[1]山東中醫(yī)藥大學(xué)第二附屬醫(yī)院,山東省中西醫(yī)結(jié)合醫(yī)院藥學(xué)部,山東濟(jì)南250001; [2]中國(guó)中醫(yī)科學(xué)院中醫(yī)臨床基礎(chǔ)醫(yī)學(xué)研究所,北京100700

文章摘要：合理性與安全性是中藥注射劑上市后臨床再評(píng)價(jià)的關(guān)鍵問(wèn)題之一。該研究隨機(jī)抽取某醫(yī)院2011年1月一12月份出院患者病歷240份，通過(guò)12種中藥注射劑藥品說(shuō)明書(shū)一致性與配伍禁忌評(píng)價(jià)、藥物利用研究（DUR）以及藥品不良反應(yīng)／事件（ADR／ADE）條件Logistic回歸分析，綜合評(píng)價(jià)該醫(yī)院2011年中藥注射劑臨床使用情況，初步探討中藥注射劑臨床使用合理性與安全性再評(píng)價(jià)方法。研究結(jié)果顯示該醫(yī)院2011年中藥注射劑臨床使用給藥劑量、給藥濃度、溶媒選擇、辨病辨證及四項(xiàng)指標(biāo)與說(shuō)明書(shū)一致性普遍偏低，其中中藥注射劑臨床超劑量與超濃度使用情況嚴(yán)重，而給藥濃度作為保護(hù)因素對(duì)于評(píng)價(jià)和預(yù)測(cè)中藥注射劑ADR／ADE發(fā)生具有借鑒意義。因此應(yīng)進(jìn)一步加強(qiáng)中藥注射劑臨床使用合理性與安全性再評(píng)價(jià)研究，可以綜合借鑒藥品說(shuō)明書(shū)一致性與配伍禁忌評(píng)價(jià)、DUR以及ADR／ADE條件Logistic回歸分析多種評(píng)價(jià)方法。

Abstr：Objective： To rationalize the clinical use and safety are some of the key issues in the surveillance of traditional Chinese medicine injections （TCMIs）. Method： In this 2011 study, 240 medical records of patients who had been discharged follow- ing treatment with TCMIs between 1 and 12 month previously were randomly selected from hospital records. Consistency between clini- cal use and the description of TCMIs was evaluated. Research on drug use and adverse drug reactions/events using logistic regression analysis was carried out. Result： There was poor consistency between clinical use and best practice advised in manuals on TCMIs. Over-dosage and overly concentrated administration of TCMIs occurred, with the outcome of modifying properties of the blood. Logistic regression analysis showed that, drug concentration was a valid predictor for both adverse drug reactions/events and benefits associated with TCMIs. Conclusion： Surveillance of rational clinical use and safety of TCMIs finds that clinical use should be consistent with technical drug manual specifications, and drug use should draw on multi-layered logistic regression analysis research to help avoid ad- verse drug reactions/events.

文章關(guān)鍵詞：

Keyword：:traditional Chinese medicine injections rationality safety differentiating disease and syndrome drug use re- search adverse drug reactions/adverse drug events conditional logistic regression analysis

課題項(xiàng)目：國(guó)家“重大新藥創(chuàng)制”科技重大專(zhuān)項(xiàng)（2009ZX09502-030）;山東省藥學(xué)會(huì)臨床藥學(xué)奧賽康中青年科研項(xiàng)目（sdpa-ask-201307）;山東省中醫(yī)藥科技發(fā)展計(jì)劃項(xiàng)目（2013104）

  本文關(guān)鍵詞：中藥注射劑臨床使用合理性與安全性再評(píng)價(jià)方法學(xué)探討，，由筆耕文化傳播整理發(fā)布。