30209例舒血寧注射液安全性醫(yī)院集中監(jiān)測研究

1、    30209例舒血寧注射液安全性醫(yī)院集中監(jiān)測研究    姜俊杰+謝雁鳴 張寅+黎明全 趙玉斌+溫澤淮 李學(xué)林 易丹輝+張一開 摘要為獲得杏雪舒血寧注射液的不良反應(yīng)特征及發(fā)生率等安全性信息，采用多中心、大樣本醫(yī)院集中監(jiān)測的設(shè)計方法，在全國27家醫(yī)療機構(gòu)中，以使用舒血寧注射液的住院患者為研究對象，進行用藥周期的全程監(jiān)測。監(jiān)測主要內(nèi)容為患者的一般信息、診斷信息、用藥信息、不良事件信息。結(jié)果共納入使用舒血寧注射液的患者30 209例，發(fā)生不良反應(yīng)34例，不良反應(yīng)發(fā)生率0113%，屬于偶見不良反應(yīng)。不良反應(yīng)發(fā)生特征為頭痛、頭暈、皮膚瘙癢、心悸、惡心等?；谝?/p>

2、上結(jié)果，說明杏雪舒血寧注射液的安全性良好。關(guān)鍵詞舒血寧注射液； 醫(yī)院集中監(jiān)測； 不良反應(yīng)； 安全性intensive hospital monitoring of shuxuening injection in 30 209 casesjiang junjie1， xie yanming1*， zhang yin1， li mingquan2， zhao yubin3， wen zehuai4，li xuelin5， yi danhui2， zhang yikai6（1 institute of basic medical sciences， chinese academy of tradit

3、ional chinese medicine， beijing 100700， china；2affiliated hospital of changchun university of traditional chinese medicine， changchun 130618， china；3shijiazhuang hospital of traditional chinese medicine， shijiazhuang 052560， china；4guangdong province traditional chinese medical hospital， guangzhou 5

4、11740， china；5the first affiliated hospital of henan university of traditional chinese medicine， zhengzhou 452486， china；6 college of statistics， renmin university of china， beijing 100872， china）abstract in order to obtain the characteristics and incidence of adverse reactions of shuxuening injecti

5、on （xingxue）， the design method of a multicenter， large sample intensive monitoring in the hospitals was adopted the hospitalized patients with use of shuxuening injection from 27 medical institutions were enrolled as the research subjects to monitor their entire process of treatment cycle the main

6、content of monitoring included the patients general information， diagnostic information， medication information， and adverse event information a total of 30 209 patients with shuxuening injection were enrolled； adverse reactions occurred in 34 cases， with an incidence of 0113%， which belonged to the

7、 rare adverse reactions adverse reactions were characterized by headache， dizziness， pruritus， palpitations， nausea， et al all the above results showed that xingxue shuxuening injection had high safety in clinical applicationkey wordsshuxuening injection； intensive hospital monitoring； adverse reactions； safety杏雪舒血寧注射液（以下簡稱“舒血寧”）的成分是銀杏葉提取物，功能是擴張血管、改善微循環(huán)，可用于缺血性心腦血管疾病，冠心病、心絞痛、腦栓塞、腦血管痙攣等。關(guān)于舒血寧注射液的安全性問題，既往諸多學(xué)者進行了安全性文獻分析、回顧性分析等12。文獻分析及不良反應(yīng)被動監(jiān)測數(shù)據(jù)分析，均可發(fā)現(xiàn)舒血寧的不良反應(yīng)信號，但均有一定的局限性，來源于多個文獻的數(shù)據(jù)質(zhì)量參差不齊，無法獲得較為準(zhǔn)確的不良反應(yīng)（adverse reaction，adr）數(shù)據(jù)。被動監(jiān)測數(shù)據(jù)分析無法計算adr發(fā)生率，且存在低報、漏報的缺點。然而，大樣本醫(yī)院集中監(jiān)測研究可獲取舒血寧注射液全部用藥