本文選題：炎琥寧注射液　切入點：不良反應(yīng)　出處：《鄭州大學(xué)》2017年碩士論文

【摘要】：研究目的本研究課題對炎琥寧注射液不良反應(yīng)的相關(guān)文獻進行Meta分析,評價其臨床應(yīng)用的安全性,以期為臨床用藥提供參考。研究方法由兩位研究人員獨立用CNKI、WanFang Data、VIP、CBM、PubMed、MEDLINE、Web of Science、ClinicalTrials.gov等數(shù)據(jù)庫,對2000年1月至2016年12月國內(nèi)外公開發(fā)表的與炎琥寧注射液不良反應(yīng)相關(guān)的臨床研究文獻進行檢索。制定文獻納入和排除標準,采用文獻管理軟件NoteExpress 3.0對文獻進行整理和篩選,利用辦公軟件Excel 2010建立數(shù)據(jù)庫,提取納入研究文獻中的數(shù)據(jù)資料。按照Cochrane協(xié)作網(wǎng)推薦的偏倚風(fēng)險評價工具對納入研究的文獻質(zhì)量進行評價。然后采用RevMan5.3軟件,對注射用炎琥寧的不良反應(yīng)進行Meta分析。通過Q檢驗法和I2統(tǒng)計量對不同研究間的異質(zhì)性進行檢驗。同時按不同年齡段、不同療程和不同對照措施分別對注射用炎琥寧的不良反應(yīng)進行亞組分析。研究結(jié)果最后符合納入標準的文獻共50篇。Meta分析結(jié)果顯示:納入研究的注射用炎琥寧患者(試驗組)共4090例,發(fā)生不良反應(yīng)128例。納入研究的對照組患者(使用其他藥物)共3790例,發(fā)生不良反應(yīng)288例。試驗組與對照組的不良反應(yīng)發(fā)生的風(fēng)險比RR為0.48,95%置信區(qū)間為(0.34,0.69),兩組結(jié)果之間有統(tǒng)計學(xué)意義(P0.0001)。亞組分析結(jié)果顯示:⑴不同年齡段亞組:患者年齡小于14歲亞組中,炎琥寧注射液不良反應(yīng)發(fā)生的風(fēng)險顯著低于對照組(P=0.0001)。炎琥寧注射液在兒科(≤14歲兒童)使用比例較高。⑵不同療程亞組:用藥療程小于等于5天亞組(P=0.001)和大于5天亞組(P=0.01)中炎琥寧注射液不良反應(yīng)發(fā)生的風(fēng)險均顯著低于對照組。⑶不同對照措施亞組:利巴韋林亞組(P=0.002)和α-干擾素亞組(P0.00001)中炎琥寧注射液不良反應(yīng)發(fā)生的風(fēng)險顯著低于對照組。對炎琥寧注射液不良反應(yīng)的臨床表現(xiàn)進行統(tǒng)計分析,結(jié)果顯示其臨床癥狀以過敏反應(yīng)和消化道反應(yīng)為主。研究結(jié)論炎琥寧注射液與利巴韋林(P=0.002)、α-干擾素(P0.00001)相比,不良反應(yīng)發(fā)生風(fēng)險低且差異均有統(tǒng)計學(xué)意義。炎琥寧注射液在臨床使用過程中的不良反應(yīng)癥狀主要表現(xiàn)為皮疹、皮膚瘙癢、惡心、嘔吐、腹痛、腹瀉等,這些不良反應(yīng)的發(fā)生可能與炎琥寧注射液的用藥對象、用藥療程長短及是否嚴格按照藥品說明書適應(yīng)癥用藥等因素有關(guān)。
[Abstract]:Objective to evaluate the safety of Yanhuning injection by Meta analysis in order to provide reference for clinical use.Methods from January 2000 to December 2016, two researchers used the database CNKI Wan Fang data VIPP CBMN MEDLINEN Web of Science and Technology Clinical Trials.gov independently to search the clinical literatures published at home and abroad from January 2000 to December 2016, which were related to adverse reactions of Yanhuning injection.The standard of literature inclusion and exclusion was established, and the document management software NoteExpress 3.0 was used to sort and screen the documents. The database was established by using the office software Excel 2010, and the data materials which were included in the research documents were extracted.The quality of literature included in the study was evaluated according to the bias risk assessment tool recommended by Cochrane Cooperative Network.RevMan5.3 software was used to analyze the adverse reactions of Yanhuning for injection by Meta.The heterogeneity of different studies was tested by Q test and I 2 statistics.At the same time, the adverse reactions of Yanhuning for injection were analyzed according to different ages, different courses of treatment and different control measures.Results A total of 50 articles were included in the study. Meta-analysis showed that 4090 patients (trial group) with Yanhuning for injection were included in the study, and 128 patients had adverse reactions.A total of 3790 patients (using other drugs) in the study group had adverse reactions.The risk ratio of adverse reactions in the trial group and the control group was 0.48 鹵95% confidence interval (CI = 0.34 0. 69), and there was statistical significance between the two groups (P 0.0001).The results of subgroup analysis showed that the risk of adverse reaction of Yanhuning injection was significantly lower than that of control group (P < 0.0001).The risk of adverse reactions of Yanhuning injection in paediatrics (鈮，

本文編號：1717817