目的 對紅花注射液在臨床應(yīng)用中的不良反應(yīng)進(jìn)行綜合定量分析，以期為臨床安全應(yīng)用提供依據(jù)。方法 檢索PubMed、Cochrane Library、中國期刊全文數(shù)據(jù)庫（CNKI）、維普中文科技期刊全文數(shù)據(jù)庫（VIP）和萬方數(shù)據(jù)庫中與紅花注射液不良反應(yīng)有關(guān)的文獻(xiàn)，檢索時間為建庫至2017年11月30日。根據(jù)納入標(biāo)準(zhǔn)以及排除標(biāo)準(zhǔn)篩選文獻(xiàn)，用RevMan 5.3軟件對提取數(shù)據(jù)進(jìn)行Meta-分析。結(jié)果 共納入25篇文獻(xiàn)，Meta-分析結(jié)果顯示，紅花注射液組的不良反應(yīng)發(fā)生率[OR=1.70，95%CI（1.19，2.42），P=0.003]明顯高于對照組。體溫中樞損害亞組[OR=7.90，95%CI（2.17，28.83），P=0.002]、5%葡萄糖注射液溶媒亞組[OR=2.05，95% CI （1.06，3.9），P<0.05]、用藥療程>14天亞組[OR=2.91，95%CI（1.34，6.30），P<0.05]、用藥劑量 ≤ 20 mL亞組[OR=1.58，95%CI（1.02，2.43），P<0.05]、用藥劑量>20 mL亞組[OR=1.91，95%CI（1.00，3.62），P=0.05]中，不良反應(yīng)發(fā)生率均明顯高于對照組，差異無統(tǒng)計學(xué)意義。結(jié)論 紅花注射液不良反應(yīng)發(fā)生率高于對照組，以發(fā)熱、皮膚黏膜及胃腸道反應(yīng)為主，不良反應(yīng)發(fā)生與溶媒、劑量、療程有一定關(guān)系，臨床應(yīng)用須密切關(guān)注。

Objective To systematically review the incidence rate of adverse drug reaction for Honghua Injection and to assess the safety of the drug using meta-analysis and provide a basis for clinical applications.Methods Literature were searched and screened from the databases as PubMed, Cochrane Library, CNKI, VIP, Wanfang from database building to September 30th, 2017. Randomized controlled trials (RCTs) related to Honghua Injection according to the inclusion and exclusion criteria were included. RevMan 5.3 software was used to conduct meta-analysis for the rate of adverse reaction of Honghua Injection.Results A total of 25 articles were included in the study. The result of meta-analysis showed that the incidence rate of adverse reaction in Honghua Injection group was significant higher than that in the control group[OR=1.70, 95%CI (1.19, 2.42), P=0.003]. Body temperature center damage subgroup[OR=7.90, 95%CI (2.17, 28.83), P=0.002], 5% glucose injection vehicle subgroup[OR=2.05, 95%CI (1.06, 3.9), P < 0.05], medication course > 14 d subgroup[OR=2.91, 95%CI(1.34, 6.30), P < 0.05], doses ≤ 20 mL subgroup[OR=1.58, 95%CI (1.02, 2.43), P < 0.05], with the dose of > 20 mL subgroup[OR=1.91, 95%CI (1.00, 3.62), P=0.05], the incidence of adverse reactions of Honghua Injection was significantly higher than the control group, the difference was statistically significant.Conclusion The incidence rate of adverse reaction in Honghua Injection group was significantly higher than that in the control group, and the main adverse reactions were fever, skin mucous membrane, and gastrointestinal reactions. And there were relations between the adverse drug reaction and solvent, dose of drug, and administration time. In summary, the safety of Honghua Injection was lower than that of the control group, which needed to be paid attention to in clinical application.

中國藥科大學(xué)藥學(xué)基地科研訓(xùn)練及科研能力提高項目（J1310032）；江蘇省級大學(xué)生創(chuàng)新創(chuàng)業(yè)訓(xùn)練計劃項目