莪术油注射液静脉注射安全性的Meta分析  

Meta-analysis of Adverse Reaction Induced by Zedorecy Turmeric Oil Injection via Intravenous Injection

作　　者：黎桂玉 林基勇 赵铁建 彭岳 段雪琳 陈永欣 马静 

机构地区：[1]广西中医药大学教务处,广西南宁530200 [2]广西中医药大学研究生学院,广西南宁530200 [3]广西中医药大学基础医学院,广西南宁530200

出　　处：《中华中医药学刊》2018年第1期133-141,共9页Chinese Archives of Traditional Chinese Medicine

基　　金：国家自然科学基金项目(81460628,81660705);广西研究生教育创新计划项目(JGY2014082);广西中医药大学研究生教育创新计划项目(YJS201643)

摘　　要：目的：评价莪术油注射液静脉注射途径的安全性,为临床上该药的应用提供指导和借鉴。方法：计算机检索2000年1月—2016年7月中文数据库中国知网（CNKI）、万方数据库（WANFANG DATA）、维普数据库（VIP）、中国生物医学文献数据库（CBM）以及PubMed、Web of Science、Embase、the Cochrane Library英文数据库,按纳入和排除标准收集相关研究,对纳入文献质量应用Jadad评分量表进行评分,RevMan 5.3软件对纳入的多个随机对照试验的结果进行Meta分析。结果：共纳入研究22个,均为莪术油注射液静脉注射的临床试验,共2335例患者,其中治疗组1264例,对照组1071例,Meta分析结果显示,比值比OR值为0.44,95%CI[0.30,0.64],治疗组与对照组不良反应发生率比较有统计学差异性（P〈0.0001）,治疗组（2.8%）〈对照组（7.4%）。亚组分析：呼吸道感染疾病亚组（1.5%〈6.7%）、2000—2005年亚组（2.0%〈6.6%）和≥7岁亚组（3.3%〈8.6%）、0~6岁亚组（2.0%〈6.5%）、疗程〈7 d亚组（2.0%〈6.0%）、疗程≥7 d亚组（3.5%〈9.6%）、抗病毒药对照用药亚组（3.8%〈10.6%）、抗病毒药＋抗生素对照用药亚组（1.7%〈5.9%）和无合并用药亚组（1.5%〈11.5%）莪术油注射液不良反应发生率低于对照组（P〈0.05）。而传染性疾病亚组、2006—2011年亚组、合并用药亚组与对照组不良反应发生率比较无统计学差异性（P〉0.05）。在所有合并用药中,与抗病毒药利巴韦林合用,不良反应发生率最高（30%）,其次是西瓜霜喷剂（10%）。结论：莪术油注射液或莪术油葡萄糖注射液用于呼吸道感染疾病的不良反应发生率可能低于利巴韦林、青霉素、头孢类等抗病毒和抗生素类药,单用不良反应发生率低于联合用药。莪术油注射液与抗病毒药利巴韦林合用时,不良反应发生率在所有联合用药中最高,其次是西瓜霜喷剂。而更为准确与综合性的结论还Objective： To evaluate the clinical safety of Zedorecy Turmeric oil injection via intravenous injection and provide guidance and reference on the clinical application of the drug. Methods： In this Meta-analysis,CNKI,VIP,WANFANG DATA,CBM,PubMed,Embase,Web of Science and the Cochrane Library were searched from Jan. 2000 to Jul. 2016 to collect relevant studies in accordance with the Inclusion and Exclusion Criteria. Then Jadad Rating Scale was applied for grading those studies,and RevMan 5. 3 software was used for statistical analysis on multiple randomized controlled trials. Results： Twenty-two clinical studies were analyzed with a total of 2335 cases,including 1264 cases in observation group and 1071 cases in the control group. The results of Meta-analysis showed that the odds ratio（ OR） and 95% CI were 0. 44 and 0. 30-0. 64,respectively. There were statistical differences in the adverse reaction rate of the observation group and control group（ P 〈 0. 000 1）,and the former’s was lower than latter’s. The results of subgroup-analysis showed that adverse reaction rate of observation group was lower than control group’s in respiratory tract infection subgroup（1. 5% 〈 6. 7%）,2000—2005 subgroup（2. 0% 〈 6. 6%）,≥seven ages subgroup（3. 3% 〈 8. 6%）,zone-six ages subgroup（2. 0% 〈 6. 5%）,therapic period 〈 seven days subgroup（2. 0% 〈 6. 0%）,therapic period≥seven days subgroup（3. 5% 〈 9. 6%）,antiviral drugs control subgroup（ 3. 8% 〈 10. 6%）,antiviral drugs and antibiotics control subgroup（ 1. 7% 〈 5. 9%）,and no combination therapy in observation group subgroup（ 1. 5% 〈 11. 5%）.While there were no significant differences between the observation group and control group in contagious disease,2005-2011 and combination therapy in observation group subgroup（ P 〉 0. 05）. Of all the drug combination,the rate of adverse reaction with ribavirin was the highest（30%）,followed by watermelon frost spray（10%）. Conclusion： The adverse reaction

关 键 词：莪术油注射液 不良反应 META分析 

分 类 号：R285.5[医药卫生—中药学]