丹参注射液辅助治疗溃疡性结肠炎疗效及安全性的系统评价  

Efficacy and Safety of Danshen Injection in Adjuvant Treatment of Ulcerative Colitis:A Systematic Review

作　　者：缪志伟[1] 顾鸣佳[2] 严晶[2] 徐艳[1] 叶柏[3] MIAO Zhiwei;GU Mingjia;YAN Jing;XU Yan;YE Bai(Zhangjiagang Hospital Affiliated to Nanjing University of Chinese Medicine,Zhangjiagang 215600,Jiangsu,China;Nanjing University of Chinese Medicine,Nanjing 215500,Jiangsu,China;Jiangsu Province Hospital of TCM,Nanjing 210029,Jiangsu,China)

机构地区：[1]南京中医药大学附属张家港医院,江苏张家港215600 [2]南京中医药大学,江苏南京210023 [3]江苏省中医院,江苏南京210029

出　　处：《中华中医药学刊》2020年第1期51-57,I0011,I0012,共9页Chinese Archives of Traditional Chinese Medicine

基　　金：国家自然科学基金青年科学基金(81503536);国家中医药管理局项目(JDZX2012082);江苏省自然科学基金青年科学基金(BK20151008);苏州市科技发展计划(SYSD2017007)。

摘　　要：目的系统评价丹参注射液辅助治疗溃疡性结肠炎(UC)的临床疗效及安全性。方法计算机检索中国期刊全文数据库(CNKI),万方数据库(Wanfang),维普数据库(VIP),PubMed,Embase,The Cochrane Library数据库。检索时间均从建库至2018年6月,语言不限。纳入丹参注射液联合西医常规疗法治疗UC的随机对照研究(RCT),由两名研究人员独立进行文献筛选、资料提取、质量评价,采用RevMan 5.3和Stata 12.0软件进行meta分析。结果最终纳入12个研究,共计1102个患者,Meta分析结果显示,与单用西药相比,联用丹参注射液可明显提高UC的临床有效率[RR=1.23,95%CI(1.16,1.29),Z=7.60,P<0.01],和降低复发率[RR=0.31,95%CI(0.18,0.54),Z=4.12,P<0.01]。并能更好的改善凝血功能,降低患者血清中PLT、FIB,提高MPV水平,以及更好的控制炎性反应,降低患者血清中的IL-6、IL-8、TNF-α水平,而且没有增加不良反应的发生率[RR=1.17,95%CI(0.69,1.99),Z=0.58,P=0.56]。结论应用丹参注射液辅助治疗UC可提高临床疗效,且安全性良好。考虑到本研究纳入文献质量较低,该结论需要更多高质量研究来进一步证明。Objective To assess the efficacy and safety of Danshen Injection in adjuvant treatment of ulcerative colitis.Method Databases such as CNKI,Wanfang,VIP,PubMed,Embase and The Cochrane Library were searched for the randomized controlled trials(RCT)about Danshen Injection combined with conventional therapy for ulcerative colitis from database creation to June 2018.Two reviewers independently screened the literature,extracted the data and evaluated the methodological quality.Then the Meta-analysis was conducted by using RevMan 5.3 and Stata 12.0.Result A total of 12 studies involving 1102 patients were included.The results of Meta-analysis showed that in comparison with conventional therapy alone,Danshen Injection combined with conventional therapy can improve the clinical efficacy significantly[RR=1.23,95%CI(1.16,1.29),Z=7.60,P<0.01]and reduce the recurrence rate[RR=0.31,95%CI(0.18,0.54),Z=4.12,P<0.01].It can improve the blood coagulation function,reduce the levels of PLT and FIB,increase the level of MPV and better control the inflammatory response,reduce the levels of IL-6,IL-8,TNF-αin the serum and do not increase the incidence of adverse reactions[RR=1.17,95%CI(0.69,1.99),Z=0.58,P=0.56].Conclusion Danshen Injection for the adjuvant treatment of UC can improve the clinical efficacy with good security.However,due to the low quality of the included literature,the conclusion needs the support from more high quality studies.

关 键 词：丹参注射液 溃疡性结肠炎 系统评价 META分析 

分 类 号：R574.62[医药卫生—消化系统]