目的 系統(tǒng)評價中藥注射液（注射用丹參多酚酸、丹紅注射液、疏血通注射液、銀杏二萜內酯葡胺注射液、銀杏內酯注射液）聯(lián)合化學藥治療急性缺血性腦卒中的有效性和安全性。方法 計算機檢索中國學術期刊全文數(shù)據(jù)庫（CNKI）、萬方數(shù)據(jù)知識服務平臺（Wanfang Data）、維普中文期刊全文數(shù)據(jù)庫（VIP）、中國生物醫(yī)學文獻數(shù)據(jù)庫（CBM）、美國生物醫(yī)學期刊文獻數(shù)據(jù)庫（PubMed）、荷蘭醫(yī)學文摘數(shù)據(jù)庫（Embase）、循證醫(yī)學圖書館（Cochrane Library）、美國引文數(shù)據(jù)庫（Web of Science），檢索時間從建庫至2023年5月31日，全面收集相關臨床隨機對照試驗（RCT），使用Cochrane系統(tǒng)評價手冊進行納入研究的質量評價，采用R 4.0.5和Stata 16軟件進行網(wǎng)狀Meta分析。結果 共納入72項研究，共納入7 343例患者，涉及5種中藥注射劑。網(wǎng)狀Meta分析結果顯示：在臨床有效率方面，注射用丹參多酚酸、丹紅注射液、疏血通注射液、銀杏二萜內酯葡胺注射液、銀杏內酯注射液聯(lián)合化學藥的臨床有效率均高于化學藥對照組，累積概率排序為疏血通注射液＋化學藥（89.36%）＞注射用丹參多酚酸＋化學藥（87.25%）＞丹紅注射液＋化學藥（54.14%）＞銀杏內酯注射液＋化學藥（44.48%）＞銀杏二萜內酯葡胺注射液＋化學藥（24.77%）＞化學藥（0.0%）；在降低美國國立衛(wèi)生研究院卒中量表（NIHSS）評分方面，注射用丹參多酚酸、丹紅注射液、疏血通注射液、銀杏二萜內酯葡胺注射液、銀杏內酯注射液聯(lián)合化學藥的NIHSS評分均低于化學藥對照組，累積概率排序為丹紅注射液＋化學藥（89.63%）＞疏血通注射液＋化學藥（71.44%）＞注射用丹參多酚酸＋化學藥（65.19%）＞銀杏內酯注射液＋化學藥（50.41%）＞銀杏二萜內酯葡胺注射液＋化學藥（23.21%）＞化學藥（0.00%）；在提高日常生活能力量表（BI）評分方面，注射用丹參多酚酸、丹紅注射液、疏血通注射液、銀杏二萜內酯葡胺注射液、銀杏內酯注射液聯(lián)合化學藥的BI評分均高于化學藥對照組，累積概率排序為銀杏二萜內酯葡胺注射液＋化學藥（81.33%）＞疏血通注射液＋化學藥（71.54%）＞丹紅注射液＋化學藥（64.85%）＞注射用丹參多酚酸＋化學藥（51.81%）＞銀杏內酯注射液＋化學藥（30.44%）＞化學藥（0.00%）。共有40項研究報告了不良反應，其中19項研究報告未出現(xiàn)不良反應，其余均無嚴重不良反應，已報告的不良反應類型均為常見不良反應類型，直接Meta分析結果表明這5種中藥注射液聯(lián)合化學藥的不良反應率與化學藥不良反應率比較，無統(tǒng)計學差異。結論 5種中藥注射液聯(lián)合化學藥治療急性缺血性腦卒中均可提高臨床有效率、降低NIHSS評分和提高BI評分，提高臨床有效率以疏血通注射液和注射用丹參多酚酸有優(yōu)勢，丹紅注射液和銀杏二萜內酯葡胺注射液在降低NIHSS評分和提高BI評分上有優(yōu)勢。受納入研究的質量等局限性，該研究結論仍需更多高質量RCT試驗進一步證實。

Objective To evaluate the efficacy and safety of traditional Chinese medicine injections [Salvianolic Acids for Injection (SAFI), Danhong Injection (DH), Shuxuetong Injection (SXT), Ginkgo Diterpene Lactone Meglumine Injection (YXETNZ), Ginkgolide Injection (YXNZ) ] combined with western medicine in the treatment of acute ischemic stroke. Methods Databases including CNKI, Wanfang Data, VIP, CBM, PubMed, Embase, the Cochrane library, and Web of Science were searched to collect randomized controlled trials from the date of establishment to May 31, 2023. ReviewManager 5.3 software was used to make studies quality bias. Network Meta-analysis was performed by R 4.0.5 and Stata 16 software. Results A total of 72 RCTs were included, with a total sample size of 7343 cases. Salvianolic Acids for Injection combined with chemical drugs (SAFI+CM), Danhong Injection combined with chemical drugs (DH+CM), Shuxuetong Injection combined with chemical drugs (SXT+CM), Ginkgo Diterpene Lactone Meglumine Injection combined with chemical drugs (YXETNZ+CM), Ginkgolide Injection combined with chemical drugs (YXNZ+CM) are five interventions. Network Meta-analysis showed that SAFI+CM, DH+CM, SXT+CM, YXETNZ+CM, YXNZ+CM could improve clinical efficiency, and the rank of cumulative probability was SXT+CM(89.36%)＞SAFI+CM (87.25%)＞DH+CM (54.14%)＞YXNZ+CM (44.48%)＞YXETNZ+CM (24.77%)＞CM (0.00%). SAFI+CM, DH+CM, SXT+CM, YXETNZ+CM, YXNZ+CM could reduce NIHSS scores, and the rank of cumulative probability was DH+CM (89.63%)＞SXT+CM (71.44%)＞SAFI+CM (65.19%)＞YXNZ+CM (50.41%)＞YXETNZ+CM (23.21%)＞CM (0.00%). SAFI+ CM, DH+CM, SXT+CM, YXETNZ+CM, YXNZ+CM could improve BI index, and the rank of cumulative probability was YXETNZ+CM (81.33%)＞SXT+CM (71.54%)＞DH+CM (64.85%)＞SAFI+CM (51.81%)＞YXNZ+CM (30.44%)＞CM (0.00%). A total of 40 studies reported adverse reactions, of which 19 studies reported no reactions. Others were no serious adverse reactions. The reported types of adverse reactions are all common types of adverse reactions. Meta-analysis results show that there is no statistically significant difference in the incidence of adverse reactions between the combination of these five traditional Chinese medicine injections and chemical drugs. Conclusion Five traditional Chinese medicine injections combined with chemical drugs in the treatment of acute ischemic stroke can improve the clinical efficiency, without serious adverse reactions. SXT+CM and SAFI+ CM have an improved effect on the total effective rate, while DH+CM and YXETNZ+CM show advantages in NIHSS score and Barthel index. The above research results still need to be verified by more multicenter, large sample and double-blind randomized controlled trials.

R286.1

河北省醫(yī)學研究重點課題計劃項目（20181487）