[關鍵詞]
[摘要]
目的 系統(tǒng)評價注射用丹參多酚酸聯(lián)合化學藥治療急性腦梗死的有效性和安全性。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(Wangfang 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(TheCochrane Library)、美國引文數(shù)據(jù)庫(Web of Science)等,檢索時間從建庫至2021年5月31日,全面收集注射用丹參多酚酸聯(lián)合化學藥治療急性腦梗死的臨床隨機對照試驗(RCT),采用RevMan 5.3軟件進行Meta分析。結果 共納入34項RCTs,總樣本量為3 401例,試驗組1 705例、對照組1 696例。Meta分析結果顯示,在化學藥常規(guī)治療基礎上加用注射用丹參多酚酸治療急性腦梗死能提高臨床有效率[RR=1.29,95% CI(1.24,1.35)]、降低美國國立衛(wèi)生研究院卒中量表評分[MD=-2.97,95% CI(-3.74,-2.19)]、提高日常生活能力量表評分[MD=12.60,95% CI(10.10,15.09)],改善蒙特利爾認知評估量表評分[MD=2.41,95% CI(2.03,2.79)],降低C反應蛋白[SMD=-1.71,95% CI(-2.23,-1.19)],與對照組比較差異有統(tǒng)計學意義(P<0.000 01);共有24項研究報道了不良反應,其中11項研究報告未出現(xiàn)不良反應,兩組不良反應發(fā)生率差異無統(tǒng)計學意義。結論 注射用丹參多酚酸治療急性腦梗死具有提高臨床有效率,促進神經(jīng)功能恢復,提高日常生活行為能力,并可改善卒中后認知功能,值得臨床推廣使用。上述研究仍需多中心、大樣本及雙盲的RCT試驗進一步證實。
[Key word]
[Abstract]
Objective To evaluate the efficacy and safety of Salvianolic Acids for Injection (SAFI) combined with western medicine in the treatment of acute cerebral infarction. Methods Databases including CNKI, Wanfang Data, VIP, CBM, PubMed, EMbase, the Cochrane Library, and Web of Science were searched to collect randomized controlled trials (RCT) of SAFI in the treatment of acute cerebral infarction from the date of establishment to May 31, 2021. Meta-analysis was performed using RevMan 5.3 software. Results A total of 34 RCTs were included, with a total sample size of 3 401 cases, including 1 705 cases in the experimental group (SAFI combined with chemical drugs) and 1 696 cases in the control group (chemical drugs alone). Meta-analysis showed that compared with control group, SAFI combined with chemical drugs could reduce increase clinical efficiency[RR=1.29, 95%CI (1.24, 1.35)], reduce NIHSS scores[MD=-2.97, 95%CI(-3.74, -2.19)], improve BI scores[MD=12.60, 95%CI(10.10,15.09)], improve MOCA scores[MD=2.41, 95%CI(2.03, 2.79)], and reduce C-reactive protein[SMD=-1.71, 95%CI(-2.23, -1.19)], the difference between two groups were statistically significant (P<0.000 01). A total of 24 studies reported adverse reactions, of which 11 studies reported no adverse reactions, and there was no significant difference in the incidence of adverse reactions between two groups. Conclusion SAFI in the treatment of acute cerebral infarction can improve the clinical effective rate, promote the recovery of neurological function, improve the ability of daily life and behavior, and improve the cognitive function after stroke. It is worthy of clinical promotion. The above research results still need to be verified by more multicenter, large sample and double-blind randomized controlled trials.
[中圖分類號]
R972;R286.2
[基金項目]