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Efficacy and Safety of Xueshuantong Injection on Acute Cerebral Infarction: Clinical Evidence and GRADE Assessment.

ABSTRACT: Introduction:Xueshuantong injection (XST), a Chinese Medicine, is clinically effective in treating acute cerebral infarction (ACI). However, the meta-analysis of XST combined with conventional treatments (CTs) on ACI remain unexplored. The purpose of this study is to investigate the efficacy and safety of XST combined with CTs on patients with ACI. Methods:Randomized controlled trials (RCTs) were screened from the Cochrane Library, PubMed, Web of Science, EMBASE, and four Chinese medical databases. The meta-analysis was performed using RevMan 5.3 and STATA 16.0. The GRADE assessment was performed by the GRADEprofiler (GRADEpro version: 3.6). The aggregate 95% confidence intervals (CIs) and relative risk (RR) estimates were calculated. Results:Forty studies were included, involving a total of 3,868 patients. XST combined with CTs performed significantly better than CTs alone on the overall response rate (ORR) after treatment (RR = 1.21, 95% CI = 1.17-1.25, P < 0.001). There was no statistical differences in the incidence of adverse reactions between the experimental group (XST plus CTs) and control group (CTs alone). Groups treated with XST substantially decreased the National Institutes of Health Stroke Scale (NIHSS) score compared to the groups without XST (WMD = -5.31, 95% CI = -6.40 to -4.22, P < 0.001). Activities of daily living (ADL) scores were significantly better in the group treated with XST than CTs alone (WMD = 12.51, 95% CI = 5.6-19.38, P < 0.001). Patients who received XST combined with CTs showed significantly higher improvements in high-sensitivity C-reactive protein (hs-CRP) (WMD = -2.47, 95% CI = -3.11 to -1.82, P < 0.001) and interleukin 6 (IL-6) (WMD = -13.66, 95% CI = -17.80 to -9.51, P < 0.001) than those who received CTs alone. The GRADE assessment indicates that the comprehensive quality of this evidence is low. Conclusions:This meta-analysis and GRADE assessment conditionally recommend that XST combined with CTs can increase the overall response rate, ameliorate neurological deficit, and improve activities of daily living function more than CTs alone. A significant reduction in the hs-CRP and IL-6 levels were observed when XST was combined with CTs.

SUBMITTER: Lyu J

PROVIDER: S-EPMC7345308 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Efficacy and Safety of Xueshuantong Injection on Acute Cerebral Infarction: Clinical Evidence and GRADE Assessment.

Lyu Jian J Xie Yanming Y Sun Menghua M Zhang Lidan L

Frontiers in pharmacology 20200702

<h4>Introduction</h4>Xueshuantong injection (XST), a Chinese Medicine, is clinically effective in treating acute cerebral infarction (ACI). However, the meta-analysis of XST combined with conventional treatments (CTs) on ACI remain unexplored. The purpose of this study is to investigate the efficacy and safety of XST combined with CTs on patients with ACI.<h4>Methods</h4>Randomized controlled trials (RCTs) were screened from the Cochrane Library, PubMed, Web of Science, EMBASE, and four Chinese ...[more]

PMID: 32714181

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Project description:Background: Acute myocardial infarction (AMI) is a common and life-threatening cardiovascular disease. However, there is a lack of pathology and drug studies on AMI within 20 min. Xueshuantong injection (XST) is mainly composed of Panax notoginseng saponins, which can dilate blood vessels and improve blood circulation, and is clinically used in the treatment of cardiovascular and cerebrovascular diseases. Purpose: The study aimed to investigate the protective mechanism of Xueshuantong injection against acute myocardial infarction within 20 min in rats by proteomic methods and molecular docking. Method: The male Sprague-Dawley rat acute myocardial infarction model was established by LAD ligation, and Xueshuantong injection (38 mg/kg) was injected into the caudal vein 15 min before surgery. Cardiac function evaluation, morphological observation, label-free quantitative proteomics, Western blotting analysis, molecular docking, and affinity measurement were applied in this study. Results: In a span of 20 min after acute myocardial infarction, the model group showed significant cardiac function impairment. Xueshuantong injection can significantly improve cardiac function and prevent pathological injury of myocardial tissue. A total of 117 vital differentially expressed proteins were identified by proteomic analysis, including 80 differentially expressed proteins (DEPs) in the sham group compared with model rats (Sham: model) and 43 DEPs in model rats compared with the Xueshuantong injection group (Model: XST). The treatment of Xueshuantong injection mainly involves "poly(A) RNA binding" and "cadherin binding involved in cell-cell adhesion." The differentially expressed levels of the pathways related to proteins Echdc2, Gcdh, Dlst, and Nampt, as well as 14-3-3 family proteins Ywhaz and Ywhab, could be quantitatively confirmed by WB. Molecular docking analysis and SPR analysis revealed that Ywhaz has a generally stable binding with five Xueshuantong injection components. Conclusion: Xueshuantong injection (XST) could protect rat myocardial function injury against AMI in 20 min. Echdc2, Ywhaz, Gcdh, Ywhab, Nampt, and Dlst play an essential role in this protective effect. In particular, Ywhaz might be the core target of Xueshuantong injection when treating acute myocardial infarction in the early stage. This study promoted the understanding of the protective mechanism of Xueshuantong injection in 20 min injury of acute myocardial infarction and contributed to the identification of possible targets of Xueshuantong injection.

Project description:Background: Ligustrazine injection has been widely used as adjunctive therapy in the treatment of acute cerebral infarction (ACI) during the past decades in China, but its clinical efficacy is not yet well confirmed. This study aims to evaluate the efficacy of ligustrazine injection as adjunctive therapy for ACI. Methods: Databases including China National Knowledge Infrastructure (CNKI), China Science and Technology Journal Database (VIP), PubMed, Medline, Google Scholar, Chinese Biomedical Literature Database, Cochrane Library, Embase, Sino-Med, Wanfang Database, and Chinese Science Citation Database were systematically searched for the published randomized controlled trials (RCTs) on ligustrazine injection in the treatment of ACI until November 2020. Meta-analysis was performed on the primary outcome measure (i.e., clinical effective rate) and the secondary outcome measure [i.e., neurological deficit score (NDS), fibrinogen, low shear blood viscosity (LBV), and high shear blood viscosity (HBV)]. The quality of the included RCTs was assessed according to the M scoring system (the refined Jadad scale). Sensitivity analysis and subgroup analysis were conducted according to the methodological quality, years of publication, and sample size. Results: Nineteen RCTs, containing 2022 patients, were included in this study. Meta-analysis indicated that ligustrazine injection combined with Western medicine could achieve a better effect in the treatment of ACI than using Western medicine alone in terms of clinical effective rate (RR = 1.24; 95% CI, 1.19-1.29), NDS (MD = -3.88; 95%CI, -4.51 to -3.61), fibrinogen (MD = -0.59; 95% CI, -0.76 to -0.42), LBV (MD = -2.11; 95% CI, -3.16 to -1.06), and HBV (MD = -0.88; 95% CI, -1.20 to -0.55). Conclusions: This research indicated that ligustrazine injection as adjunctive therapy seemed to be more effective than using western medicine alone in treating ACI. However, more evidence is required to confirm the efficacy of ligustrazine injection due to the low methodological quality of the included RCTs.

Project description:Objective: Xueshuantong (lyophilized) for injection (XST) is an effective botanical drug for treating unstable angina pectoris (UAP). However, a meta-analysis of XST combined with conventional treatment (CT) against UAP has not been conducted. Therefore, this study aimed to investigate the effectiveness and safety of XST combined with CT for UAP patients compared to CT alone. Methods: Randomized controlled trials (RCT) of XST in UAP patients were retrieved from the Cochrane Library, PubMed, Web of Science, EMBASE, CNKI, VIP, Wanfang, and Chinese Biological Medicine Database databases. A meta-analysis was performed using Revman 5.4 and Stata 16.0, and the quality of the included literature was evaluated based on the Cochrane risk-of-bias 2.0 (RoB2.0) tool. The aggregate 95% confidence intervals (CIs), mean difference (MD), and relative risk (RR) estimates were calculated. A GRADE assessment was performed using GRADEprofiler 3.6, and trial sequent analysis was performed using TSA 0.9. Results: Thirty-four studies involving 3,518 patients were included in the analysis. The combination of CT with XST improved the comprehensive clinical efficacy (RR = 1.22, 95% CI: 1.18-1.26, p < 0.00001) and ECG improvement (RR = 1.24, 95% CI: 1.18-1.31, p < 0.00001). The frequency of angina attacks was lower (MD = -0.73, 95% CI: -0.92 to -0.55, p < 0.00001), and the duration was shorter (MD = -1.08, 95% CI: -1.44 to -0.72, p < 0.00001) in the group that received CT combined with XST compared to the one without XST. Total cholesterol levels (MD = -1.30, 95% CI: -1.83 to -0.78, p < 0.00001) and triglyceride levels (MD = -0.76, 95% CI: -0.93 to -0.59, p < 0.00001) were lower in patients who received CT in combination with XST than those who received CT alone. CT combined with XST reduced whole blood viscosity (MD = -0.72, 95% CI = -0.99 to -0.44, p < 0.00001) and plasma viscosity (MD = -0.24, 95% CI: -0.46 to -0.03, p = 0.03). There was no statistically significant difference in the incidence of cardiovascular events or adverse events among patients treated with the combination of XST and CT compared to CT alone. The GRADE assessment indicated that the composite quality of the evidence was low. The trial sequent analysis showed an adequate sample size and stable findings for the clinical efficacy of CT combined with XST for unstable angina. Conclusion: The present systematic review and meta-analysis conditionally indicate that XST combined with CT improved the clinical outcomes of patients with unstable angina more than CT alone with a better safety profile. However, the results need further validation due to limitations in the quality of the included studies. Systematic Review Registration: https://www.crd.york.ac.uk/PROSPERO/, identifier CRD42022357395.

Project description:IntroductionAs a common chronic disease with high morbidity and recurrent rate, acute cerebral infarction (ACI) affects the life quality of patients and gives them heavy psychological burden. And Danshen class injections (DSCIs) are commonly adopted in treating ACI. So, this network meta-analysis (NMA) was designed to assess the clinical efficacy of eight kinds of DSCIs.MethodsA systematic literature search was performed in PubMed, the Cochrane Library, Embase, the China National Knowledge Infrastructure Database, the China Biomedical Literature Service System, the Chinese Scientific Journals Full-text Database, and Wanfang database from their inception to 16th Dec. 2017 aiming to collect related randomized controlled trials (RCTs). And then data were analyzed through Stata and WinBUGS software based on the Bayesian statistical model. The results were reported as odds ratio (OR) and mean difference (MD) with 95% credible intervals (CIs). The consistency test between direct and indirect comparisons was also evaluated and inconsistency factor was presented to manifest the heterogeneity among them. Meanwhile, the surface under the cumulative ranking probabilities (SUCRA) was utilized to rank the treatments in different outcomes.ResultsFinally, 157 RCTs with 15570 patients were included. A total of eight types DSCIs were identified. Based on the results, Sodium Tanshinone IIA Sulfonate injection (STS) plus western medicine (WM) had better effect on the clinical effectiveness rate, neurological impairment, and activities of daily living function than others. Meanwhile, Danhong injection (DS) and Danshen Salvianolic Acids injection (DSSA) had excellent performance in perfecting hemorheological indexes.ConclusionsIn conclusion, STS plus WM may be the optimum treatment for ACI. The following therapies were DS plus WM and DSSA plus WM. Nevertheless, in terms of the limitations of the study, more large samples, multicenter, and double-blind RCTs are still needed for validating our findings.

Project description:Objective: This systematic review and meta-analysis aimed to investigate the adjuvant effect and safety of Shenfu injection (SFI) on the treatment of post-acute myocardial infarction heart failure (PAMIHF). Methods: Seven databases were searched to identify randomized controlled trials (RCTs) associated with SFI and PAMIHF treatment from May 1990 to May 2022. Primary outcomes included NT-proBNP and left ventricular ejection fraction (LVEF), and secondary outcomes included total effective rate, BNP, heart rate (HR), cardiac output (CO), and adverse event (AE). The risk of bias evaluation was assessed by the ROB2 tool, meta-analysis, subgroup analysis, sensitivity analysis, and publication bias were conducted by RevMan5.3 software, and the Grade of Recommendations, Assessment, Development, and Evaluations (GRADE) system was used to evaluate the quality of evidence of meta results. Results: A total of 36 studies with 3231 PAMIHF patients were included. The meta results suggested that adjuvant SFI therapy was superior to conventional medical therapy alone. It improved the total effective rate [RR = 1.33; 95% CI (1.25.1.40); p < 0.00001], increased LVEF [SMD = 0.98; 95% CI (0.71, 1.24); p < 0.00001], and decreased HR [SMD = -1.14; 95% CI (-1.28, -0.99); p < 0.00001]. In addition, adjuvant SFI therapy (9.73%, 66/678) had a rate of AE lower than that of conventional medical therapy alone (21.7%, 147/677) when regarding safety [RR = 0.45; 95% CI (0.35, 0.57); p < 0.00001]. The quality of the evidence for the outcomes was rated from "very low" to "moderate." Conclusion: Adjuvant SFI therapy was safer to improve the total effective rate and the heart function of PAMIHF patients. However, well-designed RCTs were needed to confirm the efficacy and safety of adjuvant SFI therapy in PAMIHF treatment due to the low quality of the evidence for the outcomes caused by a small sample size and unclear risk of bias existed in included studies. Systematic Review Registration: https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=151856), identifier CRD42020151856.

Project description:Background and purposeWhether the direct aspiration approach of thrombectomy for recanalization in patients with acute ischemic stroke has a similar efficacy and safety compared to the stent-retriever remains uncertain.MethodsWe conducted a meta-analysis of 9 studies obtained through PubMed and Embase database searches to determine whether successful recanalization rate, good functional outcome at 3 months (modified Rankin score, mRS?2), procedure time from groin puncture to maximal revascularization and procedure-related adverse events differed between patients who underwent the direct aspiration and those receiving stent-retriever for recanalization in acute cerebral infarction.ResultsThere was no significant difference between the direct aspiration group and the stent-retriever group in rate of successful recanalization (summary odds ratio [OR], 0.86 [95% confidence interval (CI), 0.45-1.52]; P?=?.60), but a better functional outcomes in the direct aspiration group at 3 months defined as a mRS score of 0 to 2 (OR, 0.77; 95% CI, 0.66-0.97; P?=?.03). Furthermore, the direct aspiration patients compared with the stent-retriever patients had a tendency of shorter procedural time (Mean difference [MD], -8.77 [95% CI, from-18.90 to 1.37]; P?=?.09). Finally, there were less adverse events especially in symptomatic intracerebral hemorrhage (sICH) (OR, 0.56; 95% CI, 0.33-0.98; P?=?.04) and embolization to a new territory (ENT) (OR, 0.49; 95% CI, 0.28-0.84; P?=?.01) in the direct aspiration group when compared with the stent-retriever group, although no difference between them in the rate of any ICH (OR, 0.81; 95% CI, 0.41-1.60; P?=?.54).ConclusionsThe results support that the direct aspiration technique for those acute ischemic stroke patients may have better functional outcomes, less procedure related-adverse events and a tendency of faster revascularization time as compared to the stent-retriever thrombectomy, with a similar successful recanalization rate. However, major limitations of current evidence (mainly from retrospective and observational studies and a small number of patients population) indicate a need for adequately powered, multicenter randomized controlled trials (RCT) to answer this question.

Dataset Information

Efficacy and Safety of Xueshuantong Injection on Acute Cerebral Infarction: Clinical Evidence and GRADE Assessment.

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Efficacy and Safety of Xueshuantong Injection on Acute Cerebral Infarction: Clinical Evidence and GRADE Assessment.

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