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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: 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: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: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.

Project description:: Acute lymphoblastic leukemia (ALL) is a heterogeneous group of hematologic malignancies that arise from clonal proliferation of immature lymphoid cells in the bone marrow, peripheral blood, and other organs. The vinca alkaloid vincristine is a standard component of chemotherapy regimens used to treat ALL, because of its well-defined mechanism of action, demonstrated anticancer activity, and ability to be combined with other agents. However, the dosage of vincristine is frequently capped because of neurotoxicity concerns, and patients with large body surface areas are, therefore, almost always underdosed. Liposomal formulations have the ability to "passively" accumulate at sites of increased vasculature permeability and reduce the adverse effects of encapsulated relative to free drug. Vincristine sulfate liposome injection (VSLI) is a sphingomyelin/cholesterol-based liposome-encapsulated formulation that is delivered weekly in a 1-hour infusion. Based on the pharmacokinetics of the liposomal delivery system, vincristine is slowly released from the liposome and delivered into the tissues more efficiently than with the standard preparation, allowing a higher dose. This increase in therapeutic index from reduced toxicity is a valuable difference between the two formulations. VSLI is indicated for the treatment of adults with second or greater relapse and clinically advanced Philadelphia chromosome-negative ALL. For the first time, studies will be able to exploit the delivery of higher and uncapped doses of vincristine in randomized studies comparing first-line chemotherapy with standard vincristine versus VSLI in both ALL and lymphoma to determine whether VSLI is superior to conventional vincristine.This review summarizes the development of vincristine sulfate liposome injection, a new formulation of vincristine. The pharmacokinetics of liposomal drug delivery are examined, the limitations and advantages of conventional and liposomal vincristine are compared, and the use of vincristine sulfate liposome injection in clinical trials and case studies is included. Clinicians will be informed of a new chemotherapy agent that is indicated for the treatment of adults with Philadelphia chromosome-negative acute lymphoblastic leukemia, whose disease has relapsed two or more times or whose leukemia has progressed after two or more regimens of antileukemia therapy.

Project description:BackgroundHigh-sensitivity cardiac troponin assays enable myocardial infarction to be ruled out earlier, but the optimal approach is uncertain. We compared the European Society of Cardiology rule-out pathway with a pathway that incorporates lower cardiac troponin concentrations to risk stratify patients.MethodsPatients with suspected acute coronary syndrome (n=1218) underwent high-sensitivity cardiac troponin I measurement at presentation and 3 and 6 or 12 hours. We compared the European Society of Cardiology pathway (<99th centile at presentation or at 3 hours if symptoms <6 hours) with a pathway developed in the High-STEACS study (High-Sensitivity Troponin in the Evaluation of Patients With Acute Coronary Syndrome) population (<5 ng/L at presentation or change <3 ng/L and <99th centile at 3 hours). The primary outcome was a comparison of the negative predictive value of both pathways for index type 1 myocardial infarction or type 1 myocardial infarction or cardiac death at 30 days. We evaluated the primary outcome in prespecified subgroups stratified by age, sex, time of symptom onset, and known ischemic heart disease.ResultsThe primary outcome occurred in 15.7% (191 of 1218) patients. In those less than the 99th centile at presentation, the European Society of Cardiology pathway ruled out myocardial infarction in 28.1% (342 of 1218) and 78.9% (961 of 1218) at presentation and 3 hours, respectively, missing 18 index and two 30-day events (negative predictive value, 97.9%; 95% confidence interval, 96.9-98.7). The High-STEACS pathway ruled out 40.7% (496 of 1218) and 74.2% (904 of 1218) at presentation and 3 hours, missing 2 index and two 30-day events (negative predictive value, 99.5%; 95% confidence interval, 99.0-99.9; P<0.001 for comparison). The negative predictive value of the High-STEACS pathway was greater than the European Society of Cardiology pathway overall (P<0.001) and in all subgroups, including those presenting early or known to have ischemic heart disease.ConclusionsUse of the High-STEACS pathway incorporating low high-sensitivity cardiac troponin concentrations rules out myocardial infarction in more patients at presentation and misses 5-fold fewer index myocardial infarctions than guideline-approved pathways based exclusively on the 99th centile.Clinical trial registrationURL: http://clinicaltrials.gov. Unique identifier: NCT01852123.

Dataset Information

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

Publications

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

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