Meta AnalysisID 6748
舒血宁注射液治疗急性卒中的一项符合PRISMA的系统评价和随机对照试验的Meta分析
CRD42023418565
To systematically evaluate the efficacy and safety of Shuxuening injection (SXNI) for acute stroke, especially for clinical efficiency rate (CER), neurological deficit, daily living activities, and side effects.
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Record Fields
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- Meta Analysis Id
- 6748
- Evidence Id
- 15306
- Core Evidence Id
- 15306
- Source Meta Analysis Id
- 6731
- Herb2 Meta Analysis Id
- HBMA006731
- Crd Id
- CRD42023418565
- Title
- Shuxuening injection for the treatment of acute stroke: A PRISMA-compliant systematic review and meta-analysis of randomized controlled trials
- Review Question
- To systematically evaluate the efficacy and safety of Shuxuening injection (SXNI) for acute stroke, especially for clinical efficiency rate (CER), neurological deficit, daily living activities, and side effects.
- Study Type Included
- All RCTs on the treatment of AIS with SXNI were eligible for inclusion. The language of publication was not limited. We excluded case-control studies, retrospective studies, case reports, animal experiments, cell experiments, reviews, meta-analyses, clinical experiences, commentaries, and conference abstracts.
- Condition Being Studied
- Stroke is the third leading cause of death and disability combined globally, especially in low- and middle-income countries (Collaborators 2021). Although the morbidity and mortality rates of stroke have declined in recent decades, the absolute number of people suffering a new stroke, dying, or surviving but still disabled has almost doubled. (Krishnamurthi et al. 2020, Feigin et al. 2022). From 1990 to 2019, the absolute number of global stroke events increased by 70.0% and stroke mortality increased by 43.0% in the world (Collaborators 2021). Neurologic impairments caused by stroke often leave the patients with motor dysfunction and a varying degree of loss of activities of daily living (ADL) (Jorgensen et al. 1999), and eventually a significant decline in quality of life of stroke survivors (Chen et al. 2019, Lavados et al. 2021). According to the American Heart Association, the total cost of stroke, including direct and indirect expenditures, is projected to increase from $105.2 billion in 2012 to $240.7 billion in 2030 (Ovbiagele et al. 2013). Therefore, it is urgent to find an effective and safe intervention or program to improve the prognosis of stroke and tackle the burden of stroke (Li et al. 2017).
- Participant
- Patients who were diagnosed as AIS according to the recognized guidelines or criteria, and confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) will be included, without limitations on age, gender, culture, nationality or race. The course of stroke should been less than six months. We will exclude patients with hypoxic-ischemic encephalopathy and postpartum apoplexy.
- Animal
- Human Disease Modelled
- Intervention
- SXNI group received conventional treatments (CTs) combined with SXNI. The duration of treatment should be between 14 and 30 days. No restrictions on dosage or frequency. According to the Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2018 (Chinese Society of Neurology 2018), CTs included IVT, EVT, antiplatelet drug, neuroprotective agents, and symptomatic supportive treatment such as the managements of blood pressure, blood lipid and blood sugar level.
- Comparator Control
- non SXNI group received CTs alone or CTs combined with other therapies. The duration of treatment should be between 14 and 30 days. No restrictions on dosage or frequency. According to the Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2018 (Chinese Society of Neurology 2018), CTs included IVT, EVT, antiplatelet drug, neuroprotective agents, and symptomatic supportive treatment such as the managements of blood pressure, blood lipid and blood sugar level. Other therapies were defined as any monodrug of non-Ginkgo biloba extract or monotherapy which is not included in the CTs, such as compound Danshen injection, Shuxuetong injection, and so on.
- Main Outcome
- clinical efficiency rate (CER) Measures of effect According to the neurological deficit score (NDS) criteria developed at the Fourth Chinese National Cerebrovascular Diseases Conference in 1995 (1996), the improvement of neurological deficit was classified into 5 categories: a) Recovery: 90%-100% reduction in NDS with the disability level of 0; b) Significant improvement: 46%-89% reduction in NDS with the disability level of 1 to 3; c) Progress: 18% to 45% reduction in NDS; d) Inefficacy: less than 17% reduction in NDS; e) Deterioration: more increase in NDS. CER = (a + b + c) cases / total cases multiply by 100% (Chen, 1994; Zheng, 2002).
- Outcome Measure
- Additional Outcome
- a) neurological function; b) ADL ; and c) AEs. Measures of effect a) neurological function assessed by NIHSS, Chinese Stroke Scale (CSS), or European Stroke Scale (ESS). NHISS consists of 15 items with a total score of 42, which is a validated tool often used to assess the severity of acute stroke, the higher scores representing more severe stroke (Brott et al. 1989, Kwah and Diong 2014). CSS consists of 8 dimensions with a total score of 45. A patient with a higher CSS score indicates her or his stroke is more severe (1996). ESS involves 14 items with a total score of 100, and the score is positively correlated with the clinical prognosis of patients (Hantson et al. 1994). b) ADL assessed by Barthel Index (BI). The highest score of BI is 100, the higher the score, the better the independence (MAHONEY et al. 1965). c) AEs. The common AEs related with SXNI are headache, flushing, and so on.
- Study Method
- Intervention, Meta-analysis, Systematic review
- Keyword
- Activities of Daily Living; Drug-Related Side Effects and Adverse Reactions; Drugs, Chinese Herbal; Humans; Iatrogenic Disease; Randomized Controlled Trials as Topic; Stroke; shuxuening
- Contact
- Jie Zhan [email protected]
- Organisational Affiliation
- the Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine https://www.gdhtcm.com
- Funding Source
- Other Selection Criteria
- Final Publication
- Same Topic Review
- Published Protocol
- Review Type
- Language
- English
- Country
- China
- Review Stage
- Review Ongoing
- First Submission Date
- 2023-04-19
- Registration Date
- 2023-04-29
- Anticipated Start Date
- 2023-04-01
- Anticipated Completion Date
- 2023-06-30
- Title Cn
- 舒血宁注射液治疗急性卒中的一项符合PRISMA的系统评价和随机对照试验的Meta分析
- Title En
- Shuxuening injection for the treatment of acute stroke: A PRISMA-compliant systematic review and meta-analysis of randomized controlled trials
- Bilingual Status
- complete