Meta AnalysisID 4305
丹参酮ⅡA磺酸钠注射液对卒中患者的临床疗效和安全性：随机对照试验的系统评价与Meta分析
CRD42020204093
Does Tanshinone IIA sodium sulfonate injection be benefit for rehabilitation of stroke patients? And is it safe for stroke patients? Dose Tanshinone IIA sodium sulfonate injection enhance clinical effective rate or NIHSS
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Record Fields
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- Meta Analysis Id
- 4305
- Evidence Id
- 12863
- Core Evidence Id
- 12863
- Source Meta Analysis Id
- 4273
- Herb2 Meta Analysis Id
- HBMA004273
- Crd Id
- CRD42020204093
- Title
- The clinical effect and safety of Tanshinone IIA sodium sulfonate injection on stroke patient：a systematic review and meta-analysis of randomized control trials
- Review Question
- Does Tanshinone IIA sodium sulfonate injection be benefit for rehabilitation of stroke patients? And is it safe for stroke patients? Dose Tanshinone IIA sodium sulfonate injection enhance clinical effective rate or NIHSS scores? How does Tanshinone IIA sodium sulfonate injection affect patients blood flow after stroke?
- Study Type Included
- RCT(Randomized controlled experiment)
- Condition Being Studied
- Ischemic stroke is a second leading cause of mortality disease worldwide. The Ischemic cascade starts with a reduction in blood flow and energy supply, which subsequently leads to excitotoxicity, oxidative stress, and neuron death. Central nervous system was damaged, which is hard to repair. Fibrinolytic therapy was the most effective therapy measurement by now. However, it has a limited “time window” within 4.5 hours after stroke, which restrict its clinical application. Tanshinone IIA, a compound extracted from the root and rhizome of Salvia miltiorrhiza Bge , was sulphonated to transfer to a higher water-solubility injection, , which enhances the rate of absorption for bodies compared with Tanshinone IIA. Tanshinone IIA sodium sulfonate injection has a positive effect for coronary heart disease and against atherosclerosis, whereas, which is also benefit for ischemic stroke. It has been proved that Tanshinone IIA sodium sulfonate injection suppressed inflammatory reaction, antioxidant, decreased neuron apoptosis and promoted BBB permeability recovery. Currently, lots of clinical studies proved that Tanshinone IIA sodium sulfonate injection enhanced the effective rate, improved NIHSS scores, decreased the level of CRP, IL-6 and promoted accelerating the flow of blood.
- Participant
- Inclusion:(1) All publications were RCTs with limited to English and Chinese in languages, (2) Clinical symptoms and signs of patients were in line with diagnostic criteria, or diagnosed as acute Ischemic cerebral infarction by computerized tomography (CT) or magnetic resonance imaging (MRI), or other recognized diagnostic criteria. Baseline data of patients were comparable.(3) Control groups should be limited to apply conventional western medicine.Treatment groups were intervened by Tanshinone IIA sodium sulfonate injection via intravenous drip. All these measurements should be treated no less than 10 days and assessed immediately. (4) The primary outcome was included clinical effective rate, National Institute of Health Stroke Scale(NIHSS), Neurological Function Defect Scale(NFDS), Barthel Index (BI), ADL, life quality assessment (SF-36).The second outcome included hemorheology index , bloodstream condition of artery in brain , hyperlipidemia indexand inflammatory factors. Exclusion:(1)Repeatedly published studies, case reports , reviews or animal experiments; (2)Intervention measures in either group with TCM preparations or TCM therapies except for Tanshinone IIA ; (3)Disease except for neonatal hypoxic and ischemic encephalopathy (HIE), traumatic cerebral infarction, ischemic stroke with related psychosis diseases or vascular dementia and transient ischemic attack (TIA); (4)Studies lack of outcomes or full text; (5)Data recordings absence or plagiarized.
- Animal
- Human Disease Modelled
- Intervention
- Tanshinone IIA sodium sulfonate injection by intravenous injection at least 10 days
- Comparator Control
- Conventional western medicine (not contain substances or compounds extracted from Chinese Medicine Herbs)
- Main Outcome
- clinical effective rate, National Institute of Health Stroke Scale(NIHSS), Neurological Function Defect Scale(NFDS), Barthel Index (BI), ADL, life quality assessment (SF-36) Measures of effect Relative risks(RR) will be used for clinical effective rate, whereas, other assessment scores will apply to mean difference(MD)
- Outcome Measure
- Additional Outcome
- hemorheology index (high shear viscosity, low shear viscosity, HCT, Fib, D-D dimer, platelet aggregation rate), bloodstream condition of artery in brain (average blood flow velocity(Vm), Average blood flow(Qm), dynamic resistance(DR)), hyperlipidemia index(TC, TG, LDL-C, HDL-C) and inflammatory factors(IL-6, CRP, TNF-α Measures of effect Mean difference(MD) or standarded mean difference(SMD)
- Study Method
- Meta-analysis, Systematic review
- Keyword
- Abietanes; Humans; Phenanthrenes; Sodium; Stroke; tanshinone
- Contact
- Liu Fengzhi [email protected]
- Organisational Affiliation
- Beijing University of Chinese Medicine
- Funding Source
- National Natural Science Foundation of China Grant number(s) <span style=font-size: 14px>State the funder, grant or award number and the date of award</span> Grant Nos. 81573926 and 81173235
- Other Selection Criteria
- Final Publication
- Same Topic Review
- Published Protocol
- Review Type
- Language
- English
- Country
- China
- Review Stage
- Review Ongoing
- First Submission Date
- 2020-08-13
- Registration Date
- 2020-09-13
- Anticipated Start Date
- 2020-08-10
- Anticipated Completion Date
- 2020-12-30
- Title Cn
- 丹参酮ⅡA磺酸钠注射液对卒中患者的临床疗效和安全性：随机对照试验的系统评价与Meta分析
- Title En
- The clinical effect and safety of Tanshinone IIA sodium sulfonate injection on stroke patient：a systematic review and meta-analysis of randomized control trials
- Bilingual Status
- complete