A systematic review and meta-analysis of randomized controlled trials on the efficacy and safety of tanshinone IIA sodium sulfonate injection as adjunctive therapy for stroke.

Tanshinone IIA is the core ingredient of Salvia miltiorrhiza Bge, with the effect of blood circulation promotion and blood stasis removement, widely used in cardiovascular and cerebrovascular diseases treatment as adjunctive therapy. Stroke, remains a leading cause of disability and death, posing a serious public health threat. Tanshinone IIA sodium sulfonate injection (STS), derived from Salvia miltiorrhiza Bge (Danshen), is widely used in China as adjunctive therapy for ischemic stroke. However, its clinical efficacy and safety remain uncertain. This meta-analysis aims to evaluate the efficacy and safety of STS in treating ischemic stroke, focusing on its effects on blood circulation and biomarkers. A meta-analysis was conducted based on the PICOS framework, incorporating randomized controlled trials (RCTs). A comprehensive literature search across eight databases was performed and updated in February 2024. RCTs were screened using defined search strategies and inclusion criteria. The quality of included trials was independently assessed by two investigators following the Cochrane Handbook (version 5.1.0). Meta-analyses were performed using RevMan 5.3, and publication bias was assessed with Stata 17.0. Twenty-two trials involving 2289 participants were included. The pooled results showed that STS significantly improved the effective rate and reduced NIHSS. STS also decreased whole blood viscosity including low-shear, high-shear, and plasma viscosity-and lowered the red cell aggregation index at days 7 and 14. Additionally, it reduced levels of total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), D-dimer (Dr), fibrinogen (Fib), hematocrit (HCT), P-selectin, S100B, and neuron-specific enolase (NSE). At 14 days, D-dimer levels remained significantly lower. STS also increased high-density lipoprotein cholesterol (HDL-C), cerebral blood flow markers (Vm, Qm), and mean blood pressure (MBP). However, no significant differences were found in activities of daily living (ADL) compared to conventional treatment. There was no evidence of publication bias in analyses of effective rate or adverse effects. Tanshinone IIA sodium sulfonate injection appears to be a relatively safe neuroprotective agent for adjunctive use in ischemic stroke. It is associated with improved NIHSS scores and beneficial changes in hemorheology, lipid profiles, cerebral blood flow, coagulation parameters, and serum biomarkers (S100B, P-selectin, NSE). PROSPERO (CRD4202024093).