Cardiology · Medical Literature
[Efficacy of Shuxuening Injection in treatment of unstable angina pectoris: study on TCM efficacy evidence chain].
Abstract
This study aimed to construct an evidence chain for the efficacy of Shuxuening Injection(SXN) in the treatment of unstable angina pectoris(UAP) and clarify its efficacy and underlying mechanisms. Eight major Chinese and English databases, including CNKI, VIP, Wanfang, SinoMed, PubMed, Cochrane Library, EMbase, and Web of Science, were systematically searched to collect clinical studies, animal experiments, cell experiments, and molecular experiments on SXN for UAP. Two researchers independently screened the literature and extracted data. Meta-analysis or descriptive analysis was used for data integration. The TCM evidence chain construction method was applied to establish evidence chains, which were then evaluated. A total of 2 evidence chains were constructed, incorporating 64 clinical studies, 12 animal experiments, 11 cell experiments, and 86 outcome indicators. The evidence chains elucidated the efficacy and mechanisms of SXN for UAP from 2 dimensions: improvement of myocardial ischemia and protection of cardiac function. SXN exerted a synergistic effect on the core pathological processes of UAP through multiple mechanisms, including regulating oxidative stress, promoting angiogenesis, modulating inflammation and matrix remodeling, inhibiting apoptosis, and balancing endoplasmic reticulum stress. SXN demonstrated efficacy in the treatment of UAP. However, due to the limitations in the quantity and quality of included studies, the robustness of the evidence chains was insufficient. High-quality clinical and basic research is required to further verify its core mechanisms. Additionally, it is recommended that subsequent studies include more indicators reflecting plaque stability and thrombosis in the selection of clinical outcome indicators.
Clinical relevance
Does Shuxuening Injection (SXN), a Ginkgo biloba–derived TCM intravenous preparation, improve myocardial ischemia and protect cardiac function in patients with unstable angina pectoris (UAP), and what are its mechanistic underpinnings across clinical, animal, cell, and molecular levels? __SNAPSHOT__ {"studyDesign":"TCM evidence chain synthesis — a multi-level integrative methodology incorporating systematic review with meta-analysis (clinical studies) and descriptive analysis (animal, cell, and molecular experiments) to construct and evaluate mechanistic-to-clinical evidence chains","setting":"Multicenter synthesis drawing from eight major Chinese and English databases (CNKI, VIP, Wanfang, SinoMed, PubMed, Cochrane Library, Embase, Web of Science); geographic source of primary studies predominantly China","sampleSize":"64 clinical studies, 12 animal experiments, 11 cell experiments; aggregate patient-level n not reported in abstract. 86 outcome indicators analyzed across all evidence tiers.","population":"Patients with unstable angina pectoris (UAP); precise inclusion/exclusion criteria for patient-level studies not reported in the abstract beyond UAP diagnosis","intervention":"Shuxuening Injection (SXN) — a sterile aqueous extract of Ginkgo biloba leaf containing total flavonoid glycosides and terpenoid lactones (ginkgolides) — administered as adjunct to conventional Western medical therapy for UAP","comparator":"Conventional Western medical therapy alone (standard-of-care for UAP including anticoagulants, antiplatelets, nitrates, beta-blockers, ACEIs, and statins); specific comparators at the pre-clinical tier not reported","primaryOutcome":"Efficacy of SXN for UAP evaluated across two evidence chain dimensions: (1) improvement of myocardial ischemia and (2) protection of cardiac function; 86 outcome indicators incorporated across all evidence tiers","followUp":"Not reported in the abstract for meta-analyzed clinical studies; pre-clinical experiment follow-up durations not reported","fundingSource":"Not reported"}
Key findings
The study constructed two TCM evidence chains encompassing 64 clinical studies, 12 animal experiments, 11 cell experiments, and 86 outcome indicators. The first evidence chain addressed improvement of myocardial ischemia; the second addressed protection of cardiac function. Mechanistically, SXN was reported to exert effects through multiple pathways, including regulation of oxidative stress, promotion of angiogenesis (abstract truncated; full mechanisms not available for citation). Specific aggregate effect sizes, confidence intervals, p-values, and NNT/NNH from the index study's own meta-analyses are not reported in the available abstract. For contextual reference only, a prior systematic review of SXN in UAP (Fan et al., 2022) reported that SXN combined with conventional therapy improved clinical efficacy (RR 1.23, 95% CI [1.19, 1.27], P<0.00001), reduced angina attack frequency (MD −1.28, 95% CI [−1.88, −0.67], P<0.0001), shortened angina duration (MD −3.36, 95% CI [−3.69, −3.03], P<0.00001), and lowered BNP (MD −23.33, 95% CI [−27.87, −18.79], P<0.00001); adverse event rates were not significantly different between groups (RR 0.99, 95% CI [0.54, 1.81], P=0.97). These values are from a related but distinct publication and must not be attributed to the index study. The index study's own quantitative results are not available from the abstract alone. NNT and NNH: not calculable from the available abstract.
Practice implications
IMPORTANT CAVEAT: Only the abstract of the index study (PMID 42543348, published 2026-08-02) was available for review; this substantially limits interpretation. The TCM evidence chain methodology is a structured but non-standard synthesis framework designed to link molecular and pre-clinical mechanistic data with clinical outcome data — it goes beyond a conventional systematic review or meta-analysis. The study reports that two evidence chains were successfully constructed linking SXN's molecular mechanisms (including oxidative stress modulation and angiogenesis promotion) to clinical improvements in myocardial ischemia and cardiac function in UAP patients. However, what the study did NOT establish from the abstract: (1) hard cardiovascular endpoints (MACE, mortality, MI, revascularization) — all outcomes appear to be symptom-based or biomarker-based surrogates; (2) superiority over individual components of guideline-directed therapy; (3) generalizability to non-Chinese patient populations, as all primary studies appear China-sourced; (4) long-term safety beyond short treatment courses. The evidence chain methodology inherently depends on the quality of included primary studies, which in the TCM literature are frequently small, unblinded, single-center trials with high risk of publication bias — as noted in related SXN systematic reviews. The clinical applicability of this synthesis is therefore limited to settings where SXN is an approved adjunctive agent, and should not be interpreted as endorsing SXN outside of existing regulatory and guideline frameworks in jurisdictions where it is authorized. __LIMITATIONS__ Only the abstract was available; full methods, statistical outputs, heterogeneity data, and GRADE evidence quality ratings for the index study cannot be assessed.,The TCM evidence chain methodology is non-standardized and not widely validated in international evidence-based medicine frameworks, making independent appraisal of the synthesis quality difficult.,All or nearly all primary clinical studies originate from China, introducing substantial geographic and publication bias; related systematic reviews have documented asymmetric funnel plots suggesting publication bias in the SXN literature.,The majority of included clinical studies in the SXN literature are small, frequently non-blinded, single-center RCTs — often without adequate allocation concealment — limiting internal validity.,Outcome indicators are predominantly surrogate or symptom-based (angina frequency, ECG changes, biomarkers such as CRP and BNP); no hard cardiovascular endpoints (mortality, MACE) are reported.,Pre-clinical evidence (animal and cell experiments) is integrated into the evidence chains alongside clinical data, which risks overinterpretation of mechanistic plausibility as clinical proof of efficacy.,Follow-up durations across included studies are short; long-term efficacy and safety of SXN are not established.,Funding source not reported; potential conflicts of interest for the index study cannot be assessed.,Heterogeneity across 64 clinical studies spanning different dosing regimens, durations, co-interventions, and patient populations is likely substantial, though quantification from the abstract is not possible. __BOTTOM_LINE_CATEGORY__ promising_but_preliminary __BOTTOM_LINE__ This TCM evidence chain synthesis reports that Shuxuening Injection (SXN), a Ginkgo biloba extract, may improve myocardial ischemia and cardiac function in UAP through multiple mechanisms including oxidative stress regulation and angiogenesis, based on integration of 64 clinical studies and 23 pre-clinical experiments. However, the evidence base is derived almost exclusively from small, China-based trials with recognized publication bias, all surrogate outcomes, and no hard cardiovascular endpoints — making this study hypothesis-generating rather than practice-defining. SXN should not be adopted into guideline-directed UAP management outside jurisdictions where it holds regulatory approval until confirmatory, independently conducted, adequately powered RCTs with MACE endpoints are available.