Tongxinluo capsule (TXL) is widely used in China as an adjunctive therapy for patients with acute coronary syndromes (ACS) who underwent percutaneous coronary intervention (PCI), collectively referred to as ACS-PCI. However, current evidence on its therapeutic effects and safety remains limited and insufficiently synthesised. This review aims to evaluate the therapeutic effects and safety of adding TXL to Western medical therapy (WM) in this population.

A systematic literature search was performed in PubMed, the Cochrane Library, CNKI, VIP and Wanfang from inception to August 2024; a rapid supplemental search was conducted up to November 2025, without language restrictions, to identify randomised controlled trials (RCTs) evaluating the therapeutic effects and safety of adding TXL to WM in patients with ACS-PCI. Dichotomous outcomes were summarised using risk ratios (RRs) with 95% CIs; absolute risk reductions (ARRs) were estimated as risk differences, and corresponding numbers needed to treat (NNTs) were calculated. Continuous outcomes were summarised using mean differences (MDs) with 95% CIs. All meta-analyses were performed using a random-effects model. The included studies generally had limitations in methodological quality, heterogeneity across analyses was low to moderate and the potential for publication bias could not be excluded. The evidence certainty for each outcome was assessed using the Grading of Recommendations Assessment, Development and Evaluation approach.

Eighteen RCTs involving 1800 participants were included. Low-certainty evidence indicated that adding TXL to WM may reduce the risks of restenosis (RR=0.30, 95% CI 0.10 to 0.91; ARR=0.056, NNT=18), revascularisation (RR=0.28, 95% CI 0.10 to 0.80; ARR=0.069, NNT=15), myocardial infarction (RR=0.44, 95% CI 0.20 to 0.98; ARR=0.033, NNT=31), angina (RR=0.32, 95% CI 0.17 to 0.61; ARR=0.076, NNT=14) and other cardiovascular events (RR=0.41, 95% CI 0.24 to 0.71; ARR=0.075, NNT=14). It also improved Seattle Angina Questionnaire scores (MD=8.82, 95% CI 6.58 to 11.05) and quality of life (qualitative synthesis). However, no statistically significant reductions were observed for sudden cardiac death (RR=0.39, 95% CI 0.12 to 1.27; ARR=0.022, NNT=45), or non-cardiovascular adverse events (RR=0.67, 95% CI 0.32 to 1.40; ARR=0.043, NNT=24) when TXL was added to WM.

Current evidence suggests that adjunctive TXL may reduce key cardiovascular events and improve symptoms and quality of life in patients with ACS-PCI, without increasing the risk of non-cardiovascular adverse events. However, all findings are based on low-certainty evidence. These results provide preliminary support for the use of TXL as an adjunctive therapy, but high-quality, multicentre RCTs are needed to confirm these effects and inform clinical guidelines.

CRD42024509453.

Prognosis estimation is the basis for establishing the personal interventions in sepsis patients. Serum biomarkers are potential tools for predicting the outcomes of sepsis patients admitted to the intensive care unit (ICU). Here, we plan to perform a prospective study to investigate the prognostic value of serum biomarkers. We named this study Hospital Outcome of Host Heterogeneity, Organ dysfunction and Trajectory in sepsis (HOHHOT).

This prospective cohort study is being performed in several hospitals in the Inner Mongolia Autonomous Region between 2025 and 2027. The inclusion criteria were adult sepsis patients admitted to the ICU. A serum specimen will be collected at the onset of sepsis and stored at –80°C for future use. The endpoint of the HOHHOT study includes, but is not limited to, hospital outcome (eg, mortality, occurrence of organ dysfunction, treatment response and the progression of sepsis). We will analyse the predictive value of serum biomarkers for outcomes using a receiver operating characteristic curve and decision curve analysis. The association between baseline characteristics and serum biomarkers will be estimated using a logistic regression model, net reclassification index and integrated discriminatory index. We will also construct some predictive models using machine learning algorithms.

The HOHHOT study has been approved by the Ethics Committee of the Affiliated Hospital of Inner Mongolia Medical University (NO: KY2025005). The findings derived from the HOHHOT study will be submitted to international academic journals.

Chinese Clinical Trial Registry (ChiCTR2500100770); pre-results.