ArticleDrug design, development and therapy2018
Reevaluation of the post-marketing safety of Shuxuening injection based on real-world and evidence-based evaluations.
Article in Drug design, development and therapy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
11 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.
- Liver function monitoring: a prospective nested case-control study of Salvia miltiorrhiza polyphenol injection.Scientific reports · 2020Pooled it
- Post-marketing safety re-evaluation of placental peptide injection in China: a large-scale multicenter real-world study.Frontiers in pharmacology · 2025Article
- Post-marketing safety surveillance and re-evaluaiton of Shu-Xue-Ning injection: a real-world study based on 30,122 cases.Frontiers in pharmacology · 2023Article
- Effectiveness of Shuxuening injection in coronary heart disease: a systematic review and meta-analysis.Frontiers in pharmacology · 2023Review
- Chinese herbal injection for cardio-cerebrovascular disease: Overview and challenges.Frontiers in pharmacology · 2023Review
- Applying regulatory science in traditional chinese medicines for improving public safety and facilitating innovation in China: a scoping review and regulatory implications.Chinese medicine · 2021Article
- Shuxuening injection, derived fromPharmaceutical biology · 2020Article
- Macromolecular substances as a dangerous factor in traditional Chinese medicine injections were determined by size-exclusive chromatography.Toxicology research · 2020Article
- Identification of high-risk patients for ADR induced by traditional Chinese medicine injection: a nested case-control study.Scientific reports · 2019Article
- Shuxuening injection protects against myocardial ischemia-reperfusion injury through reducing oxidative stress, inflammation and thrombosis.Annals of translational medicine · 2019Article
- Safety Concerns of Traditional Chinese Medicine Injections Used in Chinese Children.Evidence-based complementary and alternative medicine : eCAM · 2019Article
Corrections and comments
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Authors and funding
7 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimTo evaluate the factors influencing suspected hypersensitivity and adverse systemic reactions after Shuxuening injection and to provide innovative ideas and methods for the reevaluation of post-marketing safety of Shuxuening.
methodsThis study used a prospective, nested case-control study design, combined with a prescription sequence analysis design method. It classified patients who exhibited trigger signals after administration of Shuxuening injection as suspected allergic patients and made comparisons with patients who did not report adverse effects to calculate the correlation between relevant risk factors and suspected allergic reactions. Randomized controlled studies and cohort studies of the adverse drug reaction (ADR) of Shuxuening were performed using a computer database. Data retrieval was carried out by the foundation governing the individual database. Meta-analysis was performed by using R3.2.3 software to evaluate the ADRs of Shuxuening.
resultsThe results of real-world study showed that administration of Shuxuening in combination with potassium aspartate and magnesium, atorvastatin calcium, Shengmai injection, pantoprazole sodium, or high-dose medication was a risk factor for suspected allergic reactions. Meta-analysis showed that the incidence of adverse events was 5.84% (95% CI 0.0499; 0.0674), and serious adverse reaction rate was 4.36% (95% CI 0.0188; 0.0760) when Shuxuening was used in combination with these drugs. The incidence of allergic reaction was also influenced by the vehicle, duration of treatment, single dose, and indicated vs off-label use.
conclusionRisk factors for adverse reaction following the use of Shuxuening injection in patients are associated with a single dose, vehicle, type of disease, and combination with potassium aspartate, atorvastatin calcium, Shengmai injection, injection with pantoprazole sodium, and other drugs. Physicians should be careful to follow guidelines when administering this drug. We further propose that the unique methodology used in this study may be useful for reevaluation of the safety of other traditional Chinese medicines.
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