Post-marketing safety surveillance and re-evaluaiton of Shu-Xue-Ning injection: a real-world study based on 30,122 cases
Objective: This study aims to investigate the safety of Shu-Xue-Ning injection (SXNI) in real-world clinical applications.Methods: A prospective, multi-center, large-sample intensive monitoring method was used to monitor the use of SXNI in several medical institutions across China while collecting p...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2023-11-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2023.1194367/full |
| _version_ | 1797448592438329344 |
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| author | Jin Xinyao Zhang Yifan Wang Keyi Pang Wentai Wang Chunyang Wang Hui Liu Chunxiang Xue Yunhua Zheng Wenke |
| author_facet | Jin Xinyao Zhang Yifan Wang Keyi Pang Wentai Wang Chunyang Wang Hui Liu Chunxiang Xue Yunhua Zheng Wenke |
| author_sort | Jin Xinyao |
| collection | DOAJ |
| description | Objective: This study aims to investigate the safety of Shu-Xue-Ning injection (SXNI) in real-world clinical applications.Methods: A prospective, multi-center, large-sample intensive monitoring method was used to monitor the use of SXNI in several medical institutions across China while collecting patients’ dosing and adverse event information. Patients who suspected as adverse reactions made comparisons with patients who did not report adverse reactions to calculate the correlation between relevant risk factors and suspected adverse reactions. Statistical analysis software SAS 9.1 was used for data analysis.Results: A total of 48 hospitals participated in this intensive monitoring study of SXNI, and 30,122 patients were monitored from July 2015 to December 2018. A total of 1,908 adverse events were reported during the use of SXNI, with an adverse event rate of 6.33% and a 95% confidence interval (CI) of 6.06%–6.61%. Association assessment showed that 54 cases presented with SXNI-related adverse reactions with an incidence of 0.18% and a 95% CI of 0.13%–0.23%, thereby indicating that the incidence of SXNI-related adverse reactions was occasional. SXNI-related adverse reactions involved 9 systems-organs with 20 clinical manifestations, and the most common adverse reactions were rash, pruritus, and other damages of skin and its appendages. No serious adverse reactions were observed; 27.78% of the adverse reactions occurred within 30 min of drug administration and more than half of them occurred within 2 h of drug administration; 96.3% of the adverse reactions were cured or improved. Causal analysis showed that women, long dispensing time, and slow dripping speed rate were considered as risk factors.Conclusion: The incidence of SXNI-related adverse reactions in real-world clinical applications is occasional and in a reasonable range with a good prognosis. |
| first_indexed | 2024-03-09T14:12:45Z |
| format | Article |
| id | doaj.art-604b4e3ece454334aeb789e8a45c9837 |
| institution | Directory Open Access Journal |
| issn | 1663-9812 |
| language | English |
| last_indexed | 2024-03-09T14:12:45Z |
| publishDate | 2023-11-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pharmacology |
| spelling | doaj.art-604b4e3ece454334aeb789e8a45c98372023-11-29T05:53:20ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122023-11-011410.3389/fphar.2023.11943671194367Post-marketing safety surveillance and re-evaluaiton of Shu-Xue-Ning injection: a real-world study based on 30,122 casesJin Xinyao0Zhang Yifan1Wang Keyi2Pang Wentai3Wang Chunyang4Wang Hui5Liu Chunxiang6Xue Yunhua7Zheng Wenke8Center for Evidence-Based Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin, ChinaSchool of Statistics and Data Science, Nankai University, Tianjin, ChinaCenter for Evidence-Based Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin, ChinaCenter for Evidence-Based Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin, ChinaCenter for Evidence-Based Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin, ChinaCenter for Evidence-Based Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin, ChinaCenter for Evidence-Based Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin, ChinaSchool of Mathematical Sciences, Nankai University, Tianjin, ChinaCenter for Evidence-Based Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin, ChinaObjective: This study aims to investigate the safety of Shu-Xue-Ning injection (SXNI) in real-world clinical applications.Methods: A prospective, multi-center, large-sample intensive monitoring method was used to monitor the use of SXNI in several medical institutions across China while collecting patients’ dosing and adverse event information. Patients who suspected as adverse reactions made comparisons with patients who did not report adverse reactions to calculate the correlation between relevant risk factors and suspected adverse reactions. Statistical analysis software SAS 9.1 was used for data analysis.Results: A total of 48 hospitals participated in this intensive monitoring study of SXNI, and 30,122 patients were monitored from July 2015 to December 2018. A total of 1,908 adverse events were reported during the use of SXNI, with an adverse event rate of 6.33% and a 95% confidence interval (CI) of 6.06%–6.61%. Association assessment showed that 54 cases presented with SXNI-related adverse reactions with an incidence of 0.18% and a 95% CI of 0.13%–0.23%, thereby indicating that the incidence of SXNI-related adverse reactions was occasional. SXNI-related adverse reactions involved 9 systems-organs with 20 clinical manifestations, and the most common adverse reactions were rash, pruritus, and other damages of skin and its appendages. No serious adverse reactions were observed; 27.78% of the adverse reactions occurred within 30 min of drug administration and more than half of them occurred within 2 h of drug administration; 96.3% of the adverse reactions were cured or improved. Causal analysis showed that women, long dispensing time, and slow dripping speed rate were considered as risk factors.Conclusion: The incidence of SXNI-related adverse reactions in real-world clinical applications is occasional and in a reasonable range with a good prognosis.https://www.frontiersin.org/articles/10.3389/fphar.2023.1194367/fullShineway® Shu-Xue-Ning injectionTCM injectionadverse reactionsintensive hospital monitoringreal-world study |
| spellingShingle | Jin Xinyao Zhang Yifan Wang Keyi Pang Wentai Wang Chunyang Wang Hui Liu Chunxiang Xue Yunhua Zheng Wenke Post-marketing safety surveillance and re-evaluaiton of Shu-Xue-Ning injection: a real-world study based on 30,122 cases Frontiers in Pharmacology Shineway® Shu-Xue-Ning injection TCM injection adverse reactions intensive hospital monitoring real-world study |
| title | Post-marketing safety surveillance and re-evaluaiton of Shu-Xue-Ning injection: a real-world study based on 30,122 cases |
| title_full | Post-marketing safety surveillance and re-evaluaiton of Shu-Xue-Ning injection: a real-world study based on 30,122 cases |
| title_fullStr | Post-marketing safety surveillance and re-evaluaiton of Shu-Xue-Ning injection: a real-world study based on 30,122 cases |
| title_full_unstemmed | Post-marketing safety surveillance and re-evaluaiton of Shu-Xue-Ning injection: a real-world study based on 30,122 cases |
| title_short | Post-marketing safety surveillance and re-evaluaiton of Shu-Xue-Ning injection: a real-world study based on 30,122 cases |
| title_sort | post marketing safety surveillance and re evaluaiton of shu xue ning injection a real world study based on 30 122 cases |
| topic | Shineway® Shu-Xue-Ning injection TCM injection adverse reactions intensive hospital monitoring real-world study |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2023.1194367/full |
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