ABSTRACT
Traditional Chinese medicine(TCM) formula granules are highly praised for the advanced, convenient, and modern use of Chinese medicinal materials. The safety of TCM formula granules has long been a concern of regulatory authorities and the medical industry. A multi-center, prospective, open, non-interventional, and centralized monitoring was carried out for the patients treated with TCM formula granules in 252 medical institutions from February 5, 2020 to April 19, 2022. All the case data and the incidence of adverse drug reactions/events were recorded. This study evaluated the safety of TCM formula granules, aiming to provide a reference for the clinically use. A total of 20 547 patients were included in this study. Four adverse events were recorded, including 3 adverse drug reactions with an adverse drug reaction rate of 0.015%, all of which occurred in the digestive system. There was no serious adverse event, and no factors related to adverse drug reactions/events were identified. The incidence of adverse drug reactions/events associated with China Resources Sanjiu Medical & Pharmaceutical Co., Ltd. TCM formula granules was rare, which proved their safety in clinical use. A comprehensive data mining and objective analysis was carried out for the medicines with high frequency in TCM formula granules, the commonly used medicine pairs and combinations, and departmental medication. The drug use characteristics, prescription rules, and departmental use of TCM formula granules were summarized, which can shed light on the prescription compatibility and clinical application.
Subject(s)
Humans , Medicine, Chinese Traditional/adverse effects , Drugs, Chinese Herbal/adverse effects , Prospective Studies , Drug-Related Side Effects and Adverse Reactions/epidemiology , ChinaABSTRACT
ObjectiveTo determine the reporting rate of adverse reaction of Haemophilus influenzae type b （Hib） containing vaccine in Songjiang District from 2016 to 2020， so as to provide evidence for the inclusion of Hib vaccine in children's immunization planning and safety monitoring. MethodsThe adverse reaction data of Hib vaccination were collected through the Chinese Disease Prevention and Control Information System and presented by descriptive methods. ResultsFrom 2016 to 2020， the reporting rate of adverse reaction of various Hib-containing vaccines in Songjiang District was determined to be 747.76/105 doses， among which the rates of general reaction and abnormal reaction were 734.31/105 doses and 13.45/105 doses， respectively. The reporting rate of general reaction was significantly higher than that of abnormal reaction （χ2=1 400.18，P<0.001）. Moreover， the reporting rate of adverse reaction did not differ significantly by sex or registered residence， whereas it differed significantly by age groups （χ2=366.07，P<0.001）. Children ≥12 months old had the highest reporting rate， which was caused by higher rate of general reaction （χ2=360.48，P<0.001） compared with other age groups； in contrast， there was no difference in the reporting rate of abnormal reactions across age groups. The reporting rate of adverse reaction differed significantly across four Hib-containing vaccines （χ2=508.51，P<0.001）， among which the reporting rate of pentavalent vaccine was the highest， followed by tetravalent vaccine， and Hib vaccine and meningococcal HI vaccine. This difference was mainly caused by general reaction （χ2=499.19，P<0.001）. The reporting rate of booster Hib-containing vaccines was significantly higher than that of basic immunization （χ2=462.85，P<0.001）. Furthermore， the reporting rate differed between DTaP-Hib vaccine and DTaP-IPV-Hib vaccine by injection sites（χ2=13.63，P=0.001；χ2=78.48， P<0.001）； the reporting rate on the thigh was lower than that on the hip or upper arm. Among the 1 501 reported adverse reactions， 97.21% of the general reactions and 85.19% of the abnormal reactions occurred within 72 hours following immunization. Principal clinical diagnosis was fever， redness and nodules （n=1 454）， accounting for 96.87% of the total reported adverse event following immunization（AEFI）， followed by allergic rash. ConclusionThe four types of Hib-containing vaccines have high safety. Health care practitioners at points of vaccination should improve the pre-examination， standardized operation and full notification in strict accordance with the requirements. It also warrants strengthening the AEFI monitoring， investigation and response， so as to effectively reduce the incidence and severity of adverse reactions.
ABSTRACT
Objective To evaluate the safety of Tanreqing injection among children in thereal world.Methods A multicenter,large sample,ambispective cohort study,with registration-type clinical safety monitoring.A total of 6 188 inpatients and patients from the emergency units,aged ≤14 years who all had been using Tanreqing injection in 59 secondary and tertiary hospitals in China,were recruited between January,2014 and May,2015.The main outcomes would include incidence and severity of adverse drug reaction (ADR)/adverse drug event (ADE) of Tanreqing injection.Univariate analysis was used to explain the risk factors of ADR.Results The overall incidence of ADE was 4.20％ (26 cases),including 4 serious ones.The incidence of ADR was 3.07％ (19 cases),including 17 cases of general ADR and 2 cases of new ADR.All the ADR cases were mild or moderate,mostly showing damages in skin and appendages.The onset of disease happened in 24 hours after the Tanreqing injection but all the ADR cases got improved or cured.Having histories of allergies to drugs or foods would increase the incidence of ADR.Conclusion Tanreqing injection caused low incidence of ADR in children.Progams as stratifying high-risk patients and improving administrative management could further increase the safety level of Tanreqing injection.
ABSTRACT
Objective To evaluate the safety of Tanreqing injection among children in thereal world.Methods A multicenter,large sample,ambispective cohort study,with registration-type clinical safety monitoring.A total of 6 188 inpatients and patients from the emergency units,aged ≤14 years who all had been using Tanreqing injection in 59 secondary and tertiary hospitals in China,were recruited between January,2014 and May,2015.The main outcomes would include incidence and severity of adverse drug reaction (ADR)/adverse drug event (ADE) of Tanreqing injection.Univariate analysis was used to explain the risk factors of ADR.Results The overall incidence of ADE was 4.20％ (26 cases),including 4 serious ones.The incidence of ADR was 3.07％ (19 cases),including 17 cases of general ADR and 2 cases of new ADR.All the ADR cases were mild or moderate,mostly showing damages in skin and appendages.The onset of disease happened in 24 hours after the Tanreqing injection but all the ADR cases got improved or cured.Having histories of allergies to drugs or foods would increase the incidence of ADR.Conclusion Tanreqing injection caused low incidence of ADR in children.Progams as stratifying high-risk patients and improving administrative management could further increase the safety level of Tanreqing injection.
ABSTRACT
OBJECTIVE: To analyze the safety monitoring effects of pediatric drug data protection regime in the US and provide the suggestions to improve the safety of pediatric drugs in China. METHODS: Theoretical analysis and case study of Duragesic (Fentanyl transdermal patch). RESULTS: The pediatric drug data protection regime promoted safety monitoring effectively. CONCLUSION: II is necessary to establish pediatric drug data protection system in China by referring to the experience of US, to enhance the lilecycle risk management and the responsibilities of enterprises, so as to improve the safety of pediatric drug.
ABSTRACT
OBJECTIVE: To put forward a method of construction of the safety evaluation platform related to formula-medicine dose of TCM because of the lack of the dose-effect relationship research and the insufficient of safety monitoring in Chinese medicine. METHODS: Under the guidance of Chinese medicine theory, an ADR (adverse drug reaction)/ADE (adverse drug event) monitoring scale with TCM characteristics was developed based on patients reporting, thus to promote positive and prospective evaluation researches related to formula-medicine dose. On the basis of the ADR/ADE data base, the safety monitoring module will be formed then. RESULTS AND CONCLUSION: The safety evaluation platform related to formula-medicine dose is supposed to be structured.
ABSTRACT
Objective: High Intensity Focused Ultrasound (HIFU) is classified as the third category medical instruments, which means it require much more attention on its safety to patient. Methods: To achieve this goal, a safety monitor system was applied on “High Intensity Focused Ultrasound therapeutic equipment for Shallow tissue”. To design parallel port-based safety monitor method for high intensity focused ultrasound therapeutic system and make the bidirectional data flow. Results: By using parallel computation of FPGA, the safety monitor independently monitor several modules of the “Ultrasound therapeutic equipment”, and handles mal-function. A new EPP-Parallel port basic intelligent watchdog was introducing to monitor PC working state. Conclusion: The safety monitor system enhances the safety and reliability of the equipment, and provides helpful information for malfunction diagnose.