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OBJECTIVE To provide references for the clinical safe use of axitinib. METHODS Adverse drug event （ADE） data for axitinib were collected from the US FDA Adverse Event Reporting System （FAERS） database from the first quarter of 2012 to the fourth quarter of 2022. The data were mined and analyzed by utilizing the ratio-of-reporting-ratio （ROR） method and comprehensive standard method of the United Kingdom’s Medicines and Healthcare Products Regulatory Agency （MHRA） of proportional imbalance measurement. RESULTS A total of 13 962 reports of axitinib-related ADEs were obtained， with patients’ age concentrated in 65-85 years （43.25%）， gender predominantly male （65.23%）， country of reporting predominantly US （60.01%）， and serious ADE outcomes mostly hospitalization or prolonged hospitalization （31.51%）. A total of 172 ADE risk signals were detected， involving 18 system and organ classifications （SOC）， mainly systemic diseases and various reactions at the site of administration （3 749 cases， 30.84%） and gastrointestinal system diseases （2 067 cases， 17.00%）. ADE risk signals that occurred more frequently were generally consistent with the drug instruction， such as diarrhea， fatigue， and hypertension； new ADE risk signals requiring clinical attention were death， immune-mediated nephritis， and PT signals contained in the SOC of various benign， malignant， and tumors of undetermined nature （including cysts and polyps）. CONCLUSIONS For ADEs that occur frequently with axitinib and are already contained in the drug instruction （e.g. hypertension， diarrhea）， they should be adequately evaluated before administration， especially for patients with combined use of immune checkpoint inhibitors and patients with underlying hypertension； for ADEs with stronger signals and newer ADEs （e. g. death， disease progression， tumor progression）， the patient’s disease progression should be closely monitored during the treatment period for potentially fatal ADEs； for its rare ADEs （e. g.immune-mediated nephritis， scrotal ulcer， non-infectious encephalitis）， clinical validation should be further strengthened.
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AIM: Exploring medical device clinical trial quality management indicator system to continuously improve medical device clinical trial quality system construction. METHODS: Through literature research and Delphi method, we summarized the risks of medical device clinical trials in various aspects such as quality management, clinical trial data, and clinical trial research personnel construction, analyzed the risks and proposed a clinical trial quality management index system, as well as corresponding quality improvement measures. RESULTS: To establish an appropriate medical device clinical trial quality evaluation management tool for quality risk monitoring and management, and to support and help the construction of a medical device clinical trial quality management system. CONCLUSION: To identify risks in various aspects of clinical trials and establish a preliminary assessment index system to provide a reference for the evaluation of the effectiveness of clinical trial quality management.
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OBJECTIVE:To provide reference for improving the efficiency of medicine supply in primary health care institutions. METHODS:By stratified random sampling,6 counties of Dabie Mountains in Anhui province were selected as sample areas. Medicine purchase data of 143 primary health care institutions in 2015 were collected from Anhui provincial centralized purchase platform. Those data were analyzed in respects of purchase and distribution of National Essential Medicine,medicines of Anhui Province Essential Medicine List and cheap medicines. By stratified random sampling,12 primary health care institutions were selected for on-site interview. The reasons for medicine distribution and insufficient distribution were investigated. RESULTS:The rate of medicine distribution in the sample areas was 82.27%,and the rate of essential medicine distribution was more than 80%. Ratio of purchase amount for national essential medicines and medicines of Anhui Province Essential Medicine List were all up to standard in different types of primary health care institutions. The rate of cheap medicine distribution was in low level(only 80%). The distribution rate had great difference in the primary health care institutions and different areas;the highest rate of medicine distribution reached 99.86%,and the lowest was only 46.18%. The results of on-site investigation showed that main reasons for insufficient distribution were the divided area distribution model had a certain influence on the market competitiveness of the distribution enterprises,and distribution enterprises strength had huge differences. CONCLUSIONS:The primary health care institutions have high awareness of National Essential Medicine System in Dabie Mountains of Anhui Province;purchase rate and overall distribution rate of essential medicine are also high. There are great differences in distribution efficiency among different areas and health care institutions,and some health care institutions cannot distribute medicine in time with full capacity. It is suggested to conduct"two-receipt system"of medicine distribution,perfect medicine distribution enterprise supervision system, establish medicine circulation information platform and lead cheap medicine supply guarantee by government,etc. Those measures can guarantee the accessibility and selectivity of the masses to essential medicines in grass-roots areas.
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Objective To explore the relationship between sense of coherence and coping styles among patients at the stabile phase after peritoneal dialysis. Methods About 86 patients at stable phase after peritoneal dialysis were recruited in the investigation. The sense of coherence (SOC-13) and medical coping modes questionnaire (MCMQ) were used to evaluate the sense of coherence and coping styles. Results The average score of sense of coherence was (60.93±13.77), which was at a lower level. The scores of coping styles were confrontation, avoidance and resignation, ranked from high to low. Avoidance and resignation dimensions were higher than the norm in coping styles (all P<0.001) and there was no statistically significant difference between confrontation dimension and the norm (P>0.05). There was positive relationship between confrontation and the average score of sense of coherence, comprehensibility, manageability, meaningfulness (all P<0.05). There was negative relationship between resignation and the average score of sense of coherence, comprehensibility, manageability, meaningfulness (all P<0.001). Conclusions Patients at the stable phase after peritoneal dialysis have a lower sense of coherence and are inclined to confrontation and avoidance coping styles. The higher sense of coherence, the more positive coping styles PD patients use. Medical workers should provide personal interventions according to the results of the sense of coherence so that the patients take positive coping styles.
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OBJECTIVE:To provide reference for improving the pharmaceutical care ability of the retail pharmacies.METHODS:The questionnaires were designed to investigate 180 licensed pharmacists from 180 retail pharmacies.The survey data were analyzed statistically.RESULTS:A total of 180 questionnaires were sent out,and 150 effective questionnaires were collected with effective recovery rate of 83.33％.Among 150 investigated pharmacists,the junior college degree or lower accounted for 74.67％,and the professionals of pharmacy or related only accounted for 44.66％;the pharmacists who always and often provided medication guidance accounted for 72.67％ and 21.33％,respectively;the pharmacists who always and often developed prescription review accounted for 53.33％ and 27.33％,respectively;the pharmacists who always and often collected complaint suggestions accounted for 50.67％ and 35.33％,respectively;the pharmacists who always and often established medication history both only accounted for 1.33％;the pharmacists who always and often retrospected drug use of patients accounted for 18.67％ and 14.00％,respectively;the pharmacists who always and often conducted lectures on health education and drug use accounted for 4.00％ and 6.00％,respectively;the pharmacists who satisfied with the work accounted for 58.67％.CONCLUSIONS:Recently,the degree and professional ability of the licensed pharmacists are relatively low in retail pharmacies in Hefei.The pharmaceutical care contents of drugstores are unitary,the work satisfaction degree of the licensed pharmacists is unsatisfactory.Although they can provide the patients with drug use guidance basically,the projects such as carrying out prescription auditing and collecting complaint suggestions need to be further strengthened.Less work has been done in establishing medication history and retrospecting drug use.So,we need to take some measures to improve the pharmaceutical care ability of retail pharmacies effectively.
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OBJECTIVE:To provide empirical reference for protecting the supply of clinical drugs. METHODS:Literature re-view was combined with the conditions of drugs that lost the bidding in the centralized bidding in Anhui province to determine the short drugs need to investigate. Questionnaire was adopted to investigate the situations and reasons of short drugs in 5 third-grade class-A hospitals of 5 areas in Anhui province from Nov. 2013 to Oct. 2014. RESULTS:A total of 5 questionnaires were sent out, and 5 were received with effective response rate of 100%. There were totally 54 short drugs in the 5 third-grade class-A hospitals, including the most serious shortage of drugs for neurocirculatory system,accounting for 20.37%. Shortage was mainly due to the low price of drugs,accounting for 48.15%,and insufficient supply,less suffering patients/low dosage and other reasons. CON-CLUSIONS:In view of the shortage of drugs,government departments should improve the drug pricing and bidding policy,pro-duction enterprises should enhance the enterprise production and development capabilities,business companies should optimize the distribution pattern of network and medical institutions should establish drug management system with a clear division of power and responsibility to relieve the drug shortages.
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Objective To analyze retrospectively the relationship between protein nutrition index (PNI) and survival conditions in patients with peritoneal dialysis (PD).Methods Various clinical and laboratory indexes of patients with chronic kidney disease from January 2004 to January 2014 were analyzed retrospectively.PNI score was determined by serum albumin (ALB),normalized protein nitrogen presentation rate (nPNA),lean body mass (LBM).According to PNI score,PD patients were divided into four groups:good nutrition status,nutrition status in general,poor nutrition,PEW status.Linear regression analysis was used to analyze determine factors of PNI;analysis of Kaplan-Meier was applied to examine relationship between the protein nutrition status and survival rate;COX regression analysis was used to analyze the risk factors for survival in patients with PD.Results All the indexes,age,complications index,serum Cr,K-Kt/V,T-Kt/V had a linear relationship with PNI.5-year survival rate in the four groups were respectively 95％,92％,65％,23％.Age,complications,PNI index were the survival risk factors of PD patients.Conclusions According to PNI score,evaluation of protein nutritional status of patients with PD could predict survival conditions of PD patients,the higher PNI score,the higher survival rate.
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Objective To analyze the related factors of nursing risk in department of nephrology and to explore strategies of risk management.Methods Risk management was implemented to 39 nurses in department of nephrology of our hospital.The KAP scores,the incidence of nursing risk events,nursing complaints and patients' satisfaction degree before and after the implementation of nursing risk management were compared.Results After the implementation of nursing risk management,nurses' KAP score was significantly higher; the incidence of nursing risk events and complaints significantly reduced; patients' satisfaction degree to nursing were significantly higher compared with those before the implementation.Conclusions The implementation of nursing risk management can effectively improve the quality of nursing and reduce the incidence of nursing risk events.
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Objective To investigate the clinical therapeutic effect of the vacuum-sealing drainage (VSD) combining with skin graft in a deep burn wound.Methods Sixty one patients were divided into two groups according to treatment method.Thirty tree patients were assigned as the VSD treatment group,which was treated by VSD after debridement; their wounds were transplanted by the split thickness skins binding up by VSD when they were fitted.Twenty eight patients were assigned as the routine treatment group,which was treated by means of traditional regular dressing change to remove necrotic tissue and promote granulation tissue; their wounds were transplanted by the split thickness skins binding up by packing when they were fitted.Results After treatment by VSD,there are no systemic hypersensitivity reactions and abnormal bleeding.Thirty three cases of VSD treatment group were treated by VSD for 7 ～ 10 days,the other 2 cases were treated by VSD for another 7 ～ 10 days because of granulation tissue badly.Until their granulation was fresh,skin grafting technique was used and the skin survived well.The treatment time before skin grafts,the pain score,and the cost of ablative therapy for wound were ( 8 ± 0.9) day,(5.7 ± 1.6) point,and ( 1.5 ± 0.4) ten thousand yuan in VSD group vs.( 14 ± 1.2) day,(3.1 ± 1.1 ) point,and (0.6± 0.2)ten thousand yuan in control group.The survival rate and the wound germiculture positive rate were 97.0％ and 6.5％ in the VSD group vs 75.0％ and 28.6％ in the control group.The differences between groups were statistically significant ( P ＜ 0.05 ).Conclusions VSD is a simple method that is easy to grasp,and that can promote granulation tissue growth,reduces the wound germiculture positive rate,shortens the wound healing period,increases the survival rate of skin grafts,and relieves patients 'pain.It is worth popularizing and applying in the deep burn wound therapy.
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Aim To investigate the effect of total flavonoids of Chrysanthemum indicum on proliferation of synoviocytes and TRAIL/TNF-? expression of synovial tissue with adjuvant arthritis rats.Methods SD rats were divided randomly into six groups including normol,model,TFC(84,168,336 mg?kg-1)and control drug Tripterygium glycosides(30 mg?kg-1)groups.Adjuvant arthritis rat model was induced by a single intradermal injection of 0.1 ml of the complete Freund's adjuvant into the the right hind feet pads of the SD rats.The proliferation of synoviocyte was measured by MTT;The expression of TRAIL and TNF-? on synovial tissue were detected by means of immunofluorescence.Results TFC was shown to suppress the excessive synoviocyte proliferation;The expression of TRAIL was lower in model group than that of the normal group.TFC can increase the expression of TRAIL protein;The contrary to TNF-? protein.Conclusions TRAIL play a role in the development of AA.TFC can increase the lower expression of TRAIL protein,that maybe one of the mechanisms of TFC improvement AA.
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Objective To study the effect of the extract of total flavonoids of chrysanthemum indicum(TFC) on adjuvant arthritis synovial cells. Methods 0.1ml of the complete Freund's adjuvant was subcutaneously injected into the right hind feet pads of the SD rats.24 days after immunity synovial cells in knee joint were treated with TFC and inhibition of proliferation was measured with MTT assay.DNA fragmentations were analyzed with DNA gel electrophoresis.Fluorescence staining of Hoechst 33258 to observe apoptotic body.Results The IC_50 of TFC on synovial cells was 112mg/L.DNA gel electrophoresis showed ladder-like strap.Apoptotic bodies were observed by Hoechst 33258.Conclusion TFC can inhibit proliferation and induce apoptosis in synovial cells,and exerts therapeutical effect on rheumstoid arthritis.