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OBJECTIVE To analyze the clinical manifestations and characteristics of adverse drug reactions （ADR） induced by dronedarone，and to provide reference for clinically safe drug use. METHODS Retrieved from PubMed database， Wanfang database，CNKI and VIP （up to August 31st， 2022），ADR cases of dronedarone were analyzed retrospectively in respect of patient’s age，gender，nationality，usage and dosage of dronedarone，and occurrence time，clinical manifestations，treatment measures and outcome of ADR，etc. RESULTS A total of 26 case reports were included，with a total of 27 patients. The age of the patients was 41-86 years old，with an average age of 68.8 years. The proportion of patients aged 60-79 was the largest （20 cases，74.1%）. There was no significant difference in the number of males （14 cases） and females （13 cases）. The patients came from 6 countries， of which the United States was the largest （16 cases，59.3%）. The dosage of 14 patients was 400 mg bid；one patient was 200 mg bid；the dosage for 12 patients was not specified. The most ADR cases （16 cases，59.3%） occurred within 1 month，of which 11 cases（40.7%） occurred within 1 week，and there were no ADR reports with medication more than 12 months. Organs/systems involved in ADRs were mainly liver and biliary diseases （7 case times，23.3%），skin and subcutaneous tissue diseases （6 case times， 20.0%），respiratory tract，thoracic and mediastinal diseases （5 case times，16.7%）. In addition，ADR also occurred in heart diseases， kidney and urinary system diseases，vascular diseases，medical examinations and eye diseases. Among 27 patients，there were 3 cases of death，the ADR were bronchiolitis obliterans with organizing pneumonia，toxic epidermal necrolysis and hepatic failure， respectively. One patient underwent liver transplantation. CONCLUSIONS Dronedarone can cause multiple organ system ADR. Before use，it is necessary to improve the examination including ECG，liver function，lung function，etc. and strengthen drug use monitoring within one month after the start of use，especially the ADR of hepatobiliary，skin and respiratory system. The occurrence of severe ADR has no obvious relationship with the duration of medication； even if it is taken safely for a long time，it still needs continuous pharmaceutical monitoring and follow-up to ensure the clinical medication safety of patients.
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OBJECTIVE：To systematic ally ev aluate the efficacy and safety of benralizumab in the treatment of severe eosinophilic asthma ，and to provide evidenced-based reference for clinical treatment. METHODS ：Retrieved from PubMed ， Embase，Cochrane Library ，ClinicalTrials.gov，CNKI，VIP and Wanfang database ，randomized controlled trials （RCTs）about benralizumab+routine treatment （trial group ）versus placebo+routine treatment （control group ）were collected during the inception to Dec. 2020. The relevant references were also retrieved manually. After data extraction ，the quality of included literatures was evaluated with bias risk evaluation tool 2.0 recommended by Cochrane systematic evaluator manual 6.1. Meta-analysis was conducted by using Rev Man 5.4 software. RESULTS ：Totally 5 studies involving 2 646 patients were included. Results of Meta-analysis showed that acute exacerbation rate of asthma [RR ＝0.67，95％ CI（0.61，0.74），P＜0.000 01]，asthma control questionnaire score [MD ＝－0.29，95％CI（－0.37，－0.21），P＜0.000 01] and the incidence of severe adverse event [RR ＝0.67，95％CI （0.53，0.84），P＝0.000 6] in trial group were significantly lower than control group. FEV 1[MD＝0.13，95％CI（0.09，0.17），P＜0.000 01] and asthma quality of life questionnaire score [MD ＝0.23，95％CI（0.13，0.33），P＜0.000 01] in trial group were significantly higher than control group. There was no statistical significance in the incidence of adverse event between 2 groups [RR ＝0.97，95％CI （0.92，1.02），P＝0.28]. CONCLUSIONS ：Benralizumab is effective and safe in the treatment of severe eosinophilic asthma. Due to the relatively limited data ，this conclusion needs to be confirmed by more studies.
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Objective To explore the management strategy and indications for revisionary internal fixation after percutaneous kyphoplasty/percutaneous vertebroplasty (PKP/PVP) in cancellous vertebral fractures.Methods A retrospective analysis was made of the 676 cases of single-segment PKP/PVP at Department of Orthopaedics,The Affiliated Hospital to Qingdao University from January 2008 to January 2019.They were subjected to 4 different managements after their primary PKP/PVP:rehabilitation without any treatment in 637 cases,conservative treatment in 19 cases (including 3 ones who refused any revision),KP/VP revision in 12 cases and internal fixation revision in 8 cases.The rate of volume reduction after bone cement dispersion (Vx) was calculated using software Mimics 17.0 on the basis of primary CT data of all the patients.The correlation regression analysis was made between the revision rate and the approximate quantization value of Vx.The Glasgow Coma Score (GCS) of conscious state was used to evaluate the 39 patients after failure of their primary surgery before the surgical strategy for revision was worked out.The cobb angle,pelvic incidence angle (PI),pelvic inclination angle (PT),sacral inclination angle (SS),sagittal deviation (SVA),pain visual analogue scale (VAS) were measured and recorded before operation and at the last follow-up for the KP/VP revision group and internal fixation revision group,indicated as △cobb,△PI,△PT,△SS,△SVA and △VAS,respectively.The indexes were compared between the 2 groups.Results The incidence of osteoporotic vertebral fractures treated with internal fixation revision was 1.18％ (8/676).The correlation between Vx and revision rate was y =0.53 + 0.04x (P ＜ 0.05).The regression analysis showed that Vx was positively correlated with the revision rate (r2 =0.860,P =0.001) and the fitting curve was correlated (r2 =0.916,P =0.001).The GSC scores revealed 31 normal,6 mild disturbance and 2 moderate disturbance cases.There were no significant differences in gender,age or VAS scores between the KP/VP revision group and the internal fixation revision group (P ＞ 0.05).There was a significant difference in △cobb between the 2 revision groups (6.3° ± 7.5° versus 19.2° ± 14.8°) (P ＜0.05),but there were no significant differences between the 2 groups in △PI (4.1°±5.2° versus 3.3°±6.7°),△PT (0.7°±4.6° versus 0.4° ± 3.2°),△SS (3.7° ± 6.2° versus 3.1° ± 5.3°) or △SVA (-3.2 ± 11.9 mm versus-7.9 ± 9.5 mm) (P ＞ 0.05).Conclusions The outcomes of primary PKP/PVP have a great impact on the decision-making of internal fixation revision.The mode and extent of diffusion after initial vertebral cement perfusion are particularly related to the revision rate.The revision plan should depend on clinical symptoms.The internal fixation revision should be individualized to ensure the quality of life of the patients in line with the principles of "resolving symptoms" and "moderate correction".
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OBJECTIVE： To analyze the clinical manifestations and characteristics of adverse drug reactions （ADR） induced by osimertinib mesylate， and to provide reference for clinical safe use of drugs. METHODS： Retrieved from PubMed， Wanfang database， CNKI and VIP during database establishment-Aug. 2018， ADR cases of osimertinib mesylate were analyzed retrospectively in respects of patient’s age， gender， nationality， usage and dosage of osimertinib mesylate， occurrence time of ADR， clinical manifestations， treatment measures and outcome， etc. RESULTS： A total of 20 articles were included， involving 21 patients. The age of the patients was 32-82 years old， and the proportion of patients aged 57-79 was the largest （80.9％）. The female with ADR （14 cases） were more than the male. The patients were from 5 countries， in which Japan took the most ratio （13 cases， 61.9％）. The dose of osimertinib mesylate was 160 mg/d in a patient and commonly recommended dose 80 mg/d for other patients. The most ADR cases （16 cases， 76.2％） occurred within 3 months， and no reports of ADR occurred more than 12 months. Organs/systems involved in ADRs were mainly respiratory system （11 case times， 45.8％） and digestive system （6 cases， 25.0％）， in addition， ADR also occurred in cardiovascular system， hematological system， systemic reactions， skin and eyes. Among 21 patients， 3 cases were mild ADR so that they were given same dose with same frequency. A patient suffered from interstitial pneumonia and was given medicine every other day and symptomatic treatment； the symptoms of the patient were relieved. Other 17 cases were relieved after drug withdrawal and symptomatic treatment， but 2 patients died of tumor progression. CONCLUSIONS： In clinical application of osimertinib mesylate， attention should be paid to ADR monitoring， especially short-term ADR， especially ADR of respiratory， digestive system.