Excavation and Evaluation of ADR Signals of SGLT 2 Inhibitors / 中国药房

OBJECTIVE：To excavate and evaluate ADR signals of SGLT 2 inhibitors as canagliflozin ，dapagliflozin and empagliflozin，and to provide reference for rational drug use in the clinic. METHODS ：The proportional reporting ratio （PRR）and reporting odds ratio （ROR）were used to find the adverse drug reactions （ADR）signal of SGLT 2 inhibitors as canagliflozin ， dapagliflozin and empagliflozin from the second quarter of 2013 to the third quarter of 2020 in the US FDA Adverse Event Reporting System （FAERS）. The basic information （including gender ，age，reporting year ，reporting country ，severe ADR ）and safety warning signals of corresponding patients in ADR report were analyzed. RESULTS ：Among 6 029 375 ADR reports ，SGLT2 inhibitors of 43 807 ADR reports were concomitant and suspected drugs ；there were 19 301 ADR reports of canagliflozin ，10 960 ADR reports of dapagliflozin ，13 546 ADR reports of empagliflozin. Except for the ADR patients with unknown gender and missing age ，the gender distribution of the included reports was balanced ，mainly in the range of 50-75 years old. The reporting year was mainly in 2018，and the main reporting country was the United States ，with“hospitalization or prolonged hospitalization ” as the main serious ADR. A total of 573 ADR signals were obtained ，involving 26 systems，mainly focusing on metabolic and nutritional diseases ，endocrine disorders ，kidney and urinary system disease ，infection and invasion diseases ，etc. The results showed that there were 14 main ADR signals in the top 10 ADR of canagliflozin ，dapagliflozin and empagliflozin. The strongest ADR signals of dapagliflozin and empagliflozin were ketoacidosis （PRR＝119.64/140.11，95％CI lower limit of ROR ＝148.28/ 178.78）and fungal infection （PRR＝47.76/34.77，95％ CI lower limit of ROR ＝50.69/36.28）；except above signals in addition ， toe amputation （PRR＝489.79，95％CI lower limit of ROR ＝520.15）and osteomyelitis （PRR＝61.42，95％CI lower limit of ROR＝65.38）were strong in the ADR signals of canagliflozin. CONCLUSIONS ：SGLT2 inhibitors have a higher security risk in metabolic and nutritional diseases ，endocrine disorders ，kidney and urinary system ，and infection and intrusion diseases. Dapagliflozin，canagliflozin and empag liflozin are prone to cause ADR such as ketoacidosis and fungal infection ，while canagliflozin is easy to cause ADRs such as toe amputation and osteomyelitis.

ADR Signal Mining of Rivaroxaban Based on FDA Adverse Event Reporting Database / 中国药房

OBJECTIVE：To excavate the ADR signals of rivaroxaban and provide reference for its safe and rational use in clinic. METHODS ：Based on FDA adverse event reporting system （FAERS），the ADRs of rivaroxaban reported from September 2008 to December 2020 in FDA ’s Open Data Program were mined using ratio of reports to odds （ROR）and proportional report ratio （PRR）. The related ADRs were analyzed ，and the corresponding system organ classification （SOC）was mapped. At the same time，the basic information such as gender ，age and indications of the patients were statistically reported. RESULTS & CONCLUSIONS：Among 9 373 236 ADR reports extracted ，102 027 ADR reports with rivaroxaban as concomitant and suspected drug were obtained ；883 ADR signals were mined ，involving 27 systems. Among 102 027 reports，the proportion of female patients （41 294 cases，40.47％）was similar to that of male patients （41 071 cases，40.26％）. The patients were mainly ＞50 to 75 years old（29 261 cases，28.68％）and ＞75 years old （21 470 cases，21.04％）. The reporting year was mainly in 2018（18 446 cases， 18.08％）；main reporting country was the United States （75 390 cases，73.89％）；there were 35 046 cases（34.35％）of severe ADR reports ，mainly involving hospital or prolonged hospital stay. The SOC of rivaroxaban ADR singal mainly focused on diseases of the blood and lymphatic system ，vascular diseases ，various types of examination and nervous system diseases. Among top 20 preferred terms of ADRs with the highest frequency ，except for pulmonary embolism ，acute kidney injury and atrial fibrillation ，the rest were mainly bleeding related ADRs ，of which intracranial hemorrhage was the more seriou s ADR. Intracranial hemorrhage may occur when rivaroxaban is used for the prevention of atrial fibrillation and cerebrovascular accidents ， and pulmonary embolism may occur when rivaroxaban is used for the prevention of pulmonary embolism ，（deep）venous thrombosis and thrombosis. Great importance should be paid on it.

Effect of ulinastatin on thromboxane B₂ and deep vein thrombosis in elderly patients after hip joint replacement / 中南大学学报(医学版)

OBJECTIVE@#To determine the effect of ulinastatin on plasma thromboxane B(2) and deep vein thrombosis(DVT) in elderly patients after hip joint replacement.@*METHODS@#Eighty ASAI-IIpatients aged 65-81 years undergoing hip joint replacement were randomly divided into 4 groups (n=20): Group U1 (ulinastatin 5 000 U/kg);Group U2 (ulinastatin 10 000 U/kg); Group U3 (ulinastatin 20 000 U/kg); and Group C (the same volume of saline as control).The blood samples were collected at 5 time points: preoperation (T(1)), immediately after the operation (T(2)), 1 d (T(3)), 2 d (T(4)) and 3 d after the operation (T(5)), respectively. Thromboxane B(2) was detected, and DVT was also examined through color Doppler ultrasonography 3 d after the operation.@*RESULTS@#Compared with T(1), the level of thromboxane B(2) significantly increased in Group C at T(2)-5, in Group U1 at T(2-4), in Group U2 and U3 at T(2) (P0.05).@*CONCLUSION@#Ulinastatin can inhibit blood thromboxane B(2) level in dose dependent manner and prevent DVT in elderly patients after hip joint replacement.

Efficacy of topical anesthesia with inhaled aerosolized lidocaine during tracheal intubation under guidance of fiberoptic bronchoscopy in cervical cord injury patients / 中华麻醉学杂志

Objective To evaluate the efficacy of topical anesthesia with inhaled aerosolized lidocaine during tracheal intubation under the guidance of fiberoptic bronchoscopy (FOB) in patients with cervical cord injury complicated with high paraplegia. Methods Sixty-four patients with cervical cord injury complicated with high paraplegia were randomly divided into 2 groups ( n = 32 each): group Ⅰ aerosol inhalation and group Ⅱ spray and cricothyroid membrane puncture. In group Ⅰ aerosolized 2% lidocaine was inhaled. In group Ⅱ after the pharynx and larynx was sprayed with 2% lidocaine, cricothyroid membrane puncture was performed and then 2% lidocaine 2 ml was injected. Midazolam 0.01 mg/kg and fentanyl 1 μg/kg were injected iv in both groups 15 min before tracheal intubation guided by FOB. During tracheal intubation guided by FOB, the intubation condition was assessed, and MAP, HR, ECG and SpO2 were monitored. Results The satisfactory rate of intubation condition and success rate of intubation under the guidance of FOB were significantly higher, and the incidences of arrhythmia and bad memory lower in group Ⅰ than in group Ⅱ ( P ＜ 0.05). Conclusion The topical anesthesia with inhaled aerosolized 2% lidocaine is helpful for improving the FOB-guided tracheal intubation condition, and can reduce the occurrence of adverse effects in patients with cervical cord injury complicated with high paraplegia.