ABSTRACT
OBJECTIVE To provide reference for rational clinical use of mepolizumab. METHODS The reporting odds ratio method and Bayesian confidence propagation neural network method were used to conduct signal mining and analysis of adverse drug event （ADE） reports related to mepolizumab in the United States Food and Drug Administration Adverse Event Reporting System from the first quarter of 2016 to the third quarter of 2022. RESULTS A total of 57 501 ADE reports were extracted with mepolizumab as the primary suspect drug， involving 16 358 patients. Among these reports， the proportion of males （23.51%） was lower than females （50.48%）. The reporting countries were primarily the United States （51.91%） and Canada （29.94%）. Consumers （71.18%） constituted the main reporting population. A total of 172 ADE-positive signals were identified， mainly involving 13 system organ classes such as the respiratory， thoracic and mediastinal disorders （41.63%）， as well as infectious and parasitic diseases （14.16%）. There were 60 high-risk signals， including 15 that were explicitly mentioned or related to adverse reactions in the drug instructions of mepolizumab and 45 signals （such as asthmatic crisis， sputum discoloured， purulent sputum， sleep disorder due to a general medical condition） were newly identified high-risk signals. Among them， 11 high-risk signals exhibited gender or age differences. CONCLUSIONS When clinically using mepolizumab， in addition to the adverse reactions mentioned in the drug instruction， special attention should also be given to changes in the nature of sputum， painful respiration， and sleep disorders.
ABSTRACT
Objective To investigate the clinical efficacy of unilateral small incision Quadrant channel assisted MIS?TLIF unilateral pedicle screw fixation system in the treatment of degenerative lumbar disease. Methods From January 2011 to December 2013,a total of 56 cases with low back and leg pain were selected in the People′s Hospital of Dongguan,including 25 cases with lumbar disc herniation,18 cases with lumbar tube stenosis,10 cases with discogenic low back pain,2 cases of recurrence after posterior lumbar spine surgery,1 case of recurrence after transforaminal endoscopic surgery. Unilateral pedicle screw fixation was performed in the treatment of MIS?TLIF with expandable pipeline system. VAS and Oswestry dysfunction index scoring system( ODI) were used to evaluate of pain and functional recovery in patients with preoperative and postoperative pain and functional recovery,the Suk method was used to observe the bone graft fusion. Results There were 5 cases of non operative side waist back pain after operation,and the waist circumference and anti?inflammatory pain relief were improved after treatment. One case of postoperative subcutaneous fat liquefaction, was cured by dressing change. One patient with recurrence of MED intraoperatie cerebrospinal fluid leakage,was cured after treatment by the bed,dehydration and others. Other complications such as infection,screw loosening, nerve root injury and other complications had no found. After 1 month,the VAS score from preoperative ( 6. 82 ±0. 92) points fell to (1. 95±0. 55) points,ODI score from preoperative (35. 21±2. 73) points fell to (10. 05 ±1. 72) points, significantly improved compared with the preoperative, the differences were statistically significant( t=36. 775,65. 858,P<0. 05) ,based on the fusion of Suk judgment method,2 cases of patients with possible fusion,the rest were fusion. Conclusion Unilateral small incision under the quadrant assisted MIS?TILF unilateral pedicle nail stick system has obvious advantages in treatment of degenerative lumbar spine disease,as long as we choose to suitable cases and most patients can obtain satisfactory results.