1.Efficacy of solution-focused brief therapy in the improvement of prognosis and mental state of patients with chronic bone infection
Yaoxin XU ; Shulin WANG ; Xiaoqin REN ; Zhao XIE ; Tingting ZHENG
Chinese Journal of Trauma 2024;40(3):250-256
Objective:To compare the efficacy of Solution-focused brief therapy (SFBT) and the conventional care in the improvement of the prognosis and mental state of patients with chronic bone infection.Methods:A retrospective cohort study was conducted to analyze the clinical data of 219 patients with chronic bone infection who were admitted to the First Affiliated Hospital of the Army Medical University from January 2018 to February 2019, including 172 males and 47 females, aged 15-65 years [(42.1±3.8)years]. Infection sites were the tibia in 144 patients and the femur in 75 patients. According to the classification of Cierny-Mader bone infection, there were 44 patients with type I (intramedullary bone infection), 57 with type II (superficial bone infection), 79 with type III (local bone infection), and 39 with type IV (diffuse bone infection). The patients were divided into conventional care group (admitted from January to July 2018, n=106) and SFBT group (admitted from August 2018 to February 2019, n=113) according to their admission time. The conventional care group received the conventional care, while the SFBT group underwent SFBT on the basis of the conventional care, with an intervention period of 6 months. The Hospital for Special Surgery (HSS) knee score, 36-item Short Form Health Survey (SF-36) for somatic, emotional, role and social function, Self-rating Anxiety Scale (SAS) and Self-rating Depression Scale (SDS) were compared between the two groups before surgery, at discharge and at 6 months after surgery. The rates of satisfaction with the nursing care and bone healing were collected at the last follow-up. Results:All the patients were followed up for 12-36 months [(24.5±6.3)months]. The differences in HSS knee score, SF-36 for somatic, emotional, role, and social function scores, SAS score, and SDS score between the two groups were not statistically significant before surgery ( P>0.05). At discharge, the HSS knee score and SF-36 for somatic, emotional, role, and social function scores of the SFBT group were (68.6±6.9)points, (23.0±1.8)points, (23.2±1.6)points, (23.4±1.5)points, and (23.1±1.8)points respectively, which were all significantly higher than those of the conventional care group [(66.3±7.2)points, (19.7±3.3)points, (20.0±2.7)points, (19.8±3.2)points, and (20.5±2.7)points respectively] ( P<0.05); The SAS and SDS scores in the SFBT group were (40.9±6.2)points and (41.1±6.2)points respectively, which were both significantly lower than those in the conventional care group [(46.4±6.3)points and (47.3±6.4)points] ( P<0.05). At 6 months after surgery, the HSS knee score and SF-36 for somatic, emotional, role, and social function scores in the SFBT group were (81.6±6.7)points, (26.3±1.6)points, (27.9±1.4)points, (26.6±1.4)points, and (27.9±1.6)points respectively, which were all significantly higher than those in the conventional care group [(78.5±7.2)points, (17.4±2.9)points, (18.7±2.5)points, (18.3±3.0)points, and (20.0±2.5)points respectively] ( P<0.05 or 0.01); the SAS and SDS scores in the SFBT group were (32.8±4.8)points and (30.8±5.5)points respectively, which were significantly lower than those in the conventional care group [(44.2±5.5)points and (42.5±6.2)points] ( P<0.05). At the last follow-up in the conventional care group and the SFBT group, the rates of satisfaction with the nursing care were 66.0% (70/106) and 88.5% (100/113) respectively ( P<0.01), and the bone healing rates were 96.2% (102/106) and 94.7% (107/113) respectively ( P>0.05). Conclusion:Compared with the conventional care, SFBT for intervention to patients with chronic bone infection is a safe and effective mental nursing model which can improve the recovery of the function and the quality of the patients′ life, reduce their anxiety and depression, and enhance their satisfaction rate.
2.Mining and analysis of adverse drug event signals related to mepolizumab
Yaoxin CHEN ; Shaoxing WU ; Haoxuan LI ; Yinji XU
China Pharmacy 2023;34(11):1374-1378
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.
3.Mining and analysis of adverse drug event signals related to macitentan
Zhenhu WU ; Xinyao CHEN ; Yaoxin CHEN ; Yinji XU
China Pharmacy 2024;35(13):1628-1633
OBJECTIVE To mine adverse drug event (ADE) signals related to the pulmonary arterial hypertension (PAH) therapeutic drug macitentan, and to provide reference for safe clinical medication. METHODS Macitentan-related ADE reports were collected from the US FDA Adverse Event Reporting System (FAERS) database from the fourth quarter of 2013 to the third quarter of 2023. Data mining was conducted by using the reporting odds ratio (ROR) method and the comprehensive standard method established by the UK Medicines and Healthcare Products Regulatory Agency (referred to as “MHRA method”) under the proportional imbalance approach. According to the systemic organ class (SOC) and preferred term (PT) stated in 26.0 edition of Medical Dictionary of Regulatory Activities, standardized coding of ADE names was performed, followed by the analysis of time to onset (TTO) and the Weibull shape parameter (WSP) test. RESULTS Overall, a total of 26 079 ADE reports were identified with macitentan as the primary suspect drug. These reports predominantly involved female patients (73.25%) and were concentrated in the age range of 18 to 65 years (42.39%). The majority of reports originated from the US (84.42%), with hospitalization or prolonged hospital stays (59.82%) being the most common in severe treatment outcome. A total of 269 ADE positive signals related to macitentan were identified. Among these, hypothyroidism, ADE related to renal injury such as the increase of serum creatinine and blood urea nitrogen, and ADE related to psychiatric disorders like apathy and despair were not included in the drug label. TTO analysis indicated that the majority of macitentan-related ADE signals occurred between 0-30 days after initial treatment (492 reports, 21.52%) and over 360 days (411 reports, 17.98%). The results of WSP test showed that most of the top 20 reported ADE signals conformed to the characteristics of an early failure curve. CONCLUSIONS When clinically using macitentan in patients with PAH, attention should be given not only to the adverse reactions mentioned on the drug label but also to thyroid dysfunction, kidney dysfunction and mental disorder-related ADEs.