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1.
China Pharmacy ; (12): 1628-1633, 2024.
Article in Chinese | WPRIM | ID: wpr-1036554

ABSTRACT

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.

2.
China Pharmacy ; (12): 1374-1378, 2023.
Article in Chinese | WPRIM | ID: wpr-974688

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.

3.
Article in Chinese | WPRIM | ID: wpr-603268

ABSTRACT

Objective To explore the regulatory effect of Nervilia fordii Injection ( NFI ) on inflammatory cytokines in rats with lipopolysaccharide ( LPS) -induced acute lung injury ( ALI) , and to explore its possible interfering mechanism . Methods The rats were randomly divided into normal group , model group , Shenmai Injection group, and NFI group. J774 macrophages were stimulated by LPS to establish the cell model in vitro, and in vivo ALI rat model was established by injection of LPS through the sublingual veins. Electronic microscope and enzyme-linked immunosorbent assay (ELISA) were used for observing the proliferation of J774 macrophages, the levels of supernatant inflammatory cytokines secreted by J774 cells, and the levels of serum inflammatory cytokines . Results The proliferation of LPS-induced J774 macrophages was increased , and the secretion of inflammatory cytokines was disordered. Uncontrolled inflammatory reaction occurred in the lung after the rats were administrated with intravenous injection of LPS . Both NFI and Shenmai Injection could inhibit the proliferation of J774 macrophages. NFI could also significantly inhibit the levels of supernatant and serum tumor necrosis factor (TNF) -α and interleukin 6 (IL-6) expression (P0.05). Conclusion NFI has better preventive and therapeutic effect for ALI than Shenmai Injection, and its possible mechanism is related with the inflammatory regulation and lung injury relief through the suppression of excessive expression of TNF-α and IL-6 .

4.
Article in Chinese | WPRIM | ID: wpr-567747

ABSTRACT

To investigate the establishment and evaluation of TCM diagnosis and treatment protocols of post infectious cough based on its status and problems. It will make the TCM syndrome standardization easy to popularize,and realize the optimization and simplification of TCM treatment protocols,establishment of western medicine diagnostic criteria beseem different hospital,and selection of scientific and accepted outcome measurements,to improve level of TCM diagnosis and treatment of post infectious cough and quality of its clinical research.

5.
Article in Chinese | WPRIM | ID: wpr-570684

ABSTRACT

To explore the difference of respiratory muscle strength and respiratory drive between lung qi deficiency pattern and spleen qi deficiency pattern in chronic obstructive pulmonary disease (COPD).Forty two cases of COPD were differentiated as lung qi deficiency pattern (n=23, Group A) and spleen qi deficiency pattern(n=19, Group B) and twenty healthy volunteers served as control (Group C). Pulmonary ventilatory function such as forced vital capacity(FVC), forced expiratory volume in one second (FEV 1), FVC/ FEV 1 and maximum voluntary ventilation (MVV) were examined; and the maximum inspiratory pressure (MIP), maximum expiratory pressure (MEP) and oral blocking pressure were also detected.As compared with Group C, pulmonary ventilation was decreased in both Group A and Group B and more obviously in Group B (P0 05); MIP and MEP in Group B differed from those in Group C (P

6.
Article in Chinese | WPRIM | ID: wpr-573740

ABSTRACT

[Objective] The disease distribution of in-patients in different age groups from 1993 to 2002 in respiratory disease department of Guangdong Provincial Hospital of Traditional Chinese Medicine (TCM) was analyzed to provide evidence for clinical treatment. [ Methods ] A retrospective research was adopted. Fourteen categories of diseases and 3 age groups were classified according to the case history recorded from 1993 to 2002 in respiratory disease department of Guangdong Provincial Hospital of TCM. Reasons for hospitalization of the in-patients in different age groups during 10 years were analyzed by descriptive analysis and Vilfredo Pareto analysis. [Results] The principal and secondary reasons for hospitalization were respiratory tract infection, pulmonary tuberculosis and pneumothorax in the young age group while in the old age group, they were chronic bronchitis, pulmonary emphysema, chronic pulmonary heart disease and lung cancer. [Conclusion] The focus of daily medical treatment in the department of respiratory disease should vary with the age groups and disease categories, and the control of infectious diseases should be generally strengthened.

7.
Article in Chinese | WPRIM | ID: wpr-573479

ABSTRACT

[Objective] To observe the therapeutic effect of spleen-invigorating and lung-nourishing therapy and its influence on nutritive index and quality of life (QOL) in patients with chronic obstructive pulmonary disease (COPD) at stationary phase. [ Methods ] Ninety cases of COPD were randomized into three groups. Group A was given routine symptomatic treatment; groups B and C were given oral use of Jianpi yifei Granules and routine symptomatic treatment and group C was additionally treated with garlic-partition moxibustion and acupoint injection of Shenmai Injection on bilateral Zusanli (ST 36) point alternatively. The treatment lasted 2 months. [Results] The effective rate was 93.33% in group C, 86.67% in group B and 56.67% in group A (P 0.05) compared with those before treatment. Scores of activity of daily life (ADL) , depression and anxiety and the total score of QOL were obviously decreased in groups B and C (P

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