1.Airway humidification therapy for pertussis in infants
Shifen XU ; Chaoxiong WU ; Xiaobin DOU
Chinese Journal of Primary Medicine and Pharmacy 2022;29(8):1214-1218
Objective:To investigate the effects of airway humidification therapy on pertussis in infants.Methods:Sixty children with pertussis who received treatment in Wenzhou Hospital of Integrated Traditional Chinese and Western Medicine from May 2020 to September 2021 were included in this study. They were randomly divided into study and control groups, with 30 infants per group. The control group was treated with conventional drugs. The study group was subjected to airway humidification therapy based on conventional drug treatment. Clinical efficacy was evaluated in each group. Time to an improvement in clinical symptoms and length of hospital stay were recorded. Lung function indicators and serum inflammatory factor levels were determined before and after treatment. Pertussis-related complications were recorded.Results:The overall response rate in the study group was significantly higher than that in the control group (100.00% vs. 76.7%, χ2 = 5.82, P = 0.016). Time to disappearance of spastic cough, time to resolution of cyanosis, time to disappearance of pulmonary rales, and length of hospital stay in the study group were (3.10 ± 0.67) days, (1.53 ± 0.68) days, (4.27 ± 0.58) days, and (11.57 ± 0.73) days, respectively, which were significantly shorter than (4.23 ± 1.99) days, (2.67 ± 1.77) days, (5.63 ± 2.38) days, (13.33 ± 2.40) days ( t = 2.93, 3.27, 3.04, 3.86; P = 0.005, 0.002, 0.003, P < 0.001). Respiratory rate in the study group was significantly lower than that in the control group [(21.83 ± 1.15) breaths/minute vs. (24.23 ± 3.12) breaths/minute, t = 3.94, P = 0.002]. Tidal volume/kg body weight, the ratio of time to peak expiratory flow to total expiratory time and the ratio of volume to peak expiratory flow to total expiratory volume in the study group were (10.70 ± 0.81) mL/kg, (41.60 ± 1.57)%, (42.89 ± 1.44)%, respectively, which were significantly higher than (9.78 ± 1.34) mL/kg, (39.18 ± 3.37)%, (40.20 ± 3.05)% in the control group ( t = 3.21, 3.56, 4.36; P < 0.001, P = 0.001, P < 0.001). Serum tumor necrosis alpha (TNF-α), interleukin-6 and interleukin-8 levels in the study group were (62.44 ± 2.96) ng/L, (46.59 ± 1.96) ng/L, (54.63 ± 3.27) ng/L, respectively, which were significantly lower than (79.86 ± 3.30) ng/L, (58.20 ± 2.10) ng/L, (63.31 ± 3.86) ng/L in the control group ( t =21.53, 22.13, 9.38, all P < 0.001). The overall incidence of pertussis in the study group was significantly lower than that in the control group (3.3% vs. 26.7%, χ2 = 4.71, P = 0.030). Conclusion:Airway humidification therapy can shorten the time to reduction of symptoms of spasmodic pertussis, improve clinical efficacy, strengthen pulmonary ventilation function, lower respiratory tract inflammatory responses and reduce the risk of pertussis-related complications.
2. Bioequivalence of rosuvastatin calcium tablets in Chinese healthy subjects
Ying CAO ; Wenping WANG ; Xiaobin LI ; Huawei WANG ; Xin SUI ; Ming YU ; Lu CHEN ; Xiaoyan DOU ; Xiujun WU ; Ran MA ; Meiye LI ; Xue GAO
Chinese Journal of Clinical Pharmacology and Therapeutics 2020;25(12):1369-1375
AIM: To study the bioequivalence of rosuvastatin calcium tablets produced by two different manufacturers on a fasting and postprandial basis in Chinese healthy subjects. METHODS: A single-center, randomized, balanced, open, two-sequence, two-cycle, double-crossover, and single-dose trial design was used in this study. Each of the fasting group and the postprandial group was enrolled in 52 healthy subjects. Fasting/postprandial oral rosuvastatin calcium tablets 10 mg test preparation or reference preparation, the validated LC-MS/MS method was used to determine the concentration of rosuvastatin calcium tablets in plasma, and the pharmacokinetic parameters were calculated. Human bioequivalence and safety evaluation of two rosuvastatin calcium tablets were evaluated. RESULTS: The t