[Efficacy and safety of Kangbingdu granules in the treatment of influenza: a randomized, double-blind, double-dummy, positive-drug parallel control multicenter clinical trial].

Objective: To observe the efficacy and safety of Kangbingdu granules (KBD) in the treatment of influenza. Methods: A multicenter, randomized, double-blind, double-dummy, and positive-drug parallel control trial was conducted in 27 Grade ⅢA hospitals in China and the subjects were randomly assigned to the KBD test group or the oseltamivir phosphate capsule control group at a ratio of 1∶1. 200 subjects were planned to be enrolled in each group. The experimental group was given KBD (18g each time, 3 times a day) and oseltamivir phosphate simulator orally, while the control group was given oseltamivir phosphate capsule (75 mg each time, twice a day) and KBD simulator orally for 5 days. The primary efficacy indicators included the remission time of major clinical symptoms and the time of complete defervescence. The secondary efficacy indicators included dosage of acetaminophen, the change of traditional Chinese medicine (TCM) syndrome score and the remission time of other important clinical symptoms. The efficacy of KBD in the test group and Oseltamivir phosphate control group were compared. Adverse events or adverse reactions were observed at the same time to evaluate the safety of KBD Granules. Results: A total of 393 subjects from 27 Grade ⅢA hospitals in China were enrolled. The experimental group included 195 subjects and 191 subjects (97.95%) completed the trial, While the control group included 198 subjects and 195 subjects (98.48%) completed the trial. There was no significant difference in the shedding rate and rejection rate between the two groups (P>0.05). In the Full Analysis Set (FAS), the mean age of the experimental group was (34.9±14.4) years old, with 83 males (42.78%). The mean age of the control group was (33.3±13.5) years old, with 78 males (39.59%). There were no statistically significant differences between the two groups in demographic data, physical examination, viral pathogen detection, total score of TCM syndromes and scores of each symptom at baseline (P>0.05). In the FAS, the remission time M (Q1, Q3) of major clinical symptoms was 3.0 (3.0, 4.0) days in the experimental group and 3.0 (3.0, 4.0) days in the control group, and the difference was not statistically significant (P>0.05). The time M (Q1, Q3) of complete defervescence was 34.0 (20.3, 49.0) hours in the experimental group and 36.5 (19.6, 48.8) hours in the control group, and the difference was not statistically significant (P>0.05). KBD granules had the same effect as Oseltamivir phosphate capsule (P>0.05) in terms of acetaminophen dosage, TCM syndrome effect and disappearance rate of most important clinical symptoms. Meanwhile, the disappearance rate of dizziness and chest distress on day 3 in the KBD granules group was better than that of oseltamivir phosphate capsule (P<0.05). Conclusion: KBD granules have the same efficacy as Oseltamivir Phosphate capsule in the treatment of influenza and the drug safety is good.

[Analysis of short-term respiratory adverse events in 183 bronchial thermoplasty procedures].

Objective: To analyze the short-term (3 weeks) adverse respiratory events after bronchial thermoplasty(BT) in patients with severe asthma. Methods: The China-Japan Friendship Hospital recruited 62 patients with severe asthma for BT treatment from March 2014 to July 2016, with a total of 183 BT procedures. The data of adverse respiratory events within 3 weeks after procedure were collected to analyze the factors that might potentially influence the occurrence of adverse events. Results: Forty-three patients (69.4%) experienced adverse respiratory events within 3 weeks after treatment. Totally 153 adverse respiratory events occurred after 87 procedures(47.5%). The main adverse events were cough (15 events, 8.20%), sputum production (37 events, 20.22%), temporary PEF reduction (37 events, 20.22%), chest distress (12 events, 6.56%), blood in sputum (11 events, 6.01%), asthma exacerbation (10 events, 5.46%), and pneumonia(6 events, 3.28%). Most events were relieved or resolved with standard therapy in 1 week. No severe adverse events including tracheal intubation, malignant arrhythmias or death occurred within 3 weeks after procedure. The baseline eosinophil percentage in induced sputum and blood, operation times, and preoperative FEV(1) (% predicted) might influence the occurrence of adverse events after treatment. Patients with preoperative FEV(1) (% predicted) ≥60% had lower risk of adverse events. Conclusion: BT showed a good security profile in treating patients with severe asthma within 3 weeks after procedure.