Anti-inflammatory,anti-tussive effects and toxicity evaluation of Qingfei Dayuan granules(清肺达原颗粒)

OBJECTIVE:To study the anti-inflammatory and anti-tussive effects of Qingfei Dayuan granules(清肺达原颗粒,QFDY),and to evaluate the acute and sub-chronic toxicity of QFDY.METHODS:Anti-inflammatory effects were evaluated by murine model of xylene induced ear edema in mice.Ear swelling degree was calculated and tumor necrosis factor-α,interleukin-1βand interleukin-6 were determined.Anti-tussive evaluations were carried out in the mouse cough model induced by ammonia liquor.Latent period cough and number of cough within 3 min were counted.In acute toxicity study,the rats were randomly divided into test group and solvent control group.Body weighs,food intakes and general clinical signs were monitored.In the sub-chronic toxicity study,QFDY was administered to rats at 0,4,8 and 16 g/kg per day for 28 and 30 d of post treatment was conducted.Mortalities,clinical signs,body weight changes,food intakes,ophthalmological examinations,hematological parameters,biochemical indicators,electrolyte indicators,urinalyses and histopathological examinations were monitored.RESULTS:QFDY significantly inhibited the development of ear edema in anti-inflammatory assay and decreased cough frequency caused by ammonia liquor.The results presented a dose-effect relationship.In acute toxicity study,no abnormality exhibited at dose of 24.0 g/kg per day during the 14-d observation period.In the sub-chronic toxicity study,higher reticulocyte count,lymphocyte and lower Cl-,blood urea nitrogen were analyzed compared with the solvent control group.But the differences were considered to be incidental and not clinically toxic.Obvious dose-effect relationship of urine color was observed,and the three test groups at the end of the experiments resulted in significant increase in urobilinogen,bilirubin,ketone body and urine leukocyte.However,all the positive indicators returned to normal in the recovery period.Therefore,no toxicological changes were found during the study period.CONCLUSION:QFDY showed significant anti-inflammatory and anti-tussive effects in mice.The lethal dose(LD50)of per oral QFDY in rats was estimated to be more than 24.0 g/kg per day and the no observed adverse effect level was over 16 g/kg per day,which suggested that QFDY is relatively safe for oral medication at the present dose on rats.Our experimental results provide a reference for the further development and research of QFDY.

Add-on effect of Qinbei Qingfei Yiqi granules for ventilator-associated pneumonia in intensive care units:a randomized controlled trial

OBJECTIVE:To evaluate the add-on effect of Qinbei Qingfei Yiqi(QBQFYQ) granules for ventilator-associated pneumonia(VAP) in non-infectious critically ill patients.METHODS:In this randomized controlled trial, 80non-infectious critically ill patients undergoing mechanical ventilation in the intensive care unit(ICU)were randomly divided into two groups:those receiving QBQFYQ granules plus usual treatment(experimental group, n = 50) and those receiving only the usual treatment(control group, n = 30).The main outcome measures were VAP rate, time of VAP occurrence, duration of mechanical ventilation,and length of ICU stay.Interleukin-6(IL-6), C-reactive protein(CRP), and T-lymphocyte(CD4+, CD8+,and CD4+/CD8+ ratio) serum levels were also evaluated before and after treatment.RESULTS:Compared with the control group treatment, QBQFYQ administration significantly reduced the duration of mechanical ventilation [(9.58± 3.14) vs(12.52 ± 4.33) days] and length of ICU stay [(14.57 ± 3.72) vs(17.82 ± 5.24) days] and delayed VAP occurrence [(4.31 ± 0.86) vs(2.43 ± 0.27)days].Additionally, CRP and IL-6 serum levels and CD4+/CD8+ ratio were significantly lower in the experimental group(P < 0.05) than in the control group.However, there were no significant differences in hospital mortality rate(30.0% vs 33.3%) and adverse events(4.0% vs 6.7%).CONCLUSION:QBQFYQ delays the time of VAP occurrence and shortens the duration of mechanical ventilation in non-infectious critically ill patients,possibly through anti-inflammatory and immunomodulatory mechanisms.