ABSTRACT
ObjectiveThrough a randomized， double-blind， double-simulation， positive-control， multicenter design， this study aimed to analyze the relationship between the dosage， efficacy， and safety of Pudilan anti-inflammatory oral liquid in treating acute pharyngitis/tonsillitis in adults caused by bacterial infection and validate the regulatory effect of Pudilan anti-inflammatory oral liquid on inflammatory markers such as serum amyloid A （SAA）， C-reactive protein （CRP）， white blood cells （WBC）， neutrophil percentage （NE%）， and erythrocyte sedimentation rate （ESR）， thereby exploring the feasibility of using Pudilan anti-inflammatory oral liquid as a substitute for antibiotics in the treatment of infectious diseases and providing a basis for rational clinical medication. MethodUsing a stratified randomized， double-blind， double-simulation， positive-control， multicenter design， 220 participants were enrolled from nine centers. The participants were randomly divided into three groups at 1∶1∶1 — a Pudilan anti-inflammatory oral liquid 20 mL group （73 cases）， a Pudilan anti-inflammatory oral liquid 10 mL group （73 cases）， and a control group （amoxicillin group， 74 cases）. The treatment course was 7 days. The study observed parameters including the total effective rate of sore throat， onset and disappearance time of sore throat， health status score， treatment time， and inflammation markers. Result①Dataset division： The 211 cases were included in the full analysis dataset （FAS）， 208 cases were included in the per-protocol dataset （PPS）， and 218 cases were included in the safety dataset （SS）. ② Efficacy evaluation： There were statistically significant differences （P<0.05） in the comparison of the three groups regarding the total effective rate of sore throat， disappearance time of sore throat， and health status. Both the 20 mL and 10 mL groups were non-inferior to the control group， and there was a statistically significant difference between the 20 mL and 10 mL dosage groups （P<0.05）. There was no statistically significant difference in the comparison of onset time of sore throat among the groups. CRP， WBC， and NE% of patients in all three groups significantly decreased on the 7th day of treatment compared with those before treatment （P<0.01）. ③Safety evaluation： Adverse events mainly occurred in various examination indicators. There were no statistically significant differences in the comparison between groups， and no adverse reactions or serious adverse events occurred. ④Economic evaluation： The increased cost of the 10 mL and 20 mL dosage groups was entirely justified as compared with that in the control group. When comparing the 10 mL and 20 mL dosage groups， the 10 mL dosage group was deemed less advantageous. ConclusionPudilan anti-inflammatory oral liquid can be used alone as an alternative to antibiotics in the treatment of acute pharyngitis/tonsillitis caused by bacterial infection. It demonstrates good safety and can lower inflammation markers such as CRP， WBC， and NE%， suggesting its potential to reduce the body's inflammatory response. Its mechanism of action may be related to its multi-target regulatory mechanism.
ABSTRACT
Objective To explore the characteristics and clinical significance of CD+4 CD+25 Regulatory T lymphocytes and T cell subsets in peripheral blood and malignant pleural effusion from lung cancer patients. Methods Flow cytometry was used to detect the percentage of CD+4 CD+25 regulatory T cells and T cell subsets in peripheral blood from 68 lung cancer patients and 56 healthy persons, and in pleural effusion from 32 lung cancer patients with malignant effusion. Results T lymphocyte subsets in peripheral blood of lung cancer patients in different periods were expressed differently. The percentage of CD+4 CD+25 regulatory T cells in peripheral blood were (19.52±3.32)%, (27.28±8.26)% and (32.31±15.60)% in Ⅰ+Ⅱ, Ⅲ and Ⅳ period lung cancer patients, respectively, and were higher than that of healthy volunteers (11.12±3.32) % (t =31.0040, -7.9688, -4.9770, P ＜0.05). In the lung cancer patients with malignant effusion, the percentage of CD+4 CD+25 regulatory T cells in the pleural effusion was higher than that in the peripheral blood [(34.12±18.63) % vs (26.36± 16.25)%, t =21.164, P＜0.05]. In the lung cancer patients with malignant effusion ,the percentages of CD+4 in peripheral blood and pleural effusion were (25.32±13.45) % and (34.68±12.34) %, were lower than that in healthy volunteers (t =7.3104, 4.8818, P＜0.05), the percentages of CD+56 were (8.24±7.38) % and(11.23± 7.65) %, CD+4/CD+8 were (1.02±0.56) % and (1.32±0.82)%, were lower than (18.23±9.23) % and (1.89± 0.32) % in healthy volunteers, respectively, (CD+56: t =-14.7549, -11.7216; CD+4/CD+8: t =-24.78,-4.4564, P＜0.05). Conclusion The relative increase of CD+4 CD+25 Regulatory T cells may be related to immunosuppression and tumor progression in patients with lung cancer. Conclusion The relative increase of CD+4 CD+25 regulatory T cells may be related to immunosuppression and tumor progression in patients with lung cancer.
ABSTRACT
Objective:To explore the expression of intercellular adhesion molecule-1(ICAM-1 )induced by cigarette smoking extract(CSE) as well as the influence of the adenovirus E1A gene in pulmonary epithelial cells.Methods:A549 cells were transfected with a plasmid carrying the adenovirus E1A gene and stable trasfectants expressing E1A protein were selected. The cells were tested for the expression of ICAM-1 after stimulation with different concentrations of CSE.Results:ICAM-1expression was increased in A549 markedly with CSE stimulation,and the higher CSE concentration were,the more expression of ICMA-1 was observed. As compared with parental cells or cells transfected with control plasmid, ICAM-1 expression was markedly increased with stimulation of different concentrations of CSE in E1A-positive A549 cells.Conclusion:CSE exposure induces the surface expression of ICAM-1 and adenovirus E1A gene can markedly increase ICAM-1 expression induced by CSE in pulmonary epithelial cells, which suggest that latent adenovirus infection may amplify the inflammation process present in airways of smokers.