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 observe the effect of treating asthma in remission stage(Latent phlegm in lung syndrome) withJinlong-Gubenmixture.Methods 108 patients of asthma on remission stage were randomized into a control group and a treatment group. The treatment group was givenJinLong-GuBen mixture. The control group was given nothing for treatment. Both groups were treated for 120 days and follow-up period were 360 days. The change of ACT scores and FEV1 was observed.Results After treatment, ACT scores(t=2.931, 2.618) and FEV1(t=2.011, 2.680) of treatment groups were markedly increased than before the treatment(P<0.05), and the effect of the treatment group was better than the control group(P<0.01). After treatment, the effective rate of treatment group was 93.75%(45/48), and the effective rate of control group was 78.72%(37/47),there existed statistical significance between the two groups(U=-0.4531,P<0.01). Conclusion The theory of latent phlegm in lung has a good guiding function in treating asthma in remission stage(Latent phlegm in lung syndrome).
ABSTRACT
Objective To survey the epidemiological situation of asthma in remission stage in Liaoning province,and provide evidence for preventing and treating asthma.Methods 800 patients of asthma in the remission stage were investigated through the questionnaire investigation.Results Onset age of asthma in Liaoning province was 30～40 years old.The sex ratio between male and female was 1 ∶ 1.34.The number of staff was the highest (25.75％).Most of the course of asthma was 1～5 years (33.50％).The number of patients who often receive treatments was 59 (7.38％)and the number of patients with allergy history was 531 (66.38％).Conclusion Prevention,management and treatment of asthma should be strengthened.