A Multicenter Clinical Trial of Pudilan Anti-inflammatory Oral Liquid of Different Doses in Treatment of Acute Pharyngitis/Tonsillitis Caused by Bacterial Infection in Adults
10.13422/j.cnki.syfjx.20231990
- VernacularTitle:不同剂量蒲地蓝消炎口服液治疗细菌感染所致成人急性咽炎/扁桃体炎的多中心临床研究
- Author:
Dinglei LI
1
;
Yinghai CUI
1
;
Xuefeng YU
1
;
Min PANG
1
;
Wei ZHANG
2
;
Zhanping MA
3
;
Nianzhi ZHANG
4
;
Tao HUANG
5
;
Mingbo LIAO
6
;
Yiqing QU
7
;
Zhuying LI
8
;
Xiu GU
9
;
Liqi NI
10
Author Information
1. Liaoning Academy of Traditional Chinese Medicine（TCM），The Second Affiliated Hospital of Liaoning University of TCM，Shenyang 110034，China
2. Shuguang Hospital，Shanghai University of TCM，Shanghai 201203，China
3. Shaanxi Provincial Hospital of Chinese Medicine，Xi'an 710003，China
4. The First Affiliated Hospital of Anhui University of Chinese Medicine，Hefei 230601，China
5. Changchun University of Chinese Medicine Hospital，Changchun 130021，China
6. The First Clinical Hospital of Jilin Academy of TCM，Changchun 130021，China
7. Qilu Hospital of Shandong University，Jinan 250063， China
8. First Affiliated Hospital，Heilongjiang University of Chinese Medicine，Harbin 150040，China
9. The Fourth Affiliated Hospital of China Medical University，Shenyang 110165，China
10. Jichuan Pharmaceutical Group Co.Ltd.，Taizhou 225400，China
- Publication Type:Journal Article
- Keywords:
Pudilan anti-inflammatory oral liquid;
acute pharyngitis;
acute tonsillitis;
amoxicillin capsules;
multi-center clinical research
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2023;29(19):136-144
- CountryChina
- Language:Chinese
-
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.
