1.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
Dinglei LI ; Yinghai CUI ; Xuefeng YU ; Min PANG ; Wei ZHANG ; Zhanping MA ; Nianzhi ZHANG ; Tao HUANG ; Mingbo LIAO ; Yiqing QU ; Zhuying LI ; Xiu GU ; Liqi NI
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(19):136-144
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.
2.Symptom network topological features predict the effectiveness of herbal treatment for pediatric cough.
Mengxue HUANG ; Jingjing WANG ; Runshun ZHANG ; Zhuying NI ; Xiaoying LIU ; Wenwen LIU ; Weilian KONG ; Yao CHEN ; Tiantian HUANG ; Guihua LI ; Dan WEI ; Jianzhong LIU ; Xuezhong ZHOU
Frontiers of Medicine 2020;14(3):357-367
Pediatric cough is a heterogeneous condition in terms of symptoms and the underlying disease mechanisms. Symptom phenotypes hold complicated interactions between each other to form an intricate network structure. This study aims to investigate whether the network structure of pediatric cough symptoms is associated with the prognosis and outcome of patients. A total of 384 cases were derived from the electronic medical records of a highly experienced traditional Chinese medicine (TCM) physician. The data were divided into two groups according to the therapeutic effect, namely, an invalid group (group A with 40 cases of poor efficacy) and a valid group (group B with 344 cases of good efficacy). Several well-established analysis methods, namely, statistical test, correlation analysis, and complex network analysis, were used to analyze the data. This study reports that symptom networks of patients with pediatric cough are related to the effectiveness of treatment: a dense network of symptoms is associated with great difficulty in treatment. Interventions with the most different symptoms in the symptom network may have improved therapeutic effects.