TY  - JOUR
AU  - Wang, Mengmeng
AU  - Wang, Lianxin
AU  - Liu, Fumei
AU  - Chen, Renbo
AU  - Wang, Zhifei
AU  - Cui, Xin
AU  - Li, Yuanyuan
AU  - Xie, Yanming
PY  - 2025
DA  - 2025/3/21
TI  - Clinical Safety of Pudilan Xiaoyan Oral Liquid for the Treatment of Upper Respiratory Tract Infection in the Real World: Protocol for a Prospective, Observational, Registry Study
JO  - JMIR Res Protoc
SP  - e65789
VL  - 14
KW  - Pudilan Xiaoyan oral liquid
KW  - PDL
KW  - upper respiratory tract infection
KW  - URTI
KW  - registry
KW  - adverse drug reaction
AB  - Background: Pudilan Xiaoyan oral liquid (PDL) is a proprietary Chinese medicine preparation widely used for upper respiratory tract infection, known for its significant therapeutic effects. However, the safety profiles reported in several observational studies vary, and these studies primarily focus on efficacy rather than specifically addressing safety concerns, thus representing inadequate safety monitoring. Objective: This study aimed to investigate the incidence of adverse drug reactions (ADRs) associated with PDL and explore the factors contributing to these reactions. Methods: The study is a prospective, observational, multicenter, hospital-based surveillance study. A total of 17 hospitals from China are involved. The study is expected to enroll a large sample of 10,000 patients aged between 18 and 80 years with upper respiratory tract infection who were prescribed PDL. The patients’ data, including demographics, medical history, diagnostic information, medication details, adverse events, and laboratory test results, will be monitored. The occurrence of ADRs will be recorded. The primary outcome is the incidence of ADR. Secondary outcomes are the ratio of patients whose body temperature return to the normal range (cases of body temperature normalization and the duration for achieving normal body temperature within a 3-day period will be documented) and changes in liver and kidney function (occurrence of drug-induced liver injury and acute kidney injury). Descriptive analyses will be performed for the primary and secondary outcomes. A cohort, nested, case-control study design will be used. If one patient has an ADR, then 4 patients without ADRs will be matched as the control group according to gender, age within 5 years, drug batch, and other factors, at a ratio of 1∶4 to compare the symptoms related to ADRs. The differences of ADR incidence among the possible influencing factors will be compared separately to find the factors with large differences. Then, synthetic minority oversampling technique and group least absolute shrinkage and selection operator methods will be used to identify factors influencing the occurrence of ADRs. Finally, propensity scoring methods will be used to control for confounding variables. The progress of each subcenter will be closely monitored, and the incidence of ADR will be systematically calculated. Furthermore, the characteristics and influencing factors of ADR will be analyzed, along with an investigation into its geographical distribution. Results: The study began on July 17, 2019. Due to the limited number of eligible patients, missed follow-ups, and the huge clinical burden caused by public health events in 2019, the final case will be enrolled on August 30, 2025. Conclusions: This study will obtain safety results of PDL in the real world and provide guidance on the clinical safety of traditional Chinese medicine formulations. Trial Registration: ClinicalTrials.gov NCT04031651; https://clinicaltrials.gov/study/NCT04031651 International Registered Report Identifier (IRRID): DERR1-10.2196/65789 
SN  - 1929-0748
UR  - https://www.researchprotocols.org/2025/1/e65789
UR  - https://doi.org/10.2196/65789
DO  - 10.2196/65789
ID  - info:doi/10.2196/65789
ER  -