{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,4]],"date-time":"2026-08-04T14:50:31Z","timestamp":1785855031785,"version":"3.56.0"},"reference-count":34,"publisher":"JMIR Publications Inc.","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JMIR Res Protoc"],"abstract":"\n Background<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n This study aimed to investigate the incidence of adverse drug reactions (ADRs) associated with PDL and explore the factors contributing to these reactions.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n 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\u2019 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\u22364 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.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n This study will obtain safety results of PDL in the real world and provide guidance on the clinical safety of traditional Chinese medicine formulations.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n ClinicalTrials.gov NCT04031651; https:\/\/clinicaltrials.gov\/study\/NCT04031651<\/jats:p>\n <\/jats:sec>\n \n International Registered Report Identifier (IRRID)<\/jats:title>\n DERR1-10.2196\/65789<\/jats:p>\n <\/jats:sec>","DOI":"10.2196\/65789","type":"journal-article","created":{"date-parts":[[2025,3,21]],"date-time":"2025-03-21T15:53:32Z","timestamp":1742572412000},"page":"e65789","source":"Crossref","is-referenced-by-count":1,"title":["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"],"prefix":"10.2196","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0009-0001-3923-4336","authenticated-orcid":false,"given":"Mengmeng","family":"Wang","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7321-4315","authenticated-orcid":false,"given":"Lianxin","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-8958-6930","authenticated-orcid":false,"given":"Fumei","family":"Liu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-5557-0954","authenticated-orcid":false,"given":"Renbo","family":"Chen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5687-1070","authenticated-orcid":false,"given":"Zhifei","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2257-6724","authenticated-orcid":false,"given":"Xin","family":"Cui","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8263-6130","authenticated-orcid":false,"given":"Yuanyuan","family":"Li","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5359-4242","authenticated-orcid":false,"given":"Yanming","family":"Xie","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1010","published-online":{"date-parts":[[2025,3,21]]},"reference":[{"issue":"11","key":"ref1","first-page":"2143","volume":"66","author":"Del 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Medicine"},{"key":"ref7","doi-asserted-by":"publisher","DOI":"10.1038\/s41392-020-0176-0"},{"key":"ref8","doi-asserted-by":"publisher","DOI":"10.1016\/j.phymed.2023.155037"},{"key":"ref9","doi-asserted-by":"publisher","DOI":"10.1111\/jphp.13129"},{"key":"ref10","doi-asserted-by":"publisher","DOI":"10.1016\/j.foodchem.2021.131380"},{"key":"ref11","doi-asserted-by":"publisher","DOI":"10.1016\/j.jep.2021.114648"},{"key":"ref12","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2018.01264"},{"key":"ref13","doi-asserted-by":"publisher","DOI":"10.1146\/annurev.publhealth.012809.103649"},{"key":"ref14","first-page":"i","author":"Strom, BL","year":"2012","journal-title":"Pharmacoepidemiology"},{"key":"ref15","doi-asserted-by":"publisher","DOI":"10.19335\/j.cnki.2096-1219.2021.26.007"},{"key":"ref16","doi-asserted-by":"publisher","DOI":"10.19540\/j.cnki.cjcmm.20200102.501"},{"key":"ref17","doi-asserted-by":"publisher","DOI":"10.19288\/j.cnki.issn.1000-2723.2017.06.017"},{"key":"ref18","doi-asserted-by":"publisher","DOI":"10.19540\/j.cnki.cjcmm.2017.0045"},{"key":"ref19","author":"Xie, Y","year":"2021","journal-title":"The Inclusion of Evidence-Based Traditional Chinese Medicine (TCM) in the 14th Five-Year Plan for Higher Education of the TCM Industry in China"},{"key":"ref20","doi-asserted-by":"publisher","DOI":"10.2215\/CJN.00150118"},{"key":"ref21","doi-asserted-by":"publisher","DOI":"10.13422\/j.cnki.syfjx.20231990"},{"key":"ref22","doi-asserted-by":"publisher","DOI":"10.1007\/s00204-020-02963-4"},{"key":"ref23","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.e7586"},{"key":"ref24","unstructured":"National Medical Products AdministrationGuide to key drug monitoring for manufacturing enterprisesGuide to key drug monitoring for manufacturing enterpriseshttps:\/\/www.nmpa.gov.cn\/directory\/web\/nmpa\/\/xxgk\/zhqyj\/zhqyjyp\/20130325113801579.html"},{"key":"ref25","doi-asserted-by":"publisher","DOI":"10.19540\/j.cnki.cjcmm.20190509.504"},{"key":"ref26","doi-asserted-by":"publisher","DOI":"10.13412\/j.cnki.zyyl.2020.02.019"},{"key":"ref27","unstructured":"Administrative measures on reporting and monitoring adverse drug reactions (Decree No. 81 of the Ministry of Health) [Article in Chinese]National Health Commission of China20115242025-03-05http:\/\/www.nhc.gov.cn\/fzs\/s3576\/201105\/ac4ab24c135a43379f2af1694457f65e.shtml"},{"key":"ref28","unstructured":"CIOMS Working Group IIIGuidelines for preparing core clinical-safety information on drugsCouncil for International Organizations of Medical Sciences19952025-03-05https:\/\/cioms.ch\/wp-content\/uploads\/2018\/03\/WG3_Guidelines-for-Preparing-Core-Clinical-Safety-Information-on-Drugs.pdf"},{"issue":"5","key":"ref29","first-page":"320","volume":"5","year":"2008","journal-title":"Chinese Journal of Pharmacovigilance"},{"key":"ref30","first-page":"56","volume":"6","year":"2006","journal-title":"Chinese Journal of Pharmacovigilance"},{"key":"ref31","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.2011.58"},{"key":"ref32","doi-asserted-by":"publisher","DOI":"10.1186\/cc11454"},{"key":"ref33","doi-asserted-by":"publisher","DOI":"10.7150\/ijbs.45538"},{"key":"ref34","doi-asserted-by":"publisher","DOI":"10.1503\/cmaj.202026"}],"container-title":["JMIR Research 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