含黑顺片中药饮片处方的回顾性再评价及用药风险分析OA

Objective To retrospectively re-evaluate traditional Chinese medicine decoction prescriptions containing Heishunpian with reference to the 2025 edition of the Pharmacopoeia of the People's Republic of China and to analyze medication-related risks requiring attention.Methods Outpatient traditional Chinese medicine decoction prescriptions containing Heishunpian issued at The Third People's Hospital of Henan Province from January 2024 to August 2025 were retrospectively collected,and 2,969 prescriptions were included after screening.Because all prescriptions had been issued before the official implementation of the 2025 edition of the Pharmacopoeia of the People's Republic of China,this edition was used as a unified reference standard for retrospective technical evaluation.In conjunction with relevant regulations and institutional prescription-review rules,the dose of Heishunpian,labeling of special decoction requirements,potentially inappropriate combinations related to the traditional"Eighteen Incompatibilities"and prescription–syndrome consistency were evaluated.Follow-up data related to adverse reactions were also collected.Results Among the 2,969 prescriptions,50.35%were for female patients,and prescriptions for patients aged 61–70 years accounted for the largest proportion(20.31%).The prescribed dose of Heishunpian ranged from 3 to 60 g.Using the upper recommended dose of 15 g specified in the 2025 edition of the Pharmacopoeia of the People's Republic of China as the quantitative reference,998 prescriptions(33.61%)exceeded this upper limit.A total of 1,304 prescriptions required attention,corresponding to a rate of 43.92%,and 1,357 issues requiring attention were identified.Of these,doses exceeding the upper limit recommended by the Pharmacopoeia,nonstandard labeling of special decoction requirements,and potentially inappropriate combinations related to the Eighteen Incompatibilities accounted for 73.54%,20.41%,and 6.04%,respectively.Potentially inappropriate combinations were identified in 82 prescriptions,accounting for 2.76%of all prescriptions;52 involved Pinellia-containing materia medica and 22 involved Trichosanthis Radix.After excluding 191 prescriptions that could not be evaluated,2,778 prescriptions were included in the prescription–syndrome consistency assessment,and all 2,778 were judged to be consistent,yielding a consistency rate of 100.00%.Within the available follow-up and adverse reaction monitoring data,no Heishunpian-related adverse reactions with a causality assessment of"possibly related"or higher were confirmed.Conclusion Retrospective re-evaluation using the 2025 edition of the Pharmacopoeia of the People's Republic of China as the reference standard showed that prescriptions containing Heishunpian require particular attention with regard to doses exceeding the recommended upper limit,nonstandard labeling of special decoction requirements,and potentially inappropriate combinations related to the Eighteen Incompatibilities.Because all included prescriptions were issued before the official implementation of the 2025 edition of the Pharmacopoeia,these findings represent a retrospective technical assessment based on a newer standard and should not be interpreted as a definitive judgment that the original prescriptions were clinically inappropriate.System-based alerts,dual-signature review,standardized labeling of special decoction requirements,focused review of potentially incompatible combinations,and continuous pharmacist involvement may serve as key measures for subsequent risk management.