OBJECTIVE To investigate and analyze the medication information for special populations in the package inserts and guidelines/consensuses of domestic low molecular weight heparin(LMWH) preparations. To provide an evidence base for rational clinical medication use, revision of drug package inserts, comprehensive clinical evaluation of drugs, and optimization of regulatory policies.
METHODS Based on the National Medical Products Administration(NMPA) drug database and the 2024 National Drug Information Standard Database V11.0, and in conjunction with actual clinical practice, the package inserts of domestic LMWH preparations as well as domestic and international guidelines/consensuses were collected. Information pertaining to medication use in special populations—including pediatric patients, pregnant and lactating women, elderly patients, and patients with hepatic or renal impairment—was extracted. This information covered clinical data support, dosage recommendations, statements on safety and efficacy, stage-specific advice(e.g., by trimester of pregnancy), and monitoring requirements. The collected data were then systematically classified and analyzed.
RESULTS A total of 34 package inserts for 6 different LMWH products were analyzed. For pediatric use, all inserts lacked clinical data; 17 did not recommend use, 1 listed it as a contraindication, and only 2 mentioned its use for hemodialysis in children aged 6–16. For pregnant women, 26 inserts noted no teratogenicity in animal studies but lacked trimester-specific recommendations; only dalteparin sodium provided pharmacokinetic(PK) data, and 31 recommended use under limited conditions. For lactating women, only dalteparin sodium included PK data on excretion into breast milk, with most inserts advising the discontinuation of breastfeeding or not recommending use. Information for elderly patients was relatively complete: 33 inserts recommended use, 27 provided dosage suggestions, and 18 advised monitoring anti-factor Xa levels; however, PK data was lacking for all products except enoxaparin sodium. Recommendations for patients with hepatic impairment were vague; only 5 inserts for enoxaparin sodium provided specific advice based on the type of impairment, while the remainder merely stated "use with caution". In contrast, data for patients with renal impairment were more detailed, with clearly differentiated recommendations based on varying levels of renal function. Twenty-three inserts included PK data, and all products were indicated as usable for hemodialysis patients.
CONCLUSION The information regarding the use of LMWH preparations in special populations, as presented in the package inserts, lags behind the progress of evidence-based medicine. It is imperative to strengthen the dynamic revision mechanism for package inserts, improve the reference framework for the comprehensive clinical evaluation of these drugs, and thereby promote rational clinical use and the optimization of drug regulatory policies.
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