Dual-scenario real-world study and pharmaceutical care strategy analysis of dalteparin sodium in orthopedic patients

doi:10.12092/j.issn.1009-2501.2026.07.007

Abstract

Abstract:

AIM: To analyze the asymmetric risk pattern of "controllable bleeding in prophylaxis versus suboptimal dosing in treatment" during dalteparin sodium use in orthopedic patients using a dual-scenario framework, providing insights for refined anticoagulation management. METHODS: This retrospective study included 200 inpatients receiving dalteparin sodium in an orthopedic department (September 2023 to March 2025). Patients were categorized into prophylaxis (n=185) and treatment (n=15) groups. Multivariate logistic regression identified bleeding risk factors in the prophylaxis group, with stratified analysis and propensity score matching (PSM) assessing potential confounding by indication. For the small treatment group, exploratory analyses (Fisher's exact test, Firth regression, Bayesian methods) were employed. RESULTS: In the prophylaxis group, bleeding events occurred in 22.70% of patients. A Caprini score ≥5 was an independent risk factor (OR=8.06, 95%CI: 1.79–36.20, P=0.007), while inappropriate dosing timing was associated with reduced bleeding risk (OR=0.14, 95%CI: 0.05–0.46, P=0.001). Stratified analysis and PSM suggested confounding by indication. In the treatment group, subtherapeutic dosing was observed in 93.33% of patients, with a 21.43% treatment failure rate. All failures occurred in the subtherapeutic dosing subgroup, though sample size limitations precluded definitive conclusions. CONCLUSION: Dalteparin sodium use in orthopedics shows a dual-scenario pattern: concentrated bleeding risk in prophylaxis and prevalent dosing deviations in treatment. A Caprini score ≥5 serves as a key bleeding risk indicator in prophylaxis. Failure to implement weight-stratified dosing may contribute to therapeutic failure. The proposed tiered pharmaceutical care framework offers practical guidance for optimizing dalteparin sodium use in orthopedic practice.

Key words: dalteparin sodium, orthopedics, bleeding events, treatment failure, real-world study

CLC Number:

R969.3

Yan LIU, Ji QIU, Guocui WU, Ruilin LI, Yizhao CHEN. Dual-scenario real-world study and pharmaceutical care strategy analysis of dalteparin sodium in orthopedic patients[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2026, 31(7): 913-920.

Figures/Tables 6

References 21

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Variable	Bleeding group (n=42)	Non-bleeding group (n=143)	OR (95%CI)	P
Inappropriate administration timing	4(9.52)	72(50.35)	0.10 (0.04-0.31)	<0.001
Caprini score ≥5	40(95.24)	87(60.84)	12.87 (2.99-55.39)	<0.001
Anemia	7(16.67)	6(4.20)	4.57 (1.44-14.45)	0.011*
Age ≥65 years	25(59.52)	56(39.16)	2.28 (1.13-4.61)	0.019
Male sex	15(35.71)	66(46.15)	1.54 (0.76-3.14)	0.23
Initial hemoglobin <115 g/L	6(14.29)	31(21.68)	0.60 (0.23-1.56)	0.30
Concomitant systemic NSAID use	40(95.24)	139(97.20)	0.58 (0.10-3.26)	0.62*
eGFR<60 mL/min	1(2.38)	11(7.69)	0.92 (0.25-3.48)	1.00*

Variable	Bleeding group (n=42)	Non-bleeding group (n=143)	OR (95%CI)	P
Inappropriate administration timing	4(9.52)	72(50.35)	0.10 (0.04-0.31)	<0.001
Caprini score ≥5	40(95.24)	87(60.84)	12.87 (2.99-55.39)	<0.001
Anemia	7(16.67)	6(4.20)	4.57 (1.44-14.45)	0.011*
Age ≥65 years	25(59.52)	56(39.16)	2.28 (1.13-4.61)	0.019
Male sex	15(35.71)	66(46.15)	1.54 (0.76-3.14)	0.23
Initial hemoglobin <115 g/L	6(14.29)	31(21.68)	0.60 (0.23-1.56)	0.30
Concomitant systemic NSAID use	40(95.24)	139(97.20)	0.58 (0.10-3.26)	0.62*
eGFR<60 mL/min	1(2.38)	11(7.69)	0.92 (0.25-3.48)	1.00*

Variable	β	SE	OR(95%CI)	P	VIF
Caprini score ≥5	2.09	0.77	8.06(1.79-36.20)	0.007	1.062
Inappropriate administration timing	?1.90	0.57	0.14(0.05-0.46)	0.001	1.062
Constant	?2.73	0.76	—	<0.001	—

Variable	β	SE	OR(95%CI)	P	VIF
Caprini score ≥5	2.09	0.77	8.06(1.79-36.20)	0.007	1.062
Inappropriate administration timing	?1.90	0.57	0.14(0.05-0.46)	0.001	1.062
Constant	?2.73	0.76	—	<0.001	—

Subgroup	Variable	β	SE	OR(95%CI)	P
Caprini score ≥5 (n=127,40 bleeding events)	Inappropriate administration timing	?1.890	0.594	0.151 (0.047-0.484)	0.001
	Anemia	0.717	0.642	2.047 (0.581-7.212)	0.265
	Age≥65 years	0.623	0.421	1.864 (0.816-4.257)	0.139
	Concomitant systemic NSAID use	?1.790	1.342	0.167 (0.012-2.317)	0.182