Efficacy and safety of rivaroxaban in the treatment of lower extremity calf muscle vein thrombosis after hip/knee arthroplasty

doi:10.3877/cma.j.issn.2096-0263.2019.04.001

Abstract

Abstract:

Objective

To observe the efficacy and safety of rivaroxaban in the treatment of lower extremity calf muscle vein thrombosis after total hip/knee arthroplasty.

Methods

From January 2016 to December 2017, 220 patients with lower extremity calf muscle vein thrombosis after unilateral total hip/knee arthroplasty were selected. They were randomly divided into the experimental group and the control group, with 110 cases in each group. The experimental group was given rivaroxaban 10 mg(po bid), on the basis of physical therapy. The control group was given rivaroxaban 10 mg(po qd), on the basis of physical therapy. At 3rd, 7th and 14th day after treatment, the dissolution rate of lower extremity calf muscle vein thrombosis and the incidence of bleeding tendency events such as ecchymosis, incision infection, and hematoma around the incision were observed.

Results

All patients were followed up. There was no statistically significant difference in basic informations between the two groups (P>005). At 3rd, 7th and 14th day after treatment, the thrombolytic efficiencies of the experimental group were 32.73%, 55.45% and 70%, respectively, which were higher than 1.82%, 12.73% and 25.45% of the control group. The difference between the two groups was statistically significant (P<0.05). After 3rd day of treatment, the hardness of the two groups of thrombus was soft (mainly red, P>0.05). At 7th day, the hardness of the experimental group (2.63±0.67) was higher than that of the control group (1.95±0.92). The difference was statistically significant (t=7.63, P<0.001), and after 14h day, the hardness of the lower extremity venous thrombosis was higher than the mean hardness (blue-green, P>0.05). There was no significant difference in the difference of red blood cell count and hemoglobin between the two groups before and after operation (P>0.05). The incidence of ecchymosis in the lower extremities was 18.06% and 18.42%, respectively, and the difference was not statistically significant (χ²=0.003, P=0.95). No incision infection or hematoma around the incision occurred in all patients.

Conclusion

High-dose rivaroxaban (20 mg) combined with physical pressure is safe and effective for the treatment of lower extremity calf muscle vein thrombosis after hip/knee arthroplasty.

Key words: Arthroplasty, Replacement, Hip, Deep vein thrombosis, Calf muscle vein thrombosis, Rivaroxaban

Chengzhi Ha, Dawei Wang, Kai Wang, Wei Li. Efficacy and safety of rivaroxaban in the treatment of lower extremity calf muscle vein thrombosis after hip/knee arthroplasty[J]. Chinese Journal of Geriatric Orthopaedics and Rehabilitation(Electronic Edition), 2019, 05(04): 184-189.

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References 18

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组别	例数	年龄（岁）	性别（男/女）	BMI（kg/m²）	THA/TKA（例）	THA病因（例）
组别	例数	年龄（岁）	性别（男/女）	BMI（kg/m²）	THA/TKA（例）	股骨头坏死	OA	DDH	强直性脊柱炎
试验组	110	65.44±4.25	35/75	24.83±2.27	38/72	18	10	8	2
对照组	110	64.98±5.30	38/72	25.25±2.16	34/76	15	8	10	1
统计值		t=0.713	χ²=0.193	t=1.414	χ²=0.329	χ²=0.832
P值		0.480	0.781	0.162	0.672	0.843
组别	例数	TKA病因（例）				并发症（有/无，例）
组别	例数	OA	RA	创伤性关节炎	高血压	冠心病	糖尿病	呼吸系统疾病
试验组	110	61	8	3	46/64	12/98	22/88	30/80
对照组	110	62	10	4	48/62	14/96	21/89	28/82
统计值		χ²=0.272			χ²=0.072	χ²=0.168	χ²=0.032	χ²=0.092
P值		0.883			0.792	0.684	0.873	0.762

组别	例数	年龄（岁）	性别（男/女）	BMI（kg/m²）	THA/TKA（例）	THA病因（例）
组别	例数	年龄（岁）	性别（男/女）	BMI（kg/m²）	THA/TKA（例）	股骨头坏死	OA	DDH	强直性脊柱炎
试验组	110	65.44±4.25	35/75	24.83±2.27	38/72	18	10	8	2
对照组	110	64.98±5.30	38/72	25.25±2.16	34/76	15	8	10	1
统计值		t=0.713	χ²=0.193	t=1.414	χ²=0.329	χ²=0.832
P值		0.480	0.781	0.162	0.672	0.843
组别	例数	TKA病因（例）				并发症（有/无，例）
组别	例数	OA	RA	创伤性关节炎	高血压	冠心病	糖尿病	呼吸系统疾病
试验组	110	61	8	3	46/64	12/98	22/88	30/80
对照组	110	62	10	4	48/62	14/96	21/89	28/82
统计值		χ²=0.272			χ²=0.072	χ²=0.168	χ²=0.032	χ²=0.092
P值		0.883			0.792	0.684	0.873	0.762

组别	治疗前	治疗后3 d		治疗后7 d		治疗后14 d		治疗后35 d
组别	直径（cm）	有效率（%）	直径（cm）	有效率（%）	直径（cm）	有效率（%）	直径（cm）	有效率（%）	直径（cm）
试验组（38）	0.63±0.07	26.37	0.55±0.07	47.47	0.42±0.12	71.05	0.27±0.12	76.32	0.28±0.12
对照组（34）	0.66±0.07	2.94	0.58±0.07	14.71	0.55±0.12	26.47	0.41±0.07	32.35	0.40±0.11
统计值	t=1.718	χ²=7.575	t=1.736	χ²=8.806	t=4.489	χ²=14.266	t=5.208	χ²=14.046	t=4.345
P值	0.090	0.007	0.088	0.005	<0.01	<0.01	<0.01	<0.01	<0.01

组别	治疗前	治疗后3 d		治疗后7 d		治疗后14 d		治疗后35 d
组别	直径（cm）	有效率（%）	直径（cm）	有效率（%）	直径（cm）	有效率（%）	直径（cm）	有效率（%）	直径（cm）
试验组（38）	0.63±0.07	26.37	0.55±0.07	47.47	0.42±0.12	71.05	0.27±0.12	76.32	0.28±0.12
对照组（34）	0.66±0.07	2.94	0.58±0.07	14.71	0.55±0.12	26.47	0.41±0.07	32.35	0.40±0.11
统计值	t=1.718	χ²=7.575	t=1.736	χ²=8.806	t=4.489	χ²=14.266	t=5.208	χ²=14.046	t=4.345
P值	0.090	0.007	0.088	0.005	<0.01	<0.01	<0.01	<0.01	<0.01

组别	红细胞计数（10¹²/L）			血红蛋白（g/L）
组别	术前	术后	差值	术前	术后	差值
试验组	4.45±0.61	4.05±0.63	0.42±0.07	131±4.01	107±3.86	24±2.27
对照组	4.42±0.66	3.98±0.61	0.43±0.05	130±3.69	106±3.83	26±2.86
统计值	t=0.224	t=0.863	t=0.427	t=1.481	t=1.166	t=1.964
P值	0.830	0.394	0.665	0.143	0.262	0.065

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