目的:研究氨甲环酸局部应用在手肌腱松解术中的临床效果。
方法:这是在根据赫尔辛基宣言指南获得当地伦理委员会批准后进行的一项随机对照试验。选取2021年1月至2022年12月在我院行手肌腱松解术的患者80例,随机分为2组。氨甲环酸组(40例)患者在肌腱松解术后接受术中局部应用2g氨甲环酸,常规组(40例)术中未局部应用氨甲环酸。操作时间,围手术期血红蛋白变化,总失血量,术后早期并发症的发生率,比较两组术前和术后6个月的总主动运动(TAM)。连续变量服从正态分布,以平均值±SD表示,组间比较采用t检验。同时,分类变量采用卡方检验,p<0.05表示差异有统计学意义。
结果:两组均随访7~18个月,平均10.3个月。氨甲环酸组术后血红蛋白下降明显少于常规组(t=7.611,p<0.05)。氨甲环酸组总失血量(74.33±20.50)mL少于常规组(83.05±17.73)mL,差异有统计学意义(p<0.05)。两组患者术后拇指/手指屈伸活动度均有改善,与手术前相比,TAM有所改善,差异有统计学意义(p<0.05)。氨甲环酸组术后6个月TAM改善(87.68°±10.44°)较常规组(80.47°±10.93°)更显著,差异有统计学意义(t=3.013,p<0.05)。两组患者手术时间及术后早期并发症发生率差异无统计学意义(p>0.05)。
结论:在手肌腱松解术中局部应用氨甲环酸可明显减少术后出血,提高手术疗效。值得推广。
OBJECTIVE: To study the clinical effectiveness of the topical application of tranexamic acid in hand tendon release.
METHODS: This was a randomized controlled trial conducted after receiving approval from the local ethics committee according to guidelines from the Helsinki Declaration. Eighty patients who underwent hand tendon release operation in our hospital from January 2021 to December 2022 were included and randomly divided into 2 groups. Patients in the tranexamic acid group (40 cases) received intraoperative topical application of 2 g of tranexamic acid after tendon release, while patients in the conventional group (40 cases) did not receive topical application of tranexamic acid during operation. The operation time, perioperative hemoglobin changes, total blood loss, incidence of early postoperative complications, and total active movement (TAM) before surgery and 6 months after surgery were compared between the 2 groups. The continuous variable which follows normal distribution expressed by mean ± SD and used t-test to compare between groups. Meanwhile, categorical variables were used by Chi-square test, and a p < 0.05 indicated that the differences were statistically significant.
RESULTS: Both groups were followed up for 7 - 18 months, with a mean of 10.3 months. Postoperative decrease in hemoglobin was significantly less in the tranexamic acid group than in the conventional group (t = 7.611, p < 0.001). The total blood loss in the tranexamic acid group (74.33 ± 20.50) mL was less than that in the conventional group (83.05 ± 17.73) mL, and the difference was statistically significant (p < 0.05). Both groups showed improvement in thumb/finger flexion and extension range of motion after surgery, and the TAM improved compared with those before surgery, and the difference was statistically significant (p < 0.001). The TAM improved more significantly in the tranexamic acid group (87.68° ± 10.44°) than in the conventional group (80.47° ± 10.93°) at 6 months after surgery, with a statistically significant difference (t = 3.013, p < 0.001). There was no significant difference in operation time and incidence of early postoperative complications between the 2 groups (p = 0.798, 0.499, respectively).
CONCLUSIONS: The topical application of tranexamic acid during hand tendon release can significantly reduce postoperative bleeding and improve surgical efficacy, which is worth promoting.