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目的评价云南白药胶囊在脊髓型颈椎病颈后路手术的围手术期应用的价值和安全性。方法采用多中心、随机、双盲、安慰剂对照临床研究。符合入选标准的197例患者随机接受云南白药胶囊500 mg或安慰剂治疗,每日4次,共5 d。比较两组患者的术中失血量和术后引流量,并对安全性进行评估。结果云南白药组术中失血量350 ml±190 ml,安慰剂组术中失血量443 ml±266 ml(P<0．05)。术后引流量及服药后的不良反应两组间无差异。结论口服云南白药胶囊可以明显减少脊髓型颈椎病颈后路手术中的失血量,安全有效。
Objective To evaluate the value and safety of Yunnan Baiyao Capsule in the perioperative period of posterior cervical surgery for cervical spondylotic myelopathy. Methods A multicenter, randomized, double-blind, placebo-controlled clinical study was used. 197 patients who met the inclusion criteria were randomly treated with Yunnan Baiyao Capsule 500 mg or placebo, 4 times a day for 5 days. The intraoperative blood loss and postoperative drainage were compared between the two groups and the safety was assessed. Results The intraoperative blood loss of Yunnanbaiyao group was 350 ml±190 ml, and intraoperative blood loss was 443 ml±266 ml in the placebo group (P<0.05). There was no difference between the two groups after the drainage and the adverse reactions after medication. Conclusion Oral administration of Yunnan Baiyao capsule can significantly reduce blood loss in posterior cervical surgery for cervical spondylotic myelopathy, which is safe and effective.