卡络磺钠用于下肢骨科大手术止血80例疗效及安全性评价

Application of Carbazochrome Sodium Sulfonate and Sodium Chloride Injection in 80 Cases of Hemostasis of Lower Extremity Orthopedic Major Operation

目的观察卡络磺钠氯化钠注射液用于下肢骨科大手术的止血疗效及安全性。方法将80例行下肢骨科大手术患者随机分为对照组和观察组,各40例。两组均采用对应的术式治疗原发病,对照组采用酚磺乙胺注射液止血,观察组采用卡络磺钠氯化钠注射液止血。观察两组患者术中出血量、手术时间以评价止血效果,于术前及术后72 h观察患者凝血酶原时间(PT)、活化部分凝血活酶时间(APTT)及纤维蛋白原(FIB)等凝血功能相关指标,观察两组患者治疗过程中不良反应发生情况。结果观察组患者术中出血量显著小于对照组(P<0.05),虽然平均手术时间较对照组缩短,但组间未发现明显差异(P>0.05);对照组患者PT较治疗前显著延长,且FIB较治疗前明显升高(P<0.05),观察组患者治疗前后上述指标间未见显著差异(P>0.05);两组患者治疗过程中不良反应发生率比较未见显著差异(P>0.05)。结论卡络磺钠氯化钠注射液用于下肢骨科大手术止血治疗安全、有效,值得临床推广。

Objective To investigate the efficacy and safety of Carbazochrome Sodium Sulfonate and Sodium Chloride Injection applied in hemostasis of lower extremity orthopedic major operation. Methods 80 patients undergoing lower limb orthopedic major operation were randomly divided into the control group and the observation group,40 cases in each group. The two groups all adopted the corresponding operation modes for treating the primary disease. The control group used Etamsylate Injection for conducting hemostasis,while the observation group adopted Carbazochrome Sodium Sulfonate and Sodium Chloride Injection for conducting hemostasis. The intraoperative bleeding volume and operative time in the two groups were observed for evaluating hemostasis effect. At the same time,the coagulation function related indexes of prothrombin time（ PT）,activated partialthromboplastin time（ APTT） and fibrinogen（ FIB） before operation and at postoperative72 h were observed in the two groups. In addition,the occurrence situation of adverse reactions during treatment process was observed in the two groups. Results The intraoperative bleeding amount in the observation group was significantly less than that in the control group,the difference between them was statistically significant（ P 0. 05）. Although the average operative time in the observation group was shorter than that in the control group,but no significant difference between them was found by the statistical analysis（ P 0. 05）. PT after treatment in the control group was significantly extended compared with before treatment, moreover FIB was significantly increased compared with before treatment,the differences had statistical significance（ P 0. 05）. No statistically significant differences in the above indexes in the observation group were found between before and after operation（ P 0. 05）. The occurrence rate of adverse reactions had no statistical differences between the two groups（ P 0. 05）. Conclusion Carbazochrome Sodium Sulfonate and Sodium Chloride Injection is safe and effective in the hemostatisis therapy of lower extremity orthopedic major operation and deserves to be clinically promoted.