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目的:研究复方右旋糖酐注射液作为血容量补充剂在手术中应用的安全性和有效性。方法:前瞻性、多中心、区组随机、单盲、阳性药物平行对照的临床研究。入选18~65岁ASAⅠ~Ⅱ级择期全麻手术病例,按1∶1比例随机分为试验组(复方右旋糖酐40注射液)与对照组(右旋糖酐40氯化钠注射液或者右旋糖酐40葡萄糖注射液)。在麻醉诱导后2 h内,输注试验药或对照药1000 mL,观察麻醉诱导后2 h液体总出入量、心率和血压平均变化值、波动幅度,并作为疗效评价指标。行凝血指标、血液生化、血液学及血液流变学(全血黏度高切变率、全血黏度低切变率、血浆黏度)指标检查。记录试验期间不良事件。结果:给药期间两组患者心率和血压均无异常改变。两组液体总出入量比较,差异无统计学意义。给药后两组血清K+,Na+,C l-,Ca2+和血糖的正常率均相近(P>0.05),组间比较差异无统计学意义,但接受右旋糖酐40葡萄糖注射液的对照组患者血清Na+和血糖的正常率显著低于试验组(P<0.05)。凝血指标、血液学、肝肾功能及血液流变学两组比较差异均无统计学意义。试验组4例、对照组3例出现不良反应。结论:复方右旋糖酐40注射液作为术中血容量补充剂,扩容效果确切,能维持血流动力学平稳,对维持电解质的平衡更优于右旋糖酐40葡萄糖注射液和右旋糖酐40氯化钠注射,对血液流变学和凝血功能有一定影响,手术中应用量应有所限制。
Objective: To study the safety and efficacy of compound dextran injection as a blood volume supplement in surgery. Methods: A prospective, multicenter, block randomized, single-blind, positive drug parallel control clinical study. Patients (18-65 years old) with ASA Ⅰ ~ Ⅱ elective general anesthesia were randomly divided into experimental group (compound dextran 40 injection) and control group (dextran 40 sodium chloride injection or dextran 40 glucose injection) according to the ratio of 1: . Within 2 h after the induction of anesthesia, 1000 mL of test drug or control drug was infused. The total amount of fluid, heart rate and blood pressure changes and fluctuation range at 2 h after anesthesia induction were observed and used as the evaluation index of the curative effect. Line coagulation indicators, blood biochemistry, hematology and hemorheology (whole blood viscosity high shear rate, whole blood viscosity low shear rate, plasma viscosity) index examination. Record adverse events during the trial. Results: There was no abnormal change of heart rate and blood pressure in the two groups during the administration. There was no significant difference in total fluid intake and discharge between the two groups. After administration, the normal rates of serum K +, Na +, C l-, Ca2 + and blood glucose in the two groups were similar (P> 0.05), but there was no significant difference between the two groups. However, the control group patients with dextran 40 glucose injection had significantly lower serum Na + And the normal rate of blood glucose was significantly lower than the experimental group (P <0.05). There was no significant difference in coagulation index, hematology, liver and kidney function and hemorheology between the two groups. 4 cases in the test group and 3 cases in the control group showed adverse reactions. Conclusion: The compound dextran 40 injection as an intraoperative blood volume supplement has exact expansion effect, maintains hemodynamics balance, and maintains balance of electrolyte better than dextran 40 glucose injection and dextran 40 sodium chloride injection, Rheology and coagulation have a certain impact, the amount of surgery should be limited.