术中应用糖酐注射液的疗效和安全性  

Evaluation of the efficiency and safety of the compound dextran 40 injection used in the operation

作　　者：刘小颖[1] 吴新民[1] 叶铁虎[2] 田玉科[3] 王俊科[4] 薛张刚[5] 岳云[6] 姚尚龙[7] 熊利泽[8] 邓小明[9] 田鸣[10] 类维富[11] 艾澄斌[12] 兰自侃[13] 

机构地区：[1]北京大学第一医院麻醉科,北京100034 [2]北京协和医院,北京100730 [3]华中科技大学附属同济医院,武汉430030 [4]中国医科大学附属第一医院,沈阳110000 [5]复旦大学附属中山医院,上海200032 [6]北京朝阳医院,北京100020 [7]华中科技大学附属协和医院,武汉430022 [8]第四军医大学西京医院,西安710032 [9]第二军医大学长海医院,上海200433 [10]北京友谊医院,北京100050 [11]山东大学齐鲁医院,济南250012 [12]青岛市市立医院,青岛266011 [13]陕西省人民医院,西安710054

出　　处：《中国新药杂志》2007年第18期1514-1519,共6页Chinese Journal of New Drugs

摘　　要：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^＋,Cl^-,Ca^2＋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 evaluate the efficiency and safety of the compound dextran 40 used in the volume replacement treatment for patients who suffer a surgical operation. Methods：This is a prospective multicentre randomized controlled trial. ASA Ⅰ-Ⅱ patients, aged 18 - 65 years old, scheduled for elective surgery under general anesthesia were enrolled in the study. They were randomly divided into the test group and the control group. The compound dextran 40 or control drug 1 000 mL were infused into them between the induction of anesthesia and after 2 hours. The total input and output quantity of the liquid during 2 hours, as well as the change of hemodynamics, the target of the coagulation, liver and renal function and blood rountine test and hemorheology test, recorded harmful events during the test stage were ebserved. Results： The target of the hemodynamics at each point during the experimental stage were normal. There was no difference between the two groups. The total input and output quantity of the liquid in the experimental stage had no difference in statistics between the two groups. Compared with dextran 40 injection, serum K^＋, Na^＋, Cl^-, Ca^2＋ and glucose had no difference between the targets of the two groups. But dextran 40 glucose injection used as control drug, serum Na^＋ was distinctly lower and glucose higher than that of test group. There were no statistical significance of target of coagulation, hematology,liver and renal function, hemorheology. There were four adverse effect cases in the compound dextran 40 group and three adverse effect cases in the control group. Conclusion： The safety and the efficiency of compound dextran 40 in operation have no apparent difference from dextran 40, but the action to maintain the balance of the components of electrolyte in compound dextran 40 are better than that of dextran 40 glucose injection and dexran 40 sodium chloride injection. It has a certain influence on the coagulation and the hemorheology. The dosage should be confined in the opera

关 键 词：复方右旋糖酐40 血容量 电解质 凝血 

分 类 号：R971.2[医药卫生—药品] R969.4[医药卫生—药学]