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目的:研究比阿培南治疗恶性血液病患者中重度感染的有效性与安全性。方法:收集60例恶性血液病住院期间发生中重度感染患者,随机分成治疗组(比阿培南)与对照组(亚胺培南/西司他丁)各30例。治疗组比阿培南用法0.3g/8h,静脉滴注;对照组亚胺培南/西司他丁用法1g/6h,静脉滴注。同时积极行病原菌相关检测。结果:治疗组30例患者均符合本临床实验要求;对照组有2例血培养真菌孢子阳性确诊真菌感染,排除后28例入组。治疗组与对照组的总体治疗有效率分别为66.7%、71.4%,治疗后细菌清除率分别为70.0%、72.7%;细菌培养阴性者的有效率分别为65.0%、70.6%;粒细胞缺乏者的有效率分别为52.2%、68.2%;其中粒细胞缺乏>10d者的有效率分别为53.8%、58.3%;粒细胞缺乏<10d者的有效率分别为50.0%、80.0%;无粒细胞缺乏者的有效率分别为71.4%、83.3%;以上各指标2组间比较均差异无统计学意义。不良反应方面,治疗组有1例出现胃肠道反应,1例皮肤瘙痒、皮疹;对照组有3例出现胃肠道反应。2组不良反应发生率分别为6.7%、10.7%,差异亦无统计学意义。结论:比阿培南治疗恶性血液病中重度患者感染的疗效与亚胺培南/西司他丁相当,不良反应发生率类似,其中胃肠道不良反应相对少见,经济实用。
Objective: To study the efficacy and safety of biapenem in the treatment of severe infections in patients with hematologic malignancies. Methods: Sixty patients with severe or severe hematological malignancies were collected during hospitalization and were randomly divided into treatment group (Biapenem) and control group (imipenem / cilastatin) in 30 cases. Biapenem treatment group 0.3g / 8h, intravenous drip; control imipenem / cilastatin use 1g / 6h, intravenous drip. At the same time active pathogen-related testing. Results: All the 30 patients in the treatment group met the requirements of this clinical trial. In the control group, 2 blood culture fungi spores positive were confirmed for fungal infection, and 28 patients were excluded. The total effective rates of the treatment group and the control group were 66.7% and 71.4%, respectively. The bacterial clearance rate after treatment was 70.0% and 72.7% respectively. The effective rates of the bacteria-negative patients were 65.0% and 70.6% respectively. The patients with agranulocytosis The effective rates were 53.2%, 58.3%, respectively; the effective rates were 50.0%, 80.0%, respectively; those with agranulocytosis less than 10 days, respectively, had no agranulocytosis The effective rates were 71.4% and 83.3% respectively. There was no significant difference in the above indexes between the two groups. Adverse reactions, the treatment group, 1 case of gastrointestinal reactions, 1 case of skin itching, rash; control group, 3 cases of gastrointestinal reactions. The incidence of adverse reactions in the two groups were 6.7% and 10.7% respectively, with no significant difference. CONCLUSION: The efficacy of biapenem in the treatment of severe patients with malignant hematological diseases is similar to that of imipenem / cilastatin. The incidence of adverse reactions is similar, with adverse gastrointestinal adverse reactions relatively rare and economical and practical.