摘要
目的观察恶性血液病化疗后合并感染的患者中,延长美罗培南给药时间与常规间歇给药两种方法的临床疗效与安全性。方法采取开放性随机对照单盲研究方法。研究对象为安徽理工大学第一附属医院血液内科住院的恶性血液病化疗后合并感染的患者,完成观察80例,试验组和对照组各40例。试验组采用延长美罗培南输注时间方法,对照组采用美罗培南传统的间歇给药方法,对比两组的疗效与安全性。试验组根据是否合并粒细胞缺乏分为试验-粒细胞缺乏组和试验-非粒细胞缺乏组,分别为19例及21例;对照组根据是否合并粒细胞缺乏分为对照-粒细胞缺乏组和对照-非粒细胞缺乏组,分别为16例和24例。分别比较试验-粒细胞缺乏组和对照-粒细胞缺乏组、试验-非粒细胞缺乏组和对照-非粒细胞缺乏组的临床疗效。结果试验组及对照组比较:(1)疗效:试验组的临床治愈+有效率(85.00%)高于对照组(55.00%),差异有统计学意义(χ^(2)=8.571,P<0.05);细菌清除率试验组(69.57%)高于对照组(52.63%),差异无统计学意义(χ^(2)=1.265,P>0.05);住院时间及住院费用试验组(12.20±4.97)d和(17003.08±8513.30)元,均低于对照组(16.98±6.60)d和(24343.18±12471.68)元,差异有统计学意义(t=-3.656、-3.074,P<0.05)。(2)试验组治疗72 h后体温及炎症指标降钙素原(PCT)、CRP及血清淀粉样蛋白A(SAA)(37.09±0.83)℃、(0.49±1.19)ng·mL^(-1)、(27.65±22.83)mg·L^(-1)、(40.20±33.08)mg·L^(-1),均低于对照组(37.55±0.61)℃、(2.47±4.03)ng·mL^(-1)、(53.53±48.90)mg·L^(-1)、(74.91±67.17)mg·L^(-1),差异有统计学意义(t=-2.864、-2.975、-2.997、-2.864,P<0.05)。(3)不良反应发生率试验组和对照组分别为20.00%及25.00%,差异无统计学意义(χ^(2)=0.287,P>0.05)。亚组比较:粒细胞缺乏患者中,延长美罗培南给药时间组疗效(78.95%)高于常规给药组(43.75%),延长美罗培南给药时间组住院时间及住院费用(14.74±5.14)d和(17562.72±9869.52)元,少于常规给药组(21.19±6.67)d和(28624.06±16100.95)元;在非粒细胞缺乏患者中,延长美罗培南给药时间组有效率(90.48%)高于常规给药组(62.50%),延长美罗培南给药时间组住院时间及住院费用(9.90±3.576)d和(16496.71±7286.65)元,少于常规给药组(14.17±4.92)d和(21489.25±8569.08)元,差异均有统计学意义(均P<0.05)。结论在恶性血液系统疾病化疗后合并感染的患者中,延长美罗培南给药时间相较于常规的间歇滴注的给药方法,提高了临床疗效、减少了住院时间及住院费用,未增加不良反应。
Objective To observe the clinical efficacy and safety of prolonged administration time of meropenem and routine intermittent administration in treatment of the hematological malignancies patients complicated with infections after chemotherapy.Methods By means of open-label randomized controlled single blind study,totally 80 hematological malignancies patients who were hospitalized in The First Affiliated Hospital of Anhui University of Science and Technology and were complicated with infection after chemotherapy were enrolled in the study and were divided into the experimental group and the control group,with 40 cases in each.The experimental group was treated with the prolonged infusion time of meropenem,while the control group was given the conventional intermittent administration of meropenem.The efficacy and safety were observed and compared between the two groups.The patients of the experimental group were divided into the agranulocytosis group with 19 cases and the non-agranulocytosis group with 21 cases according to the status of complication with agranulocytosis.The patients of the control group were divided into the agranulocytosis group with 16 cases and the non-agranulocytosis group with 24 cases according to the status of complication with agranulocytosis.The clinical efficacy was respectively observed and compared between the agranulocytosis group of the experimental group and the agranulocytosis group of the control group as well as between the non-agranulocytosis group of the experimental group and the non-agranulocytosis group of the control group.Results With regard to the efficacy,the clinical cure plus effective rate of the experimental group was 85.00%,higher than 55.00%of the control group,and there was significant difference(χ^(2)=8.571,P<0.05).The bacterial eradication rate of the experimental group was 69.57%,higher than 52.63%of the control group,and there was significant difference(χ^(2)=1.265,P>0.05).The length of hospital stay of the experimental group was(12.20±4.97)days,shorter than(16.98±6.60)days of the control group.The hospitalization cost of the experimental group was(17003.08±8513.30)yuan,less than(24343.18±12471.68)yuan of the control group,and there were significant differences(t=-3.656,-3.074,P<0.05).The body temperature,inflammatory factors procalcitonin(PCT),CRP and serum amyloid protein A(SAA)of the experimental group were respectively(37.09±0.83)℃,(0.49±1.19)ng·mL^(-1),(27.65±22.83)mg·L^(-1) and(40.20±33.08)mg·L^(-1),lower than(37.55±0.61)℃,(2.47±4.03)ng·mL^(-1),(53.53±48.90)mg·L^(-1) and(74.91±67.17)mg·L^(-1) of the control group,and there were significant differences(t=-2.864,-2.975,-2.997,-2.864,P<0.05).The incidence of adverse reactions was 20.00%in the experimental group,25.00%in the control group,and there was significant difference(χ^(2)=0.287,P>0.05).Among the patients with agranulocytosis,the efficacy of the prolonged administration time group was 78.95%,higher than 43.75%of the routine administration group.The length of hospital stay of the prolonged administration time group was(14.74±5.14)days,shorter than(21.19±6.67)days of the routine administration group.The hospitalization cost of the prolonged administration time group was(17562.72±9869.52)yuan,less than(28624.06±16100.95)yuan of the routine administration group.Among the patients with non-agranulocytosis,the effective rate of the prolonged administration time group was 90.48%,higher than 62.50%of the routine administration group.The length of hospital stay of the prolonged administration time group was(9.90±3.576)days,shorter than(14.17±4.92)days of the routine administration group.The hospitalization cost of the prolonged administration time group was(16496.71±7286.65)yuan,less than(21489.25±8569.08)yuan of the routine administration group,and there were significant differences(all P<0.05).Conclusion As compared with the routine intermittent administration,the prolonged administration time of meropenem can improve the clinical effect on treatment of the hematological malignancies patients complicated with infections after chemotherapy,shorten the length of hospital stay and reduce the hospitalization cost without increase of adverse reactions.
作者
邵群
方玉燕
葛剑
李文君
林云飞
刘凌霄
丰雷
胡晓武
Shao Qun;Fang Yu-yan;Ge Jian;Li Wen-jun;Lin Yun-fei;Liu Ling-xiao;Feng Lei;Hu Xiao-wu(Department of Haematology,The First Affiliated Hospital of Anhui University of Science and Technology(The First People’s Hospital of Huainan),Huainan 232007,China)
出处
《中国药物应用与监测》
2025年第1期134-138,共5页
Chinese Journal of Drug Application and Monitoring
基金
淮南市科技计划项目(2022201)。
关键词
美罗培南
延长输注时间给药
恶性血液病
感染
化疗
Meropenem
Prolonged infusion time
Hematological malignancy
Infection
Chemotherapy
