电子药盒取药记录监测肺结核患者服药行为的可行性评估  

Operational feasibility of medication monitors in monitoring treatment adherence among TB patients

作　　者：桓世彤[1] 陈嵘[2] 刘小秋[2] 欧喜超[2] 姜世闻[2] 赵雁林[2] 张治英 詹思延[1] 

机构地区：[1]北京大学医学部公共卫生学院,100191 [2]中国疾病预防控制中心结核病预防控制中心 [3]美国帕斯适宜卫生科技组织

出　　处：《中国防痨杂志》2012年第7期419-424,共6页Chinese Journal of Antituberculosis

基　　金：中国卫生部-盖茨基金会结核病防治合作项目(51914)

摘　　要：目的通过对比结核病患者的电子药盒取药记录和作为金标准的尿液中抗结核药物残留物检测结果,了解应用电子药盒的取药记录评估患者服药依从性的可行性。方法在中国卫生部-盖茨基金会结核病防治合作项目应用电子药盒开展肺结核患者管理试点的黑龙江、湖南、重庆和江苏4个省的9个县(区),纳入新登记的初治结核病患者432例作为研究对象。纳入研究患者的男女比例为3.15∶1,平均年龄为(45.98±17.36)岁,其中强化治疗期患者226例,继续治疗期患者206例。所有纳入的患者均采用隔日化疗方案2H3R3Z3E3/4H3R3,并发放电子药盒用于记录患者治疗期间的取药状况。研究人员于患者开始治疗的第2个月序或第4个月序采用随机数字表法选择日期上门收集患者尿液并用氯仿(三氯甲烷)检测尿液中利福平药物残留,确定患者的服药状况。研究共对319例患者的尿液进行了检测,其中强化治疗期的患者166例,继续治疗期的患者153例,总检测率为73.84%(319/432)。未进行检测而退组的患者113例,其中64.60%(73/113)是因为检测当日患者外出不在家;20.35%(23/113)是因为更换治疗方案或药物不良反应等退出研究,8.85%(10/113)是因为家访时患者服药时间不足6h,不符合尿液检测条件,4.42%(5/113)是因为家访时患者服药时间超过24h,医务人员误判为不符合条件而未进行检测,另有1.77%(2/113)的患者拒绝检测。研究以尿液中利福平药物残留物检测结果为金标准,计算患者24h内电子药盒取药记录反应患者服药行为的灵敏度和特异度,评估电子药盒取药记录监测患者实际服药行为的准确性及可行性。结果患者24h内电子药盒的取药记录反映患者实际服药行为的灵敏度和特异度分别为99.52%(208/209)(95%CI:97.30%～100.00%)和95.45%(105/110)(95%CI:91.56%～99.35%)。同时,电子药盒在不同性别组患者的灵敏度[男:99.38%(160/161),95%CI:98.16%～10Objective To explore the operational feasibility of using medication monitors to monitor treatment adherence in TB patients by comparing the medication monitors＇ records with those of patients＇ urine tests for traces of TB drugs.Methods Four hundred and thirty-two newly registered initial treatment TB patients were enrolled in succession in 9 counties of China MOH-Gates Foundation TB Control Project case management pilot sites in Heilongjiang,Hunan,Chongqing and Jiangsu provinces.The male-to-female ratio of the enrolled patients is 3.15∶1,and average age is（45.98±17.36） years old.Among all the enrolled patients,226 cases were in the intensive phase of treatment and 206 cases were in the continuous phase of treatment.All the patients were treated using the regimen 2H3R3Z3E3/4H3R3.An electronic medication monitor stored the patients＇ drugs and kept a record of every time patients took their medicine out of the monitor.Investigators determined the urine test date for patients by using a table of random numbers at the patients＇ 2nd or 4th month of treatment.Investigators then visited the patients＇ house to collect patients＇ urine and conducted a simple urine test to detect rifampicin to confirm whether patients had taken their medicine within the past 24 hours.Among the 319 patients tested,116 cases were in the intensive phase of treatment and 153 cases were in the continuous phase,with an overall test proportion of 73.84%（319/432）.Among the 113 patients not tested,64.60%（73/113） were not at home on the test day,20.35%（23/113） had changed their treatment regimen or quit due to adverse effects of drugs,and 8.85%（10/113） had taken their drugs less than 6 hours before the doctors＇ visit and did not meet the criteria for the urine test,4.42%（5/113） had taken their drugs more than 24 hours before the doctors＇ visit and the doctors misclassified them as unqualified cases and did not conduct urine test,and 1.77%（2/113） refused to the testing.The operational feasibility of medic

关 键 词：结核 肺/药物疗法 服药依从性 直接观察疗法 可行性研究 

分 类 号：R52[医药卫生—内科学]