全国血液透析病例信息登记系统的建立及血液透析患者贫血治疗情况分析
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摘要
研究背景：透析登记是血液透析规范化管理的重要组成部分，国际上许多发达国家都建立了成熟的透析登记系统，不仅促进了血液透析治疗的质量改进，同时也为指导医疗保险政策制定提供大量数据支持。我国多年来缺少全国范围内的透析登记，制约了我国血液透析治疗的发展，因此建立一个全国性的血液透析登记系统意义重大。
贫血是维持性血液透析（Maintance hemodialysis, MHD）患者的常见并发症，是影响MHD患者预后的重要因素。目前，虽然促红细胞生成素被广泛应用，但治疗达标率仍较低。炎症、铁代谢水平及透析充分性等多种因素影响贫血的治疗效果。中国MHD患者Hb的达标情况如何，影响中国MHD患者贫血治疗的危险因素有哪些，是本研究的主要目的。
目的：1、建立基于互联网平台的全国血液净化病例信息登记系统；2、调查分析2011年中国血液透析治疗开展基本情况；3、分析中国MHD患者贫血治疗现状及影响因素。
方法：1、利用JavaEE技术建立网络登记系统平台，分析登记系统需求后，参考《血液净化标准操作规程》制定登记系统工作表单内容；2、利用血液透析登记系统收集的数据，导出2011年血液透析患者登记数据并进行统计分析。3、从全国血液透析病例信息登记系统中导出登记有血红蛋白检查信息的患者数据（数据截止日期为2011年12月31日），选择年龄≥18岁，透析时间大于6个月以上的存活患者数据，分析中国维持性血液透析患者贫血发生情况，促红素、铁剂使用情况以及影响贫血发生及治疗的相关因素。
结果：1、全国血液透析病例信息登记系统为互联网在线登记系统，登记内容包括透析中心基本信息、透析中心设备及人员信息、透析水处理设备管理、患者基本信息、患者诊断信息、患者血透信息、患者药物治疗信息、实验室及辅助检查等，同时设置数据导出、数据查询及统计功能，并建立血液透析技术讨论论坛及信心发布平台。2、截止至2011年12月31日，系统共注册血液透析中心3,691家，登记在透存活血液透析患者165,936例，每百万人口124.8人。患者平均年龄53.8±15.3岁，男女比为1.45:1。原发病前三位分别为：原发性肾小球肾炎60.3%，糖尿病肾病15.5%，高血压肾损害9.9%。3、截止2011年底在透存活患者中共有91,715例患者登记有血红蛋白（Hemoglobin，Hb）结果，平均Hb水平为91.1±23.1g/L，Hb≥110g/L的患者比例为21.3%。TSAT≥20%的患者比例为57.1%； SF≥200ng/ml的患者比例为56.8%。患者重组人促红细胞生成素（Recombinant human erythropoietin，rHuEPO）使用率为82.6%，平均每周EPO用药剂量为8890.2±6275.2U（中位剂量：6000U）。静脉铁剂使用率26.9%。多因素Logistic回归分析显示，透析膜面积≥1.6m2、静脉铁剂、左卡尼汀、血清白蛋白(Albumin,Alb)≥40g/L、C反应蛋白（C-reactive protein, CRP）≥10mg/dl及SF≥1000ng/dl等因素是与MHD贫血发生有关的独立影响因子。
结论：1、全国血液净化病例登记系统的建立使中国第一次有了全国范围内的透析网络数据登记系统，登记系统的设计不仅满足患者数据登记的需要，同时满足透析中心管理及业务交流的需求；2、我国血液透析发展迅速，但血液透析治疗率及充分性指标达标率仍低于其它国家。3、我国MHD患者Hb蛋白达标率低，尽管促红素使用比例及剂量较高，但治疗效果较差。多因素相关分析显示影响MHD患者贫血治疗的主要因素有透析器面积、静脉铁剂使用、TSAT达标率、血白蛋白水平、C反应蛋白水平以及铁蛋白水平。
Background: Dialysis registration is an important component for standardizedmanagement of hemodialysis. Many developed countries have built comprehensiveregistration system, which in turn provide strong epidemic data support to guide theformulation of health insurance policy and the improvement of treatment. Theabsence of a national-level dialysis registration in China has limited the developmentof hemodialysis treatment, and it is now very important to establish a nation-widehemodialysis registration system.
Anemia is a common complication for patients with maintenance hemodialysis(MHD), as well as an important factor affecting the prognosis of MHD patients.Despite treatment with high dose erythropoietin (EPO), the target value ofHemoglobin (Hb) can not be achieved in serval patgients. Therefore, we intend toleverage the national hemodialysis case registration system established earlier, tocollect the related Hb data for MHD patients, to analyze the incidence and currenttreatment of anemic MHD, and to support the formulation of Chinese treatmentguideline for anemic MHD.
Objective:1. to establish the internet-based registration system for nationalhemodialysis cases.2. to study the utilization and registration status of the system.3.to study the current treatment pattern and influencing factors of anemic MHD inchina.
Methods:1. the internet-based registration platform was first built using JavaEE,and the “Blood Purification Standard Operating Procedure (SOP)” was referred indesigning the registration file layout and contents.2. The data for2011was extractedto make the statistical analysis to the situation fo hemodialysis treatment in China.3.Data was exported for patients with erythropoietin (EPO) usage and Hb information from the registration system (data collection period ends at2011December31), withpatients aged18or older, duration of dialysis treatment shall be longer than6monthsand were survival in the end of2011. The above exported data shall be used toanalyze the incidence of anemic MHD in China, the utilization of EPO and ironagents, as well as factors influencing the incidence and treatment of anemia.
Results:1. The national case registration system for hemodialysis is ainternet-based registration system. The content includes basic profile of the dialysiscenter, the device and employee information of the center, the device management ofdialysis water, patient profile, patient hemodialysis data, medical treatment data, labtest and supplementary results. Meanwhile, the system was also built withfunctions for data extraction, data query and statistics, as well as a discussion forumand publication platform for dialysis-related technologies.2. As of Dec31,2011,3,691dialysis centers （2.8centers per million population） have been registered inthe system, as well as165,936hemodialysis patients（124.8patients per millionpopulation）.3. As of the end of2011,91,715of all the surviving dialysis patientshave registered the results of hemoglobin (Hb), with the average Hb level of91.1±23.1g/L, the percentage of patients with Hb≥110g/L is31.3%; the percentage of thepatients with TSAT≥20%is57.1%; the percentage of patients with SF≥200ng/mlis56.8%. The rate of patients using rHu EPO is82.6%, with a per week dosage of8890.2±6275.2U (median dosage is6000U), the rate of patients using intravenousiron is26.9%. Logistic regression analysis indicates dialysis membrane area is≥1.6m2, intravenous iron, levocarnitine, Alb≥40g/L, CRP≥10mg/dl and SF≥1000ng/dl etc are independent factors related to occurrence of MHD anemia.
Conclusion:1. the establishment of the national case registration system forhemodialysis has ended the era in China where a national internet-based registrationsystem for dialysis has been absent. The design of the system not only meets theneeds for data registration, but also the needs for center management and businessinteraction.2. the system is still at the pilot stage where the completion rate and dataaccuracy are still low, and the improvement on data quality will be the key objective for the future research.3. The rate of meeting the protein standards among MHDpatients in China is low, despite the usage rate and dosage amount of erythropoietinis high, which means the treatment is less effective. Multivariate analysis indicatesthe main factors affecting the anemia rate of MHD patients in China include the areaof dialyzer, the usage of intravenous iron, the compliance rate of TSAT, the level ofserum albumin, C-reactive protein levels and ferritin level.
贫血是维持性血液透析（Maintance hemodialysis, MHD）患者的常见并发症，是影响MHD患者预后的重要因素。目前，虽然促红细胞生成素被广泛应用，但治疗达标率仍较低。炎症、铁代谢水平及透析充分性等多种因素影响贫血的治疗效果。中国MHD患者Hb的达标情况如何，影响中国MHD患者贫血治疗的危险因素有哪些，是本研究的主要目的。
目的：1、建立基于互联网平台的全国血液净化病例信息登记系统；2、调查分析2011年中国血液透析治疗开展基本情况；3、分析中国MHD患者贫血治疗现状及影响因素。
方法：1、利用JavaEE技术建立网络登记系统平台，分析登记系统需求后，参考《血液净化标准操作规程》制定登记系统工作表单内容；2、利用血液透析登记系统收集的数据，导出2011年血液透析患者登记数据并进行统计分析。3、从全国血液透析病例信息登记系统中导出登记有血红蛋白检查信息的患者数据（数据截止日期为2011年12月31日），选择年龄≥18岁，透析时间大于6个月以上的存活患者数据，分析中国维持性血液透析患者贫血发生情况，促红素、铁剂使用情况以及影响贫血发生及治疗的相关因素。
结果：1、全国血液透析病例信息登记系统为互联网在线登记系统，登记内容包括透析中心基本信息、透析中心设备及人员信息、透析水处理设备管理、患者基本信息、患者诊断信息、患者血透信息、患者药物治疗信息、实验室及辅助检查等，同时设置数据导出、数据查询及统计功能，并建立血液透析技术讨论论坛及信心发布平台。2、截止至2011年12月31日，系统共注册血液透析中心3,691家，登记在透存活血液透析患者165,936例，每百万人口124.8人。患者平均年龄53.8±15.3岁，男女比为1.45:1。原发病前三位分别为：原发性肾小球肾炎60.3%，糖尿病肾病15.5%，高血压肾损害9.9%。3、截止2011年底在透存活患者中共有91,715例患者登记有血红蛋白（Hemoglobin，Hb）结果，平均Hb水平为91.1±23.1g/L，Hb≥110g/L的患者比例为21.3%。TSAT≥20%的患者比例为57.1%； SF≥200ng/ml的患者比例为56.8%。患者重组人促红细胞生成素（Recombinant human erythropoietin，rHuEPO）使用率为82.6%，平均每周EPO用药剂量为8890.2±6275.2U（中位剂量：6000U）。静脉铁剂使用率26.9%。多因素Logistic回归分析显示，透析膜面积≥1.6m2、静脉铁剂、左卡尼汀、血清白蛋白(Albumin,Alb)≥40g/L、C反应蛋白（C-reactive protein, CRP）≥10mg/dl及SF≥1000ng/dl等因素是与MHD贫血发生有关的独立影响因子。
结论：1、全国血液净化病例登记系统的建立使中国第一次有了全国范围内的透析网络数据登记系统，登记系统的设计不仅满足患者数据登记的需要，同时满足透析中心管理及业务交流的需求；2、我国血液透析发展迅速，但血液透析治疗率及充分性指标达标率仍低于其它国家。3、我国MHD患者Hb蛋白达标率低，尽管促红素使用比例及剂量较高，但治疗效果较差。多因素相关分析显示影响MHD患者贫血治疗的主要因素有透析器面积、静脉铁剂使用、TSAT达标率、血白蛋白水平、C反应蛋白水平以及铁蛋白水平。
Background: Dialysis registration is an important component for standardizedmanagement of hemodialysis. Many developed countries have built comprehensiveregistration system, which in turn provide strong epidemic data support to guide theformulation of health insurance policy and the improvement of treatment. Theabsence of a national-level dialysis registration in China has limited the developmentof hemodialysis treatment, and it is now very important to establish a nation-widehemodialysis registration system.
Anemia is a common complication for patients with maintenance hemodialysis(MHD), as well as an important factor affecting the prognosis of MHD patients.Despite treatment with high dose erythropoietin (EPO), the target value ofHemoglobin (Hb) can not be achieved in serval patgients. Therefore, we intend toleverage the national hemodialysis case registration system established earlier, tocollect the related Hb data for MHD patients, to analyze the incidence and currenttreatment of anemic MHD, and to support the formulation of Chinese treatmentguideline for anemic MHD.
Objective:1. to establish the internet-based registration system for nationalhemodialysis cases.2. to study the utilization and registration status of the system.3.to study the current treatment pattern and influencing factors of anemic MHD inchina.
Methods:1. the internet-based registration platform was first built using JavaEE,and the “Blood Purification Standard Operating Procedure (SOP)” was referred indesigning the registration file layout and contents.2. The data for2011was extractedto make the statistical analysis to the situation fo hemodialysis treatment in China.3.Data was exported for patients with erythropoietin (EPO) usage and Hb information from the registration system (data collection period ends at2011December31), withpatients aged18or older, duration of dialysis treatment shall be longer than6monthsand were survival in the end of2011. The above exported data shall be used toanalyze the incidence of anemic MHD in China, the utilization of EPO and ironagents, as well as factors influencing the incidence and treatment of anemia.
Results:1. The national case registration system for hemodialysis is ainternet-based registration system. The content includes basic profile of the dialysiscenter, the device and employee information of the center, the device management ofdialysis water, patient profile, patient hemodialysis data, medical treatment data, labtest and supplementary results. Meanwhile, the system was also built withfunctions for data extraction, data query and statistics, as well as a discussion forumand publication platform for dialysis-related technologies.2. As of Dec31,2011,3,691dialysis centers （2.8centers per million population） have been registered inthe system, as well as165,936hemodialysis patients（124.8patients per millionpopulation）.3. As of the end of2011,91,715of all the surviving dialysis patientshave registered the results of hemoglobin (Hb), with the average Hb level of91.1±23.1g/L, the percentage of patients with Hb≥110g/L is31.3%; the percentage of thepatients with TSAT≥20%is57.1%; the percentage of patients with SF≥200ng/mlis56.8%. The rate of patients using rHu EPO is82.6%, with a per week dosage of8890.2±6275.2U (median dosage is6000U), the rate of patients using intravenousiron is26.9%. Logistic regression analysis indicates dialysis membrane area is≥1.6m2, intravenous iron, levocarnitine, Alb≥40g/L, CRP≥10mg/dl and SF≥1000ng/dl etc are independent factors related to occurrence of MHD anemia.
Conclusion:1. the establishment of the national case registration system forhemodialysis has ended the era in China where a national internet-based registrationsystem for dialysis has been absent. The design of the system not only meets theneeds for data registration, but also the needs for center management and businessinteraction.2. the system is still at the pilot stage where the completion rate and dataaccuracy are still low, and the improvement on data quality will be the key objective for the future research.3. The rate of meeting the protein standards among MHDpatients in China is low, despite the usage rate and dosage amount of erythropoietinis high, which means the treatment is less effective. Multivariate analysis indicatesthe main factors affecting the anemia rate of MHD patients in China include the areaof dialyzer, the usage of intravenous iron, the compliance rate of TSAT, the level ofserum albumin, C-reactive protein levels and ferritin level.
引文
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