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诊断治疗专家共识会议传达课件

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诊断 治疗 专家 共识 会议 传达 课件
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Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 山东大学齐鲁医院 侯明 2009 9 19 ITP诊断治疗中国专家共识 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 关注ITP v 免疫性血小板减少性紫癜 也称为特发性血小板减少性紫癜 ITP 是一种获得性自身免疫性疾病 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Incidence 3 new cases x 100 000 person years Prevalence 20 cases x 100 000 person years 12 10 8 6 4 2 0 1818 24 25 34 35 44 45 54 55 59 59 64 65 74 75 84 85 100 Total Age years Mean annual incidence per 100 000 person years Females Males Schoonen WM et al Br J Haematol 2009 92 1165 1171 Average annual ITP incidence by age group and gender n 1145 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Events per patient year Fatal 0 4 1 2 13 0 35 0 30 0 25 0 20 0 15 0 10 0 05 0 00 60 Non fatal 2 5 7 3 1 75 1 50 1 25 1 00 0 75 0 50 0 25 0 00 60 72 Cohen YC et al Arch Intern Med 2000 160 1630 1638 Estimated annual rate of bleeding according to age group Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 慢性ITP患者生活质量低于癌症癌症患者 American Journal of Hematology DOI 10 1002 ajh 2008 与ITP患者比较 高血压 P 0 0001 关节炎 P 0 0014 癌症 P 0 0003 糖尿病 P 0 52 健康人 普通人 癌 症 高血压 关节炎 慢性ITP 糖尿病 慢性心衰 截肢或瘫痪病人 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 内容提要 ITP诊断治疗专家共识会议背景 ITP诊断治疗专家共识会研讨内容 ITP诊断治疗专家共识 终稿 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 国际背景 v 为了进一步规范ITP的命名 定义和疗效评价等 2007 年国际上成立了由来自意大利 美国 法国 英国 加 拿大 澳大利亚 西班牙 奥地利和瑞士的20位知名 专家组成的ITP国际工作组 v 该工作组于2007年10月在意大利的维琴察 Vincenza 举行了为期两天的共识会议 v 会后对没能形成共识的问题进行了深入的沟通 最终的 工作报告于2007年12月8日在亚特兰大的第49届ASH期 间正式成文 现已正式发表 Blood 2009 12 113 11 2386 93 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial v Standardization of terminology definitions and outcome criteria in immune thrombocytopenic purpura of adults and children report from an international working group Blood 2009 March 12 113 11 2386 93 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 国内背景 v 为了推动国内ITP诊治进展 由中华医学会血液学分会止血 与血栓学组召集的 ITP诊断治疗专家共识会 于2009 年4月26日在山东省威海市举行 v 来自全国各地30余位学组成员参加了此次会议 会议由阮 长耿院士主持 中国医学科学院血液学研究所杨仁池教授 北京协和医院赵永强教授 山东大学齐鲁医院侯明教授 分别作了主题发言 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 2009年4月26日在山东省威海市 由中华医学会血液学分会血栓与止血学组组织 国内30多位专家进行了讨论 初步达成了国内ITP诊治专家共识 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 内容提要 ITP诊断治疗专家共识会议背景 ITP诊断治疗专家共识会研讨内容 ITP诊断治疗专家共识 终稿 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial ITP国际工作组报告 ITP的命名 v 建议使用 immune 免疫性 以强调本病由免疫介导而发 病 避免使用 idiopathic 特发性 v purpura 紫癜 一词认为不合适 因为许多患者仅有血 小板减少 并无出血体征 v ITP 的缩写仍然保留 但它代表的是 immune thrombocytopenia 免疫性血小板减少症 v 将ITP分为原发性ITP和继发性ITP两类 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial ITP国际工作组报告 ITP的一些定义 v 将血小板减少的阈值标准定为PLT 100 109 L 过去欧美 文献定为 150 109 L v 其依据有以下三点 v 1 在一项前瞻性队列研究中发现 血小板介于 100 150 109 L的一组无其他疾病的人在10年内发生更严重的血 小板减少 持续小于100 109 L 概率仅为6 9 v 2 非西方人群中健康人的血小板常介于 100 150 109 L v 3 新的阈值可以避免将大多数妊娠相关的血小板减少的 妇女纳入 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial ITP国际工作组报告 ITP的一些定义 v 原发性ITP 是一种自身免疫性疾病 以没有原因的单纯性 血小板减少 血小板数小于100 109 L 为特征 原发性ITP 的诊断仍然是一种排除性诊断 其主要临床问题是出血的 危险增加 尽管并非总有出血症状 v 继发性ITP 是指除了原发性ITP以外的所有形式的免疫介 导的血小板减少症 在诊断继发性ITP时 应在括号内说明 原因 比如 继发性ITP 药物诱导的 继发性ITP 狼 疮相关性 继发性ITP HIV相关性 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial ITP国际工作组报告 继发性ITP v 胎儿和新生儿同种免疫性血小板减少性紫癜 输血后紫癜 等保留原命名 v 如要诊断继发性ITP 幽门螺杆菌相关性 必须要证明 清除细菌后ITP缓解方能诊断 v 对于药物诱导的ITP 如确定药物 须明确 比如 继发 性ITP 奎宁诱导的 v 如果没有其他证据支持SLE或APS ITP患者ANA和 或aPL 阳性不能诊断为继发性 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial ITP国际工作组报告 ITP的分期 v 新诊断的ITP 指诊断后3个月以内的血小板减少的 所有患者 v 持续性ITP 指诊断后3 12个月血小板持续减少的所 有患者 包括没有自发缓解的患者或停止治疗后不 能维持完全缓解的患者 v 慢性ITP 指血小板减少持续超过12个月的所有患者 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial ITP国际工作组报告 ITP的分期 v 重症ITP 在就诊时存在需要治疗的出血症状或者发生了新 的出血症状 需要用其他提高血小板的药物治疗或者需要 增加现有治疗的药物剂量 v 难治性ITP 指满足以下所有三个条件的患者 v 脾切除后无效或者复发 v 需要 包括 但不限于小剂量激素 治疗以降低出血 的危险 v 除外了其他引起血小板减少症的原因 确诊为原发性 ITP Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial ITP国际工作组报告 ITP的疗效评价 v 完全反应 CR 治疗后血小板数 100 109 L且没有出血 v 有效 R 治疗后血小板数 30 109 L并且至少比基础血小板 数增加两倍 且没有出血 v 无效 NR 治疗后血小板数 30 109 L或者血小板数增加不 到基础值的两倍或者有出血 v 复发 有以下情况之一者 v 若患者原来为CR 当血小板数低于100 109 L 或出血 v 若患者原来为R 当血小板数低于30 109 L或者血小板数 增加不到基础值的两倍或者有出血 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial ITP国际工作组报告 ITP的疗效评价 v 糖皮质激素依赖 指患者需要继续或反复给予糖皮质激素 至少2个月 以维持血小板数在30 109 L以上和 或以避 免出血 v 治疗起效时间 指从开始治疗到达到CR或R的时间 并建 议在定义CR或R时 应至少检测两次 其间至少间隔7天 在定义NR或复发时 应至少检测两次 其间至少间隔1 天 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Platelet Production Is Suboptimal in ITP Autologous 111In platelet studies show platelet production normal in 2 3 patients TPO levels normal in 75 of ITP patients relative TPO deficiency Hou Autoantibodies inhibit both Mk growth and Mk apoptosis Houwerijl Chang McMillan Hou Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Hou et al Br J Haematol 1998 101 420 4 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Antibody effect on megakaryocyte maturation Decreased megakaryocyte apoptosis Megakaryocyte para apoptosis Hou M et al Br J Haematol 2007 139 605 11 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 新型TPO受体激动剂治疗ITP Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 重组人血小板生成素治疗慢性难治性 ITP多中心临床试验 2004年8月第43卷第8期 P608 610 参加单位 北京协和医院 重庆新桥医院 中国医科大学一附院 山东省立医院 西安西京医院 武汉同济医院 西安交通大学第一医院 武汉协和医院 上海长海医院 广州南方医院 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 特比澳治疗ITP的总有效率 疗效 有效 显效 良效 无效 进步 无效 男 女 81 6 88 6 18 4 11 4 总计 85 314 7 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 特比澳起效较快 停药后作用持续一周以上 停药后一周血小板计数中位值仍在75 109 L之上 P50 显著高于不使用rhTPO的ITP患者 2 特比澳 rhTPO 不良反应轻微 表现为发热 乏力 注射部位疼痛 头晕等 多无需特殊处理 安全性较好 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial rhTPO治疗ITP 多中心随机对照试验总结 研究负责人 中国医学科学院北京协和医院 单渊东 赵永强 王书杰 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 协作单位 中国医学科学院血液病医院 杨仁池 华中科技大学附属协和医院 邹萍 山东大学齐鲁医院 侯明 北京大学人民医院血液病研究所 卢锡京 上海交通大学医学院瑞金医院 沈志祥 中国医科大学第一临床医院 李艳 苏州大学附属第一医院 吴德沛 孙爱宁 四川大学华西医院 牛挺 郑州大学第一附属医院 孙慧 解放军总医院 于力 首都医科大学附属北京友谊医院 王昭 第四军医大学西京医院 陈协群 卫生部北京医院 常乃柏 河南省人民医院 张茵 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 病例筛选 随机入组 试验组对照组 达那唑 达那唑 rhTPO 0天7天14 天 21 天 28 天 第1阶段第2阶段 主要评价终点次要评价终点 42 天 35 天 达那唑 rhTPO 达那唑达那唑 试验方案流程图 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 治疗14天内 第1阶段 有效率 指标 FASPPS 达那唑 rhTPO达那唑达那唑 rhTPO达那唑 N 例 73636050 有效 显效 良效 44 60 27 23 36 51 38 63 33 16 32 00 无效 进步 无效 29 39 73 40 63 49 22 36 67 34 68 00 P值0 01040 0040 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 达那唑治疗14天后无效者加用rhTPO 项目FASPPS N 例 4542 显效 14 31 11 14 33 33 良效 16 35 56 16 38 10 进步 12 26 67 10 23 81 无效 3 6 67 2 4 76 有效 显效 有效 30 66 67 30 71 43 无效 进步 无效 15 33 33 12 28 57 提示 达那唑14天治疗无效情况下rhTPO治疗是有效的 且有效率与第1 阶段rhTPO治疗相近 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 总结 v 长期以来 特发性血小板减少性紫癜 ITP 发病机制被认为 是由于抗血小板自身抗体所致的血小板破坏 对ITP的治 疗主要立足于抑制血小板破坏和抗体的生成 v 近年发现 多数慢性ITP患者血清中TPO的水平与正常人 水平相近 甚至略低于正常人水平 提示ITP患者可能存 在内源性TPO相对不足 这为TPO用于ITP治疗奠定了理 论依据 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 总结 v 在给药14天内 rhTPO 1 0 g kg d 皮下注射 可明显升 高ITP患者的血小板计数 显效率 总有效率明显高于对照 组 达到有效标准的时间明显短于对照组 v 达那唑治疗14天无效的患者 rhTPO依然有效 v rhTPO治疗对Hb WBC 肝肾功能和凝血功能无明显影 响 个别患者可出现轻微嗜睡 头晕 过敏样反应 乏力 及注射部位疼痛等不良反应 v 此次试验再次证实了rhTPO是治疗成人慢性难治性ITP的安 全 有效药物 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Rituximab治疗ITP Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Rituximab的作用机制 清除CD20 B细胞克隆 增加Treg细胞数量 改善其功能 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Rituximab 治疗前后调节性T细胞的变化 Stasi等对ITP患者Rituximab治疗前后用流式细胞术检测外周血调节性 T 细胞 Tregs CD4 FOXP3 T细胞 数量 用细胞增殖检测法测 定Tregs的调节功能 结果 治疗前ITP患者的Tregs 数量减少 抑制功能减弱 克隆分析显 示Tregs 呈多克隆性 Rituximab 治疗后 Tregs 数量恢复 调节功能也恢复 特别是 治疗有效的患者 恢复更明显 结论 活动性ITP患者存在调节性T细胞缺陷 B细胞靶向治疗可改 善这种情况 Blood 2008 112 1147 1150 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial 2001 4 2004 3西班牙43家医院Rituximab治疗89例慢性难治性ITP 总有效率55 1 CR率46 1 其中 73 可维持长期疗效 PR率 9 9月内维持疗效 35 长期疗效 34 7 Ann Hematol 2006 85 400 406 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Ann Hematol 2006 85 400 406 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Arnold等对19篇Rituximab治疗ITP文献荟萃分析 Platelet Count Response 109 L Pooled Estimate 95 CI Contributing Reports Patients Overall response 50 62 5 52 6 72 5 19 313 Complete response 150 46 3 29 5 57 7 13 191 Partial response 50 150 24 0 15 2 32 7 16 284 Ann Intern Med 2007 146 25 33 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Rituximab 治疗26例成人复发或难治ITP 长期随访结果 诊断至Rituximab治疗的中位时间34 5月 Rituximab用法375 mg m 2 W 4 weeks 中位观察时间56 5月 39 77月 完全有效 CR 14 26 54 部分有效 PR 4 26 15 中位21月 8 66 后复发18例有效的患者中9例复发 中位随访57 月 range 39 69 9 26 35 长期缓解 11 26 42 不需其他治疗 estimated 5 years relapse free survival RFS 61 estimated 5 years therapy free survival TFS 72 副作用 2例出现短期毒性 其中1例出现血清病综 合征 Eur J Haematol 2008 结论 Rituximab 可使约1 3复发或难治ITP长期缓解 安全性好 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Rituximab治疗切脾无效的慢性难治性ITP v Pasa等用Rituximab治疗 17 例切脾无效的慢性难治性 ITP v 14例有效 血小板计数 50 x 109 L 其中 10例疗效维持 6月以上 不需其他治疗 J Thromb Thrombolysis 2008 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Rituximab治疗有切脾指征的慢性ITP的疗效和安全性 多中心前瞻性 II期临床试验结果 目的 慢性ITP rituximab 是否可安全有效替代切脾 60例有切脾指征的慢性ITP 病程 6 月 血小板计数 30 x109 L 给予 rituximab 375mg m2 w 连用4周 不合用其他治疗 有效 血小板计数 50 x109 L 且首次应用rituximab 1年及2年后血小板计数至少是治疗 前的2倍 随访期间若患者需要其他治疗则视为无效 1年有效率40 24 60 95 可信区间 28 52 2年有效率33 3 20 60 36例 60 无效 其中25例后来切脾 16例出现短期副作用 仅1例停止治疗 结论 对部分慢性成人ITP rituximab 可作为替代切脾安全有效的治疗选择 该试验注册于http clinicaltrials gov as NCT00225875 Blood 2008 112 999 1004 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Rituximab 地塞米松 Vs 单用地塞米松 治疗ITP的前瞻性随机研究 长期随访和最终分析结果 Francesco Zaja et al Italy ASH 2008 Five weeks of practice ended in this way and my feelings can only be summed up in eight words although hard but very substantial Material and methods v随机分组 arm A 口服Dex 40 mg d d1 4 arm B 口服Dex 40 mg d d1 4 rituximab 375 mg m2 iv d7 14 21 28 arm A患者中疗效未能持续者 从d30至6个月末 PLT 20 109 L 可接受挽救治疗 方案同 arm B Dex rituximab Five weeks of practice ended in this way and my feelings can only be su
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