目的:评价和分析维泊妥珠单抗上市后的药物不良反应(adverse drug reaction,ADR)信号,为临床安全性管理提供参考。方法:通过开放性OpenVigil数据平台,收集2019年6月10日(美国FDA批准上市时间)至2023年3月31日美国FDA不良事件报告系统(FA...目的:评价和分析维泊妥珠单抗上市后的药物不良反应(adverse drug reaction,ADR)信号,为临床安全性管理提供参考。方法:通过开放性OpenVigil数据平台,收集2019年6月10日(美国FDA批准上市时间)至2023年3月31日美国FDA不良事件报告系统(FAERS)数据库中维泊妥珠单抗的ADR报告。采用比例失衡法中的报告比值比(ROR)和比例报告比(PRR)进行信号挖掘。为提高阈值,得到信号较强、较常出现的ADR,将信号进行二次筛选。结果:共检索到维泊妥珠单抗相关ADR报告2408份,经过二次筛选得到83个ADR信号。其中,脊柱磁共振成像异常、骨吸收增加、骨质溶解、天门冬氨酸氨基转移酶降低、丙氨酸氨基转移酶降低、低纤维蛋白原血症、肺栓塞等26个ADR信号在药品说明书中未提及。信号数或累积例数较多的系统器官分类包含感染及侵染类疾病(24个信号、632例),各类检查(17个信号、675例),血液及淋巴系统疾病(11个信号、734例),各类神经系统疾病(7个信号、153例),免疫系统疾病(3个信号、95例),全身性疾病及给药部位各种反应(2个信号、145例),代谢及营养类疾病(2个信号、87例)等。结论:除说明书提示的常见ADR外,本研究发现了维泊妥珠单抗新的ADR风险信号。建议临床在关注感染、骨髓抑制、周围神经病、输液相关反应、肝功能异常等已知常见ADR的同时,予以脊柱磁共振成像异常、骨吸收增加等新的风险信号更多关注。展开更多
Primary breast lymphomas are rare. They are defined by the involvement of one or both breasts. This is the first site affected or mainly affected with the exception of ipsilateral axillary involvement. Due to the abse...Primary breast lymphomas are rare. They are defined by the involvement of one or both breasts. This is the first site affected or mainly affected with the exception of ipsilateral axillary involvement. Due to the absence of specific clinical and radiological signs, the diagnosis is confirmed by histology. The most frequent entity remains diffuse large B-cell lymphomas. The place of surgery remains exclusive in establishing the initial diagnosis. Anthracycline-based chemotherapy with or without Rituximab remains the gold standard in the therapeutic arsenal. We present the case of a 42-year-old woman with no surgical history;nulliparous;followed in nephrology for chronic renal failure, received as an outpatient for a nodule in the left breast in a context of dyspnea. This is a nodule discovered incidentally during a routine examination. Clinical examination of the left breast found nipple retraction without ulceration;a mass 7 cm in diameter located in the left upper outer quadrant. Breast ultrasound and mammography suggest a suspected lesion of malignancy. After a percutaneous micro biopsy;the histological study confirms the diagnosis of a large B-cell lymphoma of the left breast. A TAP CT scan is performed as part of the extension assessment. Chemotherapy based on R-CHOP with local radiotherapy is decided in CPR.展开更多
Primary cutaneous B cell lymphoma(PCBCL) is defined as B cell lymphomas that presents in the skin without any evidence of extra-cutaneous involvement at diagnosis. They are the second most common type of primary cutan...Primary cutaneous B cell lymphoma(PCBCL) is defined as B cell lymphomas that presents in the skin without any evidence of extra-cutaneous involvement at diagnosis. They are the second most common type of primary cutaneous lymphomas accounting for 25%-30%. Since the prognosis and treatment differ from systemic lymphomas involving the skin, differential diagnosis is very important. PCBCL is a heterogeneous group of disease comprising different B cell lymphomas with distinct treatment and prognosis. PCBCL is divided into 5 subclasses according to World Health Organization and European Organization of Research and Treatment of Cancer classification. Primary cutaneous marginal zone lymphoma and primary cutaneous follicle centerlymphoma are indolent forms and often confined to skin at presentation and during the course of the disease. But primary cutaneous diffuse large B cell lymphoma, leg type and intravascular large B cell lymphoma are more aggressive forms that may disseminate to extra-cutaneous tissues. There is not a treatment consensus since they are rare entities. Local therapies like radiotherapy, surgery or intralesional steroids are options for localized disease in indolent forms. More disseminated disease may be treated with a systemic therapy like single agent rituximab. However combination chemotherapies which are used in systemic lymphomas are also required for aggressive PCBCL. Although indolent forms have relatively better prognosis, early relapses and disseminated diseases are mostly observed in aggressive form with a consequent poor prognosis.展开更多
目的分析原发中枢神经系统(PCNS)弥漫大B细胞淋巴瘤(DLBCL)患者的临床特点,并探讨影响预后的相关因素。方法回顾性分析61例PCNS-DLBCL患者的临床资料,进行生存和预后因素分析。结果61例PCNS-DLBCL患者,发病年龄中位数为58岁(11~76岁),...目的分析原发中枢神经系统(PCNS)弥漫大B细胞淋巴瘤(DLBCL)患者的临床特点,并探讨影响预后的相关因素。方法回顾性分析61例PCNS-DLBCL患者的临床资料,进行生存和预后因素分析。结果61例PCNS-DLBCL患者,发病年龄中位数为58岁(11~76岁),以颅内高压和肢体言语障碍为最常见临床表现,病灶好发于大脑半球,深部病灶受累常见。61例均接受部分或全部肿瘤切除,29例术后接受单纯化疗,15例术后接受化疗+放疗,其余17例单纯手术治疗。累计4年总体生存率(OS)为50.1%,无进展生存率(PFS)为41.4%。对所有患者的OS进行单因素生存分析显示,接受化疗明显优于单纯手术(70.6%vs 0.0%,P=0.000),KPS评分≥70分者优于<70分者(64.8% vs 36.0%,P=0.029)。COX回归分析显示,单纯手术为预后不良的危险因素。对接受化疗的44例患者分析提示,男性、KPS评分<70分及多病灶为危险因素,但多因素分析中所有因素预后差别均无统计学意义。接受化疗+放疗的患者4年OS较接受单纯化疗更高(83.9% vs 63.7%,P=0.115),但差别无统计学意义。对于病理类型为非生发中心的30例患者,化疗中使用美罗华较未使用者4年OS较高(100.0% vs 60.9%,P=0.081)。结论PCNSDLBCL预后不佳,化疗是改善生存的重要措施,而化疗+放疗可能更优于单纯化疗。展开更多
文摘目的:评价和分析维泊妥珠单抗上市后的药物不良反应(adverse drug reaction,ADR)信号,为临床安全性管理提供参考。方法:通过开放性OpenVigil数据平台,收集2019年6月10日(美国FDA批准上市时间)至2023年3月31日美国FDA不良事件报告系统(FAERS)数据库中维泊妥珠单抗的ADR报告。采用比例失衡法中的报告比值比(ROR)和比例报告比(PRR)进行信号挖掘。为提高阈值,得到信号较强、较常出现的ADR,将信号进行二次筛选。结果:共检索到维泊妥珠单抗相关ADR报告2408份,经过二次筛选得到83个ADR信号。其中,脊柱磁共振成像异常、骨吸收增加、骨质溶解、天门冬氨酸氨基转移酶降低、丙氨酸氨基转移酶降低、低纤维蛋白原血症、肺栓塞等26个ADR信号在药品说明书中未提及。信号数或累积例数较多的系统器官分类包含感染及侵染类疾病(24个信号、632例),各类检查(17个信号、675例),血液及淋巴系统疾病(11个信号、734例),各类神经系统疾病(7个信号、153例),免疫系统疾病(3个信号、95例),全身性疾病及给药部位各种反应(2个信号、145例),代谢及营养类疾病(2个信号、87例)等。结论:除说明书提示的常见ADR外,本研究发现了维泊妥珠单抗新的ADR风险信号。建议临床在关注感染、骨髓抑制、周围神经病、输液相关反应、肝功能异常等已知常见ADR的同时,予以脊柱磁共振成像异常、骨吸收增加等新的风险信号更多关注。
文摘Primary breast lymphomas are rare. They are defined by the involvement of one or both breasts. This is the first site affected or mainly affected with the exception of ipsilateral axillary involvement. Due to the absence of specific clinical and radiological signs, the diagnosis is confirmed by histology. The most frequent entity remains diffuse large B-cell lymphomas. The place of surgery remains exclusive in establishing the initial diagnosis. Anthracycline-based chemotherapy with or without Rituximab remains the gold standard in the therapeutic arsenal. We present the case of a 42-year-old woman with no surgical history;nulliparous;followed in nephrology for chronic renal failure, received as an outpatient for a nodule in the left breast in a context of dyspnea. This is a nodule discovered incidentally during a routine examination. Clinical examination of the left breast found nipple retraction without ulceration;a mass 7 cm in diameter located in the left upper outer quadrant. Breast ultrasound and mammography suggest a suspected lesion of malignancy. After a percutaneous micro biopsy;the histological study confirms the diagnosis of a large B-cell lymphoma of the left breast. A TAP CT scan is performed as part of the extension assessment. Chemotherapy based on R-CHOP with local radiotherapy is decided in CPR.
文摘Primary cutaneous B cell lymphoma(PCBCL) is defined as B cell lymphomas that presents in the skin without any evidence of extra-cutaneous involvement at diagnosis. They are the second most common type of primary cutaneous lymphomas accounting for 25%-30%. Since the prognosis and treatment differ from systemic lymphomas involving the skin, differential diagnosis is very important. PCBCL is a heterogeneous group of disease comprising different B cell lymphomas with distinct treatment and prognosis. PCBCL is divided into 5 subclasses according to World Health Organization and European Organization of Research and Treatment of Cancer classification. Primary cutaneous marginal zone lymphoma and primary cutaneous follicle centerlymphoma are indolent forms and often confined to skin at presentation and during the course of the disease. But primary cutaneous diffuse large B cell lymphoma, leg type and intravascular large B cell lymphoma are more aggressive forms that may disseminate to extra-cutaneous tissues. There is not a treatment consensus since they are rare entities. Local therapies like radiotherapy, surgery or intralesional steroids are options for localized disease in indolent forms. More disseminated disease may be treated with a systemic therapy like single agent rituximab. However combination chemotherapies which are used in systemic lymphomas are also required for aggressive PCBCL. Although indolent forms have relatively better prognosis, early relapses and disseminated diseases are mostly observed in aggressive form with a consequent poor prognosis.
文摘目的分析原发中枢神经系统(PCNS)弥漫大B细胞淋巴瘤(DLBCL)患者的临床特点,并探讨影响预后的相关因素。方法回顾性分析61例PCNS-DLBCL患者的临床资料,进行生存和预后因素分析。结果61例PCNS-DLBCL患者,发病年龄中位数为58岁(11~76岁),以颅内高压和肢体言语障碍为最常见临床表现,病灶好发于大脑半球,深部病灶受累常见。61例均接受部分或全部肿瘤切除,29例术后接受单纯化疗,15例术后接受化疗+放疗,其余17例单纯手术治疗。累计4年总体生存率(OS)为50.1%,无进展生存率(PFS)为41.4%。对所有患者的OS进行单因素生存分析显示,接受化疗明显优于单纯手术(70.6%vs 0.0%,P=0.000),KPS评分≥70分者优于<70分者(64.8% vs 36.0%,P=0.029)。COX回归分析显示,单纯手术为预后不良的危险因素。对接受化疗的44例患者分析提示,男性、KPS评分<70分及多病灶为危险因素,但多因素分析中所有因素预后差别均无统计学意义。接受化疗+放疗的患者4年OS较接受单纯化疗更高(83.9% vs 63.7%,P=0.115),但差别无统计学意义。对于病理类型为非生发中心的30例患者,化疗中使用美罗华较未使用者4年OS较高(100.0% vs 60.9%,P=0.081)。结论PCNSDLBCL预后不佳,化疗是改善生存的重要措施,而化疗+放疗可能更优于单纯化疗。
