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Journal of Cancer Therapy 2021年第3期12卷 146-156页

作者： Raiza Ruiz-Lorente Sayly Alfonso Eduardo Santiesteban Yamilka Sánchez Kirenia Camacho Erasmo Mendoza Carmen Elena Viada Ramón Ortiz Ihosvannys Carreño Mayelin Troche Meylan Cepeda Ana Rosa Vals Leticia Cabrera Annia Gorte Delmis Batista Milagros Domenech Yanela Santiesteban Yuliannis Santiesteban Daymys Estevez Jessica García-Viamontes Conrado Ramos Mico Mayra Ramos-Suzarte González Coro hospital La Habana Cuba Celestino Hernández Robau hospital Villa Clara Cuba Jose Ramón Lopez Tabranes hospital Matanzas Cuba III Congreso hospital Pinar del Río Cuba faustino perez hospital Matanzas Cuba Center of Molecular Immunology Havana Cuba

Cervical uterine cancer represents the fourth most common malignant neoplasm worldwide in the female sex in terms of incidence, principally from epithelial origen. The high expression of EGFR in this tumor leads to the search for therapeutic alternatives. An Expanded Access Clinical Program was carried out in parallel groups, randomized, multicenter and prospective study, to evaluate the survival of patients with advanced cervical carcinoma, without therapeutic alternative, who would be treated with the therapeutic vaccine CIMAvax-EGF®, the humanized mAb nimotuzumab or the combination of both products, which targeted EGF and EGFR respectively. The patients were included between 2008 and 2010 with a more than five years follow-up. The results show that the serious adverse events related to the experimental treatments were 0.9%;1.1% and 2.6% and a median ITT survival of 9.1, 23.5, and 16.3 months fo

关键词： CIMAvax-EGF® Nimotuzumab Survival Safety Advanced Cervical Cancer

Meplazumab in hospitalized adults with severe COVID-19(DEFLECT):a multicenter,seamless phase 2/3,randomized,third-party double-blind clinical trial

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Signal Transduction and Targeted Therapy 2023年第2期8卷 842-850页

作者： Huijie Bian Liang Chen Zhao-Hui Zheng Xiu-Xuan Sun Jie-Jie Geng Ruo Chen Ke Wang Xu Yang Shi-Rui Chen Si-Yu Chen Rong-Hua Xie Kui Zhang Jin-Lin Miao Jun-Feng Jia Hao Tang Shuang-Shuang Liu Hong-Wei Shi Yong Yang Xiao-Chun Chen Vinay Malhotra Nosheen Nasir Iffat Khanum Faisal Mahmood Saeed Hamid Claudio Marcel Berdun Stadnik Kengi Itinose Caroline Cândida Carvalho de Oliveira Cesar Dusilek Lucas Rivabem Adilson Joaquim Westheimer Cavalcante Suzara Souto Lopes Wladmir faustino Saporito Fábio JoséConcilio Fucci Jesus Abraham Simon-Campos Ling Wang Lin-Na Liu Qing-Yi Wang Ding Wei Zheng Zhang Zhi-Nan Chen Ping Zhu Department of Cell Biology of National Translational Science Center for Molecular Medicine and Department of Clinical Immunology of Xijing hospital Fourth Military Medical UniversityXi’anChina Shanghai Engineering Research Center of Organ Repair School of MedicineShanghai UniversityShanghaiChina Jiangsu Pacific Meinuoke Biopharmaceutical Co.Ltd ChangzhouChina Pulse Heart Institute Cardiology Services MultiCare Institute for Research&InnovationTacomaWAUSA Department of Medicine The Aga Khan UniversityKarachiPakistan Infection Control Service Irmandade Santa Casa de Misericord de Porto AlegrePorto AlegreBrazil Clinical Research Department Hospital do RocioCampo LargoBrazil CEMEC-Centro Multidisciplinar de Estudos Clínicos São Bernardo do CampoBrazil Chronos Pesquisa Clinica BrasíliaBrazil Pesquisare Saúde Santo AndréBrazil Instituto de Moléstias Cardiovasculares Tatuí TatuíBrazil Kohler&Milstein Research/hospital Agustín O’Horán MéridaMexico College of Military Preventive Medicine Fourth Military Medical UniversityXi’anChina Department of Pharmaceutics Tangdu HospitalFourth Military Medical UniversityXi’anChina Department of Foreign Languages Fourth Military Medical UniversityXi’anChina

Meplazumab,a humanized CD147 antibody,has shown favourable safety and efficacy in our previous clinical studies.In DEFLECT(NCT04586153),167 patients with severe COVID-19 were enroled and randomized to receive three dosages of meplazumab and a placebo.Meplazumab at 0.12 mg/kg,compared to the placebo group,showed clinical benefits in significantly reducing mortality by 83.6%(2.4%vs.14.6%,p=0.0150),increasing the proportion of patients alive and discharged without supplemental oxygen(82.9%vs.70.7%,p=0.0337)and increasing the proportion of patients who achieved sustained clinical improvement(41.5%vs.31.7%).The response rate in the 0.2 mg/kg group was relatively increased by 16.0%compared with the placebo group(53.7%vs.46.3%).Meplazumab also reduced the viral loads and multiple cytokine levels.Compare with the placebo group,the 0.3 mg/kg significantly increased the virus negative rate by 40.6%(p=0.0363)and reduced IL-8 level(p=0.0460);the 0.2 mg/kg increased the negative conversion rate by 36.9%,and reduced IL-4(p=0.0365)and IL-8 levels(p=0.0484).In this study,the adverse events occurred at a comparable rate across the four groups,with no unexpected safety findings observed.In conclusion,meplazumab promoted COVID-19 convalescence and reduced mortality,viral load,and cytokine levels in severe COVID-19 population with good safety profile.

关键词： clinical mortality dosage

Effective prophylaxis with rFVIIa in young haemophiliacs with inhibitors using a schedule similar to FVIII prophylaxis in non-inhibitor patients

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Health 2013年第7期5卷 1151-1157页

作者： Maria Fernanda Lopez-Fernandez Carmen Altisent Victor Jimenez-Yuste faustino Garcia-Candel Carmen Sedano Ana Cid Eva Mingot Ramiro Nunez Maria Jose Paloma Inmaculada Soto Manuel Prieto Haematology Complejo Hospitalario Universitario A CorunaA CorunaSpain Haemophilia Unit Hospital Universitario Vall d’HebronBarcelonaSpain Haemophilia Unit Hospital UniversitarioMadridSpain Haemophilia Unit Hospital Universitario Virgen de la ArreixacaMurciaSpain Haematology Complejo Hospitalario Universitario Marques de ValdecillaSantanderSpain Congenital Coagulophaties Unit Hospital Universitario La FeValenciaSpain Haematology Hospital Universitario Carlos HayaMalagaSpain Haematology Hospital Universitario Virgen del RocíoSevillaSpain Haematology Hospital Virgen del CaminoPamplonaSpain Haematology Hospital General de AsturiasOviedoSpain Haematology Hospital General YagüeBurgosSpain

Objective: To assess the role of early prophylaxis with recombinant activated factor VII (rFVIIa) in young haemophiliacs with inhibitors and to determine whether it can reduce bleeding episodes and prevent joint damage. Patients and Methods: Ten severe haemophiliacs, less of three years old, with up to four joint bleeds and inhibitors to FVIII who started early prophylaxis with rFVIIa, were included. A number of haemorrhages/year/patient and haemarthroses/ year/patient were compared before the start of prophylaxis, which include both the time before (initial period) and after inhibitor diagnosis (inhibitor period), with those during prophylaxis (prophylaxis period). Results: The mean time of inhibitor diagnosis was 15.6 months (range: 2.3-34.1). The mean time between inhibitor diagnosis and the start of prophylaxis was 7.1 months (range: 0-23.2), shorter than the time of rFVIIa prophylaxis (mean: 10.3 months;range: 4.1-32.0). Bleeding episodes for the three time periods were 45, 36 and 17, respectively, or 0.29 and 0.51 haemorrhages/year/patient in the two periods prior to prophylaxis compared to 0.17 during prophylaxis. Total haemarthroses for the three-time periods were 7, 5 and 5, respectively. The haemarthroses/year/patient in the pre-prophylaxis period were 0.032 and 0.070, compared to0.049 inthe prophylaxis period. rFVIIa schedules were either 90 μg/kg three times weekly or 90 μg/kg daily. Conclusions: Early prophylaxis with rFVIIa may be efficacious in young haemophiliacs with inhibitors, reducing joint bleeds. After the risky period of inhibitor presence, they are able to continue rFVIII prophylaxis with success assured to prevent arthropathy.

关键词： rFVIIa Haemarthroses Haemophilia Inhibitors Prophylaxis

Female urinary incontinence during pregnancy and after delivery: Clinical impact and contributing factors

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World Journal of Obstetrics and Gynecology 2013年第4期2卷 74-79页

作者： Paolo Mannella Giulia Palla Gonzalo Pérez-Roncero María T López-Baena faustino R Pérez-López Division of Obstetrics and Gynecology Center of Pelvic Disorders University of Pisa Hospital of Pisa 56100 Pisa Italy Red de Investigación de Ginecología Obstetriciay Reproducción Instituto Aragonés de Ciencias de la Salud 50009 Zaragoza Spain Department of Obstetrics and Gynecology University of Zaragoza School of Medicine 50009 Zaragoza Spain

Urinary incontinence(UI) is a common condition affecting adult women of all ages and it could have a negative infl uence on quality of life. The etiology of UI is multifactorial, but some of the most important risk factors are obesity and ageing, as well as adverse obstetric events. Pregnancy and delivery per se have been implicated in the etiology of UI. Although several studies have demonstrated a direct association between UI and vaginal delivery in short, medium and long-term, the role of childbirth on the risk of UI remains controversial. The mechanical strain during delivery may induce injuries to the muscle, connective and neural structures. Vaginal birth can be associated with relaxation or disruption of fascial and ligamentous supports of pelvic organs. Parity, instrumental delivery, prolonged labor and increased birth weights have always been considered risk factors for pelvic floor injury. Also genetic factors have been recently raised up but still there are not appropriate guidelines or measures to reduce signifi cantly the incidence of UI. The role of pelvic fl oor muscle training(PFMT) in the prevention and treatment of UI is still unclear. However, PFMT seems to be useful when supervised training is conducted and it could be incorporated as a routine part of women's exercise programmes during pregnancy and after childbirth.

关键词：尿失禁疾病治疗方法临床分析