目的比较利妥昔单抗生物类似药与原研药治疗非霍奇金淋巴瘤(NHL)的有效性、安全性和免疫原性。方法从CNKI、万方、维普、PubMed、Embase、Cochrane Library、Web of Science数据库和ClinicalTrials.gov临床试验中心检索利妥昔单抗生物...目的比较利妥昔单抗生物类似药与原研药治疗非霍奇金淋巴瘤(NHL)的有效性、安全性和免疫原性。方法从CNKI、万方、维普、PubMed、Embase、Cochrane Library、Web of Science数据库和ClinicalTrials.gov临床试验中心检索利妥昔单抗生物类似药与原研药的随机对照研究(RCT),采用Revman 5.4.1统计软件对疗效、安全性和免疫原性进行Meta分析。结果共纳入15项研究,共12种生物类似药,包含3585例NHL患者,有效性结果如下,客观缓解率(ORR):[RR=1.01,95%CI(0.97,1.05),P=0.58 I^(2)=10%];无进展生存期(PFS):[RR=1.05,95%CI(0.99,1.10),P=0.11,I^(2)=24%];总生存期(OS):[RR=1.01,95%CI(0.94,1.08),P=0.86,I^(2)=0%];无事件生存率(EFS):[RR=0.95,95%CI(0.83,1.08),P=0.40,I^(2)=25%].安全性结果如下,输注相关反应(IRR)发生率:[RR=0.96,95%CI(0.85,1.09),P=0.59,I^(2)=0%];严重不良事件发生率(SAEs):[RR=1.09,95%CI(0.93,1.28),P=0.29,I^(2)=0%];不良事件发生率(AEs,≥3级):[RR=0.97,95%CI(0.88,1.07),P=0.59,I^(2)=0%];中性粒细胞减少(任意级别)发生率:[RR=1.01,95%CI(0.91,1.12),P=0.80,I^(2)=41%];中性粒细胞减少(≥3级)发生率:[RR=1.07,95%CI(0.88,1.30),P=0.47,I^(2)=0%];贫血发生率:[RR=1.10,95%CI(0.91,1.32),P=0.33,I^(2)=0%];发热性中性粒细胞减少(≥3级)发生率:[RR=1.15,95%CI(0.65,2.03),P=0.62,I^(2)=45%];白细胞计数下降(≥3级)发生率:[RR=0.98,95%CI(0.74,1.30),P=0.87,I^(2)=16%];感染发生率:[RR=0.89,95%CI(0.77,1.03),P=0.13,I^(2)=19%];高血压发生率:[RR=1.16,95%CI(0.78,1.74),P=0.46,I^(2)=0%];免疫原性(ATM)发生率:[RR=1.10,95%CI(0.80,1.52),P=0.56,I^(2)=0%].亚组分析显示利妥昔单抗生物类似药(GA101)在PFS上比原研药有优势(P<0.1),生物类似药CT-P10在中性粒细胞减少的发生率上比原研药高(P<0.1),其他利妥昔单抗生物类似药在疗效、安全性和免疫原性与原研药没有统计意义上的差异。结论绝大多数利妥昔单抗生物类似药在治疗NHL的疗效、安全性和免疫原性上与原研药相似,但是展开更多
By means of a double mirror interferometry a two-dimensional temperature distribution measurement in convective thermal boundary layers is presented. When the cold air flows along a hot plate model, the interferometri...By means of a double mirror interferometry a two-dimensional temperature distribution measurement in convective thermal boundary layers is presented. When the cold air flows along a hot plate model, the interferometric fringe inside the boundary layer will bend. According to the displacement of the fringe and the relation between temperature and index of refraction, a two-dimensional temperature profile is obtained. All is accomplished by optical device with the help of micro-computer without any contact with the flow field.展开更多
文摘By means of a double mirror interferometry a two-dimensional temperature distribution measurement in convective thermal boundary layers is presented. When the cold air flows along a hot plate model, the interferometric fringe inside the boundary layer will bend. According to the displacement of the fringe and the relation between temperature and index of refraction, a two-dimensional temperature profile is obtained. All is accomplished by optical device with the help of micro-computer without any contact with the flow field.