Background The benefit-risk profile of tenecteplase in the elderly patients with acute ischaemic stroke(AIS)is uncertain.We sought to investigate the efficacy and safety of 0.25 mg/kg tenecteplase compared with altepl...Background The benefit-risk profile of tenecteplase in the elderly patients with acute ischaemic stroke(AIS)is uncertain.We sought to investigate the efficacy and safety of 0.25 mg/kg tenecteplase compared with alteplase for AIS patients aged≥80 years.Methods We performed a post hoc analysis of the Tenecteplase Reperfusion Therapy in Acute Ischaemic Cerebrovascular Events-2 Trial,a randomised,phase 3,non-inferiority clinical trial.Disabling AIS patients aged≥80 years who initiated intravenous thrombolytics within 4.5 hours of symptom onset were enrolled from June 2021 to May 2022 across 53 centres in China and were randomly allocated to receive 0.25 mg/kg tenecteplase or 0.9 mg/kg alteplase.The primary efficacy outcome was the proportion of participants with a modified Rankin Scale(mRS)score of 0-1 at 90 days.Symptomatic intracranial haemorrhage(sICH)within 36 hours was the safety outcome.Results Of 137 participants,mRS 0-1 at 90 days occurred in 37(49.3%)of 75 in the tenecteplase group vs 20(33.9%)of 59 in the alteplase group(risk ratio(RR)1.47,95%CI 0.96 to 2.23).sICH within 36 hours was observed in 3(4.0%)of 76 in the tenecteplase group and two(3.3%)of 61 in the alteplase group(RR 1.30,95%CI 0.20 to 8.41).Conclusions The risk-benefit profile of tenecteplase thrombolysis was preserved in the elderly patients,which lends further support to intravenous 0.25 mg/kg tenecteplase as an alternative to alteplase in these patients.展开更多
To the Editor:Upadacitinib,an oral janus kinase(JAK)inhibitor,exhibits a higher inhibitory potency for JAK1 compared to JAK2,JAK3,or tyrosine kinase 2,making it a promising candidate for the treatment of atopic dermat...To the Editor:Upadacitinib,an oral janus kinase(JAK)inhibitor,exhibits a higher inhibitory potency for JAK1 compared to JAK2,JAK3,or tyrosine kinase 2,making it a promising candidate for the treatment of atopic dermatitis(AD).Global trials Measure Up 1,Measure Up 2,and AD Up have demonstrated efficacy and safety data for moderate-to-severe AD,both as monotherapy and in combination with topical corticosteroids(TCS).[1,2]The updated 52-week results preliminarily reported sustained clinical benefits over 52 weeks,[3,4]but data on long-term outcomes in Chinese patients remain limited.Ethnic differences in AD pathophysiology,including variations in immune signatures,underscore the need for region-specific evidence.[5]This post hoc analysis of Measure Up 1 and AD Up trials evaluates the 140-week efficacy and safety of upadacitinib in Chinese patients.展开更多
Objective: To assess the effects of Shenfu Injection(参附注射液, SFI) on blood lactate, and secondarily its effect on the lactate clearance(LC) in patients with post cardiac arrest syndrome(PCAS). Methods: The present...Objective: To assess the effects of Shenfu Injection(参附注射液, SFI) on blood lactate, and secondarily its effect on the lactate clearance(LC) in patients with post cardiac arrest syndrome(PCAS). Methods: The present study is a post hoc study of a randomized, assessor-blinded, controlled trial. Patients experienced in-hospital cardiac arrest between 2012 and 2015 were included in the predefined post hoc analyses. Of 1,022 patients enrolled, a total of 978 patients were allocated to the control group(486 cases) and SFI(492 cases) group, receiving standardized post-resuscitation care bundle(PRCB) treatment or PRCB combined with SFI(100 mL/d), respectively. Patients’ serum lactate was measured simutaneously with artery blood gas, lactate clearance(LC) was calculated on days 1, 3, and 7 after admission and compared between groups. Lactate and LC were also compared between the survivors and non-survivors according to the 28-d mortality, as well as the survivors and non-survivors subgroups both in the SFI and control groups. Results: In both groups, compared with pre-treatment levels, mean arterial pressure(MAP) and PaOwere significantly improved on 1, 3, 7 d after treatment(P<0.05), while heart rate(HR) and blood glucose levels were significantly decreased on 1, 3 and 7 d after treatment(P<0.05). compared with control group, SFI treatment improved the values of MAP and PaO(P<0.05), and significantly decreased the levels of HR and the blood glucose level on 3 and 7 d after treatment(P<0.05). Compared with the control group, lactate levels decreased faster in the SFI group versus the control group on 3 and 7 d(P<0.05). From initiation of treatment and the following 3 and 7 d, SFI treatment greatly increased the LC compared with that in the control group(P<0.05). Compared with survivors, non-survivors had higher admission lactate levels(7.3±1.1 mmol/L vs. 5.5±2.3 mmol/L;P <0.01), higher lactate levels on days 1, 3 and 7(P <0.05), and LC were decreased significantly on 3 and 7 d after treatment(P<0.05). Similar results were also found both in the SFI and control groups between survivors and non-survivors subgroups. Conclusion: SFI in combination with PRCB treatment is effective at lowering lactate level and resulted in increasing LC in a targeted population of PCAS patients.展开更多
基金funded by Beijing Municipal Science&Technology Committee(Z211100003521019)China Shijiazhuang Pharmaceutical Company Recomgen Pharmaceutical(Guangzhou)Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences(2019-I2M 5-029)National Natural Science Foundation(82111530203,82171272).
文摘Background The benefit-risk profile of tenecteplase in the elderly patients with acute ischaemic stroke(AIS)is uncertain.We sought to investigate the efficacy and safety of 0.25 mg/kg tenecteplase compared with alteplase for AIS patients aged≥80 years.Methods We performed a post hoc analysis of the Tenecteplase Reperfusion Therapy in Acute Ischaemic Cerebrovascular Events-2 Trial,a randomised,phase 3,non-inferiority clinical trial.Disabling AIS patients aged≥80 years who initiated intravenous thrombolytics within 4.5 hours of symptom onset were enrolled from June 2021 to May 2022 across 53 centres in China and were randomly allocated to receive 0.25 mg/kg tenecteplase or 0.9 mg/kg alteplase.The primary efficacy outcome was the proportion of participants with a modified Rankin Scale(mRS)score of 0-1 at 90 days.Symptomatic intracranial haemorrhage(sICH)within 36 hours was the safety outcome.Results Of 137 participants,mRS 0-1 at 90 days occurred in 37(49.3%)of 75 in the tenecteplase group vs 20(33.9%)of 59 in the alteplase group(risk ratio(RR)1.47,95%CI 0.96 to 2.23).sICH within 36 hours was observed in 3(4.0%)of 76 in the tenecteplase group and two(3.3%)of 61 in the alteplase group(RR 1.30,95%CI 0.20 to 8.41).Conclusions The risk-benefit profile of tenecteplase thrombolysis was preserved in the elderly patients,which lends further support to intravenous 0.25 mg/kg tenecteplase as an alternative to alteplase in these patients.
文摘To the Editor:Upadacitinib,an oral janus kinase(JAK)inhibitor,exhibits a higher inhibitory potency for JAK1 compared to JAK2,JAK3,or tyrosine kinase 2,making it a promising candidate for the treatment of atopic dermatitis(AD).Global trials Measure Up 1,Measure Up 2,and AD Up have demonstrated efficacy and safety data for moderate-to-severe AD,both as monotherapy and in combination with topical corticosteroids(TCS).[1,2]The updated 52-week results preliminarily reported sustained clinical benefits over 52 weeks,[3,4]but data on long-term outcomes in Chinese patients remain limited.Ethnic differences in AD pathophysiology,including variations in immune signatures,underscore the need for region-specific evidence.[5]This post hoc analysis of Measure Up 1 and AD Up trials evaluates the 140-week efficacy and safety of upadacitinib in Chinese patients.
基金Supported by the Beijing Municipal Administration of Hospitals’Youth Programme (No.QML20170301)。
文摘Objective: To assess the effects of Shenfu Injection(参附注射液, SFI) on blood lactate, and secondarily its effect on the lactate clearance(LC) in patients with post cardiac arrest syndrome(PCAS). Methods: The present study is a post hoc study of a randomized, assessor-blinded, controlled trial. Patients experienced in-hospital cardiac arrest between 2012 and 2015 were included in the predefined post hoc analyses. Of 1,022 patients enrolled, a total of 978 patients were allocated to the control group(486 cases) and SFI(492 cases) group, receiving standardized post-resuscitation care bundle(PRCB) treatment or PRCB combined with SFI(100 mL/d), respectively. Patients’ serum lactate was measured simutaneously with artery blood gas, lactate clearance(LC) was calculated on days 1, 3, and 7 after admission and compared between groups. Lactate and LC were also compared between the survivors and non-survivors according to the 28-d mortality, as well as the survivors and non-survivors subgroups both in the SFI and control groups. Results: In both groups, compared with pre-treatment levels, mean arterial pressure(MAP) and PaOwere significantly improved on 1, 3, 7 d after treatment(P<0.05), while heart rate(HR) and blood glucose levels were significantly decreased on 1, 3 and 7 d after treatment(P<0.05). compared with control group, SFI treatment improved the values of MAP and PaO(P<0.05), and significantly decreased the levels of HR and the blood glucose level on 3 and 7 d after treatment(P<0.05). Compared with the control group, lactate levels decreased faster in the SFI group versus the control group on 3 and 7 d(P<0.05). From initiation of treatment and the following 3 and 7 d, SFI treatment greatly increased the LC compared with that in the control group(P<0.05). Compared with survivors, non-survivors had higher admission lactate levels(7.3±1.1 mmol/L vs. 5.5±2.3 mmol/L;P <0.01), higher lactate levels on days 1, 3 and 7(P <0.05), and LC were decreased significantly on 3 and 7 d after treatment(P<0.05). Similar results were also found both in the SFI and control groups between survivors and non-survivors subgroups. Conclusion: SFI in combination with PRCB treatment is effective at lowering lactate level and resulted in increasing LC in a targeted population of PCAS patients.
