ABSTRACT
OBJECTIVE To provide a reference for the safe use of thrombopoietin receptor agonists romiplostim and eltrombopag in clinic. METHODS FDA adverse event reporting system （FAERS） in the United States was adopted to collect adverse drug event （ADE） reports of romiplostim and eltrombopag from their launch in the United States to September 30， 2022； the ADE signals of the two drugs were analyzed using the reporting odds ratio （ROR） method and the comprehensive standard method of the UK Medicines and Healthcare Products Regulatory Agency. RESULTS A total of 14 021 and 4 431 ADE reports were collected about romiplostim and eltrombopag， respectively， with a gender composition of more females than males. After signal screening， 563 ADE signals were obtained about romiplostim， involving 25 system organ classes （SOC）； eltrombopag had 433 ADE signals， involving 26 SOC. The most frequently reported ADE for both drugs was platelet count decreased （2 060， 1 585 cases）， which was mentioned in their drug instructions. In terms of signal intensity， romiplostim exhibited the highest signal for abnormal thrombopoietin levels （ROR of 2 268.85）， while eltrombopag had the highest signal for positive dengue virus test （ROR of 954.50）， with neither of these signals mentioned in their respective drug instructions. CONCLUSIONS The ADE of romiplostim and eltrombopag mainly affects the blood and lymphatic system， and there are many new suspicious high-risk signals.
ABSTRACT
OBJECTIVE To systematically evaluate the efficacy and safety of fondaparinux versus low molecular weight heparin（nadroparin，enoxaparin）in the treatment of non-ST-elevation acute coronary syndrome （NSTE-ACS）. METHODS The computer searched PubMed ，Medline，Embase，EBSCO，CNKI，Wanfang medical network ，VIP Chinese Journal Full-text Database and relevant clinical trial registration network for the clinical retrospective cohort study （RCS）of fondaparinux （as trial group）and low molecular weight heparin （natroparin，enoxaparin）（as control group ）in the treatment of NSTE-ACS. The retrieval time limit was from the establishment of the database to August 2021. Newcastle Ottawa scale （NOS）was used to evaluate the quality of literature. Outcome indicators included primary efficacy indicators （incidence of acute myocardial infarction and recurrent angina pectoris during hospitalization ），secondary efficacy indicators [revascularization of target vessels during 话：0835-2862024。E-mail：xiexingxing07@163.com hospitalization， prothrombin time （PT）， activated partial thromboplastin time （APTT）]，safety indicators （incidence of serious cardiovascular events ，severe bleeding ，slight bleeding and severe puncture site co mplications during hospitalization ），combined endpoint indicators （30 and 180 days combined endpoint）. RevMan 5.3 software was used for Meta-analysis of each effect index. RESULTS Finally，17 RCS articles were included，involving 4 946 patients with NSTE-ACS ，including 2 507 in the trial group and 2 439 in the control group.The results of NOS literature quality evaluation showed that there were 8 high-quality studies ，accounting for 47.06％ . The results of Meta-analysis showed that there was no significant difference in the incidence of acute myocardial infarction ，recurrent angina pectoris，revascularization of target vessels ，PT and serious cardiovascular events between 2 groups （P＞0.05）；there was significant difference in the APTT （MD＝1.34，95％CI of 0.22-2.45，P＜0.05），the incidence of severe bleeding （RR＝0.47， 95％CI of 0.30-0.74，P＜0.05），the incidence of slight bleeding （RR＝0.48，95％CI of 0.32-0.71，P＜0.05），the incidence of severe puncture site complications （RR＝0.48，95％CI of 0.25-0.95，P＜0.05），30 day combined endpoint （RR＝0.57，95％CI of 0.46-0.72，P＜0.05），180 days combined endpoint （RR＝0.73，95％CI of 0.54-0.98，P＜0.05）. CONCLUSIONS Fondaparinux in the treatment of NSTE-ACS in China has the same efficacy as low molecular weight heparin （nadroparin，enoxaparin），and has more obvious advantages in drug safety such as bleeding ，severe puncture site complications.
ABSTRACT
Objective To investigate the efficacy comparison of endovascular therapy and simple medical therapy for symptomatic intracranial artery stenosis. Methods A total of 145 patients with intracranial artery stenosis were analyzed retrospectively. They were divided into either an endovascular therapy group (n=72) or a medical therapy group (n=73). They were treated with endovascular therapy (gateway balloon,wingspan stents,Apollo stents) or medical therapy (aspirin 100 mg/d,clopidogrel 75mg/d, and atorvastatin 20-40 mg/d) according the willingness of the patients or their family members. The incidences of stroke and transient ischemic attack ( TIA ) , and restenosis rate ( stenosis rate >50% as a standard) during 1-,3-,6-,9-,and 12-month follow-up periods were observed and compared. Results On the basis of medical therapy,the patients of the endovascular therapy group were successfully stented. The success rate of stenting was 98. 6% (70/71). Seven patients had complications in the endovascular therapy group (9.9%),2 of them complicated with hemorrhage(one of was died),drinking cough,hoarseness, dizziness,headache,and excitement were one case in each, the other patients were cured and discharged with active medical treatment, and they did not have serious sequelae. At 12 months after treatment, the stroke recurrence rate of the endovascular therapy group was 8. 4% (n=6,both were TIA),and that of the medical therapy group was 26. 0% (84. 2% was minor stroke). There was significant difference (χ2 =7. 752,P0. 05). Conclusion Compared with the medical therapy,the efficacy of endovascular therapy for symptomatic intra-cranial arterial stenosis is more significant. The improvement of clinical prognosis is superior to medical therapy.