Adverse effects

不利影响
  • 文章类型: Journal Article
    目的:子宫内膜异位症和子宫腺肌病是危害妇女健康的两种常见疾病,dienogest是药物治疗方法之一,是盆腔疼痛患者和不希望立即怀孕的人的一线治疗选择。这项研究的目的是总结与糖尿病相关的不良事件的当前证据以及在治疗期间这些不良事件的患病率。
    方法:几个数据库(PubMed、Embase,CochraneCentralandClinicaltrials.gov,等。)和美国FDA不良事件报告系统(FAERS)公共仪表板于2023年5月31日进行了搜索,使用主题词以及dienogest和“不良反应”的自由词。如果研究报告或评估子宫内膜异位症治疗或子宫腺肌病治疗期间的安全性问题或不良反应,则将其纳入本研究。提取的信息包括试验设计,Dienogest和对照组人口统计学,以及报道的副作用。
    结果:本系统综述共包括39篇出版物。纳入研究的患者平均年龄为34.43岁。随访时间从3个月到60个月不等。大多数不良反应常见且不严重,最常见的不良反应是异常子宫出血(55%,95%CI37-73%),闭经(17%,95%CI2-42%)和肿胀(13%,95%CI3-28%)。不常见的不良反应包括痛经(0.2%,n=1),消化不良(0.4%,n=1),和(下)腹痛(1%,95%CI0-3%),荨麻疹(1%,95%CI0-3%)和腹膜炎(1%,n=1)。严重的不良反应包括腰椎骨密度(BMD)降低,抑郁症,腹膜炎等均有报道。异质性评估显示,患者数量和研究设计是不良反应发生率的影响因素。此外,腹痛,腹泻,恶心和呕吐,在FAERS数据库和系统评价中都报道了背痛和贫血的副作用.
    结论:Dienogest最常见的副作用并不严重。Dienogest通常用于治疗子宫内膜异位症和子宫腺肌症是安全的。然而,人们应该意识到严重的不良反应,如腰椎骨密度下降和失血性休克。
    OBJECTIVE: Endometriosis and adenomyosis are two common diseases that impair women\'s health, and dienogest is one of the pharmacologic treatments which is the first-line therapeutic option for patients with pelvic pain and individuals who have no desire for immediate pregnancy. The goal of this study was to summarize the current evidence of adverse events associated with dienogest as well as the prevalence of these adverse events during treatment with dienogest.
    METHODS: Several databases (PubMed, Embase, Cochrane Central and Clinicaltrials.gov, etc.) and the US FDA Adverse Event Reporting System (FAERS) Public Dashboard were searched on May 31, 2023, using the topic words alongside free words of dienogest and \"adverse reaction\". Studies were incorporated into this research if they reported or assessed safety issues or adverse reactions of dienogest during the period of endometriosis treatment or adenomyosis therapy. The extracted information comprised trial design, dienogest and control group demographics, as well as reported side effects.
    RESULTS: This systematic review comprehended 39 publications in total. The mean age of patients in the included studies was 34.43 years. The follow-up duration varied from 3 to 60 months. Most adverse reactions were common and not serious, and the most common adverse reactions during dienogest medication were abnormal uterine bleeding (55%, 95% CI 37-73%), amenorrhea (17%, 95% CI 2-42%) and swelling (13%, 95% CI 3-28%). Uncommon adverse reactions included dysmenorrhea (0.2%, n = 1), dyspepsia (0.4%, n = 1), and (lower) abdominal pain (1%, 95% CI 0-3%), urticaria (1%, 95% CI 0-3%) and peritonitis (1%, n = 1). Serious adverse reactions including decreased lumbar spine Bone Mineral Density (BMD), depression, peritonitis and so on have been reported. Heterogeneity assessment revealed that patient number and study design are influencing factors to adverse reaction prevalence. Moreover, abdominal pain, diarrhea, nausea and vomiting, back pain and anemia are side effects reported both in the FAERS database and in the systematic review.
    CONCLUSIONS: Dienogest\'s most frequent side effects were not severe. Dienogest is generally safe for treating endometriosis and adenomyosis. Nevertheless, people should be aware of serious adverse reactions, such as decreased lumbar spine BMD and hemorrhagic shock.
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  • 文章类型: Journal Article
    降脂治疗对于减轻动脉粥样硬化性心血管疾病的负担具有重要意义。他汀类药物在当前的血脂管理指南中作为一线治疗。然而,他汀类药物的使用仅限于(1)他汀类药物引起的不良事件,包括他汀类药物相关的肌肉症状,新发糖尿病,药物性肝损伤,急性肾损伤,认知效应,出血性中风,和白内障;(2)特殊人群,包括孕妇和哺乳期的病人,失代偿期肝硬化患者,和透析患者;(3)与他汀类药物相互作用的药物联合给药,如抗人类免疫缺陷病毒药物,抗丙型肝炎病毒药物,和免疫抑制药物。这些相当多的他汀类药物限制组迫切需要更安全的替代降脂选择。前蛋白转化酶枯草杆菌蛋白酶/kexin9型(PCSK9)抑制剂因其在一般人群中的安全性和优异的降脂特性而受到广泛关注。因此,对于对他汀类药物治疗不耐受的患者,PCSK9抑制剂是否可以成为一种安全的替代药物的问题已经被提出.在这次审查中,我们讨论了PCSK9抑制剂在他汀类药物限制条件下的安全性.我们得出的结论是,在各种他汀类药物限制的情况下,PCSK9抑制剂是一种安全的替代降脂疗法。此外,我们确定了当前文献中的几个局限性,并提出了未来的方向,用于完善血脂管理方案。
    Lipid-lowering therapy is of great importance in reducing the burden of atherosclerotic cardiovascular disease. Statins act as first-line therapy in the current lipid management guidelines. However, statin use is limited in (1) statin-induced adverse events, including statin-associated muscle symptoms, new-onset diabetes mellitus, drug-induced liver injuries, acute kidney injuries, cognitive effects, hemorrhagic strokes, and cataracts; (2) special populations, including pregnant and lactating patients, patients with decompensated cirrhosis, and patients on dialysis; (3) coadministration with statin-interactive drugs, such as anti-human immunodeficiency virus drugs, anti-hepatitis C virus drugs, and immunosuppressive drugs. These considerable statin-limited groups are in urgent need of safer alternative lipid-lowering options. Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors are attracting widespread attention for their documented safety in general populations and superior lipid-lowering properties. Therefore, questions have been raised whether PCSK9 inhibitors could be a safe alternative in patients who are intolerant to statin therapy. In this review, we discuss the safety of PCSK9 inhibitors in statin-limited conditions. We conclude that PCSK9 inhibitors are a safe alternative lipid-lowering therapy in various statin-limited conditions. Furthermore, we identify several limitations in the current literature and suggest future directions, for the refinement of lipid management regimens.
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  • 文章类型: Clinical Trial
    背景:子宫肌瘤是常见的良性妇科疾病。经历月经过多的患者,贫血,压力症状应该给药,严重的病例需要全子宫切除术。这种手术是侵入性的,会导致严重的术后疼痛,这会影响患者的术后睡眠质量,因此,恢复过程。
    目的:评价地佐辛在患者自控硬膜外镇痛(PCEA)中的应用,用于行子宫肌瘤切除术的患者术后疼痛管理。
    方法:我们选择了100例接受子宫肌瘤全腹全子宫切除术的患者,并随机分为两组:对照组接受0.2%罗哌卡因加0.06mg/mL吗啡,观察组接受0.2%罗哌卡因加0.3mg/mL二氮嗪的PCEA。评估的结果包括疼痛水平,镇静,恢复指数,PCEA使用情况,压力因素,和睡眠质量。
    结果:观察组视觉模拟量表评分较低,术后恢复指数较短,较少平均PCEA按压,降低皮质醇和血糖水平,多导睡眠图参数优于对照组(P<0.05)。观察组不良反应累积发生率低于对照组(P<0.05)。
    结论:地佐辛PCEA能有效控制子宫肌瘤全切术的疼痛,减少压力因素的负面影响,对患者睡眠的影响较小,从而导致更少的不利影响。
    BACKGROUND: Uterine fibroids are common benign gynecological conditions. Patients who experience excessive menstruation, anemia, and pressure symptoms should be administered medication, and severe cases require a total hysterectomy. This procedure is invasive and causes severe postoperative pain, which can affect the patient\'s postoperative sleep quality and, thus, the recovery process.
    OBJECTIVE: To evaluate use of dezocine in patient-controlled epidural analgesia (PCEA) for postoperative pain management in patients undergoing total myomectomy.
    METHODS: We selected 100 patients undergoing total abdominal hysterectomy for uterine fibroids and randomized them into two groups: A control group receiving 0.2% ropivacaine plus 0.06 mg/mL of morphine and an observation group receiving 0.2% ropivacaine plus 0.3 mg/mL of diazoxide in their PCEA. Outcomes assessed included pain levels, sedation, recovery indices, PCEA usage, stress factors, and sleep quality.
    RESULTS: The observation group showed lower visual analog scale scores, shorter postoperative recovery indices, fewer mean PCEA compressions, lower cortisol and blood glucose levels, and better polysomnographic parameters compared to the control group (P < 0.05). The cumulative incidence of adverse reactions was lower in the observation group than in the control group (P < 0.05).
    CONCLUSIONS: Dezocine PCEA can effectively control the pain associated with total myomectomy, reduce the negative impact of stress factors, and have less impact on patients\' sleep, consequently resulting in fewer adverse effects.
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  • 文章类型: Journal Article
    背景:直肠吲哚美辛减少了内镜逆行胰胆管造影术(ERCP)后的胰腺炎。然而,对于已经接受预防性胰腺支架置入术的患者,没有足够的证据证明其额外获益.我们的目标是评估吲哚美辛对接受胰腺支架置入术的高危患者的影响。
    方法:对所有接受有挑战性胆管插管的抢救插管技术的患者(选定的高危患者)进行队列研究。根据ERCP后胰腺炎(PEP)的预防方法将患者分为两组:一组接受吲哚美辛和胰腺支架置入术的组合,而另一个单独接受胰腺支架置入术。对PEP进行了比较分析,高淀粉酶血症,消化道出血,和ERCP术后胰腺炎患者的术后住院时间。
    结果:在2017年11月至2023年5月期间,共纳入607例天然乳头患者,140分为吲哚美辛加支架组,467分为单独支架组。整个队列的总PEP率为4.4%,两组之间在PEP率方面没有观察到统计学差异(P=0.407),轻度PEP(P=0.340),中度至重度PEP(P=1.000),高淀粉酶血症(P=0.543),消化道出血(P=0.392),术后住院时间(P=0.521)。此外,使用多变量分析的敏感性分析也验证了这些发现。
    结论:吲哚美辛不能降低常规接受预防性胰腺支架置入术的高危患者PEP的发生率或严重程度。因此,似乎没有必要额外直肠给药吲哚美辛以进一步缓解PEP.
    BACKGROUND: Rectal indomethacin reduces pancreatitis following endoscopic retrograde cholangiopancreatography (ERCP). However, there is insufficient evidence regarding its added benefits in patients already receiving prophylactic pancreatic stenting. Our goal was to evaluate the impact of indomethacin in high-risk patients undergoing pancreatic stenting.
    METHODS: A cohort study was conducted on all patients who underwent the rescue cannulation technique for challenging bile duct cannulation (selected high-risk patients). Patients were split into two groups based on the prophylaxis method for post-ERCP pancreatitis (PEP): one receiving a combination of indomethacin and pancreatic stenting, while the other received pancreatic stenting alone. Comparative analyses were carried out on PEP, hyperamylasemia, gastrointestinal bleeding, and postoperative hospital stay among post-ERCP pancreatitis patients.
    RESULTS: Between November 2017 and May 2023, a total of 607 patients with native papillae were enrolled, with 140 grouped into the indomethacin plus stent group and 467 into the stent alone group. The overall PEP rate was 4.4% in the entire cohort, with no statistical differences observed between the groups in terms of PEP rates (P = 0.407), mild PEP (P = 0.340), moderate to severe PEP (P = 1.000), hyperamylasemia (P = 0.543), gastrointestinal bleeding (P = 0.392), and postoperative hospital stay (P = 0.521). Furthermore, sensitivity analysis using multivariable analysis also validated these findings.
    CONCLUSIONS: Indomethacin did not reduce the incidence or severity of PEP in high-risk patients who routinely received prophylactic pancreatic stent placement. Therefore, the additional administration of rectal indomethacin to further mitigate PEP appears to be not necessary.
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  • 文章类型: Letter
    暂无摘要。
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  • 文章类型: Journal Article
    卡马西平,一种常用的抗癫痫药,已知会在一部分癫痫患者中诱发打嗝。虽然相对不常见,可能有重大的临床意义。这篇全面的综述探讨了卡马西平相关打嗝的临床和脑电图相关性,旨在增强对这种神经系统副作用的理解和管理。作者的综述综合了定性的流行病学数据,揭示卡马西平引起的打嗝发生在接受药物治疗的一部分患者中,报告的发病率为2.5%至40%。尽管患病率相对较低,打嗝给患者和医疗保健提供者带来了巨大的挑战。与卡马西平引起的打嗝相关的并发症包括睡眠中断,社会功能受损,生活质量下降,强调这种副作用的临床意义。有效的管理策略可以通过多学科方法来实施,包括神经学家之间的合作,药剂师,和其他医疗保健专业人员。这些可能包括剂量调整,停药,和辅助疗法,如膈呼吸练习或针灸。此外,密切监测不良反应和及时干预对于减轻打嗝对患者健康的影响至关重要.本质上,卡马西平诱发的打嗝是一种临床相关现象,在治疗癫痫时值得关注.通过识别临床表现,了解潜在的病理生理学,实施循证管理战略,医疗保健提供者可以优化患者护理并改善该患者人群的预后。
    Carbamazepine, a commonly prescribed antiepileptic drug, is known to induce hiccups in a subset of epileptic patients. Although relatively uncommon, can have significant clinical implications. This comprehensive review delves into the clinical and electroencephalographic correlates of carbamazepine-associated hiccups, aiming to enhance understanding and management of this neurological side effect. The authors\' review synthesizes qualitative epidemiological data, revealing that carbamazepine-induced hiccups occur in a subset of patients receiving the medication, with reported incidence rates ranging from 2.5 to 40%. Despite its relatively low prevalence, hiccups pose substantial challenges for patients and healthcare providers. Complications associated with carbamazepine-induced hiccups include disruption of sleep, impaired social functioning, and decreased quality of life, underscoring the clinical significance of this side effect. Effective management strategies can be implemented through a multidisciplinary approach, including collaboration among neurologists, pharmacists, and other healthcare professionals. These may include dose adjustments, medication discontinuation, and adjunctive therapies such as diaphragmatic breathing exercises or acupuncture. Additionally, close monitoring for adverse effects and timely intervention are essential to mitigate the impact of hiccups on patient well-being. Essentially, carbamazepine-induced hiccups represent a clinically relevant phenomenon that warrants attention in the management of epilepsy. By recognizing the clinical manifestations, understanding the underlying pathophysiology, and implementing evidence-based management strategies, healthcare providers can optimize patient care and improve outcomes in this patient population.
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  • 文章类型: Case Reports
    博来霉素是一种具有出色抗肿瘤作用的糖肽抗生素。博来霉素的主要不良反应是肺纤维化。然而,白内障作为严重不良反应的发展尚未有报道。
    这里,我们描述了1例22岁男性睾丸癌患者通过博莱霉素治疗诱发白内障的病例.在手术干预和BEP方案的五个连续化疗周期后,包括博来霉素,依托泊苷和顺铂,患者报告视力逐渐无痛丧失,随着视觉能力的大幅下降,尤其是右眼。在全面的眼科检查之后,诊断为白内障。最终,患者接受了白内障超声乳化术和人工晶状体置换.
    博来霉素可引起白内障,这导致了视力的显著丧失。因此,临床医生应观察早期症状,适当调整治疗方法,防止症状加重。
    UNASSIGNED: Bleomycin is a glycopeptide antibiotic with outstanding anti-tumor effects. A major adverse effect of bleomycin is lung fibrosis. However, the development of cataracts as a severe adverse effect has not been reported.
    UNASSIGNED: Herein, we describe the first case of cataract induced by bleomycin therapy in a 22-year-old male with testicular cancer. After surgical intervention and following five successive chemotherapy cycles of the BEP regimen, including bleomycin, etoposide and cisplatin, the patient reported a gradual painless loss of vision, with substantial decline in visual ability, especially in the right eye. Following comprehensive eye examinations, a cataract was diagnosed. Eventually, the patient underwent phacoemulsification and received replacement of the intraocular lenses.
    UNASSIGNED: Bleomycin can cause cataracts, which induces a significant loss of vision. Therefore, clinicians should observe early symptoms and properly adjust treatment to prevent aggravation of symptoms.
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  • 文章类型: Journal Article
    恶性肿瘤是复杂的全身性慢性疾病,是人类死亡的主要原因之一。靶向治疗,化疗,免疫疗法,和放射疗法是对中晚期恶性肿瘤有效的主流对抗疗法。常规对抗疗法的持续使用导致了不良反应和耐药性,这阻碍了它的功效。作为补充和替代医学的重要组成部分,已发现中药具有抗肿瘤作用,在增强主流对症药物的治疗敏感性方面发挥了重要作用,降低不良事件的发生率和改善免疫相关功能。辅助中药与主流对症药物的联合应用已开始被接受,并逐步应用于抗肿瘤治疗领域。传统天然药物及其活性成分,以及中成药,已被证明在各种恶性肿瘤的治疗中具有优异的治疗效果和良好的安全性。本文重点介绍了上述药物与主流对抗疗法药物结合提高治疗敏感性的作用机制及研究进展,缓解耐药性,减少不良反应,提高身体的免疫功能。鼓励临床开发和使用中药辅助疗法,并为创建更安全,更有效的抗癌药物组合提供思路和信息,详细描述了中草药疗法作为癌症治疗辅助疗法的重要功能。
    Malignant tumors are complex systemic chronic diseases and one of the major causes of human mortality. Targeted therapy, chemotherapy, immunotherapy, and radiotherapy are examples of mainstream allopathic medicine treatments that effective for intermediate and advanced malignant tumors. The ongoing use of conventional allopathic medicine has resulted in adverse responses and drug resistance, which have hampered its efficacy. As an important component of complementary and alternative medicine, Chinese medicine has been found to have antitumor effects and has played an important role in enhancing the therapeutic sensitivity of mainstream allopathic medicine, reducing the incidence of adverse events and improving immune-related functions. The combined application of adjuvant Chinese medicine and mainstream allopathic medicine has begun to gain acceptance and is gradually used in the field of antitumor therapy. Traditional natural medicines and their active ingredients, as well as Chinese patent medicines, have been proven to have excellent therapeutic efficacy and good safety in the treatment of various malignant tumors. This paper focuses on the mechanism of action and research progress of combining the above drugs with mainstream allopathic medicine to increase therapeutic sensitivity, alleviate drug resistance, reduce adverse reactions, and improve the body\'s immune function. To encourage the clinical development and use of Chinese herb adjuvant therapy as well as to provide ideas and information for creating safer and more effective anticancer medication combinations, the significant functions of Chinese herb therapies as adjuvant therapies for cancer treatment are described in detail.
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  • 文章类型: Journal Article
    膀胱内治疗是非肌肉浸润性膀胱癌(NMIBC)的常用治疗方法。这项研究的重点是总结所有膀胱内药物的信号,旨在强调这些药物之间不良事件(AE)的综合差异。
    我们根据来自食品和药物管理局不良事件报告系统(FAERS)数据库的真实世界大数据进行了药物警戒数据分析。
    我们阐明了与整个FAERS数据库或卡介苗芽孢杆菌(BCG)的其他给药途径相比的所有信号,丝裂霉素,吉西他滨,戊柔比星,和表柔比星.值得注意的是,报告的与膀胱内治疗相关的AE的分布表现出明显倾向于男性患者.此外,所有五种药物在当地AE中表现出不成比例的分布,特别是在肾脏和泌尿系统疾病。此外,我们总结了每种药物的具体信号和结果.最后,我们强调了导致每种药物严重结局的不良事件.
    我们已经汇编了与膀胱内药物相关的不良事件的概述,同时考虑了它们的个体差异。这些有见地的发现有助于丰富我们对与膀胱内治疗相关的安全性和潜在风险的理解。
    UNASSIGNED: Intravesical therapy is a commonly utilized treatment for non-muscle invasive bladder cancer (NMIBC). This study focuses on summarizing the signals of all intravesical drugs and aims to highlight the comprehensive differences in adverse events (AEs) between these drugs.
    UNASSIGNED: We conducted pharmacovigilance data analysis based on the real-world big data from the Food and Drug Administration Adverse Event Reporting System (FAERS) database.
    UNASSIGNED: We elucidated all signals compared with the overall FAERS database or other administration routes for Bacillus Calmette-Guerin (BCG), mitomycin, gemcitabine, valrubicin, and epirubicin. Notably, the distribution of reported AEs associated with intravesical therapy exhibited a noticeable inclination toward male patients. Furthermore, all five drugs demonstrated a disproportionate distribution in local AEs, particularly in renal and urinary disorders. Additionally, specific signals and findings were summarized for each individual drug. Finally, we highlighted the AEs that resulted in serious outcomes for each drug.
    UNASSIGNED: We have compiled an overview of the AEs tied to intravesical drugs whilst considering their individual distinctions. These insightful findings serve to enrich our comprehension of the safety profiles and potential risks linked to intravesical therapy.
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  • 文章类型: Journal Article
    在接受PEG-天冬酰胺酶的中国患者中,对天冬酰胺酶活性(AEA)监测的研究仍然有限。我们监测了诊断为急性淋巴细胞白血病(ALL)并根据中国儿童癌症小组研究方案治疗的儿科患者的AEA,CCCG-ALL-2015/CCCG-ALL-2020协议。我们在第7±1天和第14±1天测量了AEA,并分析了它们与患者特征和PEG-天冬酰胺酶相关不良反应(AE)的关系。我们测量了329名患者的2147个样本。平均AEA水平(四分位距)在第7±1天为931iu/L(654-1174iu/L),在第14±1天为664iu/L(463-860iu/L)。年龄较小的儿童的AEA水平较高,并且随着累积剂量数的增加而增加。PEG-天冬酰胺酶失活率为19.1%,沉默失活(SI)率为12.5%。9名患者被确定为过敏样反应。低纤维蛋白原血症,高甘油三酯血症,胰腺炎和血栓形成与年龄有关,而低血糖与年龄较小有关。高甘油三酯血症和低血糖的风险随着PEG-天冬酰胺酶的累积剂量而增加。除了低纤维蛋白原血症,AEA水平升高并未增加PEG-天冬酰胺酶相关AE的风险.药物监测可用作治疗决策的指导。个体化天冬酰胺酶剂量不会降低毒性。PEG-天冬酰胺酶的治疗目标仍然是实现持续和足够的活性。
    Studies on asparaginase enzyme activity (AEA) monitoring in Chinese patients receiving PEG-asparaginase remain limited. We monitored AEA in paediatric patients diagnosed with acute lymphoblastic leukaemia (ALL) and treated according to the Chinese Children\'s Cancer Group study protocols, CCCG-ALL-2015/CCCG-ALL-2020 protocols. We measured the AEA at days 7 ± 1 and 14 ± 1 and analysed their association with patient characteristics and PEG-asparaginase-related adverse effects (AEs). We measured 2147 samples from 329 patients. Mean AEA levels (interquartile range) were 931 iu/L (654-1174 iu/L) at day 7 ± 1 and 664 iu/L (463-860 iu/L) at day 14 ± 1. The AEA levels were higher in younger children and increased with the cumulative dose numbers. PEG-asparaginase inactivation rate was 19.1%, and the silent inactivation (SI) rate was 12.5%. Nine patients were identified with allergic-like reactions. Hypofibrinogenaemia, hypertriglyceridaemia, pancreatitis and thrombosis were associated with older age, whereas hypoglycaemia was associated with younger age. The risk of hypertriglyceridaemia and hypoglycaemia increased with cumulative dose numbers of PEG-asparaginase. Except for hypofibrinogenaemia, elevated AEA levels did not increase the risk of PEG-asparaginase-related AEs. Drug monitoring can be utilized as guidance for treatment decision-making. Individualizing asparaginase doses do not reduce toxicities. The treatment target of PEG-asparaginase remains to achieve sustained and adequate activity.
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