adverse effect

不利影响
  • 文章类型: Case Reports
    传统草药具有抗疲劳的临床使用历史。然而,已经确定了草药的几种不良反应。玫瑰糠疹样喷发(PR-LE)是一种罕见的草药皮肤并发症。据我们所知,很少有关于PR-LE以下草药的报道。这里,我们描述了一例PR-LE,在服用抗疲劳草药后6天出现。在停止乌头和人参17天后,它明显褪色。所以,当抗疲劳草药被授权用于疲劳使用时,监测潜在的不良影响是必要的。
    Traditional herbs have a history of clinical use in anti-fatigue. However, several adverse effects of herbs have been identified. Pityriasis rosea-like eruption (PR-LE) is a rare cutaneous complication of herbs. To the best of our knowledge, there have been few reports of PR-LE following herbs. Here, we described a case of PR-LE that developed 6 days after taking anti-fatigue herbs. After the 17 days of stopping Aconitum carmichaelii Debx and Panax Ginseng, it notably faded. So, when anti-fatigue herbs being authorized for fatigue use, monitoring for potential adverse effects is necessary.
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  • 文章类型: Journal Article
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  • 文章类型: Journal Article
    目的:脊柱转移瘤的立体定向放射治疗(SBRT)第二疗程的最佳方法尚不完善。这个单一中心,单臂,进行了II期试验,以提出安全有效的挽救脊柱SBRT.
    方法:最初使用SBRT进行脊柱靶向方案治疗的患者,或者脊柱附近的区域,已注册。第二SBRT剂量是以五个部分递送的30Gy;脊髓剂量约束在最大点剂量为15.5Gy。如果检测到神经和肿瘤之间的边界,则臂丛或腰骶丛的剂量限制为<30Gy。主要终点是第二次SBRT后一年内的剂量限制性毒性(DLT)(≥3级严重辐射相关毒性)。
    结果:第二次SBRT在12例患者中被给予相同的脊柱水平,在8例患者中被给予相邻的脊柱水平。对14个疼痛性病变进行了SBRT2,10MESCC,和6种寡转移酶,一些病变有多种适应症。SBRT会议之间的中位间隔为21个月(范围:6-51个月)。中位随访时间为14个月。随访期间未报告放射性脊髓病或局部衰竭。在一年内,两名患者(10%)确认了DLT,两人都患有3级腰骶丛病。这两名患者在S1-2和S1-5椎骨接受了两次SBRT,分别,并且都经历了胫骨前肌麻痹(L5级)。在整个随访期间,有25%的患者观察到3级晚期不良反应(包括腰骶丛病变和椎体压缩性骨折)。
    结论:第二脊柱SBRT取得了良好的局部控制,没有引起脊髓病变。然而,四分之一的患者经历了3级晚期不良反应,这表明治疗方案存在毒性风险。
    OBJECTIVE: The optimal method for the second course of stereotactic body radiotherapy (SBRT) for spinal metastases remains poorly established. This single-center, single-arm, phase II trial was conducted to propose a safe and effective salvage spine SBRT.
    METHODS: The patients initially treated with SBRT for spine-targeted protocol treatment, or for areas adjacent to the spine, were enrolled. The second SBRT dose was 30 Gy delivered in five fractions; the spinal cord dose constraint was 15.5 Gy at the maximum point dose. The brachial or lumbosacral plexuses were dose-constrained to <30 Gy if the boundary between the nerves and tumors was detected. The primary endpoint was dose-limiting toxicity (DLT) (grade ≥ 3 severe radiation-related toxicity) within a year after the second SBRT.
    RESULTS: The second SBRT was administered to the same spinal level in 12 patients and to an adjacent spinal level in 8 patients. SBRT2 was performed for 14 painful lesions, 10 MESCC, and 6 oligometastases, with some lesions having multiple indications. The median interval between SBRT sessions was 21 months (range: 6-51 months). The median follow-up duration was 14 months. No radiation myelopathy or local failure was reported during the follow-up period. DLT was confirmed in two patients (10%) within a year, both of whom developed grade 3 lumbosacral plexopathy. These two patients received SBRT twice to the S1-2 and S1-5 vertebrae, respectively, and both experienced paralysis of the tibialis anterior muscle (L5 level). Grade 3 late adverse effects (including lumbosacral plexopathy and vertebral compression fracture) were observed in 25% of the patients throughout the entire follow-up period.
    CONCLUSIONS: The second spine SBRT achieved good local control without causing myelopathy. However, one-quarter of the patients experienced grade 3 late adverse effects, suggesting that the treatment protocol carries a risk of toxicity.
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  • 文章类型: Journal Article
    成釉细胞瘤,一种良性但侵袭性的牙源性肿瘤,以其复发和根治性手术的严重发病率而闻名,可能受益于靶向治疗的进步。我们介绍了一例15岁女孩成釉细胞瘤的靶向治疗成功,并回顾了这个问题的文献:抗MAPK靶向治疗成釉细胞瘤安全有效吗?遵守PRISMA准则,并搜索了截至2023年12月的多个数据库,从647条记录中确定了13项相关研究,涵盖23例接受MAPK抑制剂治疗的患者。结果很有希望,因为几乎所有患者都表现出积极的治疗反应,其中4人实现了完全的放射学缓解,其他人则显示出原发性疾病的大幅减少,经常性,和转移性成釉细胞瘤的大小。副作用大多为轻度至中度。这项研究表明,抗MAPK疗法是侵入性手术治疗的重要转变,通过提供一种侵入性较小但有效的治疗替代方案,有可能提高生活质量和临床结局。这种方法可能意味着在治疗这种具有挑战性的肿瘤方面取得了突破,强调需要进一步研究分子靶向治疗。
    Ameloblastoma, a benign yet aggressive odontogenic tumor known for its recurrence and the severe morbidity from radical surgeries, may benefit from advancements in targeted therapy. We present a case of a 15-year-old girl with ameloblastoma successfully treated with targeted therapy and review the literature with this question: Is anti-MAPK targeted therapy safe and effective for treating ameloblastoma? This systematic review was registered in PROSPERO, adhered to PRISMA guidelines, and searched multiple databases up to December 2023, identifying 13 relevant studies out of 647 records, covering 23 patients treated with MAPK inhibitor therapies. The results were promising as nearly all patients showed a positive treatment response, with four achieving complete radiological remission and others showing substantial reductions in primary, recurrent, and metastatic ameloblastoma sizes. Side effects were mostly mild to moderate. This study presents anti-MAPK therapy as a significant shift from invasive surgical treatments, potentially enhancing life quality and clinical outcomes by offering a less invasive yet effective treatment alternative. This approach could signify a breakthrough in managing this challenging tumor, emphasizing the need for further research into molecular-targeted therapies.
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  • 文章类型: Journal Article
    A型肉毒杆菌神经毒素(BoNTA)和填充剂注射程序通常提供预测的结果,并发症发生率低。这些手术后的大多数并发症已经得到了广泛的讨论。在这项研究中,我们报道了这些鲜为人知的注射剂,最近报道,和新的并发症,并试图阐明潜在的机制。伪造或处理不当的BoNTA与肉毒杆菌中毒有关。此外,BoNTA与罕见的并发症有关,包括角膜样病变,非结核分枝杆菌感染,血管闭塞,颞浅动脉假性动脉瘤.注射填充剂的异常并发症包括非瘢痕性脱发,口内坏死,非结核分枝杆菌感染,类似黄体瘤的反应,颅内穿孔,和肺窦扩张。BoNTA注射后结节和因可卡因使用而导致的骨破坏引起的填充物感染是新的并发症。这些并发症对诊断和治疗提出了挑战。本出版物旨在在必要时帮助及时识别和管理这些罕见和新颖的并发症。
    Botulinum neurotoxin type A (BoNTA) and filler injection procedures usually provide predicted outcomes with a low incidence of complications. Most of the complications following these procedures have been extensively discussed. In this study, we report on these injectables\' less well-known, recently reported, and novel complications and attempt to clarify the underlying mechanisms. Counterfeit or mishandled BoNTA has been associated with botulism. Additionally, BoNTA has been linked to uncommon complications, including morphea-like lesions, nontuberculous mycobacterial infections, vascular occlusion, and pseudoaneurysm of the superficial temporal artery. Unusual complications from filler injection include nonscarring alopecia, intraoral necrosis, nontuberculous mycobacterial infections, xanthelasma-like reactions, intracranial perforation, and pneumosinus dilatans. Post-BoNTA injection nodules and filler infection from bone destruction due to cocaine use are new complications. These complications pose a challenge for diagnosis and treatment. This publication aims to assist in promptly identifying and managing these rare and novel complications when necessary.
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  • 文章类型: Journal Article
    目的:Teprotumumab是唯一被美国食品和药物管理局(FDA)批准用于治疗甲状腺眼病(TED)的药物,靶向胰岛素样生长因子-1受体。这项研究旨在通过分析2023年FDA不良事件报告系统(FAERS)数据库中的上市后安全性数据来识别teprotumumab的潜在安全性信号。
    方法:病例/非病例方法用于评估不良事件(AE)的报告比值比(ROR)和信息成分(IC),相关置信区间(95%CI)为3个或更多。
    结果:共2158例纳入分析。确定的主要安全信号是耳朵和迷宫障碍,生殖系统和乳房疾病,代谢和营养失调和胃肠道疾病。具体来说,自动化(ROR[95%CI]=4188.34[1403.29-12500.8]),眼睑回缩(ROR[95%CI]=2094.17[850.69-5155.29]),永久性耳聋(ROR[95%CI]=1552.35[789.07-3053.98]),双侧耳聋(ROR[95%CI]=73.12[41.14-129.97]),炎症性肠病(ROR[95%CI]=23.26[13.46-40.19]),高血糖性高渗性非酮症综合征(ROR[95%CI]=17.75[5.70-55.28])和闭经(ROR[95%CI]=47.98[36.22-63.54])显示了teprotumumab的显著安全信号.
    结论:这项研究确定了耳朵和迷宫障碍,生殖系统和乳房疾病,作为teprotumumab的特定安全信号。临床医生和药剂师应该对这些不良事件保持警惕。然而,现有数据目前不足,需要进一步的药物警戒和监测才能充分理解这一问题。
    OBJECTIVE: Teprotumumab is the only drug approval by The US Food and Drug Administration (FDA) for the treatment of thyroid eye disease (TED), which targets the insulin-like growth factor-1 receptor. This study aimed to identify potential safety signals of teprotumumab by analyzing post-marketing safety data from the FDA Adverse Event Reporting System (FAERS) database in 2023.
    METHODS: The case/non-case approach was used to estimate the reporting odds ratio (ROR) and information component (IC) with relevant confidence intervals (95% CI) for adverse events (AEs) that numbered three or more.
    RESULTS: Total of 2158 cases were included in the analysis. Main safety signals identified were ear and labyrinth disorders, reproductive system and breast disorders, metabolism and nutrition disorders and gastrointestinal disorders. Specifically, autophony (ROR [95% CI] = 4188.34 [1403.29-12500.8]), eyelid retraction (ROR [95% CI] = 2094.17 [850.69-5155.29]), deafness permanent (ROR [95% CI] = 1552.35 [789.07-3053.98]), deafness bilateral (ROR [95% CI] = 73.12 [41.14-129.97]), inflammatory bowel disease (ROR [95% CI] = 23.26 [13.46-40.19]), hyperglycaemic hyperosmolar nonketotic syndrome (ROR [95% CI] = 17.75 [5.70-55.28]) and amenorrhoea (ROR [95% CI] = 47.98 [36.22-63.54]) showed significant safety signals of teprotumumab.
    CONCLUSIONS: This study identified ear and labyrinth disorders, reproductive system and breast disorders, as specific safety signals of teprotumumab. Clinicians and pharmacists should be vigilant regarding these AEs. However, available data are currently insufficient, and further pharmacovigilance and surveillance are needed to fully understand this issue.
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  • 文章类型: Journal Article
    COVID-19大流行是由SARS-CoV-2病毒引起的,标志着21世纪最具灾难性的全球健康危机之一。在此期间,个人防护设备(PPE)的广泛使用和不当处置成为一个紧迫的环境问题,显著影响各种生命形式。在COVID-19大流行期间,有较高的PEP处置率。自疫情爆发以来,每天产生惊人的1.6×106吨塑料垃圾,主要来自PPE的处置不足。丢弃的PPE的管理不善和随后的降解显著导致不可生物降解的微(纳米)塑料(MNP)废物增加。这种污染对陆地产生了深远的不利影响,海洋,和水生生态系统,最近受到广泛关注。水生生物中积累的MNPs可以作为食用海鲜时人类暴露的潜在途径。这篇综述提出了一个关于MNPs造成的污染的新方面,特别是它们在大流行期间的作用及其对人类健康的有害影响。这些微塑料颗粒,通过分裂的过程,转变成纳米粒子,坚持环境和潜在危害。PPE引起的MNP患病率,尤其是面具,引起人们对其合理的健康风险的担忧,值得全球关注和全面探索。对这些过程的长期影响进行全面评估并实施有效的管理策略至关重要。
    The COVID-19 pandemic was caused by the SARS-CoV-2 virus, marking one of the most catastrophic global health crises of the 21st century. Throughout this period, widespread use and improper disposal of personal protective equipment (PPE) emerged as a pressing environmental issue, significantly impacting various life forms. During the COVID-19 pandemic, there was a high rate of PEP disposal. An alarming 1.6 × 106 tons of plastic waste each day has been generated since the onset of the outbreak, predominantly from the inadequate disposal of PPE. The mismanagement and subsequent degradation of discarded PPE significantly contribute to increased non-biodegradable micro(nano)plastic (MNP) waste. This pollution has had profound adverse effects on terrestrial, marine, and aquatic ecosystems, which have been extensively of concern recently. Accumulated MNPs within aquatic organisms could serve as a potential route for human exposure when consuming seafood. This review presents a novel aspect concerning the pollution caused by MNPs, particularly remarking on their role during the pandemic and their detrimental effects on human health. These microplastic particles, through the process of fragmentation, transform into nanoparticles, persisting in the environment and posing potential hazards. The prevalence of MNP from PPE, notably masks, raises concerns about their plausible health risks, warranting global attention and comprehensive exploration. Conducting a comprehensive evaluation of the long-term effects of these processes and implementing effective management strategies is essential.
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  • 文章类型: Journal Article
    背景:草药汤剂(HD)是最古老和最常见的草药配方。存在不同的HD,一些消费者担心他们在制造过程中可能会受到污染。因此,提出了对HDs进行安全评估的必要性。本研究旨在通过系统评价和荟萃分析对随机对照试验(RCT)进行综合分析,探讨与HDs相关的不良事件(AE)。
    方法:在PubMed上进行了系统搜索,Embase,和Cochrane图书馆的文章发表到2022年11月。纳入的RCT比较了HDs与2013年至2022年发表的其他治疗方法,并使用RevMan5.4评估偏倚风险。还对纳入的RCT中报告的与HDs相关的AE数量进行了荟萃分析。
    结果:系统评价包括26项RCT,荟萃分析包括17个报告AE的RCT。将HDs与主动对照进行比较的荟萃分析显示,不良事件的数量(14项研究;风险比(RR)=0.50例,95%置信区间(CI)[0.29,0.88];I2=42%)和抱怨不良事件的患者人数(七项研究;RR=0.51患者,HDs组的95%CI[0.28,0.94];I2=9%)低于活性对照组。
    结论:这项研究表明,根据随机对照试验的定性和定量综合结果,HDs比其他常规药物更安全。
    BACKGROUND: Herbal decoctions (HDs) are the oldest and most common herbal medicine formulations. Different HDs exist, and some consumers are concerned that they may become contaminated during manufacturing. Therefore, the need for a safety assessment of HDs has been raised. This study aimed to investigate the adverse events (AEs) associated with HDs by comprehensively analyzing randomized controlled trials (RCTs) using systematic reviews and meta-analyses.
    METHODS: A systematic search was conducted on PubMed, Embase, and the Cochrane Library for articles published up to November 2022. The included RCTs compared HDs with other treatments published between 2013 and 2022, and the risk of bias was assessed using RevMan 5.4. Meta-analyses of the number of AEs associated with HDs reported in the included RCTs were also performed.
    RESULTS: The systematic review included 26 RCTs, and the meta-analysis included 17 RCTs that reported AEs. The meta-analysis comparing HDs with active controls showed that both the number of AEs (14 studies; risk ratio (RR)= 0.50 cases, 95 % confidence interval (CI) [0.29, 0.88]; I2 = 42 %) and the number of patients who complained of AEs (seven studies; RR=0.51 patients, 95 % CI [0.28, 0.94]; I2 =9 %) were fewer in the HDs group than in the active control groups.
    CONCLUSIONS: This study showed that HDs are safer than other conventional medications based on the results of qualitative and quantitative syntheses of RCTs.
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  • 文章类型: Journal Article
    背景:很少有研究研究静脉使用拉考沙胺治疗小儿患者的集束性癫痫发作。因此,我们的目的是探讨拉科沙胺静脉注射治疗儿童集束性癫痫的疗效和安全性.
    方法:我们回顾性评估了2019年3月至2023年6月在Sa玉儿童医疗中心进行的25例丛集性癫痫患儿的静脉拉科沙胺治疗的疗效和安全性。集群性癫痫发作定义为持续时间少于五分钟的单次癫痫发作,在12小时内重复三次或更多次,癫痫发作之间的意识恢复。反应定义为输注拉科沙胺后至少12小时无癫痫发作。
    结果:癫痫发作的中位年龄为1.5(0.0至9.8)岁。中位发作频率为每12小时5次(3至20次)。病因偏远(n=17),急性(n=4),和渐进式(n=4)。给予拉科沙胺静脉治疗的中位年龄为4.2(0.0至11.3)岁。拉科沙胺的中位剂量为2.6(1.3至5.2)mg/kg。总的来说,25例患者中有12例(48.0%)有反应。在以静脉注射拉科沙胺作为一线治疗的患者中,17人中有9人(52.9%)的癫痫发作完全缓解.远端病因患者癫痫完全缓解的频率为58.8%(17个中的10个);其中,12例结构异常患者中有7例(58.3%)出现癫痫完全缓解.没有观察到不良事件。
    结论:静脉用拉科沙胺治疗是治疗儿童患者丛集性癫痫的潜在有用的治疗选择。
    BACKGROUND: Few studies have investigated intravenous lacosamide use to treat cluster seizures in pediatric patients. Therefore, we aimed to investigate the efficacy and safety of intravenous lacosamide therapy in pediatric patients with cluster seizures.
    METHODS: We retrospectively evaluated the efficacy and safety of intravenous lacosamide therapy in 25 pediatric patients with cluster seizures at Saitama Children\'s Medical Center between March 2019 and June 2023. Cluster seizures were defined as a single seizure of less than five minutes duration, repeated three or more times within 12 hours, with recovery of consciousness between seizures. Response was defined as seizure freedom for at least 12 hours after lacosamide infusion.
    RESULTS: The median age at onset of epilepsy was 1.5 (0.0 to 9.8) years. The median seizure frequency was 5 (3 to 20) times per 12 hours. The etiologies were remote (n = 17), acute (n = 4), and progressive (n = 4). The median age at which intravenous lacosamide therapy was administered was 4.2 (0.0 to 11.3) years. The median lacosamide dose was 2.6 (1.3 to 5.2) mg/kg. In total, 12 of 25 patients (48.0%) responded. Among patients treated with intravenous lacosamide as first-line therapy, nine of 17 (52.9%) had complete seizure remission. The frequency of complete seizure remission in patients with remote etiologies was 58.8% (10 of 17); among them, seven of 12 (58.3%) patients with structural abnormalities showed complete seizure remission. No adverse events were observed.
    CONCLUSIONS: Intravenous lacosamide therapy is a potentially useful treatment option for cluster seizures in pediatric patients.
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  • 文章类型: Journal Article
    背景:新益散中药汤剂(XYS)通常用于治疗台湾的过敏性鼻炎患者。茶碱主要被人细胞色素P450(CYP)1A2以高亲和力氧化,并且具有窄的治疗指数。
    目的:本研究旨在研究XYS对人CYP1A2催化茶碱氧化(THO)的抑制作用及其对患者的不良反应。
    方法:在重组酶系统中研究了人CYP。回顾性分析同时使用XYS对茶碱治疗患者的影响。
    结果:在主要的人类肝脏和呼吸道CYPs中,XYS抑制剂优先抑制CYP1A2活性,这决定了茶碱的消除和副作用。在XYS汤的草药成分中,当归含有有效的THO抑制剂。呋喃香豆素欧前胡素在XYS和白垩汤中含量丰富,和非竞争性抑制THO活性,Ki值为77-84nM,高于氟伏沙明(20-52nM),临床上与茶碱相互作用。与欧前胡素相比,对肠道细菌代谢产物黄刺醇的THO抑制作用较弱。与抑制作用的效力一致,对接分析产生的Gold适应度值的顺序为-氟伏沙明>欧前胡素>黄花素。在2017年至2018年期间,201093名茶碱用户中有2.6%使用了XYS。在逆概率加权之后,XYS用户比非XYS用户发生更高的不良影响;特别是,头痛的发生率大约高两倍(比值比(OR),2.14;95%置信区间(CI),1.99-2.30;p<0.001)和心动过速(OR,1.83;95%CI,1.21~2.77;p<0.05)。不规则心跳的发生率增加(OR,1.36;95%CI,1.07-1.72;p<0.05)仅在服用高累积剂量(≥24g)XYS的茶碱使用者中。然而,同时服用XYS的茶碱用户的死亡率低于非XYS用户(或,0.24;95%CI,0.14~0.40;p<0.001)。
    结论:XYS含有人CYP1A2抑制剂,在同时接受茶碱和XYS的患者中观察到不良反应。进一步的人体研究对于降低XYS使用者的死亡率和调整茶碱的剂量至关重要。
    BACKGROUND: The Xin-yi-san herbal decoction (XYS) is commonly used to treat patients with allergic rhinitis in Taiwan. Theophylline is primarily oxidized with high affinity by human cytochrome P450 (CYP)1A2, and has a narrow therapeutic index.
    OBJECTIVE: This study aimed to investigate the inhibition of human CYP1A2-catalyzed theophylline oxidation (THO) by XYS and its adverse effects in patients.
    METHODS: Human CYPs were studied in recombinant enzyme systems. The influence of concurrent XYS usage in theophylline-treated patients was retrospectively analyzed.
    RESULTS: Among the major human hepatic and respiratory CYPs, XYS inhibitors preferentially inhibited CYP1A2 activity, which determined the elimination and side effects of theophylline. Among the herbal components of XYS decoction, Angelicae Dahuricae Radix contained potent THO inhibitors. Furanocoumarin imperatorin was abundant in XYS and Angelicae Dahuricae Radix decoctions, and non-competitively inhibited THO activity with Ki values of 77‒84 nM, higher than those (20‒52 nM) of fluvoxamine, which clinically interacted with theophylline. Compared with imperatorin, the intestinal bacterial metabolite xanthotoxol caused weaker THO inhibition. Consistent with the potency of the inhibitory effects, the docking analysis generated Gold fitness values in the order-fluvoxamine > imperatorin > xanthotoxol. During 2017‒2018, 2.6 % of 201,093 theophylline users consumed XYS. After inverse probability weighting, XYS users had a higher occurrence of undesired effects than non-XYS users; in particular, there was an approximately two-fold higher occurrence of headaches (odds ratio (OR), 2.14; 95 % confidence interval (CI), 1.99‒2.30; p < 0.001) and tachycardia (OR, 1.83; 95 % CI, 1.21‒2.77; p < 0.05). The incidence of irregular heartbeats increased (OR, 1.36; 95 % CI, 1.07‒1.72; p < 0.05) only in the theophylline users who took a high cumulative dose (≥ 24 g) of XYS. However, the mortality in theophylline users concurrently taking XYS was lower than that in non-XYS users (OR, 0.24; 95 % CI, 0.14‒0.40; p < 0.001).
    CONCLUSIONS: XYS contains human CYP1A2 inhibitors, and undesirable effects were observed in patients receiving both theophylline and XYS. Further human studies are essential to reduce mortality and to adjust the dosage of theophylline in XYS users.
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