Adverse reactions

不良反应
  • 文章类型: Journal Article
    嵌合抗原受体(CAR)T细胞疗法是一种针对血液肿瘤疾病的相对较新的创新免疫疗法。在英国,CART细胞疗法可用于治疗一些复发性或难治性急性淋巴细胞白血病或弥漫性大B细胞淋巴瘤的患者。然而,CAR-T细胞疗法可能会产生副作用,对患者的身体和社会心理健康有影响,并可能引发可能导致危及生命的急性毒性的不良反应。护士可能在整个CAR-T细胞治疗过程中发挥重要作用,包括支持患者决策,管理输液,监测患者,识别和管理不良反应,并提供后续护理。本文概述了CAR-T细胞疗法,并描述了其一些潜在的副作用和不良反应。作者还考虑了护士的作用以及对护理人员的影响,以满足越来越多的患者的需求,这些患者可能有资格接受这种治疗,因为它扩展到其他癌症类型。
    Chimeric antigen receptor (CAR) T-cell therapy is a relatively new and innovative immunotherapy for haemato-oncological diseases. In the UK, CAR T-cell therapy can be used to treat some patients with relapsed or refractory acute lymphoblastic leukaemia or diffuse large B-cell lymphoma. However, CAR T-cell therapy can have side effects that have implications for patients\' physical and psychosocial well-being and may induce adverse reactions that can cause life-threatening acute toxicities. Nurses may have a significant role throughout the CAR T-cell therapy process, including in supporting patient decision-making, administering infusions, monitoring patients, identifying and managing adverse reactions, and providing follow-up care. This article provides an overview of CAR T-cell therapy and describes some of its potential side effects and adverse reactions. The authors also consider the role of the nurse and the implications for the nursing workforce in terms of meeting the needs of the increasing numbers of patients who may become eligible for this treatment as it is extended to other cancer types.
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  • 文章类型: Journal Article
    目标:比利时的生育诊所如何管理供体精子治疗中遗传条件的风险?
    方法:2023年6月向比利时的所有生育诊所分发了电子问卷,重点是2018年至2022年匿名精子供体的治疗。使用IBMSPSS统计数据匿名分析了15家诊所的反应。
    结果:所有诊所都评估了供体风险,包括个人和家族史,常规核型分析和(83.3%的诊所)携带者筛查常见常染色体隐性条件。对于收件人,58.3%的诊所仅依靠个人和家族史。尽管努力,在供体精子治疗中对遗传状况的怀疑或检测很普遍,每100名出生儿童报告9.4起不良事件。当不良事件发生时,如果不需要额外的基因检测,大多数诊所(58.3%)不会通知捐赠者。大约四分之一(26.7%)的诊所总是告知接受者可能与其捐赠者有关的不良事件。在不良事件被追溯到他的DNA后,同样数量(26.7%)明确排除了捐献者精子的使用,53.3%的患者在不良事件未得到基因证实时不会考虑使用供体.对于其他诊所,决定何时披露新的遗传风险信息或何时允许使用与不良事件相关的供体是一个复杂的问题,涉及不同的考虑因素.
    结论:尽管怀疑或检测到与供体治疗相关的遗传状况很常见,比利时诊所预防和管理这些情况的方式差异很大.
    OBJECTIVE: How do fertility clinics in Belgium manage risks for genetic conditions in donor sperm treatment?
    METHODS: An electronic questionnaire was distributed to all fertility clinics in Belgium in June 2023, focusing on treatments with anonymous sperm donors from 2018 to 2022. Responses from 15 clinics were analysed anonymously using IBM SPSS statistics.
    RESULTS: All clinics assessed donor risks, including a personal and family history, conventional karyotyping and (for 83.3% of the clinics) carrier screening for common autosomal recessive conditions. For recipients, 58.3% of the clinics relied only on a personal and family history. Despite efforts, the suspicion or detection of genetic conditions in donor sperm treatment was prevalent, with 9.4 adverse events reported per 100 children born. When adverse events occurred, most clinics (58.3%) would not inform the donor if no additional genetic testing was needed. Around 1 in 4 (26.7%) clinics always informed recipients about an adverse event possibly related to their donor. An equal number (26.7%) categorically ruled out the use of spermatozoa from a donor after an adverse event was traced back to his DNA, and 53.3% would not consider using the donor when the adverse event was not genetically confirmed. For the other clinics, deciding when to disclose new genetic risk information or when to allow the use of a donor linked to an adverse event was a complex matter involving different considerations.
    CONCLUSIONS: Although suspected or detected genetic conditions linked to donor treatments were common, there was wide variation in how Belgian clinics prevented and managed these situations.
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  • 文章类型: Journal Article
    绝经后骨质疏松症(PMOP)增加女性骨折风险。虽然传统的治疗方法行动缓慢,将romosozumab与常规治疗相结合显示出希望.尽管它的使用越来越多,关于有效性的研究是有限的。本研究旨在系统评价联合治疗对疼痛缓解的影响,疾病进展,以及PMOP患者的不良反应。
    包括PubMed、EMBASE,ScienceDirect,从成立至2023年9月,我们检索了Cochrane图书馆,以确定评估romosozumab在PMOP中的作用的随机对照试验(RCT).采用随机或固定效应模型进行统计分析。两名评审员独立评估了纳入研究的质量并提取了数据。Meta分析采用RevMan5.4软件进行。
    纳入6个RCT,总样本量为17,985例。治疗12个月和24个月后比较分析椎体骨折的发生率。Romosozumab在24个月时(OR=0.36;95%CI:0.35-0.52)显着降低了椎骨骨折的发生率,但在12个月时没有降低(OR=0.39;95%CI:0.14-1.05)。与标准治疗相比,它还与非椎骨骨折(OR=0.79;95%CI:0.66-0.94)和24个月时临床骨折(OR=0.70;95%CI:0.59-0.82)的发生率降低相关。Romosozumab显示骨矿物质密度(BMD)[平均差(MD)=10.38;95%CI:4.62-16.14]和髋关节BMD(MD=4.24;95%CI:2.92-5.56)的百分比变化显着改善。与标准治疗相比,不良反应没有显着差异(p>0.05)。漏斗图显示出主要的对称模式,表明在选定的文献中没有发表偏倚的证据。
    将romosozumab与常规疗法结合使用可有效治疗PMOP,显著减少椎骨,非椎骨,和临床骨折,同时增加髋部的骨密度,股骨颈,和腰椎。然而,需要进一步的高质量研究进行验证.
    UNASSIGNED: Postmenopausal osteoporosis (PMOP) increases fracture risk in women. Though traditional treatments are slow to act, combining romosozumab with conventional therapy shows promise. Despite its growing use, studies on effectiveness are limited. This study aims to systematically evaluate the combined therapy\'s impact on pain relief, disease progression, and adverse reactions in PMOP patients.
    UNASSIGNED: Databases including PubMed, EMBASE, ScienceDirect, and the Cochrane Library were searched from their inception to September 2023 to identify randomized controlled trials (RCTs) evaluating the role of romosozumab in PMOP. Random or fixed effect models were employed for statistical analysis. Two reviewers independently assessed the quality of the included studies and extracted the data. The meta-analysis was conducted using RevMan 5.4 software.
    UNASSIGNED: Six RCTs with a total sample size of 17,985 cases were included. The incidence of vertebral fractures was compared and analyzed after 12 and 24 months of treatment. Romosozumab significantly reduced the incidence of vertebral fractures at 24 months (OR = 0.36; 95% CI: 0.35-0.52) but not at 12 months (OR = 0.39; 95% CI: 0.14-1.05). It was also associated with a decreased incidence of nonvertebral fractures (OR = 0.79; 95% CI: 0.66-0.94) and clinical fractures at 24 months (OR = 0.70; 95% CI: 0.59-0.82) compared to standard therapy. Romosozumab demonstrated a significant improvement in percentage change in bone mineral density (BMD) [mean difference (MD) = 10.38; 95% CI: 4.62-16.14] and in hip joint BMD (MD = 4.24; 95% CI: 2.92-5.56). There was no notable difference in adverse reactions compared to standard care (p > 0.05). Funnel plots displayed a predominantly symmetrical pattern, suggesting no evidence of publication bias in the selected literature.
    UNASSIGNED: Combining romosozumab with conventional therapy effectively treats PMOP, significantly reducing vertebral, non-vertebral, and clinical fractures while increasing BMD in the hip, femoral neck, and lumbar spine. However, further high-quality studies are needed for validation.
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  • 文章类型: Journal Article
    目的:口罩是预防传染病传播的重要措施;然而,它们降低了通过面部表情传达和理解情绪的能力。在献血环境中,戴口罩可能会干扰专业人员的任务,降低献血者的满意度,影响他们未来的献血行为。这项初步的横断面研究探讨了2019年冠状病毒(COVID-19)大流行结束时强制佩戴口罩与献血过程质量的关系。
    方法:615名意大利自愿无偿血液和血浆捐献者完成了一项在线调查,评估他们对戴口罩的态度,在捐赠过程的不同步骤中,由于口罩而感到的痛苦,自我报告捐赠后的血管迷走反应和再次捐赠的意图。
    结果:近24%的捐献者报告说,由于戴口罩,捐赠过程质量恶化,36%的人在捐赠过程中报告了中度至重度的痛苦。对口罩持消极态度的捐赠者报告了更糟糕的捐赠经历,主要涉及与医生和护士的互动和沟通,在他们最后一次捐赠时经历血管迷走反应的可能性更高。对戴面罩的负面面罩态度之间没有观察到显着的相关性,痛苦或将来打算献血/血浆。
    结论:口罩使四分之一的捐献者的血液和血浆捐献质量恶化,确认干扰通信质量和与医疗保健专业人员的关系。
    OBJECTIVE: Facemasks represent an essential measure of prevention against the spread of infectious diseases; however, they lessen the ability to convey and understand emotions through facial expressions. In blood donation settings, facemask wearing could interfere with professionals\' tasks, reduce the satisfaction of blood donors and affect their future blood donation behaviour. This preliminary cross-sectional study explored the association of mandatory facemask wearing with the quality of the blood donation process at the end of the coronavirus 2019 (COVID-19) pandemic.
    METHODS: A sample of 615 voluntary unpaid Italian blood and plasma donors completed an online survey assessing their attitude towards facemask wearing, the perceived distress due to facemasks in the different steps of the donation process, self-reported vasovagal reactions after donation and the intention to donate again.
    RESULTS: Nearly 24% of donors reported a worsened quality of the donation process due to facemask wearing, and 36% reported moderate to severe distress during the donation itself. Donors with a more negative attitude towards facemasks reported a worse donation experience, mainly related to the interactions and the communication with physicians and nurses, and a higher probability of experiencing vasovagal reactions at their last donation. No significant correlations were observed between negative facemask attitudes towards facemask wearing, distress or future intention to donate blood/plasma.
    CONCLUSIONS: Facemasks have worsened the quality of blood and plasma donations for one fourth of donors, confirming the interference with the quality of communications and relationships with healthcare professionals.
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  • 文章类型: Journal Article
    背景:注册可以在日常临床实践中对过敏原免疫疗法(AIT)结果产生重要见解。然而,缺乏现实生活中由于AIT引起的不良事件(AE)的系统记录。
    方法:过敏原免疫治疗不良事件登记处(ADER)是一个前瞻性的,现实生活中的AIT安全多中心注册。有关患有呼吸道过敏的成年人(>18岁)接受螨虫AIT的数据,花粉,上皮,和/或模具从ADER检索和分析。频率,调查AE的特点和危险因素。MedDRA术语用于记录AE。
    结果:共纳入来自8个国家的1545名平均年龄33±10岁的个体,在中心接受1815个AIT课程(n=1060舌下(SLIT);n=755皮下(SCIT))。患者有过敏性鼻炎(65%)或,仅哮喘(3.7%)或鼻炎伴哮喘(31.2%)。草是最常见的特异性敏化剂(60.7%),其次是螨虫(45.5%),桦树花粉(20.6%),上皮(16.1%),和霉菌(8%)。115例(7.4%)患者中记录到296例不良事件。与维持相比,在向上给药(59%)期间发生更高的AE频率。严重反应罕见(0.2%),都是在SCIT的背景下。在维持6周后,仅记录到一个中度AE。最常见的症状来自呼吸系统和皮肤。有哮喘,做SCIT,艾特艾特,猫,或桦木与较高的AE风险相关,而使用变应原引起的风险较低。
    结论:在现实生活中的临床实践中,AIT相关的AE发生在少数患者中,而严重的反应是罕见的。哮喘的存在和使用SCIT是危险因素,而使用修饰的过敏原降低了风险。
    BACKGROUND: Registries can yield important insights on allergen immunotherapy (AIT) outcomes in daily clinical practice. However, systematic recordings of adverse events (AE) due to AIT in real-life are lacking.
    METHODS: The Allergen Immunotherapy Adverse Events Registry (ADER) is a prospective, multicenter registry on real-life AIT safety. Data on adults (>18 years old) with respiratory allergies receiving AIT with mites, pollens, epithelia, and/or molds were retrieved and analyzed from ADER. The frequency, characteristics and risk factors of AE were investigated. The MedDRA terminology was used to record AE.
    RESULTS: A total of 1545 individuals with a mean age of 33 ± 10 years receiving 1815 AIT courses (n = 1060 sublingual (SLIT); n = 755 subcutaneous (SCIT)) in centers from eight countries were included. Patients had allergic rhinitis (65%) or, asthma only (3.7%) or rhinitis with asthma (31.2%). Grass was the most frequent specific sensitizer (60.7%), followed by mites (45.5%), birch pollen (20.6%), epithelia (16.1%), and molds (8%). There were 296 AE recorded in 115 patients (7.4%). A higher frequency of AE occurred during up-dosing (59%) compared to maintenance. Severe reactions were rare (0.2%), all in the context of SCIT. After 6 weeks of maintenance only one moderate AE was recorded. The most frequently reported symptoms were from the respiratory system and the skin. Having asthma, doing SCIT, AIT with mugwort, cat, or birch were associated with higher risk for AE while the use of allergoids induced lower risk.
    CONCLUSIONS: In real life clinical practice, AIT-associated AE occur in a minority of patients, while severe reactions are rare. The presence of asthma and use of SCIT are risk factors, while the use of modified allergens lowers the risk.
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  • 文章类型: Journal Article
    暂无摘要。
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  • 文章类型: Journal Article
    背景:高血压性心力衰竭(HHF)发病率高,预后差。
    目的:评价Vericiguat治疗HHF的疗效和安全性,并分析C反应蛋白(CRP)水平与患者预后的关系。
    方法:将110例HHF患者分为安慰剂组和Vericiguat组。通过超声心动图和6分钟步行试验(6MWT)评估心功能。采集血样检测N末端脑钠肽前体(NT-proBNP)水平,心肌肌钙蛋白I(cTnI),内皮素(ET-1),一氧化氮(NO),CRP。
    结果:左心室收缩末期内径(LVESD)和左心室舒张末期内径(LVEDD)减小,左心室射血分数(LVEF)和6MWT增加,血清NT-proBNP水平,cTnI,ET-1,不,与安慰剂组相比,Vericiguat组降低了CRP。安慰剂组的总有效率为76.4%,Vericiguat组为92.7%(P<0.05)。不良反应发生率分别为10.9%和9.1%(P>0.05)。治疗前CRP高表达患者预后差、心功能无改善的比例高于CRP低表达患者(P<0.05)。CRP高表达是预后不良的独立危险因素。
    结论:Vericiguat在改善HHF患者心功能方面是安全有效的。
    BACKGROUND: Hypertensive heart failure (HHF) has a high incidence and poor prognosis.
    OBJECTIVE: This article evaluated the efficacy and safety of Vericiguat in HHF and analyzed the relationship between C-reactive protein (CRP) levels and patient prognosis.
    METHODS: 110 HHF patients were divided into Placebo and Vericiguat groups. Cardiac function was assessed by echocardiography and 6-minute walk test (6MWT). Blood samples were collected to detect the levels of N-terminal pro-brain natriuretic peptide (NT-proBNP), cardiac troponin I (cTnI), endothelin (ET-1), nitric oxide (NO), and CRP.
    RESULTS: Left ventricular end systolic diameter (LVESD) and left ventricular end diastolic dimension (LVEDD) were reduced, the left ventricular ejection fraction (LVEF) and 6MWT were increased, and the serum levels of NT-proBNP, cTnI, ET-1, NO, and CRP were decreased in Vericiguat group as against Placebo group; The total effective rate was 76.4% in Placebo group and 92.7% in Vericiguat group (P < 0.05). The adverse reaction rate was 10.9% and 9.1% (P > 0.05). The proportion of persons with poor prognosis and no improvement of cardiac function in patients with highly expressed CRP before treatment was higher as against patients with low expression of CRP (P < 0.05). Highly expressed CRP is an independent risk factor for poor prognosis.
    CONCLUSIONS: Vericiguat is safe and effective in improving cardiac function in HHF patients.
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  • 文章类型: Case Reports
    咪喹莫特是针对各种皮肤状况的功效的众所周知的局部治疗。虽然一般耐受性良好,如局部皮肤刺激等不良反应很常见。然而,严重的全身性影响,如史蒂文斯-约翰逊综合征(SJS)是罕见的,但有可能.我们介绍了一名82岁男性的病例,该男性在局部咪喹莫特治疗基底细胞癌后发展为SJS。尽管全身吸收很少,可能会发生严重的反应,值得谨慎。及时识别和停止治疗对于管理此类罕见但严重的不良事件至关重要。该病例强调了知情同意和警惕监测与咪喹莫特治疗相关的不良反应的重要性。
    Imiquimod is a well-known topical treatment for its efficacy against various skin conditions. While generally well-tolerated, adverse reactions like local skin irritation are common. However, severe systemic effects such as Stevens-Johnson syndrome (SJS) are rare, but possible. We present the case of an 82-year-old male who developed SJS following topical Imiquimod therapy for basal cell carcinoma. Despite minimal systemic absorption, serious reactions can occur, warranting caution. Prompt recognition and discontinuation of treatment are crucial for managing such rare but severe adverse events. This case underscores the importance of informed consent and vigilant monitoring for adverse reactions associated with Imiquimod therapy.
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  • 文章类型: Journal Article
    背景:下腰痛是骨质疏松症最常见的症状之一。疼痛会严重影响患者的情绪和生活质量,还会进一步加重骨丢失,造成严重的社会负担。米诺膦酸盐是需要每日给药的口服双膦酸盐。它显着降低了骨转换标志物(BTM)的水平,并迅速改善了骨质疏松症患者的腰背痛症状。骨质疏松需要长期治疗,和每日剂量降低患者的依从性。米诺膦酸盐具有比其他双膦酸盐更好的安全性。该试验的目的是探讨米诺膦酸钠治疗绝经后骨质疏松症患者腰背痛的有效性和安全性。
    方法:这是一个单中心,随机化,为期24周的开放标签对照试验.将72名符合条件的患者随机分为4组。受试者将以1:1的比例随机分配,每天接受米诺膦酸盐(1mg/天)或阿仑膦酸盐(10mg/天);高级女性(≥75岁)和老年女性(<75岁)的比例为1:2。主要结果是视觉模拟量表(VAS)评分从基线下降≥10所需的时间。次要结果是VAS评分相对于基线的变化,抢救药物的频率和剂量,BTMs,骨矿物质密度(BMD),与基线相比,上消化道(GI)症状评分的变化(包括胃灼热,疼痛,和腹胀)。
    结论:本研究将为米诺膦酸钠的有效性和安全性提供客观证据。此外,这将有助于评估不同年龄骨质疏松患者BTM与BMD之间的定量关系。
    背景:本研究方案已于2022年12月8日在ClinicalTrials.govIDNCT05645289(https://clinicaltrials.gov/search?term=NCT05645289)注册。注册名称为北京大学第三医院。本研究方案经北京大学第三医院医学科学研究伦理委员会(M2022465,2022.08.09,V2.0)审查批准。结果将发表在科学同行评审的期刊上。
    方法:该方案已在ClinicalTrials.gov注册(注册号:NCT05645289)。招聘已于2023年1月开始,目前仍在进行中。
    BACKGROUND: Low back pain is one of the most common symptoms of osteoporosis. The pain can seriously affect patients\' mood and quality of life; it can also further aggravate bone loss, causing a serious social burden. Minodronate is an oral bisphosphonate that needs to be administered daily. It significantly reduces levels of bone turnover markers (BTMs) and rapidly improves symptoms of low back pain in patients with osteoporosis. Osteoporosis requires long-term treatment, and daily dosing reduces patient compliance. Minodronate has a better safety profile than other bisphosphonates. The objective of the trial is to explore the efficacy and safety of minodronate in the treatment of low back pain in postmenopausal osteoporosis patients.
    METHODS: This is a single-centre, randomized, open-label controlled trial with a 24-week duration. Seventy-two eligible patients will be randomly divided into 4 groups. Subjects will be randomized at a 1:1 ratio to receive either minodronate (1 mg/day) or alendronate (10 mg/day) every day; senior women (≥ 75 years old) and older women (< 75 years old) will be at a ratio of 1:2. The primary outcome is the time required for the visual analogue scale (VAS) score to decline by ≥ 10 from baseline. The secondary outcome is the changes in VAS scores from baseline, the frequency and dosage of rescue medication, BTMs, bone mineral density (BMD), and variations in upper gastrointestinal (GI) symptom scores from baseline (including heartburn, pain, and bloating).
    CONCLUSIONS: This study will provide objective evidence for the efficiency and safety of minodronate. Furthermore, it will be helpful to evaluate the quantitative relationship between BTMs and BMD in patients with osteoporosis under different ages.
    BACKGROUND: This study protocol has been registered with ClinicalTrials.gov ID NCT05645289 ( https://clinicaltrials.gov/search?term=NCT05645289 ) on December 8, 2022. The registry name is Peking University Third Hospital. This study protocol was reviewed and approved by the Peking University Third Hospital Medical Science Research Ethics Committee (M2022465, 2022.08.09, V2.0). The results will be published in scientific peer-reviewed journals.
    METHODS: The protocol was registered at ClinicalTrials.gov (registration number: NCT05645289). Recruitment has started in January 2023 and is still ongoing.
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  • 文章类型: Journal Article
    评估卡培他滨治疗晚期结肠癌的疗效和安全性。将晚期结肠癌患者随机分为三组:对照组(n=50,每日剂量2,500mg/m2),中剂量组(n=50,日剂量2,000mg/m2),低剂量组(n=50,日剂量1,500mg/m2)卡培他滨4个周期(12周)。之后,响应率,生活质量,收集3组不良反应进行比较。有效率为50%,70%,72%,分别,低剂量组疗效最高(χ2=6.424,p=0.040);生活质量比较结果显示身体功能存在显着差异(F=98.528,p<0.001),作用函数(F=123.418,p<0.001),社会功能(F=89.539,p<0.001),情绪功能(6F=77.295,p<0.001),认知功能(F=83.529,p<0.001),三组的总体生活质量(F=99.528,p<0.001),三组得分一致,低剂量组得分最高。发病率为86.00%,46.00%,34.00%,其中对照组的发生率最高(χ2=16.505,p<0.001)。卡培他滨在1,500mg/m2的剂量下显示出良好的治疗效果,并改善了晚期结肠癌患者的生活质量。不良反应发生率较低。建议延长治疗周期并减少剂量以进一步改善治疗结果和患者预后。试验注册该研究于2024年1月30日在clicaltrials.gov\'NCT06246461\'上注册。
    To assess the efficacy and safety of capecitabine in treating advanced colon cancer. Patients with advanced colon cancer were randomized into three groups: control group (n = 50, daily dose 2,500 mg/m2), the medium-dose group (n = 50, daily dose 2,000 mg/m2), and the low-dose group (n = 50, daily dose 1,500 mg/m2) capecitabine for 4 cycles(12 weeks). Afterwards, the response rate, quality of life, and adverse reactions of the three groups were collected for comparison. Efficacy rates were 50%, 70%, and 72%, respectively, with the low-dose group showing the highest efficacy (χ2 = 6.424, p = 0.040); Quality of life comparison results indicated significant differences in physical function (F = 98.528, p < 0.001), role function (F = 123.418, p < 0.001), social function(F = 89.539, p < 0.001), emotional function (6 F = 77.295, p < 0.001), cognitive function (F = 83.529, p < 0.001), and overall quality of life (F = 99.528, p < 0.001) among the three groups, and the three groups returned consistent scores, with the low-dose group scoring highest. Incidence rates were 86.00%, 46.00%, 34.00%, with the control group having the highest rate (χ2 = 16.505, p < 0.001). Capecitabine at a dosage of 1,500 mg/m2 demonstrated a good therapeutic effect and improved the quality of life in patients with advanced colon cancer, with a lower incidence of adverse reactions. A prolonged treatment cycle with reduced dosage is suggested to further improve treatment outcomes and patient prognosis. Trial registration The study was registered on clicaltrials.gov \'NCT06246461\' on 30/01/2024.
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