duration of treatment

治疗持续时间
  • 文章类型: Journal Article
    目的:为了评估有效性,安全,以及从基于硼替佐米的静脉诱导到基于艾沙佐米的口服方案的课堂过渡(iCT)的便利性。
    方法:这项回顾性研究于2017年10月至2023年4月在16家中国医院进行,分析了新诊断(NDMM)和一线复发多发性骨髓瘤(FRMM)患者,这些患者至少从硼替佐米诱导治疗中获得了部分反应。然后是以ixazomib为基础的口服方案2年或直到疾病进展或无法耐受的毒性。
    结果:该研究招募了199名患者,中位年龄:63岁,男性55.4%,53%为高风险(HR),47%为标准风险。通过中期荧光原位杂交(M-FISH)进行细胞遗传学风险分层,基于梅奥诊所风险分层系统。总PI治疗的中位持续时间为11个月,以艾沙佐米为基础的治疗持续6个月。在20个月的中位随访中,53%的患者仍在接受治疗。从基于硼替佐米的诱导开始,24个月的PFS率为84.3%,从基于艾沙唑米的治疗开始为83.4%。硼替佐米诱导后的总反应率(ORR)为100%,基于伊沙佐米的方案6个周期后为90%。根据桑基图,89.51%的患者在2个周期的iCT后维持或改善了他们的疾病反应,6个周期(90.14%),和12个周期(80%)。发现Mayo的HR水平是缓解不良的重要独立因素(风险比(HR)2.55;p=0.033)。Ixazomib的安全性与以前的临床试验数据一致,49%的患者经历至少一个任何级别的AE。最常见的不良事件包括周围神经病变,恶心和呕吐,腹泻,血小板减少症,和粒细胞减少症.
    结论:在现实世界的中国MM人群中,NDMM和FRMM患者对基于PI的连续治疗反应良好,显示出相当大的反应率。基于ixazomib的iCT允许持续的基于PI的治疗,提供有希望的疗效和可耐受的不良事件。
    OBJECTIVE: To evaluate the effectiveness, safety, and convenience of in-class transition (iCT) from intravenous bortezomib-based induction to ixazomib-based oral regimens.
    METHODS: This retrospective real-world study was conducted in 16 Chinese hospitals between October 2017 and April 2023 and analyzed newly diagnosed (NDMM) and first-line relapsed multiple myeloma (FRMM) patients who attained at least a partial response from bortezomib-based induction therapy, followed by an ixazomib-based oral regimen for 2 year or until disease progression or intolerable toxicity.
    RESULTS: The study enrolled 199 patients, median age: 63 years old, male 55.4%, 53% as high risk (HR), and 47% as standard risk. Cytogenetic risk stratification by metaphase fluorescence in situ hybridization (M-FISH), based on the Mayo Clinic risk stratification system. The median duration of total PI therapy was 11 months, with ixazomib-based treatment spanning 6 months. At the 20-month median follow-up, 53% of patients remained on therapy. The 24-month PFS rate was 84.3% from the initiation of bortezomib-based induction and 83.4% from the start of ixazomib-based treatment. Overall response rate (ORR) was 100% post-bortezomib induction and 90% following 6 cycles of the ixazomib-based regimen. Based on the Sankey diagrams, 89.51% of patients maintained or improved their disease response after 2 cycles of iCT, 6 cycles (90.14%), and 12 cycles (80%). The HR level of Mayo was found to be a significant independent factor in a worse remission (hazard ratio (HR) 2.55; p = 0.033). Ixazomib\'s safety profile aligned with previous clinical trial data, with 49% of patients experiencing at least one AE of any grade. The most common AEs included peripheral neuropathy, nausea and vomiting, diarrhea, thrombocytopenia, and granulocytopenia.
    CONCLUSIONS: In the real-world Chinese MM population, NDMM and FRMM patients responded favorably to PI-based continuous therapy, demonstrating substantial response rates. The ixazomib-based iCT allows for sustained PI-based treatment, offering promising efficacy and tolerable AEs.
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  • 文章类型: Journal Article
    背景:初始干预和后续治疗的治疗持续时间(DOT)是确定抗癌药物预算影响分析(BIA)计算准确性的关键。然而,现有的研究只使用简单的假设作为点的代理,导致高度的偏差。
    目的:为了提高抗癌药物BIA的准确性和可靠性,解决有关DOT的问题,我们提出了一种基于个体患者数据(IPD)的替代方法,该方法从已发表的KaplanMeier生存曲线重建IPD,以估计DOT.
    方法:我们为这种新方法开发了一个四步方法框架,以帕博利珠单抗治疗微卫星不稳定性高(MSI-H)晚期结直肠癌为例:(1)重建IPD;(2)计算每位患者初始干预和后续治疗的总DOT;(3)分配随机时间和DOT;(4)多重置换采样和平均值的计算.
    结果:使用这种方法,可以计算BIA时间范围内每年初始干预和后续治疗的平均DOT,并将其用于计算每年消耗的资源和成本.在我们的例子中,从第一年到第四年,pembrolizumab初始干预的平均DOT为4.90、6.60、5.24和5.06个月,分别,而后续治疗的平均DOT为0.75、2.84、2.99和2.50个月,分别。
    结论:与常规方法相比,基于IPD的重建方法可以提高抗癌药物BIA的准确性和可靠性,并且可以广泛使用,尤其是对抗癌药物具有优异的疗效。
    BACKGROUND: The duration of treatment (DOT) of the initial intervention and subsequent treatment is the key to determining the accuracy of anticancer-drug budget impact analysis (BIA) calculations. However, existing studies only use simple assumptions as a proxy for DOT, resulting in a high degree of bias.
    OBJECTIVE: To enhance the accuracy and reliability of anticancer-drug BIA and solve the problem regarding DOT, we propose an alternative individual patient data (IPD)-based approach that reconstructs IPD from the published Kaplan Meier survival curves to estimate DOT.
    METHODS: We developed a four-step methodological framework for this new approach, taking the use of pembrolizumab in treating microsatellite-instability-high (MSI-H) advanced colorectal cancer as an example: (1) reconstructing the IPD; (2) calculating the total DOT of the initial intervention and subsequent treatment for each patient; (3) assigning a randomized time and DOT; and (4) multiple replacement sampling and calculation of the mean value.
    RESULTS: Using this approach, the average DOT for the initial intervention and subsequent treatment in each year of the BIA time horizon can be calculated and used to calculate the resources consumed and costs in each year. In our example, the average DOT for the initial intervention with pembrolizumab from the first to the fourth year was 4.90, 6.60, 5.24, and 5.06 months, respectively, while the average DOT for subsequent treatment was 0.75, 2.84, 2.99, and 2.50 months, respectively.
    CONCLUSIONS: The reconstructed IPD-based approach can improve the accuracy and reliability of anticancer-drug BIA compared with conventional methods, and can be widely used, especially for anticancer drugs with excellent efficacy.
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    文章类型: Journal Article
    BACKGROUND: According to the clinical manifestation, tuberculosis (TB) is divided into pulmonary tuberculosis (PTB) and extrapulmonary tuberculosis (EPTB). The incidence rate of EPTB has increased in many countries. The demographic and clinical characteristics of EPTB in China remain still unclear.
    METHODS: We retrospectively analyzed the medical records of 5,624 hospitalized patients with positive M. tuberculosis culture between January 2008 and June 2013 in Shandong province. We investigated the epidemiological, demographic, and clinical characteristics of patients with EPTB.
    RESULTS: Among 5,624 hospitalized TB patients with positive M. tuberculosis culture, 4,277 (76.05 %) had PTB, 618 (10.99 %) had EPTB, and 729 (12.96 %) had both PTB and EPTB. The proportion of EPTB increased significantly from 6.97 % in 2008 to 19.98 % in 2012 (p <0.001).  The most frequent sites or foci of EPTB were pleura (63.27 %), followed by bone/joint (13.75 %), and lymph nodes (8.9 %). The mean duration of treatment for pleural TB was eight months and for EPTB in the other foci was more than 15 months.
    CONCLUSIONS: The proportion of EPTB in Shandong province has significantly increased. Clinicians need to be aware of the trend and remain vigilant against EPTB. EPTB requires prolonged treatment, and clinical supervision should be strengthened to prevent drug resistance. HIPPOKRATIA 2020, 24(1): 27-32.
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  • 文章类型: Journal Article
    The present situation of the clinical application of dog-days moxibustion (moxibustion applied in the three periods of the hot season) is summarized so as to provide the guide for the theoretic study and clinical application of dog-days moxibustion. The intervention time of dog-days moxibustion is on the 1st day of each of the three periods of the hot season. Simultaneously, the geographic factors are considered. The disorders of lung system are mostly dominant among the indications of dog-days moxibustion, complicated with spleen and stomach disorders as well as cold and deficiency syndromes/patterns. The acupoints are mainly selected from the front-mu points on the chest and the back-shu points on the back, in combination with the differentiation of diseases, symptoms/patterns and the disorder stages. The duration of treatment is ranged from 1 to 3 years. The clinical therapeutic effect is improved constantly along with the increase of treatment periods by years.
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