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Analysis of neutropenia as a predictive factor of the efficacy of trifluridine-tipiracil treatment. 作为三氟吡啶-替吡拉西治疗疗效预测因素的中性粒细胞减少症分析。
IF 0.8 4区 医学 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2023-08-01 DOI: 10.5414/CP204410
Loreto Domínguez Senín, María Yeray Rodriguez Garcés, Victoria Aviñó Tarazona, María Amor Urbano, Maria Dolores Santos-Rubio, Juan Bayo Calero

Objectives: Trifluridine-tipiracil (TAS-102), an oral cytotoxic agent used in adult patients with refractory metastatic colorectal cancer (mCRC), has been associated with neutropenia (chemotherapy-induced neutropenia) (CIN)).

Materials and methods: We evaluated the efficacy and safety of TAS-102 in a group of 45 mCRC patients (median age 66 years) in Huelva province, Spain, in a retrospective, multicenter observational study.

Results: We showed that the association between TAS-102 and CIN can be used as a predictor of efficacy. 20% (9/45) of patients with an Eastern Cooperative Oncology Group (ECOG) score of 2 had received at least one previous chemotherapy treatment. Overall, 75.5% (34/45) and 28.9% (13/45) had received anti-VEGF and anti-EGFR monoclonal antibodies, respectively. Additionally, 80% (36/45) of patients had received third-line treatment. The mean treatment period, duration of overall survival (OS), and duration of progression-free survival (PFS) were 3.4, 12, and 4 months, respectively. A partial response was seen in 2 patients (4.3%), and disease stabilization was observed in 10 patients (21.3%). Neutropenia was the most frequent grade 3 - 4 toxicity (46.7%; 21/45). Other findings were anemia (77.8%; 35/45), all grades of neutropenia (73.3%; 33/45), and gastrointestinal toxicity (53.3%; 24/45). The dose of TAS-102 needed to be reduced in 68.9% (31/45) of patients, whereas treatment needed to be interrupted in 80% (36/45) of patients. Grade 3 - 4 neutropenia was a positive prognostic factor for OS (p = 0.023).

Conclusion: A retrospective evaluation shows that grade 3 - 4 neutropenia is an independent predictor of treatment response and survival in patients undergoing routine treatment for mCRC, but this finding needs confirmation in a prospective study.

目的:三氟啶-异曲西(TAS-102)是一种口服细胞毒性药物,用于难治性转移性癌症(mCRC)成年患者,与中性粒细胞减少症(化疗诱导的中性粒细胞减症)(CIN)有关。材料和方法:我们在西班牙韦尔瓦省的45名mCRC患者(中位年龄66岁)中评估了TAS-102的疗效和安全性,多中心观察性研究。结果:我们发现TAS-102和CIN之间的相关性可以作为疗效的预测指标。20%(9/45)的东部肿瘤协作组(ECOG)评分为2的患者至少接受过一次化疗。总体而言,分别有75.5%(34/45)和28.9%(13/45)接受了抗VEGF和抗EGFR单克隆抗体治疗。此外,80%(36/45)的患者接受了三线治疗。平均治疗期、总生存期(OS)和无进展生存期(PFS)分别为3.4、12和4个月。2名患者(4.3%)出现部分反应,10名患者(21.3%)病情稳定。中性粒细胞减少症是最常见的3-4级毒性(46.7%;21/45)。其他发现为贫血(77.8%;35/45)、所有级别的中性粒细胞减少症(73.3%;33/45)和胃肠道毒性(53.3%;24/45)。68.9%(31/45)的患者需要减少TAS-102的剂量,而80%(36/45)的患者则需要中断治疗。3-4级中性粒细胞减少症是OS的一个积极预后因素(p=0.023)。结论:一项回顾性评估显示,在接受mCRC常规治疗的患者中,3-4级中性白细胞减少症可以独立预测治疗反应和生存率,但这一发现需要在前瞻性研究中得到证实。
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引用次数: 0
Does methotrexate use increase the risk of dementia in patients with rheumatoid arthritis? 甲氨蝶呤是否会增加类风湿关节炎患者痴呆的风险?
IF 0.8 4区 医学 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2023-08-01 DOI: 10.5414/CP204433
Naz Elahi, Abraish Ali, Rahma Idrees
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引用次数: 0
Dexamethasone-induced hiccups in patients with COVID-19. COVID-19患者地塞米松引起的打嗝
IF 0.8 4区 医学 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2023-08-01 DOI: 10.5414/CP204429
Tomomi Yagi, Takeo Yasu, Sumi Tsubuku, Hiroyuki Jinnai, Kenta Otsuka, Shin Takahashi, Takeshi Hagino
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引用次数: 0
Factors influencing glomerular filtration rate as estimated using preoperative creatinine and cystatin C levels. 术前肌酐和胱抑素C水平估计影响肾小球滤过率的因素。
IF 0.8 4区 医学 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2023-08-01 DOI: 10.5414/CP204432
Fumihiro Nishimura, Kentaro Oniki, Shigeyuki Miyamura, Tomoko Ushijima, Hisao Harada, Tomofumi Taki, Shigeki Yanagi, Junji Saruwatari

Objectives: Estimated glomerular filtration rate (eGFR) using serum creatinine (Cr) is commonly used to evaluate renal function. However, it can be influenced by other factors, which can risk the overestimation of the true GFR. Impaired renal function prior to cardiovascular surgery reportedly increases mortality and the incidence of postoperative complications. Thus, overestimation of renal function may affect the assessment of postoperative complication risks. Therefore, we aimed to compare the eGFR calculated from serum Cr and cystatin C (Cys-C) levels to assess preoperative renal function and to investigate factors affecting renal function overestimation.

Materials and methods: 88 patients admitted for cardiovascular surgery who had preoperative serum Cr and Cys-C measurements were included in the study. Correlations between factors associated with eGFR calculated from serum Cr (eGFRcre) and Cys-C (eGFRcys) and their ratio (eGFRcre/eGFRcys) were examined using multiple regression analysis.

Results: Multiple regression analysis revealed that eGFRcre/eGFRcys was significantly negatively correlated with the Short Physical Performance Battery score (SPPB). A clinically significant difference in renal function overestimation was defined as GFRcre/eGFRcys > 1.2, with a cutoff value of 9 points for the SPPB score. The chair stand test, a component of the SPPB, had the same discriminative power as the SPPB for identification of renal function overestimation.

Conclusion: The SPPB can be used to identify likely GFR overestimation in patients. Additionally, the chair stand test may be used as an alternative to the SPPB for the identification of renal function overestimation when the SPPB is difficult to perform.

目的:利用血清肌酐(Cr)估计肾小球滤过率(eGFR)是评估肾功能的常用方法。然而,它可能受到其他因素的影响,这可能有高估真实GFR的风险。据报道,心血管手术前肾功能受损会增加死亡率和术后并发症的发生率。因此,对肾功能的过高估计可能影响术后并发症风险的评估。因此,我们的目的是通过比较血清Cr和胱抑素C (Cys-C)水平计算的eGFR来评估术前肾功能,并探讨影响肾功能高估的因素。材料与方法:本研究纳入88例术前血清Cr和Cys-C测定的心血管手术患者。采用多元回归分析检验血清Cr (eGFRcre)和Cys-C (eGFRcys)计算的eGFR相关因子及其比值(eGFRcre/eGFRcys)之间的相关性。结果:多元回归分析显示,eGFRcre/eGFRcys与短物理性能电池评分(SPPB)呈显著负相关。肾功能高估的临床显著差异定义为GFRcre/eGFRcys > 1.2, SPPB评分的临界值为9分。作为SPPB的一个组成部分,椅子站立试验与SPPB在识别肾功能高估方面具有相同的判别能力。结论:SPPB可用于鉴别患者可能存在的GFR高估。此外,当SPPB难以执行时,椅子站立试验可作为SPPB的替代方法,用于识别肾功能高估。
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引用次数: 0
Bioequivalence study of domperidone dry suspension in healthy Chinese subjects under fasted and fed conditions: An open-label, randomized, single-dose, crossover trial. 多潘立酮干混悬液在中国健康受试者禁食和进食条件下的生物等效性研究:一项开放标签、随机、单剂量、交叉试验
IF 0.8 4区 医学 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2023-07-01 DOI: 10.5414/CP204309
Lihua Wu, Qian Huang, Meihua Lin, Jiejing Kai, Yujie Huang, You Zhai, Jian Liu, Jianzhong Shentu

Background: Domperidone has long been used as a prokinetic agent in the treatment of epigastric distress symptoms. This study aimed to provide adequate evidence for registration approval of a new generic dry suspension formulation of domperidone by comparing the safety and pharmacokinetic profiles between the test and branded reference formulation in the context of fasted and fed condition.

Materials and methods: This was designed as a randomized, open-label, single-dose, two-period, two-treatment crossover study. 32 and 28 eligible healthy subjects were enrolled in the fasted and fed study, respectively. Each subject was randomly assigned to receive either the test or reference formulation in the first period, followed by a 1-week washout period and dosing of the alternate formulation in the second period. A series of blood samples were collected at scheduled timepoints within 48 hours after administration during each treatment period. Plasma concentrations of domperidone were determined by validated HPLC-MS/MS. Pharmacokinetic parameters, including Cmax, tmax, AUC0-t, AUC0-∞, and T1/2, were acquired based on the concentration vs. time profiles by non-compartmental analysis using WinNonlin software. Then the geometric mean ratios (GMR) of Cmax, AUC0-t, and AUC0-∞ between the two formulations and corresponding 90% confidence intervals (CIs) were calculated for bioequivalence determination. Safety was assessed as routine.

Results: The two formulations showed similar pharmacokinetic profiles. Under fasted condition, the GMR and corresponding 90% CIs of AUC0-t, AUC0-∞, and Cmax were 101.48% (96.79 - 106.38%), 101.17% (96.66 - 105.90%), and 104.61% (96.73 - 113.14%), respectively. Under fed condition, the GMR and corresponding 90% CIs were 105.46% (99.19 - 112.12%), 104.21% (98.19 - 110.61%), and 112.78% (103.64 - 122.73%), respectively, for AUC0-t, AUC0-∞, and Cmax. All values fell within the accepted bioequivalence range of 80 - 125%. Both the test and the reference products were well tolerated without any serious or unexpected adverse reactions.

Conclusion: Pharmacokinetic bioequivalence was established between the two dry suspension formulations of domperidone in healthy Chinese subjects. Both products were safe and well tolerated.

背景:多潘立酮长期以来被用作胃上窘迫症状的促动力学药物。本研究旨在通过在禁食和喂养条件下比较试验和品牌参比制剂的安全性和药代动力学特征,为新通用多潘立酮干混悬剂的注册批准提供充分的证据。材料和方法:这是一项随机、开放标签、单剂量、两期、两治疗的交叉研究。32和28名符合条件的健康受试者分别参加了禁食和喂养研究。每个受试者被随机分配在第一期接受测试制剂或参考制剂,随后是为期一周的洗脱期,并在第二期给药替代制剂。在每个治疗期给药后48小时内的预定时间点采集一系列血液样本。采用高效液相色谱-质谱联用技术测定多潘立酮的血药浓度。采用WinNonlin软件进行非区室分析,根据浓度-时间曲线获得Cmax、tmax、AUC0-t、AUC0-∞、T1/2等药代动力学参数。计算两种制剂Cmax、AUC0-t和AUC0-∞的几何平均比(GMR)及相应的90%置信区间(ci),进行生物等效性测定。安全性评估为常规。结果:两方具有相似的药动学特征。在禁食条件下,AUC0-t、AUC0-∞和Cmax的GMR和相应的90% ci分别为101.48%(96.79 ~ 106.38%)、101.17%(96.66 ~ 105.90%)和104.61%(96.73 ~ 113.14%)。在馈入条件下,AUC0-t、AUC0-∞和Cmax的GMR和相应的90% ci分别为105.46%(99.19 ~ 112.12%)、104.21%(98.19 ~ 110.61%)和112.78%(103.64 ~ 122.73%)。所有值均在80 - 125%的可接受生物等效性范围内。试验和参考产品均耐受良好,无任何严重或意外的不良反应。结论:多潘立酮两种干混悬制剂在中国健康人体内具有药代动力学生物等效性。两种产品都是安全且耐受性良好的。
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引用次数: 0
Opioids increase the risk of delirium in critically ill patients: A propensity score analysis. 阿片类药物增加危重患者谵妄的风险:倾向评分分析。
IF 0.8 4区 医学 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2023-07-01 DOI: 10.5414/CP204240
He-Jie Shi, Xue-Ping Zhang, Chao Hai, Wei Shi, Ping Wang, An-Min Hu

Background: Medications are biologically plausible and potentially modifiable risk factors for delirium. Therapies for delirium might involve more specific strategies such as avoiding the use of delirium-inducing drugs to reduce the incidence of delirium. The association between opioid exposure within 24 hours prior to delirium assessment and the risk of delirium was studied.

Materials and methods: Using three large databases, the MIMIC III v1.4, MIMIC-IV v0.4 and eICU Collaborative Research, we performed a multicenter, observational cohort study with two cohorts to estimate the relative risks of outcomes among patients administered opioids within 24 hours prior to delirium assessment. Propensity score matching was performed to generate a balanced 1 : 1 matched cohort and to identify potential prognostic factors. The outcomes included mortality, length of intensive care unit (ICU) stay, length of hospitalization, and odds of being discharged home.

Results: Propensity matching successfully balanced the covariates for the 9,529 patients in each group. Opioid use was associated with a significantly higher risk for delirium than not using opioids (p < 0.001). Additionally, treatment with opioids was associated with higher mortality and a longer ICU stay (p < 0.001) than treatment without opioids. However, patients treated with opioids were more likely to be discharged home (p < 0.001).

Conclusion: Opioids may be an independent risk factor for delirium in critically ill patients.

背景:药物是谵妄的生物学上合理和潜在可改变的危险因素。谵妄的治疗可能包括更具体的策略,如避免使用谵妄诱导药物来减少谵妄的发生率。研究了谵妄评估前24小时内阿片类药物暴露与谵妄风险之间的关系。材料和方法:使用MIMIC III v1.4、MIMIC- iv v0.4和eICU合作研究三个大型数据库,我们进行了一项多中心、观察性队列研究,包括两个队列,以估计谵妄评估前24小时内服用阿片类药物的患者结局的相对风险。进行倾向评分匹配,以产生平衡的1:1匹配队列,并确定潜在的预后因素。结果包括死亡率、重症监护病房(ICU)住院时间、住院时间和出院回家的几率。结果:倾向匹配成功地平衡了每组9529例患者的协变量。结论:阿片类药物可能是危重症患者谵妄的独立危险因素。
{"title":"Opioids increase the risk of delirium in critically ill patients: A propensity score analysis.","authors":"He-Jie Shi,&nbsp;Xue-Ping Zhang,&nbsp;Chao Hai,&nbsp;Wei Shi,&nbsp;Ping Wang,&nbsp;An-Min Hu","doi":"10.5414/CP204240","DOIUrl":"https://doi.org/10.5414/CP204240","url":null,"abstract":"<p><strong>Background: </strong>Medications are biologically plausible and potentially modifiable risk factors for delirium. Therapies for delirium might involve more specific strategies such as avoiding the use of delirium-inducing drugs to reduce the incidence of delirium. The association between opioid exposure within 24 hours prior to delirium assessment and the risk of delirium was studied.</p><p><strong>Materials and methods: </strong>Using three large databases, the MIMIC III v1.4, MIMIC-IV v0.4 and eICU Collaborative Research, we performed a multicenter, observational cohort study with two cohorts to estimate the relative risks of outcomes among patients administered opioids within 24 hours prior to delirium assessment. Propensity score matching was performed to generate a balanced 1 : 1 matched cohort and to identify potential prognostic factors. The outcomes included mortality, length of intensive care unit (ICU) stay, length of hospitalization, and odds of being discharged home.</p><p><strong>Results: </strong>Propensity matching successfully balanced the covariates for the 9,529 patients in each group. Opioid use was associated with a significantly higher risk for delirium than not using opioids (p < 0.001). Additionally, treatment with opioids was associated with higher mortality and a longer ICU stay (p < 0.001) than treatment without opioids. However, patients treated with opioids were more likely to be discharged home (p < 0.001).</p><p><strong>Conclusion: </strong>Opioids may be an independent risk factor for delirium in critically ill patients.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":"61 7","pages":"289-296"},"PeriodicalIF":0.8,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10047424","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Deprescribing proton pump inhibitors: A study in hospitalized patients in Slovenia. 质子泵抑制剂处方解除:斯洛文尼亚住院患者研究
IF 0.8 4区 医学 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2023-07-01 DOI: 10.5414/CP204374
Nina Ravbar, Mojca Kerec Kos, Maja Jošt, Nanča Čebron Lipovec, Lea Knez

Objective: To evaluate the possibility of deprescribing proton pump inhibitors in adult inpatients hospitalized in a teaching hospital in Slovenia.

Materials and methods: We conducted a prospective observational clinical study in 120 patients taking a proton pump inhibitor. Data were obtained from hospital medical records and patient interviews. First, treatment compliance with relevant guidelines was assessed, and then the possibility of deprescribing was considered.

Results: Treatment with a proton pump inhibitor was in accordance with guidelines in only 39% of the 120 patients. In 24% of patients, the indication for proton pump inhibitor use was invalid, and 22% and 15% of patients were taking a proton pump inhibitor at a higher dose or for a longer period than recommended, respectively. Deprescribing could be undertaken in 61% of patients, as discontinuation in 38%, and dose reduction in 23%. A deprescribing possibility was noted more frequently in patients prescribed proton pump inhibitors for peptic ulcer disease, Helicobacter pylori infection, or without a valid indication (p < 0.001), as well as in patients taking a double or higher dose of a proton pump inhibitor (p < 0.001).

Conclusion: Deprescribing of proton pump inhibitors could be undertaken in nearly 2/3 of our cohort of adult hospitalized patients. Hospitalization may serve as an opportunity to deprescribe proton pump inhibitors.

目的:评价斯洛文尼亚某教学医院成人住院患者质子泵抑制剂处方化的可能性。材料和方法:我们对120例服用质子泵抑制剂的患者进行了前瞻性观察性临床研究。数据来自医院病历和患者访谈。首先评估治疗依从性,然后考虑开处方的可能性。结果:120例患者中只有39%的患者使用质子泵抑制剂治疗符合指南。24%的患者使用质子泵抑制剂的适应症无效,分别有22%和15%的患者服用质子泵抑制剂的剂量高于推荐剂量或服用时间超过推荐时间。61%的患者可以解除处方,38%的患者可以停药,23%的患者可以减少剂量。在消化性溃疡疾病、幽门螺杆菌感染或无有效指征的患者中(p < 0.001),以及服用两倍或更高剂量质子泵抑制剂的患者中(p < 0.001),更常注意到减少处方的可能性。结论:在我们的成年住院患者队列中,近2/3的患者可以解除质子泵抑制剂的处方。住院治疗可作为撤销质子泵抑制剂处方的机会。
{"title":"Deprescribing proton pump inhibitors: A study in hospitalized patients in Slovenia.","authors":"Nina Ravbar,&nbsp;Mojca Kerec Kos,&nbsp;Maja Jošt,&nbsp;Nanča Čebron Lipovec,&nbsp;Lea Knez","doi":"10.5414/CP204374","DOIUrl":"https://doi.org/10.5414/CP204374","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the possibility of deprescribing proton pump inhibitors in adult inpatients hospitalized in a teaching hospital in Slovenia.</p><p><strong>Materials and methods: </strong>We conducted a prospective observational clinical study in 120 patients taking a proton pump inhibitor. Data were obtained from hospital medical records and patient interviews. First, treatment compliance with relevant guidelines was assessed, and then the possibility of deprescribing was considered.</p><p><strong>Results: </strong>Treatment with a proton pump inhibitor was in accordance with guidelines in only 39% of the 120 patients. In 24% of patients, the indication for proton pump inhibitor use was invalid, and 22% and 15% of patients were taking a proton pump inhibitor at a higher dose or for a longer period than recommended, respectively. Deprescribing could be undertaken in 61% of patients, as discontinuation in 38%, and dose reduction in 23%. A deprescribing possibility was noted more frequently in patients prescribed proton pump inhibitors for peptic ulcer disease, <i>Helicobacter pylori</i> infection, or without a valid indication (p < 0.001), as well as in patients taking a double or higher dose of a proton pump inhibitor (p < 0.001).</p><p><strong>Conclusion: </strong>Deprescribing of proton pump inhibitors could be undertaken in nearly 2/3 of our cohort of adult hospitalized patients. Hospitalization may serve as an opportunity to deprescribe proton pump inhibitors.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":"61 7","pages":"306-314"},"PeriodicalIF":0.8,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9681856","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Bleeding events associated with recombinant human soluble thrombomodulin, classified according to renal function, in sepsis-induced disseminated intravascular coagulation. 脓毒症引起的弥散性血管内凝血中与重组人可溶性血栓调节蛋白相关的出血事件,根据肾功能分类。
IF 0.8 4区 医学 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2023-07-01 DOI: 10.5414/CP204362
Toshihisa Onoda, Koichi Aoyama, Mikana Suzuki, Takahiro Matsumoto, Hiroyuki Tanaka, Toshihiro Ishii

Objective: Recombinant human soluble thrombomodulin (rhsTM) is a therapeutic agent for sepsis-induced disseminated intravascular coagulation (DIC) and is associated with bleeding events. rhsTM is a renal excretion drug; however, information on the role of rhsTM in renal function is limited.

Materials and methods: In this retrospective observational study, we assessed rhsTM-associated bleeding events according to the renal function of patients with sepsis-induced DIC. We analyzed the data of 79 patients administered a standard-dose of rhsTM for sepsis-induced DIC, at a single center. Patients were classified based on estimated glomerular filtration rate (eGFR). We measured fresh bleeding events following rhsTM administration, DIC score efficacy, and 28-day mortality.

Results: Fresh bleeding events were observed in 15 patients, with a significant difference in the eGFR, platelet count, and DIC scores. Furthermore, fresh bleeding events tended to increase with the deterioration of renal function (p = 0.039). The DIC scores in all renal function groups decreased after -rhsTM administration. Additionally, the 28-day mortality was less than 30% in all groups.

Conclusion: Our results indicate that the effectiveness of the standard-dose of rhsTM is not related to renal function. However, standard-dose rhsTM therapy could potentially increase the risk of adverse bleeding events with severe renal function equivalent to G5.

目的:重组人可溶性血栓调节蛋白(rhsTM)是一种治疗脓毒症引起的弥散性血管内凝血(DIC)的药物,与出血事件有关。rhsTM是一种肾排泄药物;然而,关于rhsTM在肾功能中的作用的信息是有限的。材料和方法:在这项回顾性观察性研究中,我们根据败血症性DIC患者的肾功能评估rhstm相关出血事件。我们分析了79例在单一中心接受标准剂量rhsTM治疗败血症性DIC的患者的数据。根据估计的肾小球滤过率(eGFR)对患者进行分类。我们测量了rhsTM给药后的新鲜出血事件、DIC评分疗效和28天死亡率。结果:15例患者观察到新鲜出血事件,eGFR、血小板计数和DIC评分有显著差异。此外,新鲜出血事件随着肾功能的恶化而增加(p = 0.039)。给药后各肾功能组DIC评分均下降。此外,所有组的28天死亡率均低于30%。结论:我们的研究结果表明,标准剂量rhsTM的有效性与肾功能无关。然而,标准剂量的rhsTM治疗可能会增加严重肾功能相当于G5的不良出血事件的风险。
{"title":"Bleeding events associated with recombinant human soluble thrombomodulin, classified according to renal function, in sepsis-induced disseminated intravascular coagulation.","authors":"Toshihisa Onoda,&nbsp;Koichi Aoyama,&nbsp;Mikana Suzuki,&nbsp;Takahiro Matsumoto,&nbsp;Hiroyuki Tanaka,&nbsp;Toshihiro Ishii","doi":"10.5414/CP204362","DOIUrl":"https://doi.org/10.5414/CP204362","url":null,"abstract":"<p><strong>Objective: </strong>Recombinant human soluble thrombomodulin (rhsTM) is a therapeutic agent for sepsis-induced disseminated intravascular coagulation (DIC) and is associated with bleeding events. rhsTM is a renal excretion drug; however, information on the role of rhsTM in renal function is limited.</p><p><strong>Materials and methods: </strong>In this retrospective observational study, we assessed rhsTM-associated bleeding events according to the renal function of patients with sepsis-induced DIC. We analyzed the data of 79 patients administered a standard-dose of rhsTM for sepsis-induced DIC, at a single center. Patients were classified based on estimated glomerular filtration rate (eGFR). We measured fresh bleeding events following rhsTM administration, DIC score efficacy, and 28-day mortality.</p><p><strong>Results: </strong>Fresh bleeding events were observed in 15 patients, with a significant difference in the eGFR, platelet count, and DIC scores. Furthermore, fresh bleeding events tended to increase with the deterioration of renal function (p = 0.039). The DIC scores in all renal function groups decreased after -rhsTM administration. Additionally, the 28-day mortality was less than 30% in all groups.</p><p><strong>Conclusion: </strong>Our results indicate that the effectiveness of the standard-dose of rhsTM is not related to renal function. However, standard-dose rhsTM therapy could potentially increase the risk of adverse bleeding events with severe renal function equivalent to G5.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":"61 7","pages":"297-305"},"PeriodicalIF":0.8,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9691376","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Effect of infusion time of intravenous acetaminophen on blood pressure in the intensive care unit. 重症监护病房静脉对乙酰氨基酚输注时间对血压的影响。
IF 0.8 4区 医学 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2023-07-01 DOI: 10.5414/CP204360
Yasunori Urayama, Satoshi Kosaka, Tsugumi Ide, Mikio Shirota, Takeo Yasu

Objective: To understand the effect of prolonged intravenous acetaminophen infusion on blood pressure.

Materials and methods: We retrospectively studied a cohort of intensive care patients receiving initial intravenous acetaminophen. We used propensity score matching to adjust for differences between patients who were classified into two groups: control (acetaminophen infusion for 15 minutes) and prolonged administration (acetaminophen infusion for > 15 minutes).

Results: After acetaminophen administration, diastolic blood pressure was unchanged in the control group, and was significantly lower at 30 and 60 minutes in the prolonged administration group.

Conclusion: Prolonged duration of acetaminophen infusion did not prevent acetaminophen-induced blood pressure reduction.

目的:了解长时间静脉输注对乙酰氨基酚对血压的影响。材料和方法:我们回顾性研究了一组最初静脉注射对乙酰氨基酚的重症监护患者。我们使用倾向评分匹配来调整两组患者之间的差异:对照组(对乙酰氨基酚输注15分钟)和延长给药组(对乙酰氨基酚输注> 15分钟)。结果:对乙酰氨基酚给药后,对照组舒张压无变化,延长给药组舒张压在30、60分钟明显降低。结论:延长对乙酰氨基酚输注时间并不能阻止对乙酰氨基酚所致的血压降低。
{"title":"Effect of infusion time of intravenous acetaminophen on blood pressure in the intensive care unit.","authors":"Yasunori Urayama,&nbsp;Satoshi Kosaka,&nbsp;Tsugumi Ide,&nbsp;Mikio Shirota,&nbsp;Takeo Yasu","doi":"10.5414/CP204360","DOIUrl":"https://doi.org/10.5414/CP204360","url":null,"abstract":"<p><strong>Objective: </strong>To understand the effect of prolonged intravenous acetaminophen infusion on blood pressure.</p><p><strong>Materials and methods: </strong>We retrospectively studied a cohort of intensive care patients receiving initial intravenous acetaminophen. We used propensity score matching to adjust for differences between patients who were classified into two groups: control (acetaminophen infusion for 15 minutes) and prolonged administration (acetaminophen infusion for > 15 minutes).</p><p><strong>Results: </strong>After acetaminophen administration, diastolic blood pressure was unchanged in the control group, and was significantly lower at 30 and 60 minutes in the prolonged administration group.</p><p><strong>Conclusion: </strong>Prolonged duration of acetaminophen infusion did not prevent acetaminophen-induced blood pressure reduction.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":"61 7","pages":"315-319"},"PeriodicalIF":0.8,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9691377","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Efficacy of antacids for cisplatin-induced gastrointestinal symptoms in the treatment of lung cancer. 抗酸剂对顺铂诱导的肺癌胃肠道症状的疗效观察。
IF 0.8 4区 医学 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2023-06-01 DOI: 10.5414/CP204349
Osamu Taniguchi, Yoshitaka Saito, Yoh Takekuma, Hirotoshi Akita, Ichiro Kinoshita, Yasushi Shimizu, Naofumi Shinagawa, Mitsuru Sugawara

Objective: Chemotherapy-induced nausea and vomiting (CINV) and chemotherapy-associated dyspepsia syndrome (CADS) are frequently appearing adverse effects of cisplatin (CDDP)-containing chemotherapy. Antiemetic guidelines suggest that the administration of antacids such as proton pump inhibitors (PPIs) or histamine type-2 receptor antagonists be considered for CADS, although their efficacy for treating these symptoms remains unknown. This study aimed to reveal whether antacids attenuate gastrointestinal symptoms in CDDP-containing chemotherapy.

Materials and methods: In total, 138 patients with lung cancer who received ≥ 75 mg/m2 CDDP-containing regimens were enrolled in this retrospective study. Patients were divided into an antacid group including patients administered PPIs or vonoprazan during all chemotherapy periods and controls without antacid administration. The primary endpoint was the comparison of anorexia incidence during the first cycle of chemotherapy. Secondary endpoints were CINV evaluation and risk factor analysis for the incidence of anorexia using logistic regression analysis.

Results: The incidence of anorexia during the first cycle was 54.4% in the control group and 60.3% in the antacid group, without significant differences (p = 0.60). The incidence of nausea was also similar between the groups (p = 1.00). Multivariate analysis suggested that antacid administration was not associated with anorexia.

Conclusion: Baseline antacid administration does not affect gastrointestinal symptoms associated with CDDP-containing treatment in lung cancer.

目的:化疗性恶心呕吐(CINV)和化疗相关消化不良综合征(CADS)是含顺铂(CDDP)化疗中常见的不良反应。止吐指南建议对CADS考虑使用抗酸剂,如质子泵抑制剂(PPIs)或组胺2型受体拮抗剂,尽管它们对治疗这些症状的疗效尚不清楚。本研究旨在揭示抗酸药是否能减轻含cddp化疗中的胃肠道症状。材料与方法:本回顾性研究共纳入138例接受≥75 mg/m2含cddp方案治疗的肺癌患者。患者被分为抗酸组,包括在所有化疗期间服用PPIs或vonoprazan的患者和不服用抗酸剂的对照组。主要终点是比较第一周期化疗期间厌食症的发生率。次要终点是CINV评价和使用logistic回归分析对厌食症发生率进行危险因素分析。结果:对照组和抗酸组第1周期厌食发生率分别为54.4%和60.3%,差异无统计学意义(p = 0.60)。两组间恶心发生率相似(p = 1.00)。多变量分析显示抗酸药与厌食症无关。结论:基线抗酸药不影响肺癌含cddp治疗相关的胃肠道症状。
{"title":"Efficacy of antacids for cisplatin-induced gastrointestinal symptoms in the treatment of lung cancer.","authors":"Osamu Taniguchi,&nbsp;Yoshitaka Saito,&nbsp;Yoh Takekuma,&nbsp;Hirotoshi Akita,&nbsp;Ichiro Kinoshita,&nbsp;Yasushi Shimizu,&nbsp;Naofumi Shinagawa,&nbsp;Mitsuru Sugawara","doi":"10.5414/CP204349","DOIUrl":"https://doi.org/10.5414/CP204349","url":null,"abstract":"<p><strong>Objective: </strong>Chemotherapy-induced nausea and vomiting (CINV) and chemotherapy-associated dyspepsia syndrome (CADS) are frequently appearing adverse effects of cisplatin (CDDP)-containing chemotherapy. Antiemetic guidelines suggest that the administration of antacids such as proton pump inhibitors (PPIs) or histamine type-2 receptor antagonists be considered for CADS, although their efficacy for treating these symptoms remains unknown. This study aimed to reveal whether antacids attenuate gastrointestinal symptoms in CDDP-containing chemotherapy.</p><p><strong>Materials and methods: </strong>In total, 138 patients with lung cancer who received ≥ 75 mg/m<sup>2</sup> CDDP-containing regimens were enrolled in this retrospective study. Patients were divided into an antacid group including patients administered PPIs or vonoprazan during all chemotherapy periods and controls without antacid administration. The primary endpoint was the comparison of anorexia incidence during the first cycle of chemotherapy. Secondary endpoints were CINV evaluation and risk factor analysis for the incidence of anorexia using logistic regression analysis.</p><p><strong>Results: </strong>The incidence of anorexia during the first cycle was 54.4% in the control group and 60.3% in the antacid group, without significant differences (p = 0.60). The incidence of nausea was also similar between the groups (p = 1.00). Multivariate analysis suggested that antacid administration was not associated with anorexia.</p><p><strong>Conclusion: </strong>Baseline antacid administration does not affect gastrointestinal symptoms associated with CDDP-containing treatment in lung cancer.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":"61 6","pages":"246-254"},"PeriodicalIF":0.8,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9435977","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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International journal of clinical pharmacology and therapeutics
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