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Effectiveness of Netarsudil versus Brimonidine in Eyes already Being Treated with Glaucoma Medications at a Single Academic Tertiary Care Practice: A Comparative Study 在单一学术三级保健实践中,奈沙地尔与溴莫尼定在已经接受青光眼药物治疗的眼睛中的有效性:一项比较研究
IF 1.9 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2023-01-01 DOI: 10.1016/j.curtheres.2022.100689
Alex T. Pham BS , Chris Bradley PhD , Corinne Casey OD , Henry D. Jampel MD , Pradeep Y. Ramulu MD, PhD , Jithin Yohannan MD, MPH

Background

Rho kinase inhibitors, such as netarsudil, are a relatively new class of medications recently introduced into the market for the treatment of glaucoma, the leading cause of irreversible blindness in the world. Previous clinical trials have studied netarsudil's efficacy when used as a first- or second-line agent but limited studies have investigated its effectiveness in the real world where it is more commonly used as a third, fourth, or fifth agent in combination with other topical medications. Equally important, prior studies have not compared its effectiveness to its peer medications in these settings.

Objective

To compare intraocular pressure (IOP) lowering after initiation of netarsudil or brimonidine therapy in patients with glaucoma using >2 medications for IOP management.

Methods

A chart review of 369 eyes from 279 patients followed at a single academic tertiary practice was performed with an institutional review board waiver of consent to compare IOP lowering after prescription of netarsudil (n = 176) versus brimonidine (n = 193) as a third, fourth, or fifth IOP-lowering agent. Patients were identified by querying the electronic medical record for those with a glaucoma-related diagnosis who were prescribed either medication. Five sequential IOP measurements were obtained to determine the mean change in IOP before and after treatment (ΔIOP = mean IOP4,5 – mean IOP1,2,3). A multilevel linear mixed-effects model assessed the influence of medication (independent variable) on ΔIOP (dependent variable). Additional independent variables of interest included the number of glaucoma medications at baseline, age, sex, glaucoma type and severity, race, and pretreatment IOP. Bootstrap analysis was performed to remove sampling bias and confirm mixed-effects model findings. Kaplan-Meier survival analysis evaluated the probability of requiring additional intervention within 3 years following the date of medication prescription.

Results

The unadjusted mean (SD) ΔIOP for netarsudil and brimonidine was −2.20 (4.11) mm Hg and −2.21 (3.25) mm Hg, respectively (P = 0.484). The adjusted linear mixed-effects models and bootstrap analysis demonstrated that there was no statistical difference in IOP-lowering effectiveness between the medications. Netarsudil and brimonidine failed to adequately control IOP at similar rates with 42% and 47% probabilities of survival respectively by the 3-year follow-up (P = 0.520).

Conclusions

When escalating pharmacologic therapy, the IOP-lowering effect of netarsudil appeared to be similar to that produced by brimonidine. (Curr Ther Res Clin Exp. 2023; 84:XXX–XXX)

背景Rho激酶抑制剂,如netarsudil,是最近引入市场的一类相对较新的药物,用于治疗青光眼,青光眼是世界上不可逆失明的主要原因。先前的临床试验研究了奈他舒作为一线或二线药物的疗效,但有限的研究调查了它在现实世界中的疗效,在现实世界里,它更常见地作为第三、第四或第五种药物与其他局部药物联合使用。同样重要的是,先前的研究没有将其有效性与这些环境中的同行药物进行比较。目的比较应用>;2种用于IOP管理的药物。方法对来自279名患者的369只眼睛进行图表审查,这些患者在一个单一的学术三级诊所接受了随访,机构审查委员会放弃了同意书,以比较服用耐塔舒地尔(n = 176)与溴莫尼定(n = 193)作为第三、第四或第五IOP降低剂。通过查询与青光眼相关的诊断患者的电子医疗记录来识别患者,这些患者被开了两种药物。获得了五次连续的IOP测量,以确定治疗前后IOP的平均变化(ΔIOP = 平均IOP4,5–平均IOP1,2,3)。多水平线性混合效应模型评估了药物(自变量)对ΔIOP(因变量)的影响。其他感兴趣的自变量包括基线时青光眼药物的数量、年龄、性别、青光眼类型和严重程度、种族和治疗前眼压。进行Bootstrap分析以消除抽样偏差并确认混合效应模型的发现。Kaplan-Meier生存分析评估了在药物处方日期后3年内需要额外干预的可能性。结果奈他舒地尔和溴莫尼定的未校正平均ΔIOP分别为−2.20(4.11)mm Hg和−2.21(3.25)mm Hg(P = 0.484)。调整后的线性混合效应模型和bootstrap分析表明,两种药物在降低眼压的有效性方面没有统计学差异。耐达舒地尔和溴莫尼定未能以相似的比率充分控制眼压,3年随访的存活率分别为42%和47%(P = 0.520)。结论在递增药物治疗时,耐塔舒地尔的降眼压作用与溴莫尼定相似。(Curr Ther Res Clin Exp.2023;84:XXX–XXX)
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引用次数: 1
An Acceptance and Commitment Therapy Smartphone Application for Erectile Dysfunction: A Feasibility Study 接受和承诺治疗智能手机应用于勃起功能障碍:可行性研究
IF 1.9 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2023-01-01 DOI: 10.1016/j.curtheres.2023.100728
Junichi Saito PhD , Hiroaki Kumano MD, PhD , Mohammad Ghazizadeh MD, PhD , Chigusa Shimokawa , Hideki Tanemura

Background

Erectile dysfunction (ED) is a multifactorial disorder with both psychogenic and organic components, but psychosocial factors are usually neglected.

Objective

The purpose of this study was to develop a smartphone application targeting psychosocial factors of ED and to examine its feasibility, acceptability, and treatment response to determine the parameters for a larger clinical trial.

Methods

In this single-arm feasibility study, 8 participants with situational ED were enrolled. Dr. App, a newly developed smartphone treatment application for patients with psychogenic ED consisting of 8 weekly modules based on Acceptance and Commitment Therapy, was delivered. The primary outcome was comparison of the International Index of Erectile Function-15 domain scores measured pre- and post-intervention.

Results

Six out of 8 participants completed the Dr. App and the post-intervention measures. The Wilcoxon signed-rank test showed a significant change in erectile function (P < 0.05; r = –0.65) and a significant trend in intercourse satisfaction (P < 0.10; r = –0.47) and overall satisfaction (P < .10; r = –0.47). Additionally, the reliable change index values were used to calculate the number of participants for whom a clinically meaningful difference occurred. The results showed that 33.30% of the participants had clinically meaningful differences in erectile function and 66.70% in intercourse satisfaction and overall satisfaction. On the other hand, no significant differences were shown in orgasmic function and sexual desire.

Conclusions

Findings from this study support the feasibility, acceptability, and potential usefulness of the smartphone application targeting psychosocial factors of ED and warrant a larger randomized clinical trial to confirm the results.

背景:勃起功能障碍(ED)是一种多因素的疾病,既有心理因素,也有器质性因素,但社会心理因素往往被忽视。本研究的目的是开发一款针对ED心理社会因素的智能手机应用程序,并检查其可行性、可接受性和治疗反应,以确定更大规模临床试验的参数。方法在单臂可行性研究中,8名情境性ED患者入组。新开发的心因性ED智能手机治疗应用Dr. App,基于接受与承诺治疗,每周8个模块。主要结果是比较干预前后测量的国际勃起功能指数-15域得分。结果8名参与者中有6人完成了Dr. App和干预后措施。Wilcoxon符号秩检验显示勃起功能有显著变化(P <0.05;r = -0.65),性交满意度有显著趋势(P <0.10;r = -0.47)和总体满意度(P <.10;r = -0.47)。此外,可靠的变化指标值被用来计算有临床意义的差异发生的参与者人数。结果显示,33.30%的参与者在勃起功能方面有临床意义的差异,66.70%的参与者在性交满意度和总体满意度方面有临床意义的差异。另一方面,在性高潮功能和性欲方面没有显着差异。结论:本研究的结果支持了针对ED心理社会因素的智能手机应用程序的可行性、可接受性和潜在的有用性,并需要更大规模的随机临床试验来证实结果。
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引用次数: 0
Drugs Currently Undergoing Preclinical or Clinical Trials for the Treatment of Overactive Bladder: A Review 目前正在进行治疗膀胱过动症的临床前或临床试验的药物:综述
IF 1.9 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2022-04-01 DOI: 10.1016/j.curtheres.2022.100669
Silvia Joseph, Steffie Maria, J. Peedicayil
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引用次数: 11
Nanoformulation of Plant-Based Natural Products for Type 2 Diabetes Mellitus: From Formulation Design to Therapeutic Applications 治疗2型糖尿病的植物性天然产品纳米配方:从配方设计到治疗应用
IF 1.9 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2022-04-01 DOI: 10.1016/j.curtheres.2022.100672
A. Wickramasinghe, P. Kalansuriya, A. Attanayake
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引用次数: 8
Effects of Ramosetron on Nausea and Vomiting Following Spinal Surgery: A Meta-Analysis 雷莫司琼对脊柱手术后恶心呕吐的影响:一项荟萃分析
IF 1.9 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2022-03-01 DOI: 10.1016/j.curtheres.2022.100666
Lin Yiyun, Su Tiansheng, Zhang Zhicheng, C. Xiaobin, L. Fang
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引用次数: 2
Impact of Area Under the Concentration-Time Curve-Guided Monitoring on Vancomycin Nephrotoxicity and Treatment Outcomes in Methicillin-Resistant Staphylococcus Aureus Bacteremia in Korean Patients 浓度-时间曲线引导下监测面积对韩国耐甲氧西林金黄色葡萄球菌血症患者万古霉素肾毒性及治疗效果的影响
IF 1.9 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2022-01-01 DOI: 10.1016/j.curtheres.2022.100687
Young Rong Kim MD , Ha-Jin Chun , Jung Yeon Heo MD, PhD , Jin Sae Yoo MD , Young Hwa Choi MD, PhD , Eun Jin Kim MD

Background

Current guidelines for the therapeutic monitoring of vancomycin recommend dosing based on the area under the concentration-time curve (AUC) to achieve clinical efficacy while reducing nephrotoxicity. Although a wide range of nephrotoxicity thresholds have been reported, few studies have documented clinical outcomes based on AUC-guided vancomycin dosing in Korea.

Objective

The aim of the study was to evaluate whether a relationship exists between AUC and treatment outcomes in vancomycin treated patients in methicillin-resistant Staphylococcus aureus bacteremia. Furthermore, this study tries to estimate AUC threshold for treatment failure and nephrotoxicity.

Methods

The records of adult patients with methicillin-resistant Staphylococcus aureus bacteremia treated with vancomycin for ≥72 hours without dialysis between April 2013 and April 2021, were reviewed retrospectively. Treatment success was defined as defervescence and blood culture sterilization by day 7. Nephrotoxicity was defined as an increase in serum creatinine levels ≥0.3 mg/dL or a 50% increase from baseline on 2 consecutive days. Bayesian estimation was used to predict individual vancomycin AUC. Both classification and regression tree and receiver operating characteristic curve analyses were performed to estimate the optimal AUC thresholds for vancomycin efficacy and nephrotoxicity.

Results

Of 118 patients, 61 (51.7%) experienced treatment failure and 42 (35.6%) developed acute kidney injury. The vancomycin AUC threshold for predicting acute kidney injury was 615.0 mg· hr/L. In the multivariate analysis, AUC ≥615.0 mg· hr/L was a significant risk factor for nephrotoxicity (adjusted odds ratio [aOR] = 5.24; 95% CI, 1.8–14.65). The lower threshold for treatment failure was not defined because it was not statistically significant. Risk factors for treatment failure included low body mass index (aOR = 0.82; 95% CI, 0.70–0.96), severity of acute illness represented by complicated infection (aOR = 77.56; 95% CI, 16.7–359.4) and comorbidities, such as solid organ tumors (aOR = 6.61; 95% CI, 1.19–36.81) and cerebrovascular disease (aOR = 6.05; 95% CI, 1.17–31.23).

Conclusions

Although AUC-guided vancomycin dosing was associated with a reduced risk of acute kidney injury, its ability to predict clinical outcomes was modest. Further studies are needed to define the AUC therapeutic range to maximize efficacy and minimize nephrotoxicity. (Curr Ther Res Clin Exp. 2023; 83:XXX–XXX)

背景:目前万古霉素治疗监测指南推荐根据浓度-时间曲线下面积(AUC)给药,以达到临床疗效,同时降低肾毒性。尽管有广泛的肾毒性阈值报道,但在韩国,很少有研究记录了基于auc指导的万古霉素剂量的临床结果。目的评价万古霉素治疗耐甲氧西林金黄色葡萄球菌血症患者的AUC与治疗结果之间是否存在关系。此外,本研究试图估计治疗失败和肾毒性的AUC阈值。方法回顾性分析2013年4月至2021年4月接受万古霉素治疗≥72小时未透析的耐甲氧西林金黄色葡萄球菌血症患者的临床资料。治疗成功以第7天退热和血培养灭菌为标准。肾毒性定义为连续2天血清肌酐水平升高≥0.3 mg/dL或较基线升高50%。采用贝叶斯估计预测万古霉素个体AUC。通过分类回归树和受试者工作特征曲线分析来估计万古霉素疗效和肾毒性的最佳AUC阈值。结果118例患者中,61例(51.7%)治疗失败,42例(35.6%)发生急性肾损伤。万古霉素预测急性肾损伤的AUC阈值为615.0 mg·hr/L。在多因素分析中,AUC≥615.0 mg·hr/L是肾毒性的重要危险因素(校正优势比[aOR] = 5.24;95% ci, 1.8-14.65)。治疗失败的下限没有定义,因为它没有统计学意义。治疗失败的危险因素包括低身体质量指数(aOR = 0.82;95% CI, 0.70-0.96),以并发感染为代表的急性疾病的严重程度(aOR = 77.56;95% CI, 16.7-359.4)和合并症,如实体器官肿瘤(aOR = 6.61;95% CI, 1.19-36.81)和脑血管疾病(aOR = 6.05;95% ci, 1.17-31.23)。结论:尽管auc引导的万古霉素剂量与急性肾损伤风险降低相关,但其预测临床结果的能力有限。需要进一步的研究来确定AUC的治疗范围,以最大限度地提高疗效和减少肾毒性。(中国医学杂志,2011);83: XXX-XXX)
{"title":"Impact of Area Under the Concentration-Time Curve-Guided Monitoring on Vancomycin Nephrotoxicity and Treatment Outcomes in Methicillin-Resistant Staphylococcus Aureus Bacteremia in Korean Patients","authors":"Young Rong Kim MD ,&nbsp;Ha-Jin Chun ,&nbsp;Jung Yeon Heo MD, PhD ,&nbsp;Jin Sae Yoo MD ,&nbsp;Young Hwa Choi MD, PhD ,&nbsp;Eun Jin Kim MD","doi":"10.1016/j.curtheres.2022.100687","DOIUrl":"10.1016/j.curtheres.2022.100687","url":null,"abstract":"<div><h3>Background</h3><p>Current guidelines for the therapeutic monitoring of vancomycin recommend dosing based on the area under the concentration-time curve (AUC) to achieve clinical efficacy while reducing nephrotoxicity. Although a wide range of nephrotoxicity thresholds have been reported, few studies have documented clinical outcomes based on AUC-guided vancomycin dosing in Korea.</p></div><div><h3>Objective</h3><p>The aim of the study was to evaluate whether a relationship exists between AUC and treatment outcomes in vancomycin treated patients in methicillin-resistant <em>Staphylococcus aureus</em> bacteremia. Furthermore, this study tries to estimate AUC threshold for treatment failure and nephrotoxicity.</p></div><div><h3>Methods</h3><p>The records of adult patients with methicillin-resistant <em>Staphylococcus aureus</em> bacteremia treated with vancomycin for ≥72 hours without dialysis between April 2013 and April 2021, were reviewed retrospectively. Treatment success was defined as defervescence and blood culture sterilization by day 7. Nephrotoxicity was defined as an increase in serum creatinine levels ≥0.3 mg/dL or a 50% increase from baseline on 2 consecutive days. Bayesian estimation was used to predict individual vancomycin AUC. Both classification and regression tree and receiver operating characteristic curve analyses were performed to estimate the optimal AUC thresholds for vancomycin efficacy and nephrotoxicity.</p></div><div><h3>Results</h3><p>Of 118 patients, 61 (51.7%) experienced treatment failure and 42 (35.6%) developed acute kidney injury. The vancomycin AUC threshold for predicting acute kidney injury was 615.0 mg· hr/L. In the multivariate analysis, AUC ≥615.0 mg· hr/L was a significant risk factor for nephrotoxicity (adjusted odds ratio [aOR] = 5.24; 95% CI, 1.8–14.65). The lower threshold for treatment failure was not defined because it was not statistically significant. Risk factors for treatment failure included low body mass index (aOR = 0.82; 95% CI, 0.70–0.96), severity of acute illness represented by complicated infection (aOR = 77.56; 95% CI, 16.7–359.4) and comorbidities, such as solid organ tumors (aOR = 6.61; 95% CI, 1.19–36.81) and cerebrovascular disease (aOR = 6.05; 95% CI, 1.17–31.23).</p></div><div><h3>Conclusions</h3><p>Although AUC-guided vancomycin dosing was associated with a reduced risk of acute kidney injury, its ability to predict clinical outcomes was modest. Further studies are needed to define the AUC therapeutic range to maximize efficacy and minimize nephrotoxicity. (<em>Curr Ther Res Clin Exp.</em> 2023; 83:XXX–XXX)</p></div>","PeriodicalId":10920,"journal":{"name":"Current Therapeutic Research-clinical and Experimental","volume":"97 ","pages":"Article 100687"},"PeriodicalIF":1.9,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/25/55/main.PMC9691871.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40499698","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
Stem Cell Therapy for Thyroid Diseases: Progress and Challenges 干细胞治疗甲状腺疾病:进展和挑战
IF 1.9 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2022-01-01 DOI: 10.1016/j.curtheres.2022.100665
Sunyi Ye Ph.D., Zhu Lixian M.D.

Background

Thyroid hormones are indispensable for organ development and maintaining homeostasis. Thyroid diseases, including thyroiditis and thyroid cancer, affect the normal secretion of hormones and result in thyroid dysfunction.

Objective

This review focuses on therapeutic applications of stem cells for thyroid diseases.

Methods

A literature search of Medline and PubMed was conducted (January 2000–July 2021) to identify recent reports on stem cell therapy for thyroid diseases.

Results

Stem cells are partially developed cell types. They have the capacity to form specialized cells. Besides embryonic stem cells and mesenchymal stem cells, organ resident stem cells and cancer stem cells are recently reported to have important roles in forming organ specific cells and cancers. Stem cells, especially mesenchymal stem cells, have anti-inflammatory and anticancer functions as well.

Conclusions

This review outlines the therapeutic potency of embryonic stem cells, mesenchymal stem cells, thyroid resident stem cells, and thyroid cancer stem cells in thyroid cells’ regeneration, thyroid function modulation, thyroiditis suppression, and antithyroid cancers. Stem cells represent a promising form of treatment for thyroid disorders.

甲状腺激素是器官发育和维持体内平衡不可或缺的激素。甲状腺疾病,包括甲状腺炎和甲状腺癌,影响激素的正常分泌,导致甲状腺功能障碍。目的综述干细胞在甲状腺疾病治疗中的应用。方法检索Medline和PubMed的文献(2000年1月至2021年7月),以确定干细胞治疗甲状腺疾病的最新报道。结果干细胞是部分发育的细胞类型。它们有能力形成专门的细胞。除了胚胎干细胞和间充质干细胞外,器官常驻干细胞和癌症干细胞在器官特异性细胞和癌症的形成中也有重要的作用。干细胞,尤其是间充质干细胞,具有抗炎和抗癌的功能。结论综述了胚胎干细胞、间充质干细胞、甲状腺常驻干细胞和甲状腺癌干细胞在甲状腺细胞再生、甲状腺功能调节、甲状腺炎抑制和抗甲状腺癌等方面的治疗作用。干细胞是治疗甲状腺疾病的一种很有前途的方法。
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引用次数: 2
Corrigendum to ``Protective Role of Sarpogrelate in Combination with Bromocriptine and Cabergoline for Treatment of Diabetes in Alloxan-induced Diabetic Rats'' [Current Therapeutic Research Volume 95, 2021, 100647] “sarpogreate联合溴隐亭和卡麦角林治疗四氧嘧啶诱导的糖尿病大鼠的保护作用”的勘误表[当前治疗研究卷95,2021,100647]
IF 1.9 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2022-01-01 DOI: 10.1016/j.curtheres.2022.100664
Mohammed Fouad Shalaby , Hekma A. Abd El Latif , Mohamed El Yamani , May Ahmed Galal , Sherifa Kamal , Ikhlas Sindi
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引用次数: 0
Patient Benefit of Clinical Research in Diversely Advanced African Developing Countries 不同发达非洲发展中国家临床研究的患者利益
IF 1.9 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2022-01-01 DOI: 10.1016/j.curtheres.2021.100656
Vanessa Strüver BA, MSc , Sheraz Ali PharmD, PhD Sch, MPH , Firas Fneish MSc , Gerhard Fortwengel BSc, MPH, PhD

Background

The globalization of clinical research should also benefit the population in developing markets. In this context, the approval of tested medicines and the associated expansion of medical care beyond clinical studies would be desirable as a possible long-term benefit.

Objectives

This study was designed to compare the development of the number of clinical trials with the number of marketing authorizations of medicines on the African continent. To contrast these 2 parameters, the data were analyzed using the model of an ecological study.

Methods

To reflect the broad spectrum of African developing countries with diverse levels of development, the data collection was based on 2 geographically selected sample countries each from Central, North, East, West, and Southern Africa. Based on the ClinicalTrials.gov registry, the first step was to collect trends data on the development of the clinical trials in the 10 selected countries of the country list of the African Region published by the World Health Organization for the period 2015 to 2018. Subsequently, data on the current number of marketing authorizations of medicines in the selected sample countries were identified using the online registries of the national authorities. The data were utilized in comparative analyses.

Results

Eight out of 10 model countries showed an increase in the number of clinical trials, with the exceptions of Cameroon and Libya, which showed an overall decline in research activity over the entire time. In direct comparison with drug registrations, the numbers indicate a similar development. The only exception here is Nigeria, a country with a solid performance in clinical research and yet a decrease in medicine registrations since 2015.

Conclusions

The expected increase in the development of clinical research as result of the globalization trend can basically be observed in most of the model countries. However, this increase does not guarantee an improvement in the number of medicine registrations. Although this is evident in some of the selected model countries, it cannot be projected to the entire African region. This may be linked to the diverse development of the individual countries due to the different political situations and the varying degrees of clinical research infrastructure. (Curr Ther Res Clin Exp. 2022; 82:XXX–XXX)

临床研究的全球化也应该使发展中市场的人口受益。在这种情况下,批准经试验的药物和相关的扩大临床研究以外的医疗保健将是可取的,这可能是一种长期利益。目的本研究旨在比较非洲大陆临床试验数量的发展与药物上市许可的数量。为了对比这两个参数,我们使用生态研究模型对数据进行了分析。方法为了反映具有不同发展水平的非洲发展中国家的广泛范围,数据收集基于中部、北部、东部、西部和南部非洲的2个地理上选择的样本国家。根据ClinicalTrials.gov注册表,第一步是收集2015年至2018年期间世界卫生组织公布的非洲区域国家名单中选定的10个国家开展临床试验的趋势数据。随后,利用国家主管部门的在线注册系统确定了选定样本国家当前药品上市许可数量的数据。这些数据被用于比较分析。结果在10个模式国家中,有8个国家的临床试验数量有所增加,但喀麦隆和利比亚除外,这两个国家的研究活动在整个时间内总体下降。与药品注册量直接比较,这些数字表明了类似的发展。唯一的例外是尼日利亚,这个国家在临床研究方面表现稳定,但自2015年以来药品注册数量有所下降。结论全球化趋势对临床研究发展的预期增长在大多数模式国家基本可以观察到。然而,这一增长并不能保证药品注册数量的改善。虽然这在一些选定的模范国家中是明显的,但它不能预测到整个非洲区域。这可能与各个国家由于不同的政治局势和不同程度的临床研究基础设施而导致的不同发展有关。(中国临床医学杂志,2022;82: XXX-XXX)
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引用次数: 1
A Post-Marketing Surveillance Study to Evaluate the Safety Profile of AlvotereⓇ (Docetaxel) in Iranian Patients Diagnosed with Different Types of Cancers Receiving Chemotherapy 一项评估AlvotereⓇ(多西紫杉醇)在接受化疗的伊朗不同类型癌症患者中的安全性的上市后监测研究
IF 1.9 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2022-01-01 DOI: 10.1016/j.curtheres.2021.100659
Farhad Shahi Associate Professor , Farahnaz Vafaeezadeh Post doctoral fellowship , Nafiseh Ansarinejad Associate Professor , Alireza Ahmadi Post doctoral fellowship , Ali Shahriari-Ahmadi Associate Professor , Alireza Ghazizadeh Associate Professor , Hassanali Vahedian Ardakani Associate Professor , Mohammad Reza Ravanbod Associate Professor , Sharareh Seifi Associate Professor , Mohammad Foratyazdi Associate Professor , Seyed Asadollah Mousavi Associate Professor , Mansour Rajabi Vahid Associate Professor , Hossein Rahimi Associate Professor , Mohammad Seghatoleslami Post doctoral fellowship , Seyed Mohsen Razavi Associate Professor , Amir Houshang Pourkhani Associate Professor , Davoud Babakhani Post doctoral fellowship , Nassim Anjidani Pharm. D.

Background

Docetaxel is a clinically well established antimitotic chemotherapy medication. Labeled docetaxel indications are breast cancer, gastric cancer, head and neck cancer, non–small cell lung cancer, and prostate cancer.

Objective

This is a Phase IV study to evaluate the safety profile of docetaxel (Alvotere; NanoAlvand, Iran) in Iranian patients diagnosed with different types of cancers receiving chemotherapy regimens with docetaxel.

Methods

Patients who received Alvotere as a part of their chemotherapy regimen were enrolled in this Phase IV, observational, multicenter, open-label study. Alvotere was administrated as a single agent or in combination with other chemotherapy agents. Safety parameters in each cycle were assessed, and the related data were recorded in booklets.

Findings

A total of 411 patients with different types of cancers were enrolled from 25 centers in Iran. The most common malignancies among participants were breast cancer (49.88%), followed by gastric cancer (22.63%). Participants’ mean age was 53.33 years, and the mean total dose used in each cycle was 132 mg. According to the results, 341 patients experienced at least 1 adverse event, that the most common was alopecia (41.12%). In total, 92 (22.38%) patients had at least 1 adverse event of grade 3 or 4, and 25 (6.08%) patients showed 54 serious adverse events, which the causality assessment for all was possibly related to Alvotere. There was a significant difference between men and women in the incidence of skin and subcutaneous tissue disorders (55.63% in women vs 41.73% in men; P = 0.009). Also, the incidence of gastrointestinal disorders, nervous system disorders, skin and subcutaneous tissue disorders, hepatic enzymes increase, and fluid retention was significantly higher (P < 0.05) in patients receiving anthracyclines in their chemotherapy regimens.

Conclusions

The findings of this open-label, observational, multicenter, postmarketing surveillance showed that Alvotere appears to have an acceptable safety profile in Iranian cancer patients receiving chemotherapeutic regimens. (Curr Ther Res Clin Exp. 2022; 82:XXX–XXX) © 2022 Elsevier HS Journals, Inc.

多西紫杉醇是临床公认的抗有丝分裂化疗药物。标记的多西他赛适应症包括乳腺癌、胃癌、头颈癌、非小细胞肺癌和前列腺癌。目的:这是一项评估多西他赛(Alvotere;NanoAlvand,伊朗)在接受多西紫杉醇化疗方案的不同类型癌症诊断的伊朗患者中。接受Alvotere作为化疗方案一部分的患者入组了这项IV期、多中心、开放标签的观察性研究。Alvotere作为单一药物或与其他化疗药物联合使用。评估每个周期的安全参数,并将相关数据记录在小册子中。来自伊朗25个中心的411名不同类型的癌症患者被纳入研究。参与者中最常见的恶性肿瘤是乳腺癌(49.88%),其次是胃癌(22.63%)。参与者的平均年龄为53.33岁,每个周期的平均总剂量为132 mg。结果显示,341例患者至少发生1次不良事件,其中最常见的是脱发(41.12%)。共有92例(22.38%)患者出现至少1个3级或4级不良事件,25例(6.08%)患者出现54个严重不良事件,其因果关系评价均可能与Alvotere相关。男性和女性在皮肤和皮下组织疾病的发生率上有显著差异(女性55.63% vs男性41.73%; = 0.009页)。此外,胃肠道疾病、神经系统疾病、皮肤和皮下组织疾病、肝酶增加和液体潴留的发生率显著升高(P <在化疗方案中接受蒽环类药物的患者中,0.05)。这项开放标签、观察性、多中心、上市后监测的结果表明,Alvotere在接受化疗方案的伊朗癌症患者中似乎具有可接受的安全性。(中国临床医学杂志,2022;82: XXX-XXX)©2022 Elsevier HS Journals, Inc。
{"title":"A Post-Marketing Surveillance Study to Evaluate the Safety Profile of AlvotereⓇ (Docetaxel) in Iranian Patients Diagnosed with Different Types of Cancers Receiving Chemotherapy","authors":"Farhad Shahi Associate Professor ,&nbsp;Farahnaz Vafaeezadeh Post doctoral fellowship ,&nbsp;Nafiseh Ansarinejad Associate Professor ,&nbsp;Alireza Ahmadi Post doctoral fellowship ,&nbsp;Ali Shahriari-Ahmadi Associate Professor ,&nbsp;Alireza Ghazizadeh Associate Professor ,&nbsp;Hassanali Vahedian Ardakani Associate Professor ,&nbsp;Mohammad Reza Ravanbod Associate Professor ,&nbsp;Sharareh Seifi Associate Professor ,&nbsp;Mohammad Foratyazdi Associate Professor ,&nbsp;Seyed Asadollah Mousavi Associate Professor ,&nbsp;Mansour Rajabi Vahid Associate Professor ,&nbsp;Hossein Rahimi Associate Professor ,&nbsp;Mohammad Seghatoleslami Post doctoral fellowship ,&nbsp;Seyed Mohsen Razavi Associate Professor ,&nbsp;Amir Houshang Pourkhani Associate Professor ,&nbsp;Davoud Babakhani Post doctoral fellowship ,&nbsp;Nassim Anjidani Pharm. D.","doi":"10.1016/j.curtheres.2021.100659","DOIUrl":"10.1016/j.curtheres.2021.100659","url":null,"abstract":"<div><h3>Background</h3><p>Docetaxel is a clinically well established antimitotic chemotherapy medication. Labeled docetaxel indications are breast cancer, gastric cancer, head and neck cancer, non–small cell lung cancer, and prostate cancer.</p></div><div><h3>Objective</h3><p>This is a Phase IV study to evaluate the safety profile of docetaxel (Alvotere; NanoAlvand, Iran) in Iranian patients diagnosed with different types of cancers receiving chemotherapy regimens with docetaxel.</p></div><div><h3>Methods</h3><p>Patients who received Alvotere as a part of their chemotherapy regimen were enrolled in this Phase IV, observational, multicenter, open-label study. Alvotere was administrated as a single agent or in combination with other chemotherapy agents. Safety parameters in each cycle were assessed, and the related data were recorded in booklets.</p></div><div><h3>Findings</h3><p>A total of 411 patients with different types of cancers were enrolled from 25 centers in Iran. The most common malignancies among participants were breast cancer (49.88%), followed by gastric cancer (22.63%). Participants’ mean age was 53.33 years, and the mean total dose used in each cycle was 132 mg. According to the results, 341 patients experienced at least 1 adverse event, that the most common was alopecia (41.12%). In total, 92 (22.38%) patients had at least 1 adverse event of grade 3 or 4, and 25 (6.08%) patients showed 54 serious adverse events, which the causality assessment for all was possibly related to Alvotere. There was a significant difference between men and women in the incidence of skin and subcutaneous tissue disorders (55.63% in women vs 41.73% in men; <em>P</em> = 0.009). Also, the incidence of gastrointestinal disorders, nervous system disorders, skin and subcutaneous tissue disorders, hepatic enzymes increase, and fluid retention was significantly higher (<em>P</em> &lt; 0.05) in patients receiving anthracyclines in their chemotherapy regimens.</p></div><div><h3>Conclusions</h3><p>The findings of this open-label, observational, multicenter, postmarketing surveillance showed that Alvotere appears to have an acceptable safety profile in Iranian cancer patients receiving chemotherapeutic regimens. (<em>Curr Ther Res Clin Exp</em>. 2022; 82:XXX–XXX) © 2022 Elsevier HS Journals, Inc.</p></div>","PeriodicalId":10920,"journal":{"name":"Current Therapeutic Research-clinical and Experimental","volume":"96 ","pages":"Article 100659"},"PeriodicalIF":1.9,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/a0/92/main.PMC8749121.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39825622","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 2
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Current Therapeutic Research-clinical and Experimental
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