Current Therapeutic Research-clinical and Experimental最新文献_第6页

Bioequivalence Study of Ibuprofen and Diphenhydramine Hydrochloride mini liquid-filled capsules: A Size Reduction Alternative 布洛芬与盐酸苯海拉明微型液体胶囊的生物等效性研究：缩小尺寸的选择

IF 1.6 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Current Therapeutic Research-clinical and Experimental

Pub Date : 2025-01-01 DOI: 10.1016/j.curtheres.2025.100779

David J. Wyatt , Mako Araga , Natali McCloskey , Richard Petruschke , Marianna Armogida MD

Background

Advil PM Liqui-Gels are widely used to improve the quality of life for individuals experiencing sleep disturbances due to pain. To accommodate those who have difficulty swallowing traditional capsules, Advil PM Liqui-Gels Minis, a smaller capsule variant containing the same composition (ibuprofen/diphenhydramine hydrochloride 200 mg/25 mg) as the original Advil PM Liqui-Gels, was developed as a more manageable alternative.

Objective

Establish the bioequivalence of new size-reduced Advil PM Liqui-Gels Minis (test) compared to the currently marketed Advil PM Liqui-Gels (reference) product under fasting conditions.

Method

This Phase I study was a randomized, open-label, two-treatment, two-sequence, two-period crossover trial. Subjects either received a single dose of test or reference product, separated by a 7-days washout period. Primary endpoints included PK parameters (C_max, AUC_0-t, AUC_0-inf) for ibuprofen and diphenhydramine. Secondary endpoints were t_max, t_1/2, Cl/F, V_z/F, and λ_Z. Safety assessments covered adverse events, lab results, and physical exams.

Results

Forty-four subjects were randomized, 42 completed both treatment periods for ibuprofen and 41 for diphenhydramine. The population was balanced in age, BMI, and gender, predominantly Hispanic/Latino. Mean C_max values for test and reference products were comparable, with a median t_max of 3 hours for diphenhydramine (both test and reference) and 1 hour (test) and 0.875 hour (reference) for ibuprofen. The geometric mean ratios (90% CI) for all pharmacokinetic (PK) parameters (AUC_0-t, AUC_0-inf, and C_max) were 99.15% (96.76–101.61), 99.20% (96.82–101.63) and 95.13% (88.31–102.47), respectively, for ibuprofen, and 102.62% (98.15–107.30), 102.73% (98.31–107.34), and 102.51% (93.54–112.35), respectively, for diphenhydramine. All values fell within the bioequivalence acceptance criteria of 80%–125%. No serious adverse events were reported, and subjects rated the ease of swallowing positively for both formulations.

Conclusion

The new Advil PM Liqui-Gels Minis formulation is bioequivalent to the marketed Advil PM Liqui-Gels. The smaller capsule size may offer a more convenient option for individuals with swallowing difficulties, without compromising the drug's efficacy or safety.

vil PM液体凝胶被广泛用于改善因疼痛而睡眠障碍的个人的生活质量。为了适应那些吞咽传统胶囊有困难的人，Advil PM液体凝胶Minis是一种更小的胶囊变体，含有与原始Advil PM液体凝胶相同的成分（布洛芬/盐酸苯海拉明200毫克/25毫克），是一种更易于管理的替代品。目的在禁食条件下，与目前上市的Advil PM liquid - gel（参比）产品相比，建立新的缩小尺寸Advil PM liquid - gel mini（试验）的生物等效性。方法本研究采用随机、开放标签、两治疗、两序列、两期交叉试验。受试者接受单剂量试验产品或参考产品，间隔7天洗脱期。主要终点包括布洛芬和苯海拉明的PK参数（Cmax, AUC0-t, AUC0-inf）。次要终点为tmax、t1/2、Cl/F、Vz/F和λZ。安全性评估包括不良事件、实验室结果和身体检查。结果随机抽取44例受试者，42例完成布洛芬治疗期，41例完成苯海拉明治疗期。人口在年龄、BMI和性别上是平衡的，主要是西班牙裔/拉丁裔。试验品和参比品的平均Cmax值具有可比性，苯海拉明（试验品和参比品）的tmax中位数为3小时，布洛芬（试验品）的tmax中位数为1小时，对照品为0.875小时。布洛芬各药代动力学参数AUC0-t、AUC0-inf和Cmax的几何平均比值（90% CI）分别为99.15%（96.76 ~ 101.61）、99.20%（96.82 ~ 101.63）和95.13%(88.31 ~ 102.47)，苯海拉明的几何平均比值（90% CI）分别为102.62%（98.15 ~ 107.30）、102.73%（98.31 ~ 107.34）和102.51%（93.54 ~ 112.35）。所有值均在80%-125%的生物等效性接受标准范围内。没有严重的不良事件报告，受试者对两种配方的吞咽容易度评价都是积极的。结论新制剂与市售Advil PM液体凝胶具有生物等效性。较小的胶囊尺寸可能为吞咽困难的个人提供更方便的选择，而不会影响药物的功效或安全性。

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引用次数: 0

Inhibition of Contractility of Isolated Caprine Detrusor by the Rho Kinase Inhibitor Fasudil and Reversal by the Guanylyl Cyclase Inhibitor ODQ Rho激酶抑制剂法舒地尔对离体羊逼尿肌收缩力的抑制和关酰环化酶抑制剂ODQ的逆转

IF 1.6 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Current Therapeutic Research-clinical and Experimental

Pub Date : 2025-01-01 DOI: 10.1016/j.curtheres.2025.100795

Niranjana Jeba Jeeviha MD, Aniket Kumar PhD, Rohini Ann Mathew MD, Silvia Joseph MD, Mohammed Haris MSc, Margaret Shanthi MD, Jacob Peedicayil MD

Background

Rho kinase (also called rho-associated protein kinase or ROCK), a serine/threonine kinase, is involved in muscle contractility since it phosphorylates myosin light chain phosphatase, hence inhibiting it. This leads to enhanced muscle contractility. Fasudil is an inhibitor of rho kinase that has been approved for the treatment of cerebral vasospasm in some Asian countries.

Objective

In this study, we tested the ability of fasudil to inhibit the contractility of the isolated caprine (goat) detrusor.

Methods

Twelve caprine detrusor strips were contracted using 80 mM KCl before and after the administration of 3 concentrations (10, 30, and 60 µM) of fasudil. Two reversal agents, the guanylyl cyclase inhibitor ODQ (10 µm) and the P2X receptor agonist diadenosine pentaphosphate (DAPP) (10 µM), were tested for their ability to reverse the inhibitory effect of fasudil on isolated detrusor contractility.

Results

Fasudil caused a dose-dependent inhibitory effect of KCl-induced detrusor contractility that was statistically significant at 30 and 60 µM concentrations. The inhibitory effect of 30 µM fasudil on detrusor contractility was significantly reversed by the addition of ODQ, but not by the addition of DAPP.

Conclusions

These results suggest that fasudil inhibits the contractility of the isolated detrusor. Fasudil could be investigated for use in clinical conditions such as overactive bladder that require detrusor muscle relaxation.

rho激酶（也称为rho相关蛋白激酶或ROCK）是一种丝氨酸/苏氨酸激酶，它使肌球蛋白轻链磷酸酶磷酸化，从而抑制肌球蛋白轻链磷酸酶，从而参与肌肉收缩。这可以增强肌肉的收缩力。法舒地尔是一种rho激酶抑制剂，在一些亚洲国家已被批准用于治疗脑血管痉挛。目的研究法舒地尔对离体山羊逼尿肌收缩力的抑制作用。方法法舒地尔给药前后分别用80 mM氯化钾收缩12条羊逼尿条。我们测试了两种逆转剂，即观乙酰环化酶抑制剂ODQ（10µm）和P2X受体激动剂二腺苷五磷酸（DAPP）（10µm），以逆转法舒地尔对离体逼尿肌收缩的抑制作用。结果法舒地尔对kcl诱导的逼尿肌收缩有剂量依赖性的抑制作用，在30和60µM浓度下具有统计学意义。30µM法舒地尔对逼尿肌收缩力的抑制作用被ODQ显著逆转，而不被DAPP逆转。结论法舒地尔能抑制离体逼尿肌的收缩力。法舒地尔可以研究用于临床条件，如膀胱过度活动，需要逼尿肌放松。

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引用次数: 0

Development of Biosimilar Aflibercept SDZ-AFL 生物仿制药afliberept SDZ-AFL的研制

IF 1.5 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Current Therapeutic Research-clinical and Experimental

Pub Date : 2025-01-01 DOI: 10.1016/j.curtheres.2025.100812

Francis Dodeller PhD , Peter Alliger PhD , Jens Heyn MD , Dragan Urosevic MD , Lisa Allmannsberger PhD , Cornelia Wersig PhD , Rufino Silva MD, PhD

<div><h3>Purpose</h3><div>Aflibercept is a recombinant fusion protein that binds with high affinity to vascular endothelial growth factor A (VEGF-A), and other growth factors, reducing pathological neovascularization and abnormal vascular permeability. Aflibercept is approved as a first-line treatment for several retinal diseases, including neovascular age-related macular degeneration (nAMD); however, the high costs of these biologic agents can impede patient access. In 2024, Sandoz biosimilar aflibercept (SDZ-AFL; SOK583A1, Enzeevu/Afqlir) was approved by the US Food and Drug Administration and the European Medicines Agency as a biosimilar of reference aflibercept (Ref-AFL; Eylea, a trademark of Bayer AG and in the US of Regeneron Pharmaceuticals, Inc) based on a comprehensive package of data.</div></div><div><h3>Methods</h3><div>This narrative review summarizes the totality of evidence demonstrating biosimilarity between SDZ-AFL and Ref-AFL, including physicochemical and biological characterization data from analytical in vitro studies, results of an ocular pharmacokinetic (PK) study in rabbits, and clinical efficacy, safety, immunogenicity, and systemic PK data from Phase III clinical studies.</div></div><div><h3>Results</h3><div>Analytical evaluation demonstrated that SDZ-AFL has structural homology with Ref-AFL, including identical amino acid sequences, indistinguishable higher-order structures, and highly similar levels of structural variants. SDZ-AFL and Ref-AFL also demonstrated highly similar in vitro biologic activities<em>,</em> including target binding affinity, and potency in terms of neutralization of VEGF-A. In a single-dose ocular PK study in rabbits, vitreal exposure was comparable between SDZ-AFL and Ref-AFL after intravitreal administration. A 52-week Phase III clinical study (Mylight) evaluated the efficacy, safety, immunogenicity, and systemic PK of SDZ-AFL and Ref-AFL in 484 participants with nAMD. The primary endpoint was mean change from baseline to week 8 in best corrected visual acuity (BCVA): the difference between the SDZ-AFL and Ref-AFL groups in this endpoint was –0.3 letters (90% CI −1.5 to 1.0), which met predefined bioequivalence margins. Secondary efficacy endpoints, including changes from baseline in BCVA and central subfield foveal thickness over the whole 52-week study, were also similar for SDZ-AFL and Ref-AFL. Two subsequent “in-use” studies confirmed the safe use of SDZ-AFL provided in either a vial kit or a prefilled syringe.</div></div><div><h3>Conclusion</h3><div>This comprehensive totality of evidence has established biosimilarity between SDZ-AFL and Ref-AFL based on comparable physicochemical and biological characteristics, as well as similarity in clinical efficacy, safety, and immunogenicity. The introduction of aflibercept biosimilars to the market is anticipated to reduce barriers to access, potentially increasing the number of appropriate patients with retinal diseases benefiting from this biologi

目的：aflibercept是一种重组融合蛋白，与血管内皮生长因子a （VEGF-A）和其他生长因子具有高亲和力，可减少病理性新生血管和异常血管通透性。afliberept被批准作为几种视网膜疾病的一线治疗药物，包括新生血管性年龄相关性黄斑变性（nAMD）；然而，这些生物制剂的高成本可能阻碍患者获得。2024年，山德士生物仿制药aflibercept （SDZ-AFL; SOK583A1, Enzeevu/Afqlir）被美国食品和药物管理局和欧洲药品管理局批准为参比生物仿制药aflibercept （Ref-AFL; Eylea，拜耳公司和美国Regeneron制药公司的商标）。方法本综述总结了SDZ-AFL和Ref-AFL生物相似性的所有证据，包括体外分析研究的理化和生物学特性数据、家兔眼药代动力学（PK）研究结果、临床疗效、安全性、免疫原性和III期临床研究的全身PK数据。结果分析评价表明，SDZ-AFL与Ref-AFL具有结构同源性，包括相同的氨基酸序列、难以区分的高阶结构和高度相似的结构变异水平。SDZ-AFL和Ref-AFL也表现出高度相似的体外生物活性，包括靶标结合亲和力和VEGF-A的中和效力。在兔单剂量眼PK研究中，SDZ-AFL和Ref-AFL在玻璃体内给药后的玻璃体暴露具有可比性。一项为期52周的III期临床研究（Mylight）在484名nAMD患者中评估了SDZ-AFL和reff - afl的有效性、安全性、免疫原性和全身PK。主要终点是最佳矫正视力（BCVA）从基线到第8周的平均变化：SDZ-AFL组和Ref-AFL组在该终点的差异为-0.3个字母（90% CI为- 1.5至1.0），符合预定的生物等效性界限。在整个52周的研究中，SDZ-AFL和Ref-AFL的次要疗效终点，包括BCVA和中央亚野中央凹厚度从基线的变化，也相似。随后的两项“使用中”研究证实了SDZ-AFL在小瓶试剂盒或预填充注射器中的安全使用。结论综合证据表明，SDZ-AFL与Ref-AFL在理化和生物学特性上具有相似性，在临床疗效、安全性、免疫原性等方面具有相似性。预计afliberept生物类似药的上市将减少准入障碍，可能会增加从这种生物疗法中受益的视网膜疾病患者的数量。

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引用次数: 0

Inhibitory effects of heat-killed lactic acid bacterium Enterococcus faecalis on the growth of Porphyromonas gingivalis 热处理杀死的乳酸菌粪肠球菌对牙龈卟啉单胞菌生长的抑制作用

IF 1.9 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Current Therapeutic Research-clinical and Experimental

Pub Date : 2024-02-01 DOI: 10.1016/j.curtheres.2024.100731

Tomoe Matsuo, Koji Nakao, Kosuke Hara

OBJECTIVES

The effects of heat-killed Enterococcus faecalis (HkEf), a lactic acid bacterium, on the growth of Porphyromonas gingivalis were evaluated in vitro by measuring the viable cell count of P. gingivalis and gingipain activity.

METHODS

HkEf solution (1.63 or 163 mg/mL) was added to 1 mL P. gingivalis culture to generate a final HkEf concentration of 0.64 or 64 mg/mL. The cultures were incubated anaerobically. The number of viable P. gingivalis cells and gingipain activity were measured after incubation for 0, 12, 24, 48, and 72 h. The number of viable P. gingivalis cells was calculated by counting the number of colonies after culture. Gingipain activity was quantified by adding a chromogenic substrate to P. gingivalis culture medium and measuring the absorbance of the reaction solution with a plate reader. Mean ± SE was calculated for viable cell counts and gingipain activity, and Wilcoxon rank sum test was used to test for significant differences.

RESULTS

The counts of viable P. gingivalis cells in the control group increased as incubation time progressed for 12, 24, 48, and 72 h; similar results were observed in the low-concentration HkEf group. In the high-concentration HkEf group, the increase in the viable cell count was significantly inhibited compared to that of the control group. Furthermore, gingipain activity in the low- and high-concentration HkEf groups was significantly inhibited over time compared to that of the control group. Although the pH of the culture solution tended to decrease in the high-concentration HkEf group, it was not considered to have affected the growth of P. gingivalis.

CONCLUSIONS

HkEf exhibits inhibitory effects on the growth of P. gingivalis and gingipain activity.

目的通过测量牙龈卟啉单胞菌的存活细胞数和龈肽酶活性，在体外评估热杀灭粪肠球菌（HkEf）（一种乳酸菌）对牙龈卟啉单胞菌生长的影响。方法将 HkEf 溶液（1.63 或 163 mg/mL）添加到 1 mL 牙龈卟啉单胞菌培养物中，以产生 0.64 或 64 mg/mL 的最终 HkEf 浓度。培养物进行厌氧培养。培养 0、12、24、48 和 72 小时后，测量存活的牙龈脓胞数量和龈肽酶活性。在牙龈脓胞培养基中加入发色底物，用平板阅读器测量反应溶液的吸光度，从而量化牙龈肽酶活性。结果对照组存活的牙龈脓胞数随着培养时间的延长而增加，分别为 12、24、48 和 72 h；低浓度 HkEf 组也观察到类似的结果。与对照组相比，高浓度 HkEf 组显著抑制了存活细胞数的增加。此外，与对照组相比，低浓度和高浓度 HkEf 组的gingipain 活性随着时间的推移受到明显抑制。虽然高浓度 HkEf 组培养液的 pH 值呈下降趋势，但这并不影响牙龈脓胞的生长。

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引用次数: 0

Acute Ischemic Stroke in a Patient with Multiple Sclerosis after Initiating Teriflunomide Treatment: A Challenging Case 一名多发性硬化症患者在接受特立氟胺治疗后发生急性缺血性中风：一个棘手的病例

IF 1.9 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Current Therapeutic Research-clinical and Experimental

Pub Date : 2024-01-01 DOI: 10.1016/j.curtheres.2024.100732

Arsh Haj Mohamad Ebrahim Ketabforoush MD , Armin Tajik MD , Mohammad Amin Habibi MD , Nahid Abbasi Khoshsirat MD

Multiple sclerosis is an autoimmune disease of the central nervous system, during which vascular events, including atherosclerosis, are more common and progress faster. Teriflunomide (TFN) is an oral drug that studies have indicated has low side effects alongside high efficiency. In this article, a middle-aged woman with multiple sclerosis was introduced, whose medication was changed to TFN. Thirty-five days later, she presented with focal neurologic symptoms, and investigations reported a lacunar infarction. Having excluded potential causes of acute ischemic stroke, such as vascular and rheumatologic factors, the only identifiable factor was the introduction of a new medication. The process of conclusively attributing TFN as the causative agent requires further clarification in future studies.

多发性硬化症是中枢神经系统的一种自身免疫性疾病，在这种疾病中，包括动脉粥样硬化在内的血管事件更为常见，进展也更快。特立氟胺（TFN）是一种口服药物，研究表明其副作用小、疗效好。本文介绍了一位患有多发性硬化症的中年女性，她的用药改为特立氟胺。35 天后，她出现了局灶性神经症状，检查报告显示为腔隙性梗死。在排除了急性缺血性中风的潜在病因（如血管和风湿病因素）后，唯一可确定的因素是引入了一种新药。将 TFN 确定为致病因素的过程需要在今后的研究中进一步澄清。

引用次数: 0

The Effects of Propolis Consumption on Body Composition and Blood Pressure: A Systematic Review and Dose-Response Meta-Analysis 食用蜂胶对身体成分和血压的影响：系统回顾与剂量反应荟萃分析

IF 1.6 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Current Therapeutic Research-clinical and Experimental

Pub Date : 2024-01-01 DOI: 10.1016/j.curtheres.2024.100754

Mahdi Vajdi Ph.D , Atefeh Bonyadian MSc , Fatemeh Pourteymour Fard Tabrizi Ph.D , Reza Hassanizadeh Ph.D , Nooshin Noshadi MSc , Beitullah Alipour Ph.D , Mahdieh Abbasalizad-Farhangi Ph.D , Melika Darzi MSc , Sahar Golpour-Hamedani Ph.D , Gholamreza Askari Ph.D

Introduction and Aim

Research on the effects of propolis consumption on body composition, and blood pressure (BP) has produced inconsistent results. This systematic review and dose-response meta-analysis was carried out to compile the data from the randomized controlled trials (RCTs) on how propolis supplementation affects body composition, and BP level in adults.

Materials and Methods

A systematic literature search was conducted using electronic databases, including PubMed, Embase, Scopus, Web of Science, and Cochrane library, up to January 2024. The RCTs, evaluating the effects of propolis consumption on weight, body mass index (BMI), waist circumference (WC), hip circumference (HC), waist-hip ratio (WHR), fat mass (FM), systolic BP (SBP), and diastolic BP (DBP), were included in the study. We used the random-effects model to establish the pooled effect size.

Results

A total of 22 RCTs involving 1082 participants were included in the study. Propolis supplementation demonstrated significant reductions in weight (weighted mean difference [WMD]: –0.37 kg; 95% confidence interval [CI]: –0.63 to –0.12), and BMI (WMD: –0.11 kg/m²; 95% CI: –0.13 to –0.09). However, there were no significant effects on WC, WHR, FM, HC, SBP, and DBP levels. The dose-response analysis revealed a significant nonlinear relationship between propolis dosage and WC (P = 0.020). Moreover, the BMI (P = 0.047) and WC (P = 0.004) reduction trend continues until 8 weeks of intervention and then this impact plateaued.

Conclusions

Supplementation with propolis seems to be effective in reducing weight and BMI. However, it should be noted that the anti-obesity properties of propolis supplementation were small and may not reach clinical importance. Therefore, future well-designed studies with a large sample size are needed to investigate the effect of propolis on body composition and BP in adults.

引言和目的关于食用蜂胶对身体成分和血压（BP）影响的研究结果并不一致。本系统综述和剂量反应荟萃分析汇编了有关补充蜂胶如何影响成人身体成分和血压水平的随机对照试验（RCTs）数据。研究纳入了评估食用蜂胶对体重、体重指数（BMI）、腰围（WC）、臀围（HC）、腰臀比（WHR）、脂肪量（FM）、收缩压（SBP）和舒张压（DBP）影响的研究性临床试验。我们使用随机效应模型确定了汇总效应大小。补充蜂胶可显著降低体重（加权平均差 [WMD]：-0.37 千克；95% 置信区间 [CI]：-0.63 至 -0.12）和 BMI（WMD：-0.11 千克/平方米；95% 置信区间 [CI]：-0.13 至 -0.09）。但是，对腹围、体重指数、FM、HC、SBP 和 DBP 水平没有明显影响。剂量-反应分析表明，蜂胶剂量与体重指数之间存在显著的非线性关系（P = 0.020）。此外，BMI（P = 0.047）和WC（P = 0.004）的下降趋势一直持续到干预8周，然后这种影响趋于平稳。然而，应该注意的是，补充蜂胶的抗肥胖作用很小，可能不会达到临床重要性。因此，今后需要进行设计合理、样本量大的研究，以探讨蜂胶对成年人身体成分和血压的影响。

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引用次数: 0

Immunogenicity and Potential for Intraocular Inflammation of Intravitreal Anti-VEGF Drugs 玻璃体内抗血管内皮生长因子药物的免疫原性和眼内炎症的可能性

IF 1.9 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Current Therapeutic Research-clinical and Experimental

Pub Date : 2024-01-01 DOI: 10.1016/j.curtheres.2024.100742

Hyeong Min Kim MD, MSc , Se Joon Woo MD, PhD

Background

Concerns of intraocular inflammation associated with intravitreal administration of anti-VEGF drugs have been risen and the exact mechanism is not yet elucidated.

Objective

To explore the relationship between immunogenicity and intraocular inflammation in intravitreal anti-VEGF drugs.

Methods

This review examines the immunogenicity of individual intravitreal anti-VEGF drugs and their potential link to intraocular inflammation.

Results

We suggest that the main cause of intraocular inflammation is the presence of pre-existing and treatment-induced antidrug antibodies, along with considerations related to the molecular structure, which includes the drug's format and size.

Conclusions

Researchers and clinicians involved in the advancement of new anti-VEGF drugs should take into consideration the factors related to intraocular inflammation that have been discussed.

目的探讨玻璃体内抗血管内皮生长因子药物的免疫原性与眼内炎症之间的关系。方法本综述研究了个别玻璃体内抗血管内皮生长因子药物的免疫原性及其与眼内炎症的潜在联系。结果我们认为，眼内炎症的主要原因是已有的和治疗诱导的抗药物抗体的存在，以及与分子结构有关的考虑因素，包括药物的形式和大小。

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引用次数: 0

Herbal Self-medication Practice for Coronavirus Disease 2019 in Sudan: A Public Survey, 2021 苏丹 2019 年冠状病毒病的草药自我治疗实践：2021 年公众调查

IF 1.6 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Current Therapeutic Research-clinical and Experimental

Pub Date : 2024-01-01 DOI: 10.1016/j.curtheres.2024.100761

Ahmad Izzoddeen MBBS, MSc, FETP , Mustafa Magbol MBBS , Safaa Fadlelmoula MBBS , Sabir Ali MBBS, MD , Wesam Yousif BSc , Mawada Abouzeid BSc , Alaa Hamed Dafaala BSc, MPH , Magam Musa BSc , Mohamed Hashim MBBS , Elfatih Malik MBBS, MD, FPH-UK

Background

The coronavirus disease 2019 (COVID-19) emerged in China in late 2019 with high rate of spread and transmission. As there was no recognized therapy many people worldwide used herbs in attempt to help their body overcome the disease.

Objective

This study aims to evaluate the use of herbs by patients with COVID-19 in Sudan and tries to identify a possible role in cure or lowering the severity of the illness.

Methods

A cross-sectional population-based online survey was done targeting those who experienced COVID-19 among Sudanese through an online internet-based questionnaire distributed on social media platforms (mainly Facebook and WhatsApp). Descriptive statistics used to summarize data and present it as frequency tables and graphs. Multivariate logistic regression was used to measure the association between independent variables (comorbidities and use of herbs) and the outcome variable reflecting the severity of the disease (hospitalization).

Results

A total of 204 responses received from COVID-19 former and active cases. Typical symptoms of the disease were identified: fever (68.1%), cough (52.7%), shortness of breathing (59.3%), sore throat (76.5%), and loss of smelling and/or taste (67.2%). All the respondents reported using traditional herbs or plants for cure with strong statement of their usefulness. Citrus plants such as lemon, orange, and grape fruits, were the commonest, used by 94%, followed by the local herbs, acacia (65%), ginger (56%), baobab fruit (46%), hibiscus (45%), black seed (45%), and cinnamon (17%). Other used plants included onion (29%) and garlic (24%). An adjusted analysis found that obesity was associated with higher hospital admission, while using herbs had no effect on hospital admission.

Conclusions

All participants reported the use of herbs for cure beside other treatment. The most commonly used herbs were citrus fruits followed by acacia and ginger and other herbs. All participants stated that herbs were useful for their recovery, however our analysis revealed no significant effect on rate of hospitalization. We recommend further deeper, well-designed study to better assess the effect of herbs.

背景2019年冠状病毒病（COVID-19）于2019年末在中国出现，传播速度快，传播范围广。本研究旨在评估苏丹 COVID-19 患者使用草药的情况，并试图确定草药在治愈或降低疾病严重程度方面可能发挥的作用。方法通过在社交媒体平台（主要是 Facebook 和 WhatsApp）上分发基于互联网的在线问卷，针对苏丹 COVID-19 患者开展了一项横断面人群在线调查。描述性统计用于总结数据，并以频数表和图表的形式呈现。多变量逻辑回归用于衡量自变量（合并症和使用草药）与反映疾病严重程度的结果变量（住院）之间的关联。典型的疾病症状包括：发烧（68.1%）、咳嗽（52.7%）、呼吸急促（59.3%）、喉咙痛（76.5%）、嗅觉和/或味觉丧失（67.2%）。所有受访者都表示使用传统草药或植物进行治疗，并强烈表示它们非常有用。最常见的是柑橘类植物，如柠檬、橙子和葡萄，使用率为 94%，其次是当地草药、金合欢（65%）、生姜（56%）、猴面包树（46%）、木槿（45%）、黑种子（45%）和肉桂（17%）。其他常用植物包括洋葱（29%）和大蒜（24%）。调整后的分析发现，肥胖与较高的入院率有关，而使用草药对入院率没有影响。最常用的草药是柑橘类水果，其次是金合欢、生姜和其他草药。所有参与者都表示草药对他们的康复很有帮助，但我们的分析表明，草药对住院率没有显著影响。我们建议进一步开展更深入、设计更合理的研究，以更好地评估草药的效果。

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引用次数: 0

Clinical Performance and Safety of Cerviron® Vaginal Ovules in the Management of Symptomatic Cervical Lesions: A National, Multicentric Study Cerviron®阴道胚珠治疗症状性宫颈病变的临床表现和安全性：一项全国性、多中心研究

IF 1.6 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Current Therapeutic Research-clinical and Experimental

Pub Date : 2024-01-01 DOI: 10.1016/j.curtheres.2024.100762

Izabella Petre Ph.D, MD , Daniela Oana Toader Ph.D, MD , Ramona Petrita PharmD, MS , Alexandru-Remus Pinta PharmD, MS , Andreea-Anda Alexa Ph.D , Romina Georgiana Bita Ph.D, MD

Background

Cervical ectropion is frequently associated with vaginal symptoms requiring therapeutic intervention. However, no scientific consensus has been reached regarding the use of local re-epithelialization therapy to prevent severe bleeding, wound inflammation, and infection of cervical lesions.

Objective

The aim of our study was to investigate the aspect of the cervix by colposcopy after a 3-month treatment with an intravaginal medical device in the context of postoperative care of the symptomatic ectropion. The study analyzed additional clinical parameters, such as the evolution of primary and secondary inflammation and the degree of cervical epithelialization as secondary objectives.

Methods

Our pilot study included 27 participants with symptomatic cervical ectopy, with or without an associated human papillomavirus infection. The treatment protocol consisted of the monthly delivery of the medical device intravaginally, during day 1 to day 15, with a total study duration of 3 months.

Results

The medical device had a positive impact on cervical epithelialization, in terms of aspect of the cervix returning to normal for 100% of the participants. Between study visits, it was observed that primary inflammation was reduced by 85.19%, whereas vaginal ulceration, colpitis, and leukorrhea were improved by 70.37%, 81.48%, and by 66.67%, respectively.

Conclusions

The degree of cervical epithelialization reflects how well the cervix has healed after an injury or infection. The device showed clinical performance in complete re-epithelialization after surgical procedures. Moreover, our study findings suggest that supportive treatment with this intravaginal medical device can be recommended for cervical wound healing in patients with human papillomavirus infection. ClinicalTrials.gov identifier: NCT04735718.

背景：宫颈外翻常与阴道症状相关，需要治疗干预。然而，关于使用局部再上皮化治疗来预防严重出血、伤口炎症和宫颈病变感染，尚未达成科学共识。目的：本研究的目的是探讨阴道内医疗器械治疗3个月后阴道镜对症状性外翻的护理。该研究分析了其他临床参数，如原发性和继发性炎症的演变以及宫颈上皮化程度作为次要目标。方法：我们的初步研究包括27名有症状的宫颈异位，伴有或不伴有相关的人乳头瘤病毒感染的参与者。治疗方案包括每月在第1天至第15天阴道内给药，总研究时间为3个月。结果：医疗器械对宫颈上皮化有积极的影响，100%的参与者宫颈恢复正常。在两次研究访问之间，观察到原发性炎症减少了85.19%，而阴道溃疡、阴道炎和白带分别改善了70.37%、81.48%和66.67%。结论：宫颈上皮化程度反映了损伤或感染后宫颈的愈合程度。该装置在外科手术后完全再上皮化方面表现出临床性能。此外，我们的研究结果表明，可以推荐使用这种阴道内医疗设备进行支持治疗，用于人乳头瘤病毒感染患者的宫颈伤口愈合。ClinicalTrials.gov识别码：NCT04735718。

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引用次数: 0

Impact of Magnesium Supplementation on Blood Pressure: An Umbrella Meta-Analysis of Randomized Controlled Trials 补充镁对血压的影响：随机对照试验的总括性元分析

IF 1.6 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Current Therapeutic Research-clinical and Experimental

Pub Date : 2024-01-01 DOI: 10.1016/j.curtheres.2024.100755

Abdullah M Alharran , Mooza M Alzayed , Parsa Jamilian , Kousalya Prabahar , Aminah Hassan Kamal , Muteb N Alotaibi , Omar E Elshaer , Mshal Alhatm , Mohd Diya Masmoum , Benjamin Hernández-Wolters , Raghad Sindi , Hamed Kord-Varkaneh , Ahmed Abu-Zaid

Background and aim

Conflicting results on the effect of magnesium supplementation on blood pressure have been published in previous meta-analyses; hence, we conducted this umbrella meta-analysis of RCTs to provide a more robust conclusion on its effects.

Methods

Four databases including PubMed, Scopus, EMBASE, and Web of Science were searched to find pertinent papers published on international scientific from inception up to July 15, 2024. We utilized STATA version 17.0 to carry out all statistical analyses (Stata Corporation, College Station, TX, US). The random effects model was used to calculate the overall effect size ES and CI.

Findings

Ten eligible review papers with 8610 participants studied the influence of magnesium on SBP and DBP. The pooling of their effect sizes resulted in a significant reduction of SBP (ES = -1.25 mmHg; 95% CI: -1.98, -0.51, P = 0.001) and DBP (ES = -1.40 mmHg; 95% CI: -2.04, -0.75, P = 0.000) by magnesium supplementation. In subgroup analysis, a significant reduction in SBP and DBP was observed in magnesium intervention with dosage ≥400 mg/day (ES for SBP = -6.38 mmHg; ES for DBP = -3.71mmHg), as well as in studies with a treatment duration of ≥12 weeks (ES for SBP = -0.42 mmHg; ES for DBP = -0.45 mmHg).

Implications

The findings of the present umbrella meta-analysis showed an overall decrease of SBP and DBP with magnesium supplementation, particularly at doses of ≥400 mg/day for ≥12 weeks.

背景和目的在以往的荟萃分析中，关于补充镁对血压的影响曾出现过相互矛盾的结果；因此，我们对 RCTs 进行了这项总括荟萃分析，以便为其效果提供更可靠的结论。方法检索了 PubMed、Scopus、EMBASE 和 Web of Science 等四个数据库，以查找从开始到 2024 年 7 月 15 日期间发表的国际科学论文。我们使用 STATA 17.0 版进行了所有统计分析（Stata Corporation，College Station，Texas，US）。研究结果10篇符合条件的综述性论文共有8610名参与者，研究了镁对SBP和DBP的影响。汇总这些论文的效应大小后发现，补充镁可显著降低 SBP（ES = -1.25 mmHg；95% CI：-1.98, -0.51，P = 0.001）和 DBP（ES = -1.40 mmHg；95% CI：-2.04, -0.75，P = 0.000）。在亚组分析中，观察到剂量≥400 毫克/天的镁干预可显著降低 SBP 和 DBP（SBP 的 ES = -6.38 mmHg；DBP 的 ES = -3.71mmHg），治疗持续时间≥12 周的研究也是如此（SBP 的 ES = -0.本总括荟萃分析的结果表明，补充镁后 SBP 和 DBP 总体下降，尤其是剂量≥400 毫克/天且持续时间≥12 周时。

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引用次数: 0