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Reliability and feasibility of centralized monitoring approach in source data verification during clinical trials 集中监测方法在临床试验源数据验证中的可靠性和可行性
Pub Date : 2022-04-02 DOI: 10.37022/wjcmpr.v4i2.208
Mary Supriya G, Abhishekar M, B. B, Meghana Ch, P. P, S. B
As per ICH GCP, monitoring can be defined as “The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).” Clinical experiments are important for deeper understanding of how interventions work in humans. The aim of the monitoring of the clinical trial is to avoid errors that may compromise patient safety and results of the trial and enables more frequent monitoring of the integrity of the trial and could improve safety concerns by detecting errors earlier than expected. Risk-based monitoring in clinical trials is the process of identification, assessment, monitoring and mitigation of risks that could affect the quality or safety of a study. Centralized monitoring has a direct impact on the clinical trials. One of the most basic and fundamental need of centralized monitoring is to avoid the repetition in clinical trials, saving both time and Money. Central monitoring greatly influences the Patient safety, data integrity and monitoring costs in a clinical trial. This helps in increasing the effectiveness of the monitoring process reducing the burden on the sponsor. The basic and fundamental priority of a clinical trial is to ensure the safety and well-being of the subject. In this article, we will be focusing on how Centralized monitoring can increase the effectiveness and efficiency of the monitoring process and source data verification (SDV) in clinical trials with a special emphasis on Risk based monitoring (RBM)
根据ICH GCP,监测可以定义为“监督临床试验进展的行为,并确保其按照方案、标准操作程序(sop)、良好临床操作规范(GCP)和适用的监管要求进行、记录和报告。”临床实验对于深入了解干预措施如何在人体中起作用非常重要。临床试验监测的目的是避免可能危及患者安全和试验结果的错误,并能够更频繁地监测试验的完整性,并可以通过比预期更早地发现错误来改善安全问题。临床试验中基于风险的监测是识别、评估、监测和减轻可能影响研究质量或安全的风险的过程。集中监测对临床试验有直接影响。集中监测最基本、最根本的需求之一是避免临床试验的重复,节省时间和金钱。在临床试验中,集中监测对患者安全、数据完整性和监测成本有很大影响。这有助于提高监测过程的有效性,减轻发起人的负担。临床试验的基本和根本的优先事项是确保受试者的安全和健康。在本文中,我们将重点讨论集中监测如何提高临床试验中监测过程和源数据验证(SDV)的有效性和效率,并特别强调基于风险的监测(RBM)。
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引用次数: 0
Ethno-medicinal plant species used for animal and insect bite (sting) of vijayapur(bijapur) district of karnataka, India 印度卡纳塔克邦vijayapur(bijapur)地区用于动物和昆虫叮咬(刺痛)的民族药用植物物种
Pub Date : 2022-02-08 DOI: 10.37022/wjcmpr.v4i1.205
Laddimath Arati
An ethnomedicinal plant species survey of the Vijayapur district of Karnataka comprising thirteen talukas was conducted from March 2018 to July 2021.  The purpose of this survey was to document the Ethnomedicinal plant species used for animal and insect bites. The present study was initiated with an aim to identify Ethno-medicinal plant species resources from traditional practitioners of the Vijayapur district. There are about 21 plant species of angiosperms belonging to 20 genera and 15 families were found to be used as animal and insect bites.
2018年3月至2021年7月,对卡纳塔克邦Vijayapur地区进行了一项民族药用植物物种调查,其中包括13种taluka。本次调查的目的是记录用于动物和昆虫叮咬的民族药用植物物种。本研究的目的是鉴定维查亚普尔地区传统从业者的民族药用植物物种资源。已发现被子植物约21种,隶属于15科20属。
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引用次数: 0
Pharmacological profile of ficus thonningii: a review 刺榕的药理研究进展
Pub Date : 2021-12-08 DOI: 10.37022/wjcmpr.v3i6.206
Manisha, A. Singh, A. Singh
Ficus thonningii is an African ethnomedicine plant used to treat a number of diseases. The nutritional, phytochemical, and pharmacological aspects of F. thonningii in relation to its therapeutic purposes are numerous. Ficus thonningii contains alkaloids, terpenoids, flavonoids, tannins, active proteins, and active proteins. Continue to identify, isolate, and quantify the active ingredients, as well as their medicinal purposes. Chronic toxicity, toxicology, antineoplastic effects, acute toxicity, hypoglycemic effects, antidiarrheal effects, analgesic effects, anti-inflammatory effects, antioxidants, antifungal activity, antimicrobial effects, antiprotozoal properties etc.
无花果是一种非洲民族药植物,用于治疗许多疾病。在营养,植物化学和药理学方面,有关其治疗目的是无数的。无花果含有生物碱、萜类、黄酮类、单宁、活性蛋白和活性蛋白。继续鉴定、分离和量化有效成分及其药用用途。慢性毒性、毒理学、抗肿瘤作用、急性毒性、降糖作用、止泻作用、镇痛作用、抗炎作用、抗氧化作用、抗真菌活性、抗菌作用、抗原虫性质等。
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引用次数: 0
Formulation and evaluation of oral disintegrating tablets of furosemide 呋塞米口腔崩解片的研制及评价
Pub Date : 2021-12-07 DOI: 10.37022/wjcmpr.v3i6.200
M. Khadka, D. Khanal, Deeptipiya Baniya, Prakat Karki, S. Shrestha
Orally disintegrating tablets of Furosemide were prepared, evaluated and the comparison of the action of different concentrations of disintegrants on disintegration and dissolution of the tablets were studied. Direct compression method was used to prepare the orally disintegrating tablets containing 20 mg of Furosemide. The formulation was conducted using different concentrations of crospovidone, croscarmellose and sodium starch glycolate as superdisintegrants and their interactions with Furosemide were also evaluated using FTIR.  FTIR studies using the drug and its mixtures with the excipients showed that the peaks correlate with one another which signify that there is no interaction between the drug molecule and the excipients used. The obtained results revealed that the disintegration time of ODTs were between 9 to 59 seconds. The percentage drug content of tablets in all the formulations was found between 91.51% to 106.69%, which complies with the limits established in pharmacopoeia. The in-vitro dissolution studies show maximum release of 89.47% in formulation F3 and minimum of 77.64% in formulation F12. Higher concentration of crospovidone and croscarmellose in formulations F3 and F6 showed better dissolution properties than SSG. So by varying the concentrations of superdisintegrants, oral disintegrating tablets can be formulated.
制备了速尿口腔崩解片,对其进行了评价,并比较了不同崩解剂浓度对其崩解和溶出的影响。采用直接压片法制备含速尿20 mg口腔崩解片。采用不同浓度的交联维酮、交联棉糖和乙醇酸淀粉钠作为超崩解剂进行配方研究,并利用红外光谱(FTIR)评价其与速尿的相互作用。使用药物及其与辅料的混合物进行的FTIR研究表明,这些峰彼此相关,这表明药物分子与所用辅料之间没有相互作用。结果表明,ODTs的崩解时间在9 ~ 59秒之间。各制剂中片剂的药物含量在91.51% ~ 106.69%之间,符合药典规定。体外溶出度研究表明,F3的最大释放度为89.47%,F12的最小释放度为77.64%。F3和F6中较高浓度的交联维酮和交联棉糖比SSG具有更好的溶出性能。因此,通过改变超级崩解剂的浓度,可以配制出口服崩解片。
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引用次数: 1
a comparative analysis of canthal index of ekowe indigenes, bayelsa state 巴耶尔萨州埃科韦土著人的坎塔尔指数比较分析
Pub Date : 2021-12-07 DOI: 10.37022/wjcmpr.v3i6.204
T. R. Ogoun, Tobia P.S S, A. T. T
Human body parts are useful in the predictive study of the unknown. The aim of this study is to know the normative values of the canthi of the Ekowe people. Measurements such as inner and outer canthal distances were carried out. The mean value of the innercanthal distance for males and females are 3.55±0.58 and 3.43±0.52. The mean outer canthal distance for male and female is 13.91±0.84 and 13.62±0.76. The canthal index for male and female is 25.59±4.54 and 25.30±4.03. Sexual dimorphism exists and statistical significant difference was noticed in the outer canthal distance between the males and females (P˂0.05). This study has provided us with normative reference values of inner and outer canthal distances and canthal index for the Ekowe Population which is import to the health care givers, Anatomist, ophthalmic industry and anthropologist
人体部位在对未知事物的预测性研究中是有用的。本研究的目的是了解埃科威人的canthi的规范价值。测量了内眦和外眦的距离。男性和女性的内眦距离平均值分别为3.55±0.58和3.43±0.52。男性和女性的平均外眦距离分别为13.91±0.84和13.62±0.76。男性和女性的眦指数分别为25.59±4.54和25.30±4.03。性别二态性存在,雌雄外眦距离差异有统计学意义(P小于0.05)。本研究为埃科威人群的内、外眦距离和眦指数提供了规范的参考值,对卫生保健工作者、解剖学家、眼科行业和人类学家具有重要意义
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引用次数: 0
Pulmonary delivery of sirna for the treatment of cystic fibrosis and pulmonary delivery platforms 肺输送sirna治疗囊性纤维化及肺输送平台
Pub Date : 2021-12-06 DOI: 10.37022/wjcmpr.v3i6.202
Nensi Raytthatha, Isha Shah, Jigar Vyas
Cystic fibrosis (CF) is one of the most deadly diseases of lungs that involves symptoms such as breathing difficulties, coughing and lung infection. Despite important therapeutic advances, the definitive treatment for CF remains elusive. CF is a good candidate for gene therapy because it is relatively common, lethal and monogenic and it does not have adequate treatment options. In this review article, we have reviewed gene therapy as a potential treatment option for CF. Various platforms and strategies for pulmonary gene delivery have also been discussed in detail.
囊性纤维化(CF)是最致命的肺部疾病之一,其症状包括呼吸困难、咳嗽和肺部感染。尽管有重要的治疗进展,但CF的最终治疗仍然难以捉摸。CF是一个很好的基因治疗候选者,因为它是相对常见的,致命的和单基因的,它没有足够的治疗选择。在这篇综述文章中,我们回顾了基因治疗作为CF的潜在治疗选择,并详细讨论了肺基因传递的各种平台和策略。
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引用次数: 0
Phytochemical screening & in-vitro evaluation of anti-inflammatory activity of clerodendrum indicum roots 竹叶根的植物化学筛选及抗炎活性体外评价
Pub Date : 2021-11-28 DOI: 10.37022/wjcmpr.v3i6.201
S. M, L. S, M. A, Sailaja K.E
This study aims to extract the phytochemical constituents and in-vitro evaluation of   anti-inflammatory activity of roots of clerodendrum Indicum. Clerodendrum indicum (L.) kuntz. Commonly known as bharangi or chingari, belongs to the family verbenaceae. The plant is expectorant, stomachic, Anti-bronchitis, Anti-nociceptive, Anti-microbial, Anti-diarrheal, anti-oxidant and anti-cancer. Preliminary phytochemical screening revealed the presence of flavonoids, steroids, steroid glycosides, terpenoids etc. This study has taken with the Anti-inflammatory  activity and preliminary phytochemical screening on the clerodendrum indicum. In the present study, qualitative study of    the phytochemicals present in the sample was determined, Anti-inflammatory  activity  were carried out. On the premise of the prevailing study, the outcomes eventually concluded that the ethanolic extract of clerodendrum indicum own anti inflammatory pastime. This evaluation offers an concept that the compound of the plant clerodendrum indicum may be used as lead compound for designing robust pills which may be used for remedy of diverse diseases.
本研究的目的是提取籼米根的植物化学成分并对其抗炎活性进行体外评价。竹竹(L.)俗称马鞭草或chingari,属于马鞭草科。该植物具有祛痰、健胃、抗支气管炎、抗伤害、抗微生物、抗腹泻、抗氧化、抗癌等功效。初步的植物化学筛选显示,黄酮类化合物、类固醇、类固醇糖苷、萜类化合物等均存在。本研究对竹叶豆的抗炎活性进行了初步的植物化学筛选。在本研究中,对样品中存在的植物化学物质进行了定性研究,并进行了抗炎活性研究。在现有研究的前提下,本研究最终得出结论:竹叶乙醇提取物具有抗炎消炎作用。该评价为该植物化合物可作为先导化合物用于设计治疗多种疾病的强效丸剂提供了思路。
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引用次数: 1
Preventive effect of Macaranga barteri Mül Arg. (Euphorbiaceae) aqueous leaf extract on amiodarone induced non-alcoholic fatty liver disease in rats 黄芩的预防作用。(大戟科)叶水提取物对胺碘酮诱导大鼠非酒精性脂肪肝的影响
Pub Date : 2021-11-17 DOI: 10.37022/wjcmpr.v3i6.197
Nomane Bernard Goze, K. Léandre, N. OussouN’GuessanJean-BaptisteOussou, Ehile Ehile Herve, Koffi Kouassi Bah Abel, Y. Paul
Macaranga barteri is a plant used in traditional medicine to treat non-alcoholic fatty liver disease. However, its potential against hepatic steatosis has not been scientifically proven yet. This work aimed to investigate the preventive effect of the aqueous extract of Macaranga barteri leaves (AEMb) on hepatic steatosis experimentally induced with amiodarone in rats. 36 rats were divided into 6 groups of 6 rats each. Group 1, the non-intoxicated group and Group 2, used as controls were pretreated with distilled water (10 ml/kg b.w.). Group 3 received silymarin at 100 mg/kg b.w. while Groups 4, 5 and 6 were pretreated with AEMb at doses of 125, 250 and 500 mg/kg b.w. respectively. The weights of the rats were monitored during the experimentation. After 7 days of daily pretreatment with the different substances, rats of groups 2 to 6 were administered intraperitoneally amiodarone (200 mg/kg bw) three times daily for seven other consecutive days. At the end of the experiments, blood samples were collected on fasted and anesthetized rats kept in dried and EDTA tubes in order to assess some hematological and biochemical parameters and also rats livers were removed for gross observation and hepatic triglyceride assessment. The results revealed that AEMb and silymarin inhibited the weight loss induced by amiodarone and even favored weight gain. The reduction of heamatological indices (leukocytes and leukocyte indices, erythrocytes and erythrocyte indices (MCV, MCH and MCHC), hemoglobin, hematocrit and thrombocytes) by amiodarone was impeded in AEMb treated rats. AEMb significantly reduced (p <0.001) lipid profile parameters (plasma triglycerides, cholesterols (LDL, HDL and total)) augmented by amiodarone. Increased hepatic parameters (alkaline phosphatase, bilirubins (total and conjugated), transaminases (AST and ALT)) elicited by amiodarone were restored by AEMb pretreatment while decreased HDL values were normalized as well. Silymarin and AEMb also restored livers appearance and hepatic triglyceride. In conclusion, AEMb have a real preventive potential against amiodarone induced-hepatic steatosis in rats.
马龙果是一种在传统医学中用于治疗非酒精性脂肪肝的植物。然而,它对肝脂肪变性的潜在作用尚未得到科学证实。本研究旨在探讨黄芩叶水提物(AEMb)对胺碘酮诱导大鼠肝脂肪变性的预防作用。36只大鼠分为6组,每组6只。1组为未中毒组,2组为对照组,用蒸馏水(10 ml/kg b.w)预处理。3组水飞蓟素预处理剂量为100 mg/kg b.w., 4、5、6组AEMb预处理剂量分别为125、250、500 mg/kg b.w.。实验过程中监测大鼠体重。2 ~ 6组大鼠经不同物质每日预处理7 d后,每日3次腹腔注射胺碘酮(200 mg/kg bw),连续7 d。实验结束时,取空腹大鼠和麻醉大鼠的血样,保存在干燥和EDTA管中,以评估一些血液学和生化参数,并取大鼠肝脏进行大体观察和肝脏甘油三酯评估。结果表明,AEMb和水飞蓟素抑制胺碘酮引起的体重下降,甚至有利于体重增加。胺碘酮对AEMb处理大鼠血液学指标(白细胞和白细胞指数、红细胞和红细胞指数(MCV、MCH和MCHC)、血红蛋白、红细胞压积和血小板)的降低均有抑制作用。AEMb显著降低(p <0.001)胺碘酮增加的血脂参数(血浆甘油三酯、胆固醇(LDL、HDL和总胆固醇)。经AEMb预处理后,胺碘酮引起的肝脏参数(碱性磷酸酶、胆红素(总胆红素和结合胆红素)、转氨酶(AST和ALT))升高得到恢复,HDL值下降也得到恢复。水飞蓟素和AEMb也能恢复肝脏外观和肝脏甘油三酯。综上所述,AEMb对胺碘酮诱导的肝脂肪变性有一定的预防作用。
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引用次数: 0
Jatamansi (nardostachys jatamansi): insight of its morphological, Ethno-pharmacological and therapeutical aspect Jatamansi (nardostachys Jatamansi):其形态学,民族药理学和治疗方面的见解
Pub Date : 2021-10-16 DOI: 10.37022/WJCMPR.V3I5.194
E. Mohammad, A. Kushwaha
Plants have been use for the treatment, mitigation and cure of the disease since time immemorial. The natural recourses are considered as safe for human use. Ayurveda advocates the Jatamansi in various human ailments. In the present review article we tried to establish the morphological, ehno-pharmacological and therapeutic aspect of the Jatamansi. The various search engines like, Google scholar, EMBASE, pub med, pub med central are used to search the literary information and published article. We tried to put the facts that are demand of this article and explore the proficiency of the Jatamansi as panacea for various ailments.
自古以来,植物就被用于治疗、缓解和治愈这种疾病。这些自然资源被认为对人类使用是安全的。阿育吠陀在各种人类疾病中提倡Jatamansi。在本文中,我们试图从形态学、药理和治疗等方面对其进行综述。利用谷歌scholar、EMBASE、pub med、pub med central等搜索引擎进行文献信息和发表文章的检索。我们试图把这篇文章所需要的事实和探索的熟练的Jatamansi作为各种疾病的灵丹妙药。
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引用次数: 1
Tolvaptan to Achieving High Urine Output and Avoiding Hyponatremia in COVID-19 with ADHF Patient: Case Report 托伐普坦对COVID-19合并ADHF患者实现高尿量和避免低钠血症的作用:病例报告
Pub Date : 2021-10-08 DOI: 10.37022/WJCMPR.V3I5.195
I. Made, Bayu Puradipa, Cyndiana Widia, Dewi Sinardja
Background: Pandemic of Coronavirus Disease 2019 (COVID-19) is a world health problem, with rapidly growing infected subjects. Recently, hyponatremia has been found to be associated with increased morbidity and mortality in hospitalized patients with severe acute respiratory syndrome-Coronavirus 2 (SARS-COV2) pneumonia. On the other hand, Acute heart failure (AHF) is a leading cause of hospitalization and readmission in the US. The standard management of AHF is removing the fluid primarily with loop diuretics or ultrafiltration. Unfortunately, the loop diuretics could lead to electrolyte imbalance. Case Description: A Male 71 years old with confirmed COVID-19 came to emergency room with shortness of breath and history of coronary artery disease (CAD). Unfortunately, the infection leads patient to non-ST Elevation Myocardial Infarction (NSTEMI). During the treatment, patient down to acute decompensated heart failure (ADHF). The congestion did not respond to Furosemide 40mg intravenously and Spironolactone 25mg orally. Discussion: Arginine‑vasopressin (AVP) levels are elevated in heart failure. AVP acts via V2 cause fluid retention and hyponatremia. Aquaretic (i.e., Tolvaptan) are antagonists of AVP-2 receptors in the renal tubules to promote solute-free water clearance and correct hyponatremia. Conclusion: Important to avoid hyponatremia to prevent mortality and sepsis in patient COVID-19.
背景:2019冠状病毒病大流行(COVID-19)是一个全球性卫生问题,感染人数迅速增加。最近,已发现低钠血症与严重急性呼吸综合征-冠状病毒2 (SARS-COV2)肺炎住院患者发病率和死亡率增加有关。另一方面,急性心力衰竭(AHF)是美国住院和再入院的主要原因。AHF的标准处理是主要用利尿剂或超滤去除液体。不幸的是,循环利尿剂会导致电解质失衡。病例描述:男性,71岁,确诊COVID-19,呼吸急促,有冠状动脉疾病(CAD)病史。不幸的是,感染导致患者发生非st段抬高型心肌梗死(NSTEMI)。在治疗过程中,患者出现急性失代偿性心力衰竭(ADHF)。静脉滴注速尿40mg和口服螺内酯25mg对充血无反应。讨论:精氨酸-抗利尿激素(AVP)水平在心力衰竭时升高。AVP通过V2引起体液潴留和低钠血症。Aquaretic(即Tolvaptan)是肾小管中AVP-2受体的拮抗剂,可促进无溶质水的清除和纠正低钠血症。结论:预防低钠血症对预防COVID-19患者死亡和败血症具有重要意义。
{"title":"Tolvaptan to Achieving High Urine Output and Avoiding Hyponatremia in COVID-19 with ADHF Patient: Case Report","authors":"I. Made, Bayu Puradipa, Cyndiana Widia, Dewi Sinardja","doi":"10.37022/WJCMPR.V3I5.195","DOIUrl":"https://doi.org/10.37022/WJCMPR.V3I5.195","url":null,"abstract":"Background: Pandemic of Coronavirus Disease 2019 (COVID-19) is a world health problem, with rapidly growing infected subjects. Recently, hyponatremia has been found to be associated with increased morbidity and mortality in hospitalized patients with severe acute respiratory syndrome-Coronavirus 2 (SARS-COV2) pneumonia. On the other hand, Acute heart failure (AHF) is a leading cause of hospitalization and readmission in the US. The standard management of AHF is removing the fluid primarily with loop diuretics or ultrafiltration. Unfortunately, the loop diuretics could lead to electrolyte imbalance. \u0000Case Description: A Male 71 years old with confirmed COVID-19 came to emergency room with shortness of breath and history of coronary artery disease (CAD). Unfortunately, the infection leads patient to non-ST Elevation Myocardial Infarction (NSTEMI). During the treatment, patient down to acute decompensated heart failure (ADHF). The congestion did not respond to Furosemide 40mg intravenously and Spironolactone 25mg orally. \u0000Discussion: Arginine‑vasopressin (AVP) levels are elevated in heart failure. AVP acts via V2 cause fluid retention and hyponatremia. Aquaretic (i.e., Tolvaptan) are antagonists of AVP-2 receptors in the renal tubules to promote solute-free water clearance and correct hyponatremia. \u0000Conclusion: Important to avoid hyponatremia to prevent mortality and sepsis in patient COVID-19.","PeriodicalId":23642,"journal":{"name":"World Journal of Current Medical and Pharmaceutical Research","volume":"32 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79726570","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","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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World Journal of Current Medical and Pharmaceutical Research
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