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  • 文章类型: Journal Article
    背景:我们重点研究使用大隐静脉的冠状动脉旁路移植术,并比较了无接触大隐静脉和常规大隐静脉。方法2007/04至2022/08年在我院进行了15年的大隐静脉冠状动脉旁路移植术。主要终点是出院时大隐静脉的通畅,次要终点是大隐静脉收获伤口的延迟愈合,中胸伤口延迟愈合,与冠状动脉搭桥手术相关的因素。结果183例患者采用大隐静脉行冠状动脉搭桥手术。有131名男性患者(72%)和52名女性患者(28%),平均年龄为69岁(38-94岁)。大隐静脉的采集方法为无接触大隐静脉移植物(NT-SVG)29例(16%),常规SVG154例(84%)。将患者分为两组:NT-SVG组和标准收集隐静脉移植(SVG)组。我们比较了出院时的移植物通畅性,小腿伤口愈合失败,中胸伤口愈合失败,和通过传输时间流量测量(TTFM)的流量。结论本研究中NT-SVG组和常规SVG组的围手术期结局无明显差异。
    Background We focused on coronary artery bypass grafting using the great saphenous vein and compared the no-touch great saphenous vein and conventional great saphenous vein. Methods Coronary artery bypass grafting using the great saphenous vein was performed at our hospital over a 15-year period from 2007/04 to 2022/08. The primary endpoint was the patency of the great saphenous vein at discharge, and secondary endpoints were delayed healing of the great saphenous vein harvest wound, delayed healing of the mid-thoracic wound, and factors related to coronary artery bypass surgery. Results There were 183 patients who underwent coronary artery bypass surgery using the great saphenous vein during the study period. There were 131 male patients (72%) and 52 female patients (28%) with a mean age of 69 years (38-94 years). The method of harvesting the great saphenous vein was a no-touch great saphenous vein graft (NT-SVG) in 29 cases (16%) and conventional SVG in 154 cases (84%). Patients were divided into two groups: the NT-SVG group and the standard-collection saphenous vein graft (SVG) group. We compared graft patency at discharge, healing failure of the lower leg wound, healing failure of the mid-thoracic wound, and flow by transit-time flow measurement (TTFM). Conclusion There were no significant differences in perioperative outcomes between the NT-SVG and conventional SVG groups in this study.
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  • 文章类型: Journal Article
    目的:本研究的目的是确定成人卵圆孔未闭(PFO)患者的心电图(ECG)特征,并分析其对成人PFO的预测价值。
    方法:回顾,267名接受过心电图检查的患者,经胸超声心动图(TTE),经食管超声心动图(TEE)与激动性盐水超声心动图,从2021年1月到2023年3月连续招募。分析心电图以研究右束支传导阻滞(RBBB)和R波的存在。
    结果:PFO患者下导联R波的比率为45.3%,无PFO患者为21.2%。有17例(6.4%)患者中R波和RBBB共存,包括13例(6.5%)PFO患者和4例(6.1%)无PFO患者。TTE的准确性,crochetageR波,RBBB分别为0.637、0.535和0.314。crochetageR波和RBBB的组合显示出0.507的灵敏度和0.758的特异性。当TTE,crochetageR波,和RBBB合并,准确性,灵敏度,特异性,正预测值,阴性预测值分别为0.712、0.801、0.439、0.813和0.420。Logistic回归分析显示PFO与R波的存在(比值比[OR]:3.073,95%置信区间[CI]:1.601-5.899,p<0.001),以及R波和RBBB之间的组合(OR:3.220,95%CI:1.720-6.028,p<0.001)。
    结论:心电图中的交叉R波与PFO相关。CrochetageR波,特别是结合RBBB和TTE,可能有助于PFO患者的早期发现。
    OBJECTIVE: The objective of this study was to identify the characteristics of electrocardiogram (ECG) in adult patients with patent foramen ovale (PFO) and to analyze the predictive value of the characteristics of ECG for PFO in adult patients.
    METHODS: Retrospectively, 267 patients who had undergone ECG, transthoracic echocardiography (TTE), transesophageal echocardiography (TEE) with agitated saline contrast echocardiography in our hospital, were recruited continuously from January 2021 to March 2023. Electrocardiographs were analyzed to investigate the presence of right bundle branch block (RBBB) and crochetage R wave.
    RESULTS: The ratio of crochetage R wave in inferior leads in patients with PFO was 45.3% and 21.2% without PFO. There were 17 (6.4%) patients with coexistence of crochetage R wave and RBBB, including 13 (6.5%) patients with PFO and four (6.1%) patients without PFO. The accuracies of TTE, crochetage R wave, and RBBB were 0.637, 0.535, and 0.314, respectively. A combination of crochetage R wave and RBBB demonstrated a sensitivity of 0.507 and a specificity of 0.758. When TTE, crochetage R wave, and RBBB were combined, the accuracy, sensitivity, specificity, positive predictive value, and negative predictive value were 0.712, 0.801, 0.439, 0.813, and 0.420, respectively. Logistic regression analysis revealed a correlation between PFO and the presence of crochetage R wave (odds ratio [OR]: 3.073, 95% confidence interval [CI]: 1.601-5.899, p < 0.001), and also a combination between crochetage R wave and RBBB (OR: 3.220, 95% CI: 1.720-6.028, p < 0.001).
    CONCLUSIONS: Crochetage R wave in ECG was associated with PFO. Crochetage R wave, especially combined with RBBB and TTE, may be helpful in the early detection of patients with PFO.
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  • 文章类型: Journal Article
    背景:知识产权(IPRs)对于当今知识型社会的可持续增长越来越重要。关于知识产权的不当知识可能无法为自己的智力创造保留权利。因此,这项研究的目的是评估知识,意识,以及在Belagavi市的医疗保健专业人员中有关印度知识产权的做法。
    方法:在Belagavi的六个医疗保健专业机构的研究生和教职员工中进行了描述性横断面研究,卡纳塔克邦.使用方便的采样记录总共724个响应。数据是使用自我管理的验证问卷收集的,其中包括人口统计细节和总共20个与知识有关的问题,意识,和知识产权方面的做法。使用两点李克特量表。描述性统计,Mann-WhitneyU-test,采用卡方检验。
    结果:共记录了724个反应,411名研究生和313名来自6个医疗保健专业机构的教师。据观察,24.3%和39.3%的研究生和教师参与者,分别,拥有最大的知识,而35.5%的教师和27.5%的研究生对印度的知识产权有最大的认识。只有17.6%和10.2%的教师和研究生以前参加过知识产权研讨会。
    结论:本研究发现,医疗保健专业的教师和研究生对知识产权的了解和认识都较少。然而,与研究生相比,教师对知识产权的知识和意识都更好。因此,学术界需要对印度的知识产权进行更高水平的宣传和接触。
    BACKGROUND: Intellectual property rights (IPRs) are increasingly becoming significant for sustainable growth of today\'s knowledge-based society. An inappropriate knowledge regarding IPR can fail to reserve rights for one\'s intellectual creation. Hence this study was planned with an aim to assess knowledge, awareness, and practices regarding intellectual property rights in India amongst the health-care professionals in Belagavi city.
    METHODS: A descriptive cross-sectional study was conducted among the postgraduate students and faculty of six health-care professional institutions in Belagavi, Karnataka. A total of 724 responses were recorded using convenient sampling. Data was collected using self-administered validated questionnaire which included demographic details and total 20 questions pertaining to knowledge, awareness, and practices regarding IPR. Two-point Likert scale was used. Descriptive statistics, Mann-Whitney U-test, and Chi-square test were applied.
    RESULTS: A total of 724 responses were recorded, 411 from postgraduate students and 313 from faculty of 6 health-care professional institutions. It was observed that 24.3% and 39.3% of postgraduate students and faculty participants, respectively, had maximum knowledge while 35.5% of faculty and 27.5% of postgraduate students had maximum awareness regarding IPR in India. Only 17.6% and 10.2% of faculty and postgraduate students had previously attended workshops on IPR.
    CONCLUSIONS: The present study identified that both faculty and postgraduate students of health-care profession have less knowledge and awareness regarding IPR. However, both knowledge and awareness regarding IPR were better among faculty when compared to postgraduate students. Thus, the academic community requires a higher level of sensitization and exposure to IPR in India.
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  • 文章类型: Journal Article
    未经批准:多年来,静脉消炎痛已在婴儿中用作动脉导管的药物闭合,但是发病率,风险,吲哚美辛治疗婴儿急性肾损伤(AKI)的危险因素,仍然稀缺。
    未经评估:要确定发病率,风险,与匹配的未暴露婴儿相比,吲哚美辛(暴露组)治疗动脉导管未闭(PDA)的婴儿发生AKI的危险因素。
    UNASSIGNED:对2003年1月至2018年12月在宋卡兰加林德医院新生儿重症监护病房住院的婴儿进行了一项匹配的回顾性队列研究。所有数据均从计算机病历中收集。未暴露的婴儿通过胎龄和出生体重与每个暴露的婴儿相匹配(1:1)。AKI,兴趣的结果,根据新生儿AKI定义诊断。估计各组的AKI发生率(95%CI)。使用条件逻辑回归来估计接受消炎痛的人与未接受消炎痛的人发生AKI的比值比(OR)。调整潜在的混杂因素(伴随使用的肾毒性潜在药物,包括氨基糖苷类,两性霉素B,万古霉素,呋塞米,全身性皮质类固醇,和全身性血管加压药和肌动蛋白)。进行Kaplan-Meier估计以检查AKI事件后从AKI恢复的概率。
    UNASSIGNED:匹配导致193对暴露和非暴露婴儿。暴露组和非暴露组的AKI发生率[95%CI],分别为33.7%[27.0%:40.4%]和15.5%[10.4%:20.7%],分别。吲哚美辛在统计学上增加发生AKI的风险,原油OR2.94[95CI1.77:4.90],McNemar的卡方p<0.001,调整后OR为2.73[95CI1.55:4.80],p=0.001。与潜在肾毒性药物相关的AKI风险尚无定论。从AKI恢复的时间相对较快,两组的中位恢复时间均为3天,所有发生AKI的婴儿均在6天内恢复.
    UNASSIGNED:使用吲哚美辛封堵PDA的婴儿中AKI的发生率是未暴露于吲哚美辛的婴儿的两倍。吲哚美辛显著增加AKI的风险,而与其他伴随的肾毒性药物相关的风险尚无定论。与吲哚美辛相关的短暂肾毒性应与延迟PDA关闭相关的风险相平衡。所有接受吲哚美辛的婴儿应常规监测血清肌酐和/或尿量,在整个治疗过程中以及治疗停止后一到两周。在AKI风险较高的人群中,应考虑肾脏安全性较好的替代方案。
    UNASSIGNED: Intravenous indomethacin has been used in infants for many years as the pharmacological closure of ductus arteriosus, but the incidence, risk, and risk factors of acute kidney injury (AKI) among infants treated with indomethacin, were still scarce.
    UNASSIGNED: To determine the incidence, risk, and risk factors of AKI among infants treated with indomethacin (exposed group) for patent ductus arteriosus (PDA) closure compared with the matched non-exposed infants.
    UNASSIGNED: A matched retrospective cohort study of infants admitted to the neonatal intensive care unit of Songklanagarind Hospital from January 2003 to December 2018 was performed. All data were collected from computerized medical records. A non-exposed infant was matched (1:1) by gestational age and birth weight to each exposed infant. AKI, the outcome of interest, was diagnosed according to neonatal AKI definitions. The incidence (95% CI) of AKI was estimated for each group. Conditional logistic regression was used to estimate the odds ratio (OR) of developing AKI among those who received indomethacin compared with those who did not, adjusted for potential confounders (concomitantly used nephrotoxic potential medications including aminoglycosides, amphotericin B, vancomycin, furosemide, systemic corticosteroids, and systemic vasopressors and inotropes). Kaplan-Meier estimate was performed to examine probability of recovery from AKI after AKI events.
    UNASSIGNED: The matching resulted in 193 pairs of exposed and non-exposed infants. The incidences [95% CI] of AKI in the exposed and the non-exposed group, were 33.7% [27.0%:40.4%] and 15.5% [10.4%:20.7%], respectively. Indomethacin statistically increased the risk for developing AKI, crude OR 2.94[95%CI 1.77:4.90], McNemar\'s chi square p<0.001, and adjusted OR 2.73 [95%CI 1.55:4.80], p=0.001. The risk of AKI associated with potentially nephrotoxic medications were inconclusive. Time to recovery from AKI was relatively rapid, median recovery time was 3 days in both groups and all infants who developed AKI recovered within 6 days.
    UNASSIGNED: The incidence of AKI among infants treated with indomethacin for PDA closure were doubled that in the indomethacin-nonexposed infants. Indomethacin significantly increased the risk of AKI, while the risk associated with other concomitant nephrotoxic medications were inconclusive. Transient nephrotoxicity associated with indomethacin should be balanced with the risk associated with delayed PDA closure. All infants receiving indomethacin should be routinely monitored for serum creatinine and/or urine output, throughout the treatment and one to two weeks after treatment cessation. Alternatives with better renal safety profiles should be considered in the population with higher risk of AKI.
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  • 文章类型: Journal Article
    BACKGROUND: The pharmaceutical industry is heavily regulated. Partly for this reason, new drugs generally take over 10 years from the product development stage to market entry. Although regulations affect the pharmaceutical industry over a long period, previous studies investigating the impact of new regulatory policies have usually focused on the short period before and after implementing that policy. Therefore, the purpose of this study is to examine whether and how significantly regulatory policies affect long-term innovation in the pharmaceutical industry in Korea.
    METHODS: This study focused on three significant regulatory policies: the introduction of the product patent system, changes in the Good Manufacturing Practice (GMP) system, and the Drug Expenditure Rationalization Plan (DERP). The study used interrupted time series (ITS) analysis to investigate the long-term impacts of the policies before and after implementation.
    RESULTS: Our results show that introducing the product patent system in 1987 significantly increased the number of Korean patent applications. The effect of the revised GMP policies was also statistically significant, both before and after implementation and between pre-emptive companies and non-pre-emptive ones. However, due to the companies\' negotiations with the regulatory authorities or the regulatory system that links drug approval and price evaluation, the DERP did not significantly delay new drug registration in Korea.
    CONCLUSIONS: This study showed that the policies of the product patent system, GMP policies, and DERP regulations have significantly encouraged pharmaceutical companies to strive to meet regulatory requirements and promote innovation in Korea. The study suggests that it is necessary for companies to pre-emptively respond to systemic changes in development and production strategies to deal with regulatory changes and achieve sustainable growth. Also, our study results indicate that since government policies motivate the innovative system of the pharmaceutical industry, governmental authorities, when formulating pharmaceutical policies, need to consider the impact on the long-term innovation of the industry.
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  • 文章类型: Journal Article
    UNASSIGNED: Patent ductus arteriosus (PDA) is one of the more common congenital heart defects in preterm neonates. The closure of PDA can be done with ibuprofen; however, this drug is associated with many contraindications and potential side-effects. In the past years, paracetamol has been proposed for the treatment of PDA. This study was designed to evaluate the efficacy and gastrointestinal complications of paracetamol and ibuprofen for the pharmacological closure of PDA in preterm infants.
    UNASSIGNED: In a clinical trial study, 40 preterm infants with echocardiographically confirmed PDA were randomly assigned to receive either paracetamol (n = 23; 15 mg/kg every 6 h for 2 days) or ibuprofen (n = 17; initial dose of 10 mg/kg, followed by 5 mg/kg every 12 h for 2 days). The neonates matched for gestational age and weight. We used t-test for parametric, Chi-square for categorial, and Wilcoxson for nonparametric variables. Significant level was considered less than 0.05.
    UNASSIGNED: Platelet count, BUN and creatinine levels, and closure of PDA had not significant difference between two groups (P > 0.05). Incidence and severity of GI bleeding, feeding intolerance, and NEC were significantly more in infants who received paracetamol than ibuprofen (P < 0.05).
    UNASSIGNED: There were no differences in the rate of PDA closure between the two drugs, but with respect to complications, rate and severity of GI bleeding, feeding intolerance, and NEC were significantly more in infants who received paracetamol than ibuprofen. Therefore, paracetamol could not be used as a proper alternative agent for ibuprofen in the treatment of PDA in preterm infants.
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  • 文章类型: Journal Article
    The efficacy of patent foramen ovale (PFO) closure to reduce the frequency of migraine attacks remains controversial.
    This was a planned sub-study in migraine patients enrolled in a randomized, clinical trial designed to assess the superiority of PFO closure plus antiplatelet therapy over antiplatelet therapy alone to prevent stroke recurrence in patients younger than 60 years with a PFO-associated cryptogenic ischaemic stroke. The main outcome was the mean annual number of migraine attacks in migraine patients with aura and in those without aura, as recorded at each follow-up visit by study neurologists.
    Of 473 patients randomized to PFO closure or antiplatelet therapy, 145 (mean age 41.9 years; women 58.6%) had migraine (75 with aura and 70 without aura). Sixty-seven patients were randomized to PFO closure and 78 to antiplatelet therapy. During a mean follow-up of about 5 years, there were no differences between antiplatelet-only and PFO closure groups in the mean annual number of migraine attacks, both in migraine patients with aura (9.2 [11.9] vs. 12.0 [19.1], p = 0.81) and in those without aura (12.1 [16.1] vs. 11.8 [18.4], p > 0.999). There were no differences between treatment groups regarding cessation of migraine attacks, migraine-related disability at 2 years and use of migraine-preventive drugs during follow-up.
    In young and middle-aged adults with PFO-associated cryptogenic stroke and migraine, PFO closure plus antiplatelet therapy did not reduce the mean annual number of migraine attacks compared to antiplatelet therapy alone, in migraine patients both with and without aura.
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  • 文章类型: Journal Article
    Intellectual property rights such as Copyright, Trademark, Patents and Trade secrets etc. help us to gain some protection against certain inventions by acknowledging the founder. In today\'s industry it is agreed that Intellectual Property Rights has a big role to play. This current study envisages the knowledge, attitude, practice regarding Intellectual Property Rights among dental task force attending private dental colleges.The survey was conducted among students of which were Interns, Post Graduates, faculty members and other dental surgeons attending private dental colleges in Navi Mumbai. The subjects of this study comprised of a total of 1020 students, faculty members and other dental surgeons from five different private dental institutes. The survey includes closed ended questions. Data analysis was performed using SPSS software version 17. Explaining calculations were used to summarize all the answers. A total of 889 students, faculty and other dental surgeons from private dental colleges responded. Results showed that about 83.5% believe the statement \"Articles and other publications are protected by copyright.\" 66.6% of participants would select trademark in order to protect their clinic or organization name. About 38.7% were aware of the term Intellectual Property Rights. It also suggests that only 10.9% have attended any seminar/conference pertaining to IPR. The students and faculty members have an overall sense of eagerness to learn and gain more knowledge based on IPR. Thus conducting more workshops and seminars based on IPR should be encouraged.
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  • 文章类型: Journal Article
    BACKGROUND: The health area in its most diverse fields has progressively incorporated nanotechnology into its products, such as in dermatology. In this sector, nanoparticles are one of the strategies that allow improvements, both in terms of value-added, as well as the efficacy, safety and stability of products for cosmetic or therapeutic purposes.
    OBJECTIVE: To understand the scenario of development and innovation of dermatological products with nanoparticles, through a patent prospection, evaluating the annual evolution, the main technology investors countries, the profile of the depositors, besides the uses and purposes of the products.
    METHODS: The Espacenet® database was used for consultation, using the search term \"nanoparticle and skin\". A total of 285 patents were found, of which 208 were available and 89 were based on the scope.
    RESULTS: There was a progressive evolution in the number of patents after the year 2000, with South Korea, the United States, China and Japan as the main depositor countries. Private companies and Education and Research Institutions were the entities with the largest amount of deposits. The cosmetic purpose was the predominant use compared to the therapeutic one. The most prominent nanoparticles were polymeric, metallic and lipid, while the therapeutic area presented a larger number of the functionalized ones.
    CONCLUSIONS: The market for dermatological products has been innovating and growing over the years through the use of nanoparticles, evidencing a prominent development of nanotechnology-based cosmetics. Countries investing in nanotechnology and major developers of innovative products are highlighted in this scenario.
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  • 文章类型: Journal Article
    BACKGROUND: Lack of access to insulin and poor health outcomes are issues for both low and high income countries. This has been accompanied by a shift from relatively inexpensive human insulin to its more expensive analogs, marketed by three to four main global players. Nonetheless, patent-based market exclusivities are beginning to expire there for the first generation insulin analogs. This paper adds a global dimension to information on the U.S. patent landscape for insulin by reviewing the patent status of insulins with emphasis on the situation outside the US and Europe.
    METHODS: Using the term \"insulin\", we searched for patents listed on the United States Food and Drug Administration\'s (USFDA) Orange Book and the Canadian Online Drug Product Database Online Query and its Patent Register. With this information, we expanded the search globally using the World Intellectual Property Organization (WIPO) PatentScope database, the European Patent Office\'s INPADOC database and various country-specific Patent Offices.
    RESULTS: Patent protected insulins marketed in the U.S. and other countries are facing an imminent patent-expiration \"cliff\' yet the three companies that dominate the global insulin market are continuing to file for patents in and outside the U.S, but very rarely in Africa. Only a few local producers in the so-called \"pharmerging\" markets (e.g., Brazil, India, China) are filing for global patent protection on their own insulins. There is moderate, but statistically significant association between patent filings and diabetes disease burden.
    CONCLUSIONS: The global market dominance by a few companies of analog over human insulin will likely continue even though patents on the current portfolio of insulin analogs will expire very soon. Multinationals are continuing to file for more insulin patents in the bigger markets with large disease burdens and a rapidly emerging middle class. Off-patent human insulins can effectively manage diabetes. A practical way forward would be find (potential) generic manufacturers globally and nudge them towards opportunities to diversify their national insulin markets with acceptable off-patent products for export.
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