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At least 703 records · Page 39Linked to original sources
PubMed1984

Prolonged bleeding time in preterm infants receiving indomethacin for patent ductus arteriosus.

Sequential bleeding times were performed on 25 preterm infants receiving intravenous indomethacin for closure of the patent ductus arteriosus. Prolongation of bleeding time was observed after the initial dose of indomethacin, with an increase from a pretreatment mean of 3.6 minutes to 8.7 minutes. The bleeding time was not further prolonged at the end of the three-dose course of indomethacin, but was still elevated 48 hours after the completion of therapy. Clinical bleeding developed in six of the patients, but was generally limited to occult hematuria. Serial echoencephalography during indomethacin therapy showed progression from mild periventricular-intraventricular hemorrhage to moderate or severe grades in five of 21 infants at risk for this complication. However, no clear temporal relationship between indomethacin administration and intraventricular hemorrhage extension was observed, and no difference in the degree of bleeding time prolongation was noted between infants with and without hemorrhage extension. Other factors, including surfactant deficiency, amount of volume expansion used, and lowest PO2 in the first day of life, did distinguish those with hemorrhage extension. The results suggest that indomethacin-induced platelet dysfunction is not associated with major hemorrhagic complications in the majority of preterm infants with patent ductus arteriosus.

Bleeding Time↗
PubMed1989

Transcatheter closure of patent ductus arteriosus in pediatric patients.

A "double disk" occlusion device (Rashkind PDA occluder system) has been designed to allow transcatheter closure of patent ductus arteriosus (PDA). During a 3-year period, we examined 37 infants and children (not premature neonates) with PDA as their only significant cardiovascular defect. Seventy-eight percent of these patients were considered potential candidates for the use of the PDA occlusion device, and it was successfully placed in all but 2 of 27 patients who underwent cardiac catheterization (PDA too small in one and too large in one). Only one of the remaining 25 patients had a significant residual shunt after placement of the device, which therefore was removed in the catheterization laboratory before surgical ligation of the PDA. There was no clinical evidence of a residual PDA in any patient. The duration of hospitalization was less than 24 hours for each of the last 20 procedures. Echocardiography demonstrated return to normal chamber dimensions in all patients, but a tiny, clinically undetectable residual leak around the device was found in three patients by Doppler evaluation. The transcatheter procedure was preferred over surgery by more than 90% of families and can be completed with a much shorter hospitalization than surgical ligation. We conclude that transcatheter closure of patent ductus arteriosus is feasible in the majority of children with PDA.

Cardiac Catheterization↗
PubMed1997

Comparative evaluation of the effects of indomethacin and ibuprofen on cerebral perfusion and oxygenation in preterm infants with patent ductus arteriosus.

OBJECTIVE: To compare the effects on cerebral perfusion and oxygenation of intravenous ibuprofen and indomethacin as treatment for patent ductus arteriosus in preterm infants. STUDY DESIGN: Sixteen infants receiving mechanical ventilation (< 31 weeks gestation) with patent ductus arteriosus received either 0.2 mg/kg indomethacin (n = 8) or 10 mg/kg ibuprofen (n = 8) infused over 1 minute. Near-infrared spectroscopy was used to measure changes in cerebral blood volume and in oxidized cytochrome oxidase concentration. Cerebral blood flow velocity in the pericallosal artery was measured using Doppler ultrasonography. RESULTS: Indomethacin caused a significant reduction of CBV (maximal changes in cerebral blood volume: -320 +/- 171 microL/100 gm) and, in four of eight patients, a fall in oxidized cytochrome oxidase concentration (maximal change in oxidized cytochrome oxidase concentration in the eight patients: -0.68 +/- 0.98 mumol/L, NS). Cerebral blood flow velocity fell significantly. Ibuprofen caused no significant reduction of cerebral blood volume, oxidized cytochrome oxidase concentration, or cerebral blood flow velocity, whereas a significant increase of cerebral blood volume (+207 +/- 200 microL/100 gm) was observed after 60 minutes. Ductus closure was seen in six of eight infants after the first dose of indomethacin and in five of eight infants after the first dose of ibuprofen. The therapeutic cycle involved administration of a second and third dose, provided no side effects occurred. Treatment was effective in all infants. CONCLUSION: Compared with indomethacin, treatment with ibuprofen does not significantly reduce cerebral perfusion and oxygen availability; the observed increase in cerebral blood volume requires further investigation.

Blood Flow Velocity↗
PubMed1995

Video-assisted thoracoscopic surgical interruption: the technique of choice for patent ductus arteriosus. Routine experience in 230 pediatric cases.

Video-assisted thoracoscopic surgical interruption for patient ductus arteriosus is a well-standardized procedure already described. We present our entire series of such cases, from the first case (performed on Sept. 5, 1991) to March 1, 1995. Two hundred thirty patients in a variety of age groups underwent video-assisted interruption: younger than 6 months (70 patients, 30%), 6 to 48 months (123 patients, 54%), and older than 48 months (37 patients, 16%). The mean weight was 12.6 kg (range 1.2 to 65 kg). Thirty-nine patients had symptomatic pulmonary hypertension. Associated intracardiac anomalies included atrial septal defect (three), ventricular septal defect (five), and anomalous pulmonary venous return (one). All patients underwent video-assisted interruption of the patient ductus arteriosus with two titanium clips. Closure was evaluated by postoperative echocardiography before extubation. Five patients had a persistent patent ductus after video-assisted interruption, all early in our experience and related to insufficient dissection resulting in inadequate clip placement. Four patients had successful immediate clip repositioning (three by video-assisted interruption and one by thoracotomy). Subsequent echocardiography revealed persistent closure in these patients. A persistent patent ductus arteriosus with minimal flow was discovered in one patient without symptoms after discharge. Recurrent laryngeal nerve dysfunction was noted in six patients (2.6%, five transient and one persistent). There were no deaths, hemorrhages, transfusions required, or chylothoraces in this series. Mean operative time was 20 +/- 15 minutes, and hospital stay averaged 48 hours for patients younger than 6 months and 72 hours for patients older than 6 months. This is a safe, rapid, cost-effective technique that results in excellent results and a shortened hospital stay. Video-assisted interruption represents the technique of choice for closure of a patient ductus arteriosus.

Child, Preschool↗
PubMedDate not supplied

Patents and access to essential drugs.

This paper provides a brief overview of historical developments in patent law including its recent incorporation into world trade law. The impact of patents on access to essential drugs will be discussed. The relationship between intellectual property rights and the right to health will be considered.

Commerce↗
PubMed2003

How ordinary judges and juries decide the seemingly complex technological questions of patentability over the prior art.

Determinations of patentability over the prior art are often thought to raise questions that are so technologically complex that they require special training and judgment to answer, especially in fast-moving fields like modern biotechnology. This essay explores the somewhat counterintuitive argument that under the U.S. system they do not and should not. According to this view, determinations of patentability over the prior art are based entirely on factual inquiries that are best made by lay judges and juries, just like the factual determinations these people regularly make in any ordinary nonpatent trial. This is good because judges and juries are adept at these determinations, and because appellate courts are adept at reviewing them. It leads to a system that is cheaper overall in allowing private litigants to better predict outcomes that also better approximate the correct answer than would be possible under other regimes premised upon the expert technological knowledge and judgment of a decisionmaker.

Biotechnology↗
PubMed2002

'Biogenerics': the off-patent biotech products.

The first patents of biopharmaceuticals derived from recombinant DNA will expire shortly, which raises the possibility of marketing generic products ('biogenerics') with limited documentation, similar to that which occurs with conventional pharmaceuticals. We propose the term off-patent biotechnological products (OPBPs) as an alternative to biogenerics when describing such products. It is questionable whether the majority of OPBPs can be classified as similar to the innovator products, considering the size and complexity of the molecules and the many factors that influence biological activity. There are three classes of OPBPs, each of which needs to meet different regulatory demands when seeking marketing authorization.

Biotechnology↗
PubMed2001

Patent ductus arteriozus associated with anomalous origin of the right coronary artery: a case report.

Patent ductus arteriozus (PDA) is the most common type of extracardiac shunt and it usually closes within 2 or 3 days of birth, but it may remain patent for one's lifetime. In this paper, we report a 65-year-old woman with PDA associated with a right coronary arising anomaly. To our knowledge, the anomalous origin of the right coronary artery associated with PDA has not been published to date. In this case report, we used only the standard Judkins type of a left coronary catheter for cannulation of both left and right coronary arteries and as well as PDA.

Aged↗
PubMed2001

Patents and the human genome project--new claims for old?

The development and application of genomics is set to revolutionize the life sciences. Commercial exploitation of this research will allow the development of novel therapies and diagnostic assays. However, some argue that a 'gold rush' is underway and conflicts have already arisen over the question of filing patents and sharing data. In this article we consider some of the issues that relate to patenting genomic inventions.

Computers↗
PubMed2002

From patenting genes to proteins: the search for utility via function.

The debate regarding the patenting of genes has extended into the post-genome era. With only approximately 35000 genes deduced from the draft sequence of the human genome, there are fears that a few companies have already gained monopoly on the potential benefits from this knowledge. Nevertheless, it is accepted that proteins determine gene function and function is not readily predicted from gene sequence. Furthermore, genes can encode multiple proteins and a single protein can have multiple functions. Here, we argue that unraveling the intrinsic complexity of proteins and their functions is the key towards determining the utility requirement for patenting protein inventions and consider the possible socioeconomic impact.

DNA↗
PubMed2002

[Transcatheter closure of patent ductus arteriosus using the Amplatzer duct occluder: initial results and mid-term follow-up].

INTRODUCTION AND OBJECTIVES: Transcatheter closure of patent ductus arteriosus is a well-established procedure. The aim of this study was to assess the initial and mid-term results of the treatment of PDA with the Amplatzer duct occluder. PATIENTS AND METHODS: From October 1999 to December 2001, 30 children underwent transcatheter closure of persistent ductus arteriosus at a mean SD age of 5 4.02 years (range: 3 months to 14 years) and weight of 20.3 10.3 kg (range: 4.5-45 kg). Infants under 10 kg weight made up 46% of total patients. A lateral view aortogram was made to determine the morphology of the ductus and select the size of the device. Occlusion was achieved using the anterograde venous approach. Follow-up evaluations were made with chest X-ray and echocardiogram at 24 hours and 1, 4 and 12 months after implantation. RESULTS: Twenty-eight patients (93.3%) immediately achieved complete occlusion, and on color Doppler examination the closure rate was 100% within 24 hours of implantation. There was no device embolization. In the follow-up, a 19-month-old patient developed a 20 mmHg gradient across the aortic arch. CONCLUSIONS: Patent ductus arteriosus can be easily occluded with the Amplatz Duct Occluder, which is effective and particularly useful in infants and children with relatively large PDA. Further experience and long-term follow-up are still needed to assess the safety of this device in smaller children.

Adolescent↗
PubMed1986

Patent ductus arteriosus in adults--long-term follow-up: nonsurgical versus surgical treatment.

The long-term prognosis of adult patients with patent ductus arteriosus treated medically or surgically has not been demonstrated. One hundred seventeen adult patients ranging in age from 18 to 81 years (mean 36) were followed up for 1 to 37 years (mean 18). Forty-five patients were treated nonsurgically and 72 had surgical closure. The nonsurgical group experienced significantly more cyanosis (p = 0.002) and had fewer diastolic murmurs (p greater than 0.001) than did the surgical group. In the nonsurgical group, patients with cardiomegaly before treatment were more likely to die (p greater than 0.001) than were patients who did not have cardiomegaly. In the surgical group, patients with cardiomegaly before treatment had a worse prognosis (p = 0.09) than that of patients with normal heart size. Seven patients, five in the nonsurgical and two in the surgical group, presented with a pulmonary artery systolic pressure greater than 100 mm Hg. Five of these patients are alive and well at a mean follow-up time of 18 years. The two nonsurvivors were in the nonsurgical group and died at 4 and 19 years of follow-up, respectively. Adult patients with patent ductus arteriosus should be treated surgically, especially if cardiomegaly is seen at initial presentation.

Adult↗
PubMed1995

Aortic arch dissection from patent ductus arteriosus.

An unusual case of aortic arch dissection from a patent ductus arteriosus (PDA) is described. An adult man had been diagnosed as suffering from pectus excavatum and PDA 10 years before. At that time the pectus was repaired, but he failed to return for surgery on the PDA and the sub-sternal strut for pectus repair was also never removed. Recently he was admitted in a peripheral hospital with chest infection. Patent ductus arteriosus murmur was audible on clinical examination. The chest X-ray showed a widened mediastinum and the pectus strut. On further investigations dissection of the aortic arch was discovered and arch replacement performed.

Adult↗
PubMed1999

Mild or subclinical intravascular haemolysis subsequent to transcatheter occlusion of the patent arterial duct.

One of the important complications of transcatheter occlusion of the patent duct by insertion of either the Rashkind double umbrella or coil devices is intravascular haemolysis, particularly the severe form which occurs in 0.5-0.6% of cases. The incidence of subclinical or mild intravascular haemolysis including morphologic changes in the red cells, however, is not known, especially in the group of patients with residual shunt. We studied laboratory and haematologic changes in 37 patients subsequent to transcatheter occlusion. Their ages ranged from 2 years 2 months to 11 years 8 months (6.2 + 2.7 years), and the duration of occlusion had ranged from 1 month to 2 years 11 months (1.24 + 0.89 years). In 30 cases we had used the Rashkind double umbrella device, and nine of these patients (30%) had a residual shunt. The other seven ducts were closed with detachable coils, and five of these cases (71%) had residual shunting. There was evidence of mild or subclinical intravascular haemolysis in almost half the cases, although no patient developed acute intravascular haemolysis. Fragmented red cells, blur cells and spherocytes from blood smears were found in up to one-third of the overall series, with no differences found according to persistence of shunting. Haemosiderin was found in the urine of the group with residual shunting and in 13-23% of those with complete occlusion. Serum hypohaptoglobin was found in 9-13% of the patients with a residual shunt, and in 9-23% of those with complete occlusion. Four of the patients had haptoglobin levels < 50 mg/dl. There were no patients with reticulocytes counts > 2% in the blood smears. We conclude that subclinical or mild intravascular haemolysis, along with morphologic changes in the red blood cells, are significant findings subsequent to occlusion of the patent arterial duct with either the Rashkind double umbrella or detachable coils.

Anemia, Hemolytic↗
PubMed2000

Immediate and early results of closure of moderate to large patent arterial ducts using the new Amplatzer device.

OBJECTIVES: Our aim was to assess the immediate and short term results of closure of moderate and large patent arterial ducts using the self-expanding and repositionable Amplatzer device. METHOD: We attempted closure in 25 patients (10 Females and 15 males) using the Amplatzer occluder. Their median age was 48 months with a range from 8 months to 26 years and median weight of 14 kg with a range from 4.5 kg to 48 kg. The mean ductal diameter was 4.1 mm (S.D 1.51 mm). A 6F/7F long sheath was used to deliver the device. Follow up was performed with colour- flow mapping of the pulmonary trunk within 24 hours, at 3 months, and 6 months of closure. RESULTS: Of the 25 patients, the device was placed successfully in 23. Concurrent angiography showed immediate closure in 12 patients, while 8 had trivial shunting and 3 had mild shunting. Within 24 hours, Doppler examination revealed complete closure in all but three patients, who had a mild residual shunt. Two attempts were unsuccessful. Both these patients underwent successful surgical ligation. All except one patient were discharged on the next day. Of the 23 patients, 15 (65%) have been followed up for 3 months, while 8 (35%) have completed 6 months of follow-up. Of the three patients initially with mild residual flow, two had completely closed at 3 months The one remaining patient is yet to be seen at the 3 month follow-up. Thus, at 3 months, all patients studies had shown complete closure. CONCLUSION: Antegrade transcatheter closure using the Amplatzer duct occluder is an efficacious treatment for bigger patent arterial ducts. Long-term follow-up is necessary to show sustained benefits and confirm the absence of side effects.

Adolescent↗
PubMed2002

Percutaneous transcatheter occlusion of the patent arterial duct using the pfm DuctOcclud Coil via a trans-aortic and trans-pulmonary approach.

Occlusion using coils is now the treatment of choice for closure of the patent arterial duct. The DuctOcclud (pfm AG, Cologne, Germany) device is a relatively new retrievable coil for such trans-catheter closure. This study expands on previously reported experience with this device, summarizes the advantages of the device, and compares trans-pulmonary and trans-aortic delivery in 47 patients. There were 27 females. The mean, and median, ages were 4.6, and 2.85 years, respectively. The youngest patient was aged 9 months, weighing 7 kg. A trans-aortic delivery was used in 41 cases, and a trans-pulmonary approach in 6 cases. Of the 47 procedures, 45 (96%) were successful at the first attempt. The other two patients were treated successfully at the second attempt, giving a 100% rate of success. The technical characteristics of the coil allowed for its repeated maneuvering until an optimal position was obtained prior to release. Closure was confirmed by lack of ductal flow by echo-doppler on follow- up echocardiography. No short- or long-term complications of the procedure were noted in any of the patients. We conclude that the DuctOcclud device is an effective and safe method for closure of the small-to-moderately patent arterial duct. In a large proportion of patients, trans-aortic delivery is the preferred approach.

Aorta↗
PubMedDate not supplied

Information sources on post-grant actions to pharmaceutical patents.

Over the past two decades, many industrialized countries have implemented changes in their patent laws to provide an extended period of protection for commercially marketed pharmaceuticals. The process has been adopted piecemeal, using widely different procedures. The information sources relating to such term extension are consequently scattered and poorly organized, compared with conventional patent legal status data. This paper reviews the legal processes behind term extension and provides a survey of the key principles and information sources available.

Marketing of Health Services↗