Biomedical subjects
Publications and source records attributed to E Deutsch.
An international comparison shows that the German criminal law is severe on physicians. In the majority of the other countries the doctor is just liable for criminal or gross negligence. There are some countries where lack of informed consent leads to a special criminal action. The comparative law shows us that it is better to keep the current criminal law.
Private law and criminal law are different in more than one way. On occasion, they overlap. Further liability may result from disregard of a criminal act. As far as the evidence is concerned, criminal law requires a higher degree of probability than private law. If the same case is subject to criminal and civil proceedings, both courts are not bound by each other's decisions.
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Since 1755, when Roederer first described choanal atresia, more than 350 papers have been published dealing with the various aspects of this entity. Many surgical techniques have been used to treat the malformation, each with its advantages and disadvantages. Endoscopic transnasal repair of choanal atresia provides excellent visualization and enables accurate surgery to be performed on patients of all ages and even on newborn infants. Described are two newborn infants, one with bilateral choanal atresia and the other with bilateral choanal stenosis, successfully treated by endoscopic transnasal repair, with a 12 month follow-up. The technique of endoscopic choanal repair is described, emphasizing it as a highly successful, short and safe procedure with swift recovery and short hospitalization.
The placebo effect will have a growing importance in the field of nuclear medicine as the potentials for palliative therapy with internal sources are realized. It is important for nuclear medicine physicians and their colleagues to be familiar with the role of placebo responses in clinical trials, especially when such trials involve the subjective assessment of pain. A summary of the literature on the placebo effect in pain studies is presented in which traditional values for placebo responses are contrasted with more current thinking in the field. The few published double-blind studies of pain relief after treatment with radiotherapeutic agents are summarized specifically with respect to their cited placebo response.
This article draws on international experience to explore the ethical and legal aspects of performing clinical studies on patients in intensive care units. It discusses aspects of consent relevant to clinical studies in this medical environment, it considers the involvement of ethical committees, and the role and appropriate level of intensive cover.
Clinical research can be therapeutic or purely scientific. The therapeutic trial is usually chosen to obtain treatment liberty. On the other hand, the physicians in controlled clinical trials have relatively little choice of treatments. In Germany, special statutes and the general law limit clinical trials. The sec. 41 AMG, 18 MPG allow therapeutical trials under special circumstances. There are requirements for clinically controlled trials, especially the provision to seek the approval of an ethic commission.
Reduction-substitution reactions on [99mTcO4]- with both o-phenylenebis(dimethylarsine) (DIARS) and various thiols produce a series of monocationic [99Tc(DIARS)2(SR)2]+ complexes. Addition of [99gTcO4]- to the above reaction mixtures allows the characterization of the "carrier-added" complexes by means of reverse-phase high-performance liquid chromatography with radiometric and optical detection systems. The identity of the [99mTc(DIARS)2(SR)2]+ complexes is confirmed by fast atom bombardment mass spectroscopy; equivalence of the [99gTc(DIARS)2-(SR)2]+ and [99mTc(DIARS)2(SR)2]+ species is demonstrated by identical HPLC retention times. All the [99mTc(DIARS)2(SR)2]+ complexes tested accumulate in the myocardium of Sprague-Dawley rats with an average uptake of 1.5-2.0% of injected dose/g at 30 min. Thus, as designed, these nonreducible Tc(III) complexes do not exhibit the rapid myocardial washout observed for reducible Tc(III) complexes. These [99mTc(DIARS)2(SR)2]+ complexes also exhibit an initially high liver uptake, but the presence of ether groups within the thiolate ligands causes this liver uptake to decrease over time without affecting the heart uptake, thereby improving the heart/liver ratio.
Subperiosteal abscess of the orbit (SPA) should be considered an important part of the group of orbital complications following acute sinusitis. This situation requires early surgical intervention to avoid visual loss or ophthalmoplegia. Six cases of children with SPA of the orbit treated successfully by Functional Endoscopic Sinus Surgery (FESS) are reviewed. The importance of ophthalmological examination, nasal endoscopy and CT scan is emphasized concerning the management protocol. The major advantage of FESS is the avoidance of external ethmoidectomy with the resultant scar. FESS is demonstrated as a safe and convenient procedure with excellent post operative recovery of the patients.
Human TNF-beta (lymphotoxin) gene expression is down-regulated by immunosuppression. Induction of TNF-beta mRNA in lymphoid cells is greatly enhanced by gamma-irradiation, cyclophosphamide and cimetidine, agents that each inhibit activation of suppressive cells. The level of TNF-beta mRNA expressed in response to stimulation, whether by mitogen or antigen, is reduced strongly by concomitant activation of suppressive cell subsets. Removal of CD8 or CD11b cells leads to a pronounced superinduction of TNF-beta mRNA in the depleted cell population. Induction of TNF-beta mRNA precedes appearance of suppressive cell activity, allowing for temporary expression. The TNF-beta gene is as sensitive as IFN-gamma and IL-2 genes to suppression. Hence, three genes characteristically expressed in Th1 cells, encoding IL-2, IFN-gamma, and TNF-beta, are similarly regulated by cell-mediated suppression. Actual levels of TNF-beta during an immune response are determined by the balance between activities of expressing and suppressing cell subsets, both transiently manifested.
We propose a renal imaging agent, the 99mTc complex of the bidentate-N,S chelate N-(mercaptoacetyl)glycine (99mTc-2GAM), with the imaging characteristics of 99mTc-DMSA but a faster kidney uptake; chemical evidence supports the formulation of 99mTc-2GAM as [Tc(v)(O)(GAM)2]-. After biodistribution and toxicity studies in animals, 99mTc-2GAM was evaluated in five normal volunteers. 99mTc-2GAM is rapidly cleared from the blood (t1/2 = 9 min) and 50% of the ID is excreted in the urine in the first 2 h. Dynamic data show a rapid renal uptake that increases up to 1 h with no significant wash-out between 1 and 8 h. The uptake in each kidney ranges from 11.3% to 20.7% ID. Low, stable liver uptake is observed. No significant activity is detected in other organs. We showed no differences between 99mTc-2GAM and 99mTc-DMSA compared in three patients with unilateral kidney disease. We conclude that 99mTc-2GAM has good practical and dosimetric features for renal imaging.
The freedom of research is guaranteed in Art. 5 sub. 3 of the German Basic Law (GG) as against intrusion by the state. Sec.s 40 AMG contain requirements for the clinical trials for pharmaceutical products which range from medical admissibility to informed consent all the way to a positive evaluation by an ethics committee. From there a route to analogy for other medical research is called for, because health and well-being of a person should be promoted even outside the area of pharmaceutical products. The international instrument of the Revised Declaration of Helsinki by the World Medical Association also requires an adequate risk and the information of the patient. Even medical research concerning the mentally ill is admissible when it is directed at the illness itself. In this case the informed consent of the guardian is normally sufficient.
This brief article addresses the current status and future potential of nuclear medicine, X-ray computed tomography (CT), ultrasound (US), and magnetic resonance (MR) imaging in the diagnosis of cardiovascular diseases. The currently perceived advantages and disadvantages, as well as the possible future roles, of each of the modalities with regard to the evaluation of coronary artery disease are delineated. The certain advent of MR and US myocardial contrast agents, combined with the inexorable pressures of health care reform, will alter the future usage patterns of all four modalities. Future debates about which modality should be used in which clinical situation will be based not on "anatomy vs function", nor on which specialty owns which "turf", but rather on the issues of cost effectiveness and patient outcomes.
The expert testimony in the common law countries is fundamentally different from the one in the continental European countries. According to the anglo-american law, both parties present the evidence to the court. Witnesses are examined and cross-examined. Most important, the expert is not appointed by the court or a helper of the court, but the expert is an expert witness. He is presented by one of the parties, examined and cross examined. Because some of the expert witnesses may be biased, there can be a war of experts.
BACKGROUND: Antithromboxane therapy with aspirin reduces acute procedural complications of coronary angioplasty (PTCA) but has not been shown to prevent restenosis. The effect of chronic aspirin therapy on long-term clinical events after PTCA is unknown, and the utility of more specific antithromboxane agents is uncertain. The goal of this study was to assess the effects of aspirin (a nonselective inhibitor of thromboxane A2 synthesis) and sulotroban (a selective blocker of the thromboxane A2 receptor) on late clinical events and restenosis after PTCA. METHODS AND RESULTS: Patients (n = 752) were randomly assigned to aspirin (325 mg daily), sulotroban (800 mg QID), or placebo, started within 6 hours before PTCA and continued for 6 months. The primary outcome was clinical failure at 6 months after successful PTCA, defined as (1) death, (2) myocardial infarction, or (3) restenosis associated with recurrent angina or need for repeat revascularization. Neither active treatment differed significantly from placebo in the rate of angiographic restenosis: 39% (73 of 188) in the aspirin-assigned group, 53% (100 of 189) in the sulotroban group, and 43% (85 of 196) in the placebo group. In contrast, aspirin therapy significantly improved clinical outcome in comparison to placebo (P = .046) and sulotroban (P = .006). Clinical failure occurred in 30% (49 of 162) of the aspirin group, 44% (73 of 166) of the sulotroban group, and 41% (71 of 175) of the placebo group. Myocardial infarction was significantly reduced by antithromboxane therapy: 1.2% in the aspirin group, 1.8% in the sulotroban group, and 5.7% in the placebo group (P = .030). CONCLUSIONS: Thromboxane A2 blockade protects against late ischemic events after angioplasty even though angiographic restenosis is not significantly reduced. While both aspirin and sulotroban prevent the occurrence of myocardial infarction, overall clinical outcome appears superior for aspirin compared with sulotroban. Therefore, aspirin should be continued for at least 6 months after coronary angioplasty.
BACKGROUND: Heparin is often administered during and after coronary angioplasty to prevent closure of the dilated vessel. However, ischemic or hemorrhagic complications occur in 5 to 10 percent of treated patients. We studied whether these complications could be prevented when the direct thrombin inhibitor bivalirudin (Hirulog) was used in place of heparin. METHODS: We performed a double-blind, randomized trial in 4098 patients undergoing angioplasty for unstable or postinfarction angina. Patients were assigned to receive either heparin or bivalirudin immediately before angioplasty. The primary end point were death in the hospital, myocardial infarction, abrupt vessel closure, or rapid clinical deterioration of cardiac origin. RESULTS: In the total study group, bivalirudin did not significantly reduce the incidence of the primary end point (11.4 percent, vs. 12.2 percent for heparin) but did result in a lower incidence of bleeding (3.8 percent vs. 9.8 percent, P < 0.001). In the prospectively stratified subgroup of 704 patients with postinfarction angina, bivalirudin therapy resulted in a lower incidence of the primary end point (9.1 percent vs. 14.2 percent, P = 0.04) and a lower incidence of bleeding (3.0 percent vs. 11.1 percent, P < 0.001), but in a similar cumulative rate of death, myocardial infarction, and repeated revascularization in the six months after angioplasty (20.5 percent vs. 25.1 percent, P = 0.17). CONCLUSIONS: Bivalirudin was at least as effective as high-dose heparin in preventing ischemic complications in patients who underwent angioplasty for unstable angina, and it carried a lower risk of bleeding. Bivalirudin, as compared with heparin, reduced the risk of immediate ischemic complications in patients with postinfarction angina, but this difference was no longer apparent after six months.
The level of transient expression of human IL-2 and IFN-gamma genes, we show, is regulated by dynamic interaction between two functionally distinct cell populations. One is able to express these genes, while the other, bearing one of several specific surface markers, actively inhibits their expression. Defined cell subsets were isolated from PBMC and tonsil cells using immunomagnetic beads coated with monoclonal antibodies directed against surface markers. Depletion of CD8, CD11a (Leu15), or Leu8 subsets led to a pronounced superinduction of IL-2 and IFN-gamma gene expression when the remaining cell population was stimulated with mitogen (PHA) or antigen (SEB). Thus, a 10-fold increase in production of IFN-gamma was observed after removal of CD11a (Leu15) cells constituting only a small percentage of the total cell population. By contrast, depletion of cells expressing CD19, a B cell marker, did not yield any superinduction. Conversely, CD8, CD11a (Leu15), or Leu8 cell subsets, but not CD19 cells, each inhibited the induction of IL-2 and IFN-gamma gene expression almost completely in depleted or total cell populations from which they were derived. Gene expression occurring within one cell subset could be effectively inhibited by cells from a second subset. Introduction of inhibitory cells (Leu8) into a population that actively expressed IL-2 and IFN-gamma mRNA resulted in an immediate cessation of gene expression. This suppression involves a soluble mediator, since the culture medium in which such cells were activated exerted a similarly effective inhibition.
Mutational analysis of cap'n'collar (cnc), a bZIP transcription factor closely related to the mammalian erythroid factor NF-E2 (p45), indicates that it acts as a segment-specific selector gene controlling the identity of two cephalic segments. In the mandibular segment, cnc has a classical homeotic effect: mandibular structures are missing in cnc mutant larvae and replaced with duplicate maxillary structures. We propose that cnc functions in combination with the homeotic gene Deformed to specify mandibular development. Labral structures are also missing in cnc mutant larvae, where a distinct labral primordia is not properly maintained in the developing foregut, as observed by the failure to maintain and elaborate patterns of labral-specific segment polarity gene expression. Instead, the labral primordium fuses with the esophageal primordium to contribute to formation of the esophagus. The role of cnc in labral development is reciprocal to the role of homeotic gene forkhead, which has an identical function in the maintenance of the esophageal primordium. This role of homeotic selector genes for the segment-specific maintenance of segment polarity gene expression is a unique feature of segmentation in the preoral head region of Drosophila.