Lege Artis Medicinae

[SOME ETHICAL DILEMMAS OF PLACEBO-CONTROLLED STUDIES]

KOVÁCS József

JULY 20, 2005

Lege Artis Medicinae - 2005;15(07)

[The article deals with the question where and when is it ethically acceptable in a randomized controlled clinical trial to give the investigational drug to one of the groups, while placebo to the other. First, it gives a short overview on the origin of the problem and the history of its reemergence before and after the revision of the Declaration of Helsinki 2000. It examines the various forms of placebo use, the pros and cons of its implementation, the international debate before the revision of the Declaration of Helsinki 2000 and the corrections after its acceptance. Finally it declares some principles in connection with placebo controlled clinical trials and examines when such a trial is acceptable in various psychiatric disorders.]

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Lege Artis Medicinae

[A NEW SURGICAL TECHNIQUE FOR THE TREATMENT OF SEVERE BRAIN EDEMA OF TRAUMATIC ORIGIN - RESULTS OF THE APPLICATION OF VASCULAR TUNNELS]

CSÓKAY András

[INTRODUCTION - Decompressive craniectomy with durotomy is a well known, although strongly disputed method of treatment in cases of brain trauma, brain swelling and during persisting danger of fatal incuneation. It is not without significance that literature mentions this method only as an option. Although the method successfully diminishes the ICP this can still result in a partial or total lesion occuring in the herniating part of the brain. The actual cause of these symptoms is found in the blockage of the veins and arteries, caused by the shear and the pressure forces between the dural edge and brain tissue. PATIENTS AND METHODS - The new surgical technique consists of the creation of a vascular tunnel around the main cortical veins and the arteries of herniated brain. 36 patients have been operated on with this method. We used historical control (28 patients treated conservatively, 20 patients treated with decompressive craniotomy). RESULTS - A retrospective comparison was performed and the results in connection with the mortality and morbidity rate was promising. CONCLUSION - With the help of our new technique we managed not only to reduce the ICP greatly but we could also avoid further vascular laesion. This is due to the fact that we can assure the circulation and veinous drainage of the herniated part of the brain. This method can be used in any severe edematous state generated by other causes.]

Lege Artis Medicinae

[SUBCLINICAL THYROID DISEASES]

FÖLDES János, WINKLER Gábor

[More and more data are indicating that subclinical thyroid diseases can not be regarded as innocuous states. It seems very likely that slight changes in the serum thyroid hormone levels, still within the normal reference range, are sensed beside the pituitary also by other tissues and organs and their function may become abnormal. Considering these problems, it would be advisable to elucidate the proper time to start treatment, whether it is beneficial or not and to determine what the risks are for the applied therapy. Though the recommended guidelines for the management of subclinical thyroid diseases are becoming more and more evident, many questions remain still unanswered. It is not advisable to start an overzelous therapy, however, a too long waiting time for the installation of treatment could also be harmful. Large prospective and randomized trials are needed to clear these questions. This seems to be an urgent task, since due to their high prevalence, subclinical thyroid dysfunction might be regarded as a public health problem.]

Lege Artis Medicinae

[In the focus: traveller’s diseases]

JELENIK Zsuzsanna, LUDWIG Endre

Lege Artis Medicinae

[ESPRIT]

MATOS Lajos

Lege Artis Medicinae

[MANAGEMENT OF CUTANEOUS MALIGNANT MELANOMAS]

OLÁH Judit

[Malignant melanoma, the disease originating from pigment cells of the skin, mucous membrane, eye and rarely from other tissues, shows increasing incidence in the Caucasian population. The Hungarian statistical data correspond with the data of other countries. In the early stages of malignant melanoma surgical removal of the tumor is often curative, but patients with disseminated tumors have a poor survival rate. Regrettably, in Hungary the majority of melanoma patients are diagnosed with advanced tumors, with nodal or systemic metastasis. Physicians working in other fields of medicine have a great responsibility in patient education and in early detection of susceptible pigmented lesions. Diagnosis and treatment of malignant melanoma requires an experienced dermatologist. The clinical diagnosis of melanoma is aided by several new techniques, like digital dermatoscopy. In recent years, surgical therapy of malignant melanoma has changed: today we routinely perform sentinel node biopsy. This type of surgical technique requires experience. In advanced disease the use of chemotherapy and immunotherapy requires onco-dermatological experience. Educating the public and physicians provides the basis for prevention. Survival rate is mainly dependent on the quality of primary care which determines survival rate, therefore it is essential that patients with melanomas are followed up in onco-dermatological centers.]

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Clinical Neuroscience

Fluoxetine use is associated with improved survival of patients with COVID-19 pneumonia: A retrospective case-control study

NÉMETH Klára Zsófia, SZÛCS Anna , VITRAI József , JUHÁSZ Dóra , NÉMETH Pál János , HOLLÓ András

We aimed to investigate the association between fluoxetine use and the survival of hospitalised coronavirus disease (COVID-19) pneumonia patients. This retrospective case-control study used data extracted from the medical records of adult patients hospitalised with moderate or severe COVID-19 pneumonia at the Uzsoki Teaching Hospital of the Semmelweis University in Budapest, Hungary between 17 March and 22 April 2021. As a part of standard medical treatment, patients received anti-COVID-19 therapies as favipiravir, remdesivir, baricitinib or a combination of these drugs; and 110 of them received 20 mg fluoxetine capsules once daily as an adjuvant medication. Multivariable logistic regression was used to evaluate the association between fluoxetine use and mortality. For excluding a fluoxetine-selection bias potentially influencing our results, we compared baseline prognostic markers in the two groups treated versus not treated with fluoxetine. Out of the 269 participants, 205 (76.2%) survived and 64 (23.8%) died between days 2 and 28 after hospitalisation. Greater age (OR [95% CI] 1.08 [1.05–1.11], p<0.001), radiographic severity based on chest X-ray (OR [95% CI] 2.03 [1.27–3.25], p=0.003) and higher score of shortened National Early Warning Score (sNEWS) (OR [95% CI] 1.20 [1.01-1.43], p=0.04) were associated with higher mortality. Fluoxetine use was associated with an important (70%) decrease of mortality (OR [95% CI] 0.33 [0.16–0.68], p=0.002) compared to the non-fluoxetine group. Age, gender, LDH, CRP, and D-dimer levels, sNEWS, Chest X-ray score did not show statistical difference between the fluoxetine and non-fluoxetine groups supporting the reliability of our finding. Provisional to confirmation in randomised controlled studies, fluoxetine may be a potent treatment increasing the survival for COVID-19 pneumonia.

Clinical Neuroscience

Late simultaneous carcinomatous meningitis, temporal bone infiltrating macro-metastasis and disseminated multi-organ micro-metastases presenting with mono-symptomatic vertigo – a clinico-pathological case reporT

JARABIN András János, KLIVÉNYI Péter, TISZLAVICZ László, MOLNÁR Anna Fiona, GION Katalin, FÖLDESI Imre, KISS Geza Jozsef, ROVÓ László, BELLA Zsolt

Although vertigo is one of the most common complaints, intracranial malignant tumors rarely cause sudden asymmetry between the tone of the vestibular peripheries masquerading as a peripheral-like disorder. Here we report a case of simultaneous temporal bone infiltrating macro-metastasis and disseminated multi-organ micro-metastases presenting as acute unilateral vestibular syndrome, due to the reawakening of a primary gastric signet ring cell carcinoma. Purpose – Our objective was to identify those pathophysiological steps that may explain the complex process of tumor reawakening, dissemination. The possible causes of vestibular asymmetry were also traced. A 56-year-old male patient’s interdisciplinary medical data had been retrospectively analyzed. Original clinical and pathological results have been collected and thoroughly reevaluated, then new histological staining and immunohistochemistry methods have been added to the diagnostic pool. During the autopsy the cerebrum and cerebellum was edematous. The apex of the left petrous bone was infiltrated and destructed by a tumor mass of 2x2 cm in size. Histological reexamination of the original gastric resection specimen slides revealed focal submucosal tumorous infiltration with a vascular invasion. By immunohistochemistry mainly single infiltrating tumor cells were observed with Cytokeratin 7 and Vimentin positivity and partial loss of E-cadherin staining. The subsequent histological examination of necropsy tissue specimens confirmed the disseminated, multi-organ microscopic tumorous invasion. Discussion – It has been recently reported that the expression of Vimentin and the loss of E-cadherin is significantly associated with advanced stage, lymph node metastasis, vascular and neural invasion and undifferentiated type with p<0.05 significance. As our patient was middle aged and had no immune-deficiency, the promoting factor of the reawakening of the primary GC malignant disease after a 9-year-long period of dormancy remained undiscovered. The organ-specific tropism explained by the “seed and soil” theory was unexpected, due to rare occurrence of gastric cancer to metastasize in the meninges given that only a minority of these cells would be capable of crossing the blood brain barrier. Patients with past malignancies and new onset of neurological symptoms should alert the physician to central nervous system involvement, and the appropriate, targeted diagnostic and therapeutic work-up should be established immediately. Targeted staining with specific antibodies is recommended. Recent studies on cell lines indicate that metformin strongly inhibits epithelial-mesenchymal transition of gastric cancer cells. Therefore, further studies need to be performed on cases positive for epithelial-mesenchymal transition.

Lege Artis Medicinae

[Vaccines against COVID-19 pandemic]

FALUS András, SZEKANECZ Zoltán

[The rapidly spreading SARS-CoV2 respiratory virus has evoked an epidemic with serious aftermath around the world. In addition to the health effects, the global economic damage is actually unpredictable. At the same time, the pandemic has launched a series of unprecedented collaborative scientific research, including the development of vaccines. This study summarizes up-to-date information on vaccines, immune memory, and some emerging clinical effects.]

Lege Artis Medicinae

[A short chronicle of three decades ]

KAPRONCZAY Katalin

[Hungarian professional periodicals started quite late in European context. Their publish­ing, editing and editorial philosophy were equally influenced by specific historical and political situations. Certain breaking points of history resulted in termina­tion of professional journals (War of In­de­pendence 1848-1849, First and Se­cond World Wars), however there were pe­riods, which instigated the progress of sciences and founding of new scientific journals. Both trends were apparent in years after the fall of former Hungarian regime in 1990. The structure of book and journal publishing has changed substantially, some publishers fell “victim” others started successfully as well. The latters include the then-established publishing house Literatura Medica and its own scientific journal, Lege Artis Me­di­cinae (according to its subtitle: New Hun­garian Medical Herald) issued first in 1990. Its appearance enhanced significantly the medical press market. Its scientific publications compete with articles of the well-established domestic medical journals however its philosophy set brand-new trends on the market. Concerning the medical community, it takes on its problems and provides a forum for them. These problems are emerging questions in health care, economy and prevention, in close interrelation with system of public health institutions, infrastructure and situation of those providing individual health services. In all of them, Lege Artis Medicinae follows consequently the ideas of traditional social medicine.]

Lege Artis Medicinae

[Risk of nonsteroidal antiinflammatory drugs. Focus on aceclofenac]

FARSANG Csaba

[Nonsteroidal antiinflammatory drugs (NSAIDs) are among the most frequently used pharmaceuticals. Nevertheless, a number of studies emphasized that NSAIDs were damaging not only the gastrointestinal (GI), but also the cardiovascular (CV) system, could increase the blood pressure, the frequency of coronary events (angina, myocardial infarction) and stroke incidence, as well as they might deterio­rate renal functions. The National Institute for Health and Care Excellence (NICE) did not find evidence that administering NSAIDs could increase the risk of developing COVID-19 or worsened the condition of COVID-19 patients. However, unwanted effects of specific drugs differ substantially in their occurrence and seriousness as well. It seemed to be for a long time that the NSAIDs provoked higher GI-risk was closely related to the COX1/COX2 selectivity, like the cardiovascular (CV) risk to the COX2/COX1 selectivity, however, the recent data did not prove it clearly. Based on the available literature while pondering the gastrointestinal and cardiovascular adverse events, among all NSAIDs the aceclofenac profile seemed to be the most favourable.]