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Long term results of high dose vancomycin loaded spacers for treating infected massive prostheses

Poster spacer ciment athenes 2019-2               Delepine F, Alkhallaf S. Delepine G.

 

Aim

infection is of the most devastating complication of conservative surgery using massive prosthesis, leading frequently to amputation. The aim of this bi centric study is to precise the influence of spacer loaded with high doses of vancomycin on late results

 

Patients From 1984 to 2010, we operated more than 670 patients with bone sarcoma. Aged 4,5 to 82 years (mean 25 y). Histology was osteosarcoma (330), Ewing (175), chondrosarcomas (148), fibrosarcomas or MFH (23), giant cell tumours in others. In 502 cases, p received chemotherapy, and radiotherapy in 50 cases. The median follow-up from tumour removal is 20.5 years. 62 p suffered of deep infection of the material used to reconstruct the skeletal defect. 3 p were refered to us for recurrence of deep infection initially treated elsewhere. Altogether, we treated 65 patients for deep infections.

Method 28 p had debridment and cleaning of the prosthesis and long adapted antibiotherapy as first treatment. When ineffective (25/28), a removal of the prosthesis was performed with immediate re insertion of prosthesis in 19 cases. When infection recurred (16/19) and in 34 other patients the treatment included a two stages protocol with interposition of a spacer with antibiotic loaded cement during 4 to12 weeks .Until 2004, the spacer was made with gentamycin containing palacos mixed with conventional doses of antibiotics adapted to the germ. From 2004/6 we used high doses of vancomycin (4 g per batch of 40 g) with an average total dose of 11g of vancomycin per spacer. The new prosthesis was replaced secondarly when infection, cutaneous and muscular problems were solved.

RESULTS : At last control, 16 were amputated, following a mean of 6 ineffective procedures. 46 p. benefited from conservation surgery but a new prosthesis could be inserted only in 43, following a mean of 3.2 surgical procedures. Analysis shows the very bad prognostic value of initial radiotherapy, of distal locations, the importance of muscular coverage and the efficacy of high dose vancomycin in spacer. Up to date, none of the high dose vancomycin loaded spacers was followed by amputation

CONCLUSION Infection of massive prostheses is the most serious orthopaedic complication of limb salvage. Treatment must be preventive, avoiding any radiotherapy. Good prognostic factors of deep infection are early removal of the prosthesis, improvement of the muscular coverage, and use of spacers with high dose vancomycin.

 

slides 

Poster Ew périosté athenes 2019-2 (1)   

 

 

 

Long term follow-up of 7 periosteal Ewing. Key points for surgery 

F Delépine, G Delépine, S Alkhallaf

Aim of the study. Few cases of periosteal Ewing (PES) were reported and surgical implications of such a diagnosis has not been sufficiently underlined. Our goal is to evaluate the incidence of this topographic form and the consequence on surgery and long-term results.

Material. The 7 reported cases fulfilled the diagnosis criteria of Bator: Ewing of bone histologically proved, with pure periosteal location without medullary extension. The CT scan was the most reliable exam for diagnosis. Histology of resected specimen may ignore an initial medullary involvement cured by preoperative chemotherapy. M.R.I. can overestimate a PES with intense inflammatory reactive tissue inside the medullary canal.

Results

Out of 175 Ewing of bone of our file, only 7 (4 %) could be classified as PES. 6 involved the femoral bone (4 diaphyseal orand 2 metaphyso diaphyseal) and one the tibia (distal metaphysis). Age of patients at biopsy ranged 11 to 19. Two patients have been referred to us after biopsy. One was irradiated before we saw her. According to Ennecking classification, 3 were graded IIA and 4 II B. All patients were treated by resection after preoperative chemotherapy. With an median follow up of 198 months, all 7 patients are event free survivors.

In three cases a transcortical biopsy was performed compelling to perform a resection interrupting the long bone continuity; Two patients were reconstructed with long stem prosthesis and were re operated 2 and 4 times during the 18 and 19 years of follow up. For the distal tibia the limb salvage using allograft and vascularized fibula was followed by pseudarthrosis then infection with a total of 6 operations (in 3 years) before cure. In four cases the biopsy did not open the medullary bone; Nevertheless in three case sthe local extension compells to interrupt the long bone continuity before allograft reconstructions with 2 excellent and 1 good long-term results. The last case could benefit of partial resection of bone with cement filling and excellent immediate result.

Comments.With these cases (6 had been already reported), only 35 cases of PES have been described, 32 / 35 located on long bones. Most were stage II disease, treated by chemotherapy and surgery. At last follow up 33 / 35 patients (94 %) were in first remission confirming the good prognostic value of PES.

Conclusions.The surgical consequences of PES must be underlined. When computed imaging permits to suspect this diagnosis biopsy should be confined to the soft tissues and/or the cortical bone without medullary contamination. Such a procedure eventually permits subsequent partial resection without interruption of the bone continuity, allowing easier reconstruction and much better long term functional results.

 

système de santé Nice AMETIST 16 NOV 2019

cliquez sur le lien pour dérouler le diaporama de la conférence donnée à Biot le 16 NOV 2019

 

 

GUERIR NOTRE SYSTEME DE SANTE EN QUELQUES GRANDES REFORMES PAR RETOUR A LA LIBERTE DE SOIGNER ET D ETRE SOIGNE

 

Il faut une volonté politique plus que de l’argent magique : déplacer les sommes colossales détournées par la technocratie, les rendre aux hôpitaux publics et à la médecine libérale, pour redonner des couleurs à nos soignants et à nos structures de soins et donc à nos patients

Comment : en rendant la liberté thérapeutique, tarifaire, organisationnelle aux médecins libéraux et autres professionnels de santé, aux établissements publics et privés, en les libérant du joug bureaucratique créé par les ministères successifs depuis des décennies, en supprimant les agences régionales de santé

Du temps où notre système de santé était au premier rang mondial, les médecins de ville, les cliniques privées, les hôpitaux publics, ainsi que les autres professionnels de santé (dentistes, opticiens, kinésithérapeutes, psychologues etc) avaient de grandes libertés de manœuvre, tant thérapeutiques, tarifaires, qu’organisationnelles. Les individus devaient démontrer leurs compétences par leurs diplômes nationaux, et une fois ceux-ci obtenus, exercer leur art en toute indépendance, comme il sied pour une profession libérale dans une démocratie. Les patients étaient là pour protester en cas de problèmes (justice), et il n’y avait pas besoin de gendarme derrière chaque médecin, chaque kinésithérapeute, chaque dentiste pour qu’ils fassent efficacement et honnêtement son métier.

Les jeunes médecins, qui n’ont pas exercé avant les années 2000, n’imaginent pas la vie sans ARS. Classé premier système de santé au monde en 1998, le système mis au point par le Conseil National de la Résistance (ordonnances 4 et 19 octobre 1945), la sécurité sociale, était robuste et a mis plusieurs décennies à craquer. Nous y sommes.

Nous parlerons ensemble des outils du pouvoir pour contraindre les soignants et malades : les agences régionales de santé, mortifères qu’il faut supprimer, et la main-mise de l’état sur la sécurité sociale en vente au privé.

 

voir aussi sur agoravox nos tribunes sur la bureaucratie mortifère  qui a tué notre système de santé ou sur ce site

 

 

 

 

 

colloque bobigny 2017 resultats-pivots

Colloque_2017_bobigny-poster-SSP_G_DELEPINE

two presentations in french  with curves of the results

 

“Are the results of pivotal studies in oncology reliable?”

by G. Delépine, N. Delépine, S. Alkhallaf

 

 

 

Introduction

Over the last fifteen years, the authorization to put innovative therapies on the market has been granted after one or sometimes two short placebo-controlled studies on a small number of patients. To see if these pivotal studies are reliable, we compared their initial results with the latest published results.

 

Material and methods

A computerized search with key words Avastin, herceptin, erbitux, erlotinib, sorafenib, gefitinib, crizotinib, afatinib, temsirolimus, pazopanib, sunitinib, axitinib, in bronchopulmonary squamous cell carcinoma, kidney, colon, breast and ENT cancers has been realized to find 42 pivotal studies. We then looked for those with distant results specifying the duration of progression-free survival, Overall survival and toxicity were published (32) and compared the results of the pivotal studies with those of the last trials on these three criteria.

 

Results

Less than 30% of the results presented to the regulatory agencies during marketing authorization applications are fully confirmed by subsequent trials. 20% of them are confirmed for 1 or 2 criteria. The discrepancies observed between initial and late results are always in the direction of greater efficacy or less toxicity of the new drug in the pivotal study.

 

Conclusions

In targeted therapies of solid tumors the favourable initial results of the pivotal studies are rarely confirmed by subsequent publications and the discrepancy still favours the new drug, suggesting that many of these trials do not represent real population use and that some of them benefited from the  » improvement  » of their results before presentation to regulatory agencies.

 

 

Conference « Overconsumption, overtreatment » of Medicine Faculty of Bobigny, Seine Saint Denis (France)

Summary of a communication (April 2017)

 

 

SEE  THE POSTER http://surmedicalisation.fr/?page_id=4556#Gerard_DELEPINE1  IN FRENCH

 

 

 

 

15 5 2019 gardasil chicago (002) 5     diaporama 

Paradoxical oncologic results of Gardasil in the real world. A cancer registers study.

Dr G Delépine, surgeon oncologist, Paris, France[1] N Delépine paediatric oncologist, Paris, France[2]

Oral presentation by Dr G Delépine 24 th of may 2019 Chicago Illinois USA

Summary

Aim: the authors evaluate the results of HPV vaccination on the incidence of invasive cervical cancer in different countries, comparing published data in national cancer registries and those of HPV vaccine coverage.

Method. After collecting crude figures and standardized incidences from oncologic registers of Australia (Australian Institute of Health and Welfare), Great Britain (Cancer research UK), Sweden and Norway (Nordcan), they analyse the evolution and their tendencies before and after the era of vaccination in the different countries and different age groups, with a particular attention to 20-29 age groups(high vaccine coverage).

Results In all studied countries, these evolutions are similar. During the 1989-2007 ( pre-anti HPV vaccination period), the incidence of invasive cervical cancer declined in all countries, results linked with smear screening.

Vaccination campaigns were initiated in 2007 (Australia) or 2008 (Great Britain), and we have now 7 to 9 years of follow up. Since 2007, a trend reversal has been observed in all countries with high immunization coverage studied (Australia, Great Britain, Norway, Sweden). Their official cancer registries reveal an increase in the incidence of invasive cervical cancer that appears 3 to 5 years after the beginning of the vaccination campaign and affects almost exclusively the age groups the most vaccinated.

In 20-24 group the increase reaches 100% in Sweden (1.86/100000 in 2007 vs 3.72 in 2015), 70% in Great Britain, (2,7 in 2007 vs 4,6 in 2014), 113% in Australia (0.7 vs 1.5), 10% in Norway (2.18 in 2007 vs 2.4 in 2015). In the 25-29 age groups, the increase reaches 100% in Great Britain (11 in 2007 vs 22 in 2016), 36% in Australia (5.9 in 2007 vs 8 in 2014), 9% in Norway (5.9 in 2007 vs 8 in 2015),10% in Sweden.

The crude figures are small, and, for this reason, the differences are individually not all statistically significant, but their convergence constitute a strong alarm signal, while unvaccinated (older women) have their risk of cervical cancer stabilized or continuing to decrease.

Comments. The contrast of the increasing rate of invasive cancer despite nearly eradication of HPV viruses after vaccination is paradoxical.

For vaccinated women, the evolution is dramatic. In France, a country with low vaccination coverage (<20%), the world standardized incidence rate of cervical cancer continues to decline in all age groups and is now lower (2017ASR 6/100000) than of more vaccinated countries

Conclusion. This unexpected paradoxical result, absolutely distressing for vaccinated women, requires additional studies to determine as quickly as possible the causes of such a health disaster and justifies an immediate review of vaccine recommendations.

[1] No link of financial interest with any drug company or anti-vaccine association

 

[2] Idem 1

 

Venez participer au colloque annuel de Bobigny :   Colloques de Bobigny

et en particulier à nos présentations

 

nous y présenterons un résumé de nos travaux sur Gardasil et cancer 

samedi 25 Mai atelier n° 3 Les vaccins.  10 H30 -12H30

 

 » Les « Colloques de Bobigny », constituent la première manifestation scientifique et de réflexion sur la thématique « Sous-médicalisation, Surmédicalisation, Surdiagnostics, Surtraitements », déjà organisée à sept reprises en France par le groupe d’initiative Princeps, avec le concours de :

– Le Département de Médecine Général de la Faculté de Médecine de Bobigny,

– La Société de Formation Thérapeutique du Généraliste

– L’Association « Civic Santé »

Ce colloque se tiendra, sous le patronage du Doyen de la Faculté de Médecine de Bobigny (UFR SMBH), les vendredi 24 et samedi 25 mai 2019, Faculté de médecine de Bobigny (entrée avenue de la Convention)

Le montant de l’inscription est de 40 euros (20 euros pour les étudiants et Internes en Médecine).

Ces frais d’inscription très limités, qui comprennent les accueils et pauses café, le repas de midi du vendredi, et l’intendance du colloque, ne sont possibles que grâce aux locaux mis à disposition par la Faculté de médecine de Bobigny, et l’engagement de la SFTG. Cette modeste somme est le prix de notre indépendance.

Les inscriptions doivent être adressées à la SFTG, 233 bis rue de Tolbiac 75013 Paris, avec la mention « Colloque de Bobigny ». L’inscription en ligne est possible : ici.

Vous pouvez également télécharger ici le bulletin d’inscription, le remplir et l’adresser à la SFTG

N’hésitez-pas à diffuser à vos réseaux ou connaissances cette invitation Le groupe Princeps »

 

Devant la découverte de l’effet paradoxal du vaccin Gardasil qui augmente le risque du cancer du col de l’utérus chez les femmes vaccinées de façon systématique dans tous les pays dont le taux élevé de sujets vaccinés, permet une analyse statistique significative, nous avons décidé d’approfondir le problème, et de tenter de livrer ce travail à la population générale  le fruit de cette découverte.

La présentation du DR G Delépine, chirurgien et statisticien, à Perpignan le 23 Novembre 2018  détaille les courbes comparatives de taux de cancer du col de l’utérus, avant et après vaccination large des populations.

Gardasil G Delépine 22 11 2018 présentation Perpignan

n’hésitez pas à ouvrir le diaporama, ou à nous joindre si vous avez des questions, suggestions, commentaires

 

Parlement de Wallonie Bruxelles 24/9/2018 présentation du DR Gérard Delépine à la commission d’enquête des députés sur une proposition de loi tendant à généraliser le Gardasil

 

Gardasil  cliquez sur le diaporama
présentation des résultats avérés sur le cancer du col Rapport aux Députés de Wallonie v2