Systémová enzymoterapie pro odborníky
Chcete zobrazit informace, které jsou určeny výhradně odborníkům (podle § 2a zákona č. 40/1995 Sb., o regulaci reklamy, v platném znění), tedy osobám oprávněným léčivé přípravky předepisovat, nebo vydávat.
  1. Kliknutím na tlačítko "ANO" výslovně prohlašuji a potvrzuji, že jsem odborníkem, tedy osobou oprávněnou léčivé přípravy vydávat či předepisovat. V případě, že nepatříte mezi osoby oprávněné léčivé přípravky předepisovat, nebo vydávat, opusťte prosím tyto stránky stisknutím tlačítka NE.
  2. Kliknutím na tlačítko "ANO" výslovně prohlašuji a potvrzuji, že je mi známa definice odborníka. V případě, že nikoliv nebo v případě, že nepatříte mezi osoby oprávněné léčivé přípravky předepisovat, nebo vydávat, opusťte prosím tyto stránky stisknutím tlačítka NE.
  3. Pro případ, že nejsem odborníkem, pak jsem seznámen s riziky, kterým se vystavuji v důsledku možného chybného vyhodnocení informací, které jsou určeny odborníkům, přičemž tato rizika zcela akceptuji.
Přejete-li si pokračovat a tím potvrdit, že jste tímto odborníkem, stiskněte ANO.
AnoNe
Úvod pro odborníky        O firmě        Kontakty        Pomáháme druhým        Poradna        Stránky pro laiky         wobenzym.info
Literatura


Efficacy and tolerability of proteolytic enzymes as an anti-inflammatory agent in lymphoedema after axillary dissection due to mammary cancer


Lymphoedema is a chronic disease caused by the damage of lymphatic vessels due to surgical treatment and/or radiotherapy (secondary). Another cause is the malformation or lack of lymphatic vesels (primary).
The aim of the study was to demonstrate the efficacy and tolerability of the proteolytic enzyme combination preparation Wobenzym in additional reduction of arm volume (primary criterion) in patients with secondary lymphedema after dissection of axillary nodes due to mammary cancer. Secondary criteria were improvement of the skinfold thickness, CRP values, tension, and global judgement of the efficacy by both investigator and patient.
The study population comprised of 88 female patients aged between 30 and 80 with one sided secondary arm lymphedema after dissection of the axillary lymph nodes (level I or II according to the St. Gallen consensus conference) due to mammary cancer, who have been treated with combined decongestive therapy. All patients received the standard treatment - a combined decongestive therapy, comprising the manual lymphatic drainage on affected sites with consecutive bandaging of the affected arm and specially designed exercises and skin care from day 1 to day 20. The test group of patients received additionally Wobenzym at a dose of 5 coated tablets three times daily over 6.5 weeks.
Both treatment groups were well comparable. The median time between the lymph node dissection and the baseline visit was 47.5 months in the Wobenzym group and 48 months in the placebo group.
For measuring the indicator volume reduction in arm lymphedema, a Volometer was used. For the indicator tension, a four point rating scale was used. All the measurements were carried out on days 1, 9, 19, and 45 (final visit). CRP value was measured on days 1 and 19.
On the ill arm both groups showed a decrease of volume until visit 4 (day 45). Both groups showed an almost identical course of the volumetric development between baseline visit and final end point visit, although there was a slight superiority of Wobenzym for the development between visit 3 and 4 with regard to the percent changes of –5% and more without statistical significance.
Both groups showed the greatest decrease of skinfold thickness between visits 2 and 3 with a very similar development between baseline visit and final visit with regard to the results of the ill arm.  The results of the percent changes from baseline with regard to visit 2, 3, and 4 showed a mean reduction by –29.84% for the verum group and –15.73% for placebo group. The development between visit 3 and 4 showed only slight superiority for the verum group. 
Both groups showed an almost similar decrease of tension in the ill arm until visit 4. A percent change of 100 % (total improvement) was reached by 62.79 % patients in the Wobenzym group and by 47.62 % patients in the placebo group. The percent changes between visits 3 and 4 – time where no concomitant combined decongestive therapy was applied – showed a clear superiority of the Wobenzym treated patients.
CRP was measured at visit 1 (baseline) and 3 (day 19). Wobenzym group showed better results than placebo group with regard to the CRP development between baseline visit and visit 3: out of 15 patients with high baseline findings five patients normalized in the Wobenzym group. Out of 13 patients with high baseline findings in the placebo group, only one patient normalized. For patients with high CRP-values at baseline there has been mean percent change from baseline of –39.8%, while in the placebo group –17.4%. There was a clear superiority for the verum group with regard to the CRP development between visit 1 and 3.
Overall, 15 adverse events were recorded, 7 for the verum group and 8 for the placebo group. The adverse events in the verum group were all gastrointestinal complaints of moderate intensity and rated as possibly (6 cases) or definitely (1 case) related to the study medication. All the patients showing adverse events completely recovered without sequelae.
All in all, the study failed to demonstrate efficacy in edema-related criteria (most likely due to extensive concomitant physical therapy in all patients) but demonstrated efficacy of Wobenzym with regard to the inflammation-related criteria. The inflammation-related criteria showed more than small superiority of Wobenzym. Moreover, for the subgroup “no chemotherapy” the inflammation-related criteria showed more than medium-sized superiority of Wobenzym. Reduced inflammatory tissue conditions are the basis for minimizing fibrosis thus preventing further inflammation and infection.


Source: The European Journal of Lymphology, 2002-2003, 10 (37-38), 18-26, author: Kasseroller R., Wenning H.G.

 

Datum aktualizace stránky: 19. 1. 2016
Zkrácené informace přípravků Wobenzym a Phlogenzym
Volně prodejné léky. Bez úhrady ze zdrojů veřejného zdravotního pojištění.

Inzertní stránky společnosti MUCOS Pharma CZ, s.r.o. - tel: (+420)-267 750 003