Systémová enzymoterapie pro odborníky

Phlogenzym^® in patients with relapsing urinary tract infections

Efficacy and tolerance
Study Nr.: MU-692411
Randomized double blind clinical phase III (acc. to German drug law) trial with two paralIel groups against Placebo

Primary Investigator: Dr. med. Peter Schlüter

Gartenstraße 96, D-69502 Hemsbach, Germany

Report by: MUCOS Pharma GmbH & Co, Abt. Klinische Forschung, Kirchplatz 8, D-82538 Geretsried, Germany

Summary

Efficacy and tolerance of the enzyme combination preparation Phlogenzym^® were tested in a randomized double blind clinical phase III (acc. to German drug law) trial with two paralIel groups in patients with relapsing urinary tract infections (UTI) as compared with placebo.

Forty (40) patients with the typical symptoms of UTI (as pollakisuria, nycturia, dysuria, imperative strangury, painful micturition and suprapubic pain) were taken into this study.

All 40 patients received an antibacterial therapy during the first week. Twenty (20) patients took the test preparation Phlogenzym^® and another 20 patients got placebo: each two tablets t.i.d. of the active or the placebo drug, resp., for three weeks. The data of all 40 patients were evaluable.

The primary investigator was Peter Schlüter. M.D., Gartenstrasse 16, D-69502 Hemsbach, Germany.

At baseline, the groups were comparable with regard to age, sex, height and weight, and the six symptoms of UTI mentioned above (p > .05 in Wilcoxon- Mann-Whitney-U-test).

A sum score of the six clinical symptoms was defined as main endpoint for efficacy. Secondary criteria were urinalysis, blood picture and serum diagnosis, and global judgement of efficacy by physician and patients.

The main endpoint "sum score" showed a statistically significant superiority (p < .0001 ) in favor of Phlogenzym^® at days 3, 7, and 14.

The inflammation was healed in all patients at day 14 in the Phlogenzym^® group, whereas some patients still had UTI at day 14 and even day 21 in the placebo group.

Laboratory values from urinalysis, typical for UTI normalized earlier in the Phlogenzym^® group, with several significant differences (p < .05).

Improvement of ESR and reduction of leucocytes in the blood correlated with the decrease of inflammation.

Physician and patients judged the efficacy of Phlogenzymâ significantly superior to that of placebo (p < .0001, and p = .0002, resp.).

The tolerance was excellent, as seen from the global judgement of tolerance by physician and patients, as well as from the complete lack of unwanted side effects.


Úvod pro odborníky O firmě Kontakty Pomáháme druhým Poradna
Zánět a jeho ovlivnění SET Zvýšení využitelnosti antibiotik proteolytickými enzymy Angiologie, flebologie Diabetologie Gynekologie Chirurgie, traumatologie, ortopedie Imunologie Lymfologie ORL Pediatrie Revmatologie Sportovní medicína Stomatologie Urologie Literatura Časopisy s Impact faktorem Ostatní literatura SPC Wobenzym SPC Phlogenzym	Phlogenzym^® in patients with relapsing urinary tract infections Efficacy and tolerance Study Nr.: MU-692411 Randomized double blind clinical phase III (acc. to German drug law) trial with two paralIel groups against Placebo Primary Investigator: Dr. med. Peter Schlüter Gartenstraße 96, D-69502 Hemsbach, Germany Report by: MUCOS Pharma GmbH & Co, Abt. Klinische Forschung, Kirchplatz 8, D-82538 Geretsried, Germany Summary Efficacy and tolerance of the enzyme combination preparation Phlogenzym^® were tested in a randomized double blind clinical phase III (acc. to German drug law) trial with two paralIel groups in patients with relapsing urinary tract infections (UTI) as compared with placebo. Forty (40) patients with the typical symptoms of UTI (as pollakisuria, nycturia, dysuria, imperative strangury, painful micturition and suprapubic pain) were taken into this study. All 40 patients received an antibacterial therapy during the first week. Twenty (20) patients took the test preparation Phlogenzym^® and another 20 patients got placebo: each two tablets t.i.d. of the active or the placebo drug, resp., for three weeks. The data of all 40 patients were evaluable. The primary investigator was Peter Schlüter. M.D., Gartenstrasse 16, D-69502 Hemsbach, Germany. At baseline, the groups were comparable with regard to age, sex, height and weight, and the six symptoms of UTI mentioned above (p > .05 in Wilcoxon- Mann-Whitney-U-test). A sum score of the six clinical symptoms was defined as main endpoint for efficacy. Secondary criteria were urinalysis, blood picture and serum diagnosis, and global judgement of efficacy by physician and patients. The main endpoint "sum score" showed a statistically significant superiority (p < .0001 ) in favor of Phlogenzym^® at days 3, 7, and 14. The inflammation was healed in all patients at day 14 in the Phlogenzym^® group, whereas some patients still had UTI at day 14 and even day 21 in the placebo group. Laboratory values from urinalysis, typical for UTI normalized earlier in the Phlogenzym^® group, with several significant differences (p < .05). Improvement of ESR and reduction of leucocytes in the blood correlated with the decrease of inflammation. Physician and patients judged the efficacy of Phlogenzymâ significantly superior to that of placebo (p < .0001, and p = .0002, resp.). The tolerance was excellent, as seen from the global judgement of tolerance by physician and patients, as well as from the complete lack of unwanted side effects.
	Lék pro vnitřní užití. Čtěte pečlivě příbalovou informaci. Inzertní stránky společnosti MUCOS Pharma CZ, s.r.o. - tel: (+420)-267 750 003