ITMI20011705A1 - NON-ASTEROID ANTI-FLAMMERS FOR RECTAL TREATMENT DIOLIGASTENOSPERMIA - Google Patents
NON-ASTEROID ANTI-FLAMMERS FOR RECTAL TREATMENT DIOLIGASTENOSPERMIA Download PDFInfo
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- ITMI20011705A1 ITMI20011705A1 IT2001MI001705A ITMI20011705A ITMI20011705A1 IT MI20011705 A1 ITMI20011705 A1 IT MI20011705A1 IT 2001MI001705 A IT2001MI001705 A IT 2001MI001705A IT MI20011705 A ITMI20011705 A IT MI20011705A IT MI20011705 A1 ITMI20011705 A1 IT MI20011705A1
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- Prior art keywords
- varicocele
- treatment
- cinnoxicam
- flammers
- dioligastenospermia
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- 201000004822 varicocele Diseases 0.000 claims description 15
- 229950001983 cinnoxicam Drugs 0.000 claims description 11
- GPUVGQIASQNZET-CCEZHUSRSA-N cinnoxicam Chemical group C=1C=CC=CC=1/C=C/C(=O)OC=1C2=CC=CC=C2S(=O)(=O)N(C)C=1C(=O)NC1=CC=CC=N1 GPUVGQIASQNZET-CCEZHUSRSA-N 0.000 claims description 11
- 229940021182 non-steroidal anti-inflammatory drug Drugs 0.000 claims description 9
- 239000002253 acid Substances 0.000 claims description 3
- 150000007513 acids Chemical class 0.000 claims description 3
- 229940111133 antiinflammatory and antirheumatic drug oxicams Drugs 0.000 claims description 3
- 239000003814 drug Substances 0.000 claims description 3
- 239000000041 non-steroidal anti-inflammatory agent Substances 0.000 claims 2
- 238000002560 therapeutic procedure Methods 0.000 description 6
- 239000000902 placebo Substances 0.000 description 4
- 229940068196 placebo Drugs 0.000 description 4
- 230000000694 effects Effects 0.000 description 3
- 150000003180 prostaglandins Chemical class 0.000 description 3
- 230000002381 testicular Effects 0.000 description 3
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 2
- 208000007466 Male Infertility Diseases 0.000 description 2
- 230000004075 alteration Effects 0.000 description 2
- 238000000540 analysis of variance Methods 0.000 description 2
- 239000007920 enema Substances 0.000 description 2
- 229940079360 enema for constipation Drugs 0.000 description 2
- 238000009472 formulation Methods 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 229940094443 oxytocics prostaglandins Drugs 0.000 description 2
- 230000021595 spermatogenesis Effects 0.000 description 2
- 238000004659 sterilization and disinfection Methods 0.000 description 2
- 239000000829 suppository Substances 0.000 description 2
- 238000001356 surgical procedure Methods 0.000 description 2
- 230000001225 therapeutic effect Effects 0.000 description 2
- 210000003462 vein Anatomy 0.000 description 2
- 241000792859 Enema Species 0.000 description 1
- 241000282412 Homo Species 0.000 description 1
- HEFNNWSXXWATRW-UHFFFAOYSA-N Ibuprofen Chemical compound CC(C)CC1=CC=C(C(C)C(O)=O)C=C1 HEFNNWSXXWATRW-UHFFFAOYSA-N 0.000 description 1
- CMWTZPSULFXXJA-UHFFFAOYSA-N Naproxen Natural products C1=C(C(C)C(O)=O)C=CC2=CC(OC)=CC=C21 CMWTZPSULFXXJA-UHFFFAOYSA-N 0.000 description 1
- 206010033307 Overweight Diseases 0.000 description 1
- 230000003110 anti-inflammatory effect Effects 0.000 description 1
- 230000037396 body weight Effects 0.000 description 1
- 239000000969 carrier Substances 0.000 description 1
- 230000001684 chronic effect Effects 0.000 description 1
- 229960001259 diclofenac Drugs 0.000 description 1
- DCOPUUMXTXDBNB-UHFFFAOYSA-N diclofenac Chemical compound OC(=O)CC1=CC=CC=C1NC1=C(Cl)C=CC=C1Cl DCOPUUMXTXDBNB-UHFFFAOYSA-N 0.000 description 1
- 230000010339 dilation Effects 0.000 description 1
- 238000002651 drug therapy Methods 0.000 description 1
- 230000035558 fertility Effects 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 235000011187 glycerol Nutrition 0.000 description 1
- 229960001680 ibuprofen Drugs 0.000 description 1
- 208000000509 infertility Diseases 0.000 description 1
- 230000036512 infertility Effects 0.000 description 1
- 231100000535 infertility Toxicity 0.000 description 1
- 230000004968 inflammatory condition Effects 0.000 description 1
- 239000003112 inhibitor Substances 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- DKYWVDODHFEZIM-UHFFFAOYSA-N ketoprofen Chemical compound OC(=O)C(C)C1=CC=CC(C(=O)C=2C=CC=CC=2)=C1 DKYWVDODHFEZIM-UHFFFAOYSA-N 0.000 description 1
- 229960000991 ketoprofen Drugs 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 238000012544 monitoring process Methods 0.000 description 1
- 229960002009 naproxen Drugs 0.000 description 1
- CMWTZPSULFXXJA-VIFPVBQESA-N naproxen Chemical compound C1=C([C@H](C)C(O)=O)C=CC2=CC(OC)=CC=C21 CMWTZPSULFXXJA-VIFPVBQESA-N 0.000 description 1
- 231100000957 no side effect Toxicity 0.000 description 1
- 238000010606 normalization Methods 0.000 description 1
- 230000007170 pathology Effects 0.000 description 1
- 229960002702 piroxicam Drugs 0.000 description 1
- QYSPLQLAKJAUJT-UHFFFAOYSA-N piroxicam Chemical compound OC=1C2=CC=CC=C2S(=O)(=O)N(C)C=1C(=O)NC1=CC=CC=N1 QYSPLQLAKJAUJT-UHFFFAOYSA-N 0.000 description 1
- 230000008092 positive effect Effects 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 229960002871 tenoxicam Drugs 0.000 description 1
- WZWYJBNHTWCXIM-UHFFFAOYSA-N tenoxicam Chemical compound O=C1C=2SC=CC=2S(=O)(=O)N(C)C1=C(O)NC1=CC=CC=N1 WZWYJBNHTWCXIM-UHFFFAOYSA-N 0.000 description 1
- 230000009466 transformation Effects 0.000 description 1
- 238000002604 ultrasonography Methods 0.000 description 1
Landscapes
- Saccharide Compounds (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Description
Descrizione del brevetto per invenzione industriale avente per titolo: Description of the patent for industrial invention entitled:
ANTIINFIAMMATORI NON STEROIDEI PER IL TRATTAMENTO PER VIA RETTALE DI OLIGOASTENOSPERMI A” NON-STEROID ANTI-INFLAMMATORS FOR THE RECTAL TREATMENT OF OLIGOASTENOSPERMS A "
La presente invenzione ha per oggetto l’uso di antiinfiammatori non steroidei somministrabili per via rettale per la preparazione di medicamenti per il trattamento per via rettale di oligoastenospermia, in particolare di oligoastenospermia associata a varicocele. The present invention relates to the use of non-steroidal anti-inflammatory drugs that can be administered rectally for the preparation of medicaments for the rectal treatment of oligoasthenospermia, in particular of oligoasthenospermia associated with varicocele.
STATO DELL’ARTE STATE OF THE ART
Attualmente il vericocele viene ritenuto la causa più facilmente diagnosticabile e correggibile di infertilità maschile, difatti sono presenti in letteratura una gran quantità di lavori a proposito della terapia chirurgica. La chirurgia del varicocele è la chiusura (legatura o sclerotizzazione) delle vene spermatiche interne che in questa patologia sono dilatate: questo approccio si basa sul concetto che l oligoastenospermia sia secondaria alla dilatazione venosa la quale provocherebbe una serie di alterazioni del parenchima testicolare. Vericocele is currently considered the most easily diagnosed and correctable cause of male infertility, in fact there are a large number of works in the literature on surgical therapy. Varicocele surgery is the closure (ligation or sclerotization) of the internal spermatic veins that are dilated in this pathology: this approach is based on the concept that oligoasthenospermia is secondary to venous dilation which would cause a series of alterations of the testicular parenchyma.
Modelli sperimentali hanno però dimostrato che, invece della dilatazione venosa, sia un iperafflusso arterioso ad ingegnare le alterazioni della spermatogenesi (Human Reprod.Updaate 7: 78-84, 2001. J. Urol. 145:282-A, 1991); tale dato è stato confermato da studi ecocolordoppler sull’uomo ove è riscontrabile un iperafflusso arterioso in oligoastenosopermici portatori di varicocele (Urology 44: 535-539, 1994 - Benoff S., Gilbert B.: Varicocele and male fertility. Pari I: preface. Human Reprod.Update 7: 478-84, 2001). Inoltre la dilatazione venosa non è sufficiente a provocare le alterazioni istopatologiche del parenchima testicolare in corso di oligoastenosperinia associata a varicocele (Fertil.Steril.: 73, 459-464, 2000). Inoltre il ruolo della chirurgia è stato messo pesantemente in dubbio da recenti lavori caso-controllo e da successive meta-analisi di revisione della letteratura (Benoff. S., Gilbert B.: Varicocele and male fertility. Pari I: preface. Human Reprod.Update 7: 478-84, 2001), a tal punto che il Royal College of Ostetricians and Gynaecologysts è stato portato a concludere nel corso del 35° gruppo di studio (35<th >RCOG Study Group 1998): “There is insufficient evidence to recommend occlusion of thè left internai spermatic vein in subfertile or oligozoospermic men with varicocele”. However, experimental models have shown that, instead of venous dilatation, it is an arterial hyperflow to engineer the alterations in spermatogenesis (Human Reprod.Updaate 7: 78-84, 2001. J. Urol. 145: 282-A, 1991); this data has been confirmed by echocolordoppler studies on humans where an arterial overflow is found in oligoasthenosopermic carriers of varicocele (Urology 44: 535-539, 1994 - Benoff S., Gilbert B .: Varicocele and male fertility. Pari I: preface. Human Reprod. Update 7: 478-84, 2001). Furthermore, venous dilatation is not sufficient to cause histopathological alterations of the testicular parenchyma in the course of oligoasthenosperinia associated with varicocele (Fertil.Steril .: 73, 459-464, 2000). Furthermore, the role of surgery has been heavily questioned by recent case-control work and subsequent meta-analyzes of literature reviews (Benoff. S., Gilbert B .: Varicocele and male fertility. Pari I: preface. Human Reprod. Update 7: 478-84, 2001), to such an extent that the Royal College of Obstetricians and Gynaecologysts was led to conclude during the 35th study group (35 <th> RCOG Study Group 1998): "There is insufficient evidence to recommend occlusion of the left internoi spermatic vein in subfertile or oligozoospermic men with varicocele ".
Pertanto l’uso della chirurgia nella terapia del varicocele è attualmente quanto meno dubbia. Therefore, the use of surgery in the treatment of varicocele is currently at least doubtful.
Una terapia farmacologica capace di risolvere casi di oligoastenosperinia associata a varicocele sarebbe pertanto di grande utilità. A drug therapy capable of resolving cases of oligoastenosperinia associated with varicocele would therefore be of great use.
Benché esistano indicazioni preliminari su un potenziale effetto positivo di farmaci anti-infiammatori non steroidei (FANS) sulla qualità dello sperma (Fuse H., Minagawa H., Ito H., Shimazaki J.: The effects of prostaglandin sintetase inhibitor on male infertility. Hinyokika Kiyo 30: 1439-1445, 1984 -Ito H., Fuse H., Minagawa H., Kawamura K., Marukami M., Shimazaki J.: Internai spermatic vein prostaglandins in varicocele patients. Fertil.Steril. 37: 218-222, 1982 -Bendvold E., Gottlieb C., Svanborg K., Bygdeman M., Eneroth P.: Concentration of prostaglandins in seminai fluid of fertile men. Int.J.Andol. 10: 463-469, 1987), le evidenze di una loro utilità terapeutica sono del tutto preliminari e riguardano in ogni caso una somministrazione cronica per via orale. Although preliminary indications exist on a potential positive effect of nonsteroidal anti-inflammatory drugs (NSAIDs) on sperm quality (Fuse H., Minagawa H., Ito H., Shimazaki J .: The effects of prostaglandin sintetase inhibitor on male infertility. Hinyokika Kiyo 30: 1439-1445, 1984 -Ito H., Fuse H., Minagawa H., Kawamura K., Marukami M., Shimazaki J .: Internai spermatic vein prostaglandins in varicocele patients. Fertil.Steril. 37: 218- 222, 1982 -Bendvold E., Gottlieb C., Svanborg K., Bygdeman M., Eneroth P .: Concentration of prostaglandins in seminai fluid of fertile men. Int. J. Andol. 10: 463-469, 1987), the evidence of their therapeutic usefulness is entirely preliminary and in any case relates to chronic oral administration.
Si è ora trovato che i FANS, somministrati per via rettale, consentono un sorprendente miglioramento del. quadro spermatico soprattutto in casi di oligoastenospermia associata a varicocele, a dosaggi inferiori rispetto a quelli normalmente usati per il trattamento anti-infiammatorio convenzionale. It has now been found that NSAIDs, administered rectally, allow a surprising improvement of the. spermatic picture especially in cases of oligoastenospermia associated with varicocele, at lower doses than those normally used for conventional anti-inflammatory treatment.
In accordo con l’invenzione, possono essere impiegati tutti i farmaci antiinfiammatori non steroidei compatibili con la somministrazione per via rettale, quali acidi arilpropionici (ketoprofen, ibuprofen, naproxen), arilacetici (diclofenac), oxicam ( tenoxicam, piroxicam, cinnoxicam) etc. Sono comunque preferiti gli oxicam e in particolare il cinnoxicam. In accordance with the invention, all non-steroidal anti-inflammatory drugs compatible with rectal administration can be used, such as arylpropionic acids (ketoprofen, ibuprofen, naproxen), arylacetics (diclofenac), oxicam (tenoxicam, piroxicam, cinnoxicam) etc. However, oxicams and in particular cinnoxicam are preferred.
La posologia secondo l’invenzione prevede una somministrazione singola di una formulazione rettale dei FANS, quali supposte, enemi, microclismi e simili, da una volta al giorno fino a una volta ogni 6-7 giorni, preferibilmente una volta ogni 3-4giomi. Il trattamento può essere prolungato per diversi mesi, fino alla normalizzazione del quadro spermatico. Tale posologia è nettamente inferiore a quella convenzionalmente impiegata per il trattamento di condizioni infiammatorie, che richiedono più somministrazioni al giorno. The dosage according to the invention provides for a single administration of a rectal formulation of NSAIDs, such as suppositories, enemas, micro-enemas and the like, from once a day to once every 6-7 days, preferably once every 3-4 days. The treatment can be prolonged for several months, until the sperm picture is normalized. This dosage is significantly lower than that conventionally used for the treatment of inflammatory conditions, which require several administrations per day.
Nel caso del cinnoxicam, la dose singola preferita è di 30 mg, ma possono essere impiegate dosi superiori (ad esempio fino a 60-90 mg), in caso di pazienti poco sensibili e/o sovrappeso, o inferiori (10-15 mg), in caso di pazienti con peso corporeo notevolmente sotto la media o comunque sensibili al trattamento. In the case of cinnoxicam, the preferred single dose is 30 mg, but higher doses (e.g. up to 60-90 mg) can be used, in the case of insensitive and / or overweight patients, or lower (10-15 mg) , in the case of patients with body weight considerably below the average or in any case sensitive to treatment.
Nel caso degli altri FANS, la dose singola raccomandata può essere quella convenzionalmente proposta per le formulazioni già disponibili in commercio. In the case of other NSAIDs, the recommended single dose may be that conventionally proposed for formulations already available on the market.
L’efficacia dei FANS per via rettale, in particolare del cinnoxicam, nel trattamento deH’oligoastenospermia, è stata messa in evidenza da studi clinici, riportati di seguito a scopo esemplificativo. The efficacy of rectal NSAIDs, in particular cinnoxicam, in the treatment of oligoasthenospermia, has been highlighted by clinical studies, shown below for illustrative purposes.
38 pazienti affetti da infertilità primaria da 12-24 mesi, con oligoastenospermia associata a varicocele sinistro sono stati randomizzati in due gruppi: il primo gruppo è stato trattato con cinnoxicam (1 supposta, da 30 mg ogni 4 giorni per 6 mesi) mentre il secondo gruppo è stato trattato con placebo (glicerina). I pazienti sono stati controllati mediante ecocolordoppler (per valutare il volume testicolare) e spermiogrammi (in 3 campioni) prima della terapia e a 1, 3, 6 e 8 mesi dall’ inizio della terapia (l’ultimo controllo avveniva a 2 mesi dalla sospensione della terapia). I risultati della monitorizzazione ecografica gli speriogrammi sono stati espressi in termini di “sperm production rate score” così calcolato: concentrazione di spermatozoi per mi. x volume eiaculato x spermatozoi mobili di classe A/100 x spermatozoi a morfologia normale/100: giorni di astinenza x volume testicolare (Fertl.Steril. 74: 240-244, 2000): i dati sono stati analizzati mediante analisi della varianza per blocchi randomizzati (1 paziente = 1 blocco) eseguita su dati sottoposti a trasformazione angolare (Lison L.: Statistica applicata alla biologia sperimentale. Casa Editrice Ambrosiana, Milano 1972). 38 patients suffering from primary infertility from 12-24 months, with oligoasthenospermia associated with left varicocele were randomized into two groups: the first group was treated with cinnoxicam (1 suppository, 30 mg every 4 days for 6 months) while the second group was treated with placebo (glycerin). Patients were checked by echocolordoppler (to evaluate testicular volume) and spermiograms (in 3 samples) before therapy and at 1, 3, 6 and 8 months from the start of therapy (the last control took place 2 months after the suspension of the therapy). The results of the ultrasound monitoring the speriograms were expressed in terms of "sperm production rate score" calculated as follows: concentration of spermatozoa per ml. x ejaculate volume x class A motile spermatozoa / 100 x spermatozoa with normal morphology / 100: days of abstinence x testicular volume (Fertl.Steril. 74: 240-244, 2000): data were analyzed by analysis of variance by blocks randomized (1 patient = 1 block) performed on data subjected to angular transformation (Lison L .: Statistics applied to experimental biology. Ambrosiana Publishing House, Milan 1972).
14 pazienti oligoastenospermici con varicocele essenziale sinistro di II grado e 7 di III e di età media 32, range 27-34, sono stati sottoposti a terapia con cinnoxicam con le modalità indicate più sopra. 14 oligoasthenospermic patients with left grade II and 7 grade III essential varicocele and with a mean age of 32, range 27-34, underwent cinnoxicam therapy as indicated above.
11 pazienti oligoastenospermici con varicocele essenziale sinistro di II grado e 6 di III e di età media 34, range 29-36, hanno assunto placebo con le modalità indicate sopra. 11 oligoasthenospermic patients with left grade II and 6 grade III essential varicocele and with mean age 34, range 29-36, received placebo as described above.
Sono stati valutati gli effetti collaterali. Side effects were evaluated.
Risultati. Results.
I risultati ottenuti sono presentati nella figura 1. I dati sono presentati come media di 3 repliche. The results obtained are presented in Figure 1. The data are presented as a mean of 3 replicates.
L’analisi della varianza ha dimostrato che la somministrazione di cinnoxicam è in grado di influenzare in maniera statisticamente significativa lo score di spermatogenesi nei varicoceli di II grado: la normalizzazione dello score ed il suo picco massimo hanno coinciso con il 3° mese della somministrazione senza differenza significativa fra 3 e 6 mesi, a 2 mesi dalla sospensione della somministrazione di cinnoxicam lo score tornava alla linea di base del preterapia. Al contrario cinnoxicam non ha avuto alcune efficacia sullo score dei pazienti con varicocele di III grado, analogamente alla somministrazione del placebo. The analysis of variance showed that the administration of cinnoxicam is able to statistically significantly influence the spermatogenesis score in grade II varicoceles: the normalization of the score and its maximum peak coincided with the 3rd month of administration without significant difference between 3 and 6 months, 2 months after the cessation of cinnoxicam administration the score returned to the pre-therapy baseline. On the contrary, cinnoxicam did not have any efficacy on the score of patients with grade III varicocele, similar to the administration of placebo.
Nel corso di queste indagini preliminari non si sono mai verificati effetti collaterali. In the course of these preliminary investigations, no side effects have ever occurred.
II cinnoxicam somministrato a spot si è dimostrato pertanto in grado di normalizzare lo score di oligoastenospermici di II grado; tale somministrazione non si è avuta nei varicoceli di III grado e neppure col placebo. L’assenza di effetti collaterali dimostra la sostanziale innocuità di questo approccio terapeutico. The cinnoxicam administered on a spot has therefore shown to be able to normalize the score of grade II oligoasthenospermics; this administration did not occur in grade III varicoceles and not even with placebo. The absence of side effects demonstrates the substantial harmlessness of this therapeutic approach.
Claims (6)
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| IT2001MI001705A ITMI20011705A1 (en) | 2001-08-03 | 2001-08-03 | NON-ASTEROID ANTI-FLAMMERS FOR RECTAL TREATMENT DIOLIGASTENOSPERMIA |
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| IT2001MI001705A ITMI20011705A1 (en) | 2001-08-03 | 2001-08-03 | NON-ASTEROID ANTI-FLAMMERS FOR RECTAL TREATMENT DIOLIGASTENOSPERMIA |
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| Publication Number | Publication Date |
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| ITMI20011705A0 ITMI20011705A0 (en) | 2001-08-03 |
| ITMI20011705A1 true ITMI20011705A1 (en) | 2003-02-03 |
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| IT2001MI001705A ITMI20011705A1 (en) | 2001-08-03 | 2001-08-03 | NON-ASTEROID ANTI-FLAMMERS FOR RECTAL TREATMENT DIOLIGASTENOSPERMIA |
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