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1. IN879/DELNP/2004 - A MEDICINE FOR TREATING BENIGN PROSTATE HYPERPLASIA AND REDUCING THE LEVEL OF PROSTATE SPECIFIC ANTIGEN DUE TO BENIGN PROSTATE CONDITIONS AND A METHOD OF PREPARING AND USING THE SAME

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[ EN ]
Claims appended herewith. DETAILED DESCRIPTION OF THE INVENTION The instant invention derived from the observation that the human prostate comprises a modified sebaceous gland and that, given the many years of usage of successful Accutane/ isotretinoic/ retinoic acid in the treatment of acne, this through the shrinking of sebaceous glands within the face and neck, that a similar action might occur upon the prostate gland if Accutane were taken as an oral medication.Operating with the informed consent of approximately twelve patients exhibiting either or both an elevated PSA, that is, patients with a PSA of greater man 4 mg/ml and/or with exhibiting benign prostatic hyperplasia, the patients were treated with Accutane manufactured by Roche.The treatment method involves essentially two periods: an initial treatment, and a sustaining treatment. First, in the initial treatment the patients orally administrate an initial dosage about 40 mg of 13-cis-retinoic acid daily for a period from about ten days to about twenty days. Thereafter, the patients orally administrate a sustaining dosage about 40 mg of 13-cis-retinoic acid about every five to seven days in a sustaining period. Typically, the sustaining period is about one year. However, it can be extended longer if extended maintenance is needed. Preferably, the initial treatment period is about fourteen days, because beyond fourteen days side effects of the medicine, such as tenderness at sites of old injuries to the fibro-musculo-skeletal system, dry skin, chapped lips, dry eyes, and dry nose, tend to occur. If these side effects occur during the initial treatment period, they normally subside after the sustaining dosage is instituted.In the initial treatment, 40 mg of 13-cis-retinoic acid can be administrated in a single dose, or divided doses. Commercially, Accutane has three available doses, 10 mg, 20 mg, and 40 mg soft gelatin capsules. The patients can either take one 40 mg capsule, or take two 20 mg capsules daily. The same applies to the dosage in the sustaining treatment. For convenience, the patients can take one 40 mg dose every five to seven days.The initial dosage of about 40 mg 13-cis-retinoic acid daily is determined based on average men's body weight of about 160 lbs, i.e. at about 0.2S mg/lb of body weight. For patients who weigh substantially above or less than the average body weight, the dosage described above can be adjusted accordingly. The same principle applies to the sustaining dosage.The 13-cis-retinoic acid used for the purpose of the present invention can be in various forms, such as powders, pills, capsules, tablets, and liquids. The liquids comprise 13-cis-retinoic acid in a suitable pharmaceutical media, such as water, glycols, oils, alcohols, and syrups. Other suitable examples of pharmaceutical media include beewax. butvlated hvdroxvanisole. edetate disodium. hvdrogenated soybean oil flakes, hvdroeenated vegetable oil, glycerin and combination thereof, which have been used in capsule form.This treatment method resulted in subjective as well as objective amelioration of benign prostatic hyperplasia and symptoms thereof, and a measurable reduction in the prostate specific antigen (PSA). In particular, through examination of these patients and through their own anecdotal comments, a reduction in prostate enlargement was confirmed. Furthermore, the blood test results showed that PSA levels had been dramatically reduced to levels in a range of 0 to 2 mg/ml among these patients.Example 1 to 4 illustrate clinical effectiveness of the above described treatment method. It was found that none of the conditions of these patients worsened either in terms of PSA or hyperplasia, and none progressed into any form of diagnosable malignancy. Further, no serious adverse side effects or contra-indications of any kind were observed among the patients in the informal trials. Example 1A patient started a slowly progressive prostatic enlargement and attenuated urine stream 20 years ago. Hand examination confirmed a palpably enlarged prostate, probably secondary to post vasectomy prostatitis.The patient was placed on Accutane 40 mg orally for 14 days in the initial treatment. Then he was placed on sustaining dose of 40 mg every 5 days for about one year.The patient's symptoms improved steadily. His prostate decreased in palpable size, and PSA dropped from 4 to less than one.No adverse side effects were noted other than drying of lips and some musculo-skeletal soreness at sites of old injuries to the fingers and neck. This soreness subsided slowly after the sustaining dose was instituted. Blood chemistries remained normal on this low sustaining dosage.Example 2The patient had prior histories of urethritis and prostatitis from sexually transmitted diseases. The patient had steadily increasing prostatic enlargement, with decreasing urine flow, plus urgency and nocturia. PSA was 3, and prostate palpably enlarged.The patient was placed on Accutane 40 mg orally for 14 days. Then the dosage was decreased to 40 mg every 5 days for about one year.The patient had steady improvement in symptoms and after 6 months PSA had dropped to less than one. No adverse side effects were observed from administration of the Accutane. Example 3A patient had history of posttraumatic prostatitis caused by a bicycle accident in 1987. The patient's condition became chronic especially after long auto trips, and required frequent courses of antibiotics and steroids to calm the inflammation. PSA was 5.The patient was placed on Accutane 40 mg daily for 14 days. Thereafter, the patient had a maintenance dosage of 40 mg every 5 days for about one year.The patient rapidly became symptom free after the initial treatment, and had remained so during the sustaining period. PSA dropped to less than 1. Example 4The patient had a history of sexually transmitted diseases in college and subsequent history of prostatitis. Enlargement of prostate was noted 6 years prior to the Accutane treatment, with steadily worsening urinary tenesmus.The patient was placed on Accutane 40 mg per day. After 14 days, the dosage was decreased to 40 mg every 5 days for about one year.The patient's symptoms readily improved and PSA dropped from 4 to less than 1 within 6 months.While there has been shown and described the preferred embodiment of the instant invention it is to be appreciated that the invention may be embodied otherwise than is herein specifically shown and described and that, within said embodiment, certain changes may be made in the form and arrangement of the parts without departing from the underlying ideas or principles of this invention as set forth in the Claims appended herewith.