Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
2000-07-10
2001-03-06
Henley, III, Raymond (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
C514S356000, C514S398000, C514S561000
Reexamination Certificate
active
06197776
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates to an improved treatment for symptoms associated in humans with reactive arthritis or idiopathic bursitis.
Reactive arthritis refers to a spondyloarthritity which usually arises as a complication of an infection elsewhere in the body. Reactive arthritis can be caused by species of Shigella bacteria (most notably
Shigella flexneri
),
Yersinia enterocolitica, Campylobacter jejuni
, several species of Salmonella, genitourinary pathogens,
Chlamydia trachomatis, Neisseria gonorrhea, Ureaplasma urealyticum, Streptococcus pyogenes
, and other yet unidentified infectious agents.
Reactive arthritis commonly occurs in young men and women, but can occur at any age. Sufferers experience joint pain, stiffness, redness or swelling. Common symptoms may include fatigue, malaise, fever, and weight loss. The joints of the lower extremities, including the knee, ankle, and joints of the foot, are the most common sites of involvement, but symptoms can also occur in the wrists, fingers, elbows, shoulders, neck, and lower back. Other symptoms may include urethritis and prostatitis in males, and cervicitis or salpingitis in females. Ocular disease is common ranging from transient, asymptomatic conjunctivitis to aggressive anterior uveitis that occasionally results in blindness. Mucocutaneous lesions and nail changes are frequent. On less frequent or rare occasions manifestations of reactive arthritis include cardiac conduction defects, aortic insufficiency, central or peripheral nervous system lesions, and pleuropulmonary infiltrates.
Treatment of patients suffering from reactive arthritis with nonsteroidal anti-inflammatory drugs (“NSAID”) provides some benefit, although symptoms of reactive arthritis are rarely completely alleviated and some patients fail to respond at all. The preferred initial treatment of choice for acute reactive arthritis is indomethacin in divided doses of 75 to 150 milligrams per day. The NSAID of last resort is phenylbutazone, in doses of 100 milligrams twice or three times per day, because of its potentially serious side effects. Patients with debilitating symptoms refractory to NSAID therapy may be treated with cytotoxic agents such as azathioprine or methotrexate, or with sulfasalazine. Tendinitis, other lesions, and uveitis may benefit from corticosteroids. Minocycline hydrochloride, a semisynthetic derivative of tetracycline, is indicated for infections caused by at least Shigella microorganisms,
Streptococcus pyogenes
, and
Neisserie gonorrhoeae
. It is therefore an accepted treatment in incidents of reactive arthritis triggered by these biological entities.
Long-term follow-up studies have suggested that some joint symptoms persist in many, if not most, patients with reactive arthritis. Recurrences of the more acute symptoms are common and as many as twenty-five percent of patients either become unable to work or are forced to change occupations because of persistent joint problems.
Bursitis is inflammation of a bursa, a thin-walled sac lined with synovial tissue. The function of the bursa is to facilitate movement of tendons and muscles over bony prominences. Bursitis may be caused by excessive frictional forces, trauma, systemic disease such as rheumatoid arthritis or gout, or infection. The most common form of bursitis is subacromial. Trochanteric bursitis causes patients to experience pain over the lateral aspect of the hip and upper thigh, and tenderness over the posterior aspect of the greater trochanter. Retrocalcaneal bursitis involves the bursa located between the calcaneus and the posterior surface of the Achilles tendon. Pain is experienced at the back of the heel, and swelling appears on either or both of the medial and lateral sides of the tendon. Retrocalcaneal bursitis occurs in association with spondyloarthritities, rheumatoid arthritis, gout, and trauma.
Treatment of bursitis generally consists of prevention of the aggravating condition, rest of the involved part, an NSAID, and local steroid injection. In the long term, bursitis can result in loss of use of a joint and chronic pain syndrome.
The long term effects of reactive arthritis and bursitis range from chronic pain to crippling disability. It is also thought that many instances of osteoarthritis and psoriatic arthritis are in actuality reactive arthritis. Unfortunately, current procedures for management treat the symptoms of these diseases rather than their underlying pathogens.
SUMMARY OF THE INVENTION
The inventors have discovered that significant benefits can be obtained by treating humans affected with conditions associated with reactive arthritis or bursitis using combinations of acyclovir, L-lysine, minocycline hydrochloride, and metronidazole. An alternate embodiment of the invention involves the addition of isonicotinic acid hydrazide (commonly referred to as InH) to the above combination.
Acyclovir is an anti-viral drug. The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one. Acyclovir is commercially available under the brand name ZOVIRAX® in capsules, tablets, or suspension. Acyclovir has demonstrated anti-viral activity against herpes simplex virus types I and II, varicella-zoster virus, Epstein-Barr virus and cytomegalovirus, both in vitro and in vivo.
L-lysine has been shown to inhibit the growth of herpes virus cultures and can be effective in alleviating the symptoms associated with herpes infections, both oral and genital.
Minocycline hydrochloride is a bacteriostatic antibiotic which exerts its antimicrobial effect by inhibition of bacterial protein synthesis. It has been shown to be effective against gram-negative bacteria, some gram-positive bacteria and other microorganisms.
Metronidazole is an oral synthetic antiprotozoal and antibacterial agent. Heretofore it has been indicated for treatment of symptomatic trichomoniasis, intestinal amebiasis, and a wide range of intra-abdominal, skin, and gynecological, bone and joint, and lower respiratory tract and central nervous system infections, bacterial septicemia and endocarditis.
InH is known to act against actively growing tubercle bacilli. Heretofore, InH has been indicated for treatment of pulmonary tuberculosis. Adults with high doses of InH sometimes are observed to have a deficiency of pyridoxine hydrochloride. Appropriate doses of pyridoxine hydrochloride are therefore administered to patients being treated with InH.
A beneficial method for treatment of the symptoms in human beings of reactive arthritis or idiopathic bursitis, or both, comprises the administration of the combination of L-lysine, minocycline hydrochloride, and metronidazole. The preferred method includes administration of acyclovir with the underlying combination of L-lysine, minocycline hydrochloride, and metronidazole. An alternative method includes the administration of InH.
The method of treatment of the invention puts the diseases of reactive arthritis and bursitis into remission. The treatment may effect a cure of reactive arthritis and bursitis, but definitive testing has not been performed to confirm that fact.
It is therefore a primary object of the invention to provide a method of treatment for conditions in human beings associated with either or both reactive arthritis or idiopathic bursitis.
Another object of the invention is to provide a method of treatment for conditions in human beings associated with either or both reactive arthritis or idiopathic bursitis that puts the disease being treated into full remission.
A further object of the invention is to provide a method of treatment for any constellation of symptoms amenable to treatment using the above combination, including for example, cases of reactive arthritis which have been misdiagnosed as osteoarthritis or psoriatic arthritis.
DETAILED DESCRIPTION OF THE INVENTION
The method of treatment described in application Ser. No. 09/270,962 involves administration of a combination of L-lysine, minocycline hydrochloride, and metronidazole. An alternate method includes administration of
Bonner, Jr. Ernest L.
Hines Robert
Beverly Brian
Henley III Raymond
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