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Evaluation of Role of Oxitard Capsules in The Treatment of OSMF
Evaluation of Role of Oxitard Capsules in The Treatment of OSMF
Oral submucous fibrosis is a chronic debilitating disease of the oral cavity. It is characterized by
inflammation and progressive fibrosis of the oral submucosal tissues.
Present study evaluates the role of Oxitard capsules in the treatment of oral sub mucous fibrosis.
This study comprised of 48 cases who attended the Out Patient Department of Sir Sunderlal
Hospital of Banaras Hindu University, Varanasi for chronic oral mucosal fibrosis lesions. Oxitard
was given to all the patients a dose of 2 capsules, twice daily for a period of 3 months. All the
patients were evaluated at monthly intervals for a period of 3 months, for the parameters like
difficulty in opening mouth, hyperkeratosis, pain and lesion size. All the parameters were
evaluated by a random score as 0 nil, 1 mild, 2 moderate, 3 severe.
The parameters of difficulty in opening the mouth, pain over the lesion, and hyperkeratosis
reduced significantly. There was mild decrease in the size of the lesion. This study indicates that
Oxitard capsules used in cases of oral submucous fibrosis showed statistically significant improvement
in the symptoms like difficulty in opening the mouth, pain in the mouth and hyperkeratosis. Oxitard
capsules was safe in the dose administered and well tolerated by the patients.
Key Words: oral submucosal fibrosis, Oxitard, hyperkeratosis
INTRODUCTION
October 2009
503
504
events
must
have
definitive
relationship to the study drug, which
cannot be explained by concurrent
disease or any other agent).
Patients
were
allowed
to
voluntarily withdraw from the study
if they had experienced serious
discomfort during the study or
sustained serious clinical events
requiring specific treatment. For
patients withdrawing from the study,
efforts were made to ascertain the
reason for dropout. Non-compliance
(defined as failure to take less than
80% of the medication) was not
regarded as treatment failure, and
reasons for non-compliance were
noted.
Statistical analysis
48
40.50 4.50
58.50 4.30
29:19
14
31
THE ANTISEPTIC
October 2009
Degree of difficulty
At entry
1st month
2nd month
Nil-0
09
21
34*
44*
Mild-1
12
10
05*
01*
Moderate-2
27
17
09*
03*
Severe- 3
3rd month
DISCUSSION:
Degree of hyperkeratosis
Number of patients(n=40)
At entry
1st month
Nil-0
18
25
34*
Mild-1
18
12
4*
Moderate-2
16
10
2*
Severe- 3
Degree of pain
1st month
Nil-0
03
18
30*
40*
Mild-1
14
5*
0*
Moderate-2
12
4*
2*
Severe- 3
13
10
3*
0*
505
Palani
of oral submucous fibrosis is believed
to be multifactorial. A number of
factors trigger the disease process
by
causing
a
juxtaepithelial
inflammatory reaction in the oral
mucosa. Factors include areca nut
chewing, ingestion of chillies, genetic
and
immunologic
processes,
nutritional deficiencies, and other
factors.
Arecoline, an active alkaloid found
in betel nuts, stimulates fibroblasts
to increase production of collagen
by 150%.4 In one study, arecoline
was found to elevate the mRNA and
protein expression of cystatin C, a
nonglycosylated
basic
protein
consistently up-regulated in a variety
of fibrotic diseases, in a dosedependent manner in persons with
oral submucous fibrosis.5
In 3 separate but similar studies,
keratinocyte growth factor-1, insulin
like growth factor-1, and interleukin 6
expressions, which have all been
implicated in tissue fibrogenesis, were
also significantly up-regulated in
persons with oral submucous fibrosis
due to areca quid chewing, and
arecoline may be responsible for their
enhanced expression. 6 8 Further
studies have shown that arecoline is
an inhibitor of metalloproteinases
(particularly metalloproteinase-2) and
a stimulator of tissue inhibitor of
metalloproteinases, thus decreasing
the overall breakdown of tissue
collagen.9
Flavanoid, catechin, and tannin in
betel nuts cause collagen fibers to
cross-link, making them less
susceptible
to
collagenase
degradation. 10 This
results
in
increased fibrosis by causing both
increased collagen production and
decreased collagen breakdown.2 Oral
submucous fibrosis remains active
even after cessation of the chewing
habit, suggesting that components
of the areca nut initiate oral
submucous fibrosis and then affect
gene expression in the fibroblasts,
which then produce greater amounts
of normal collagen.11 Chewing areca
quid may also activate NF-kappaB
expression, thereby stimulating
collagen fibroblasts and leading to
further fibrosis in persons with oral
submucous fibrosis.12
506
Degree of change
in the lesion
Nil-0
05
13
29
Mild-1(0-1 cm)
25
23
20
16
18
16
12
00
05
04
03
03
No Significant change
Areca nuts have also been shown
to have a high copper content, and
chewing areca nuts for 5-30 minutes
significantly increases soluble copper
levels in oral fluids. This increased
level of soluble copper supports the
hypothesis that copper acts as an
initiating factor in persons with oral
submucous fibrosis by stimulating
fibrogenesis through up-regulation of
copper-dependent lysyl oxidase
activity. 13 Further, a significant
gradual increase in serum copper
levels from precancer to cancer
patients has been documented, 14
which may have a role in oral fibrosis
to cancer pathogenesis.
Iron deficiency anemia, vitamin B
complex deficiency, and malnutrition
are promoting factors that derange
the repair of the inflamed oral mucosa,
leading to defective healing and
resultant scarring.2
Management of oral submucosal
fibrosis include advising the patient
to avoid chewing betel nut and
tobacco,
spicy
foods
and
consumption of chillies should be
minimal, to maintain proper oral
hygiene. Specific treatment include
steroids, placental extracts, IFN
gamma, lycopene, pentoxyfylline,
surgical exicision, laser removal of
the lesion etc. 2
Glycyrrhiza
glabra
has
immunomodulatory effect. It is known
to have anti-inflammatory,15 has a role
in normalising hoarsness of voice.16
THE ANTISEPTIC
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