Clinical observations with Paxirasol nasal spray


Szabadka, H.

Therapia Hungarica 40(1): 31-36

1992


The effect of Paxirasol nasal spray has been examined in 25 patients by the open method. The goal of the study was to assess and evaluate the clinical effectivity of the product and to observe the eventual side-effects. Among the examined patients 14 were acute and 11 chronic disease cases. In 20 of the 25 patients treated with Paxirasol nasal spray the pathological alteration of the nasal mucosa was controlled, mild alteration persisted in 4 patients, and moderately severe condition in 1 patient. The product significantly improved the voscosity of nasal discharge in all of them. The cessation or moderation of difficult nose blowing improved the general condition of the patients and accelerated recovery. Occasionally manifesting olfactory disorders ceased as well. The treatment needed not be discontinued because of the development of side-effects. Considering the healing tendency difference could be observed between the acute and chronic cases, especially in rhinitis sicca patients who were treated with Paxirsaol nasal spray. In 23 of the 25 patients notable improvement of both the subjective and objective symptoms was observed. Paxirasol nasal spray is of value in very frequently occurring diseases of the nasal mucosa accompanied by dehydration. In the majority of acute disease patients the use of the product as monotherapy may result in complete cessation of symptoms.

Department
of
Otorhinolaryngology,
Bajcsy-Zsilinszky
Hospital—Outpatient
Clinic,
Budapest
Clinical
Observations
with
Paxirasol
nasal
spray
By
H.
SZABADKA
De
Heide
and
Leuwenhoek
were
the
first
ones
who
described
cilia
in
the
17th
century
[15],
but
mucus
transport
and
its
altera-
tions
caused
by
irritating
factors
have
become
the
centre
of
interest
only
in
this
century.
The
secretion
of
the
mucosa
of
the
upper
respiratory
tract
is
cal-
led
mucus.
Under
physiological
conditions
mucus
of
normal
composition
[21]
has
a
very
important
purifying,
moistening
function
and
due
to
its
IgA,
lysozyme,
lactoferrin,
and
plasma
protein
content
it
also
has
a
role
in
the
protection
against
infec-
tions
[15].
The
epithelium
of
the
whole
respiratory
tract
is
covered
by
a
mucus
layer
of
about
5-10
microns.
The
motion
of
this
mucus
carpet
is
assured
by
active
ciliary
movement
and
the
optimum
flow
characteristics
of
bronchial
mucus
[4,
24].
These
two
factors
are
closely
related
and
influence
reciprocally
the
function
of
each
other
which
means
that
the
deterioration
of
the
function
of
one
factor
affects
the
function
of
the
other
as
well.
Thus
cilia,
being
one
of
the
components
of
shear
direc-
tion,
assure
the
special
flow
conditions
required
for
mucus
transport.
The
physiological
function
of
cilia
may
be
hindered
by
different
exogenous
noxas
such
as
smoking,
polluted
urban
air,
different
occupational
injuries,
cold
and
dryness,
etc.
In
these
cases
the
viscosity
of
mucus
increases,
and,
as
a
result,
the
function
of
cilia
is
also
injured,
thus
developing
a
vitious
circle.
The
organic
constituents
of
mucus
are
responsible
for
the
rheo-
logical
changes
occurring
within.
For
the
change
in
elasticity
primarily
the
acid
glycoproteins,
especially
sialomucines,
for
the
increase
of
viscosity
IgA
are
responsible
[23].
Arne
et
al.
[1]
demonstrated
that
lysozyme
also
has
a
viscosity
increasing
action.
According
to
some
authors
in
case
of
puru-
lent
excretion
the
viscosity
increasing
role
of
DNA
which
is
released
from
the
cells
become
more
important
[21,
6],
how-
ever,
this
question
needs
further
elucidation
[23].
A
low
number
of
pharmacological
studies
have
dealt
with
the
problem
on
how
do
drugs
influence
the
mucus
production.
The
majority
of
these
studies
were
based
on
animal
experiments
which
cannot
be
transferred
to
humans
without
reservation.
The
examinations
showed
that
bromhexine
(Paxira-
sol
EGIS),
N-acethylcystein,
S-carboxymethylcys-
tein,
and
the
Na
salt
of
2-mercapto-ethane
sulfonic
acid
exert
their
effects
especially
through
the
secre-
tory
IgA
[21,
7,
26,
27].
The
clinical
effectivity
of
these
agents
surpasses
that
of
the
traditional
drugs
[18,
19].
Different
therapeutic
methods
have
been
used
for
assuring
the
degree
of
humidity
playing
an
impor-
tant
role
in
the
protection
of
the
respiratory
tract.
In
Hungary
ICOvy,
Muller
et
al.
[13],
Midler,
Szabo
[17]
have
used
N-acethylcystein
(Fluimucil)
brom-
hexine
(Bisolvon),
later
Jasper
[12]
trypsin,
Erodi
[5]
Glanduitrin
nasal
drops,
and
Petreczky
[20],
Sziiverffy
et
al.
[32]
aerosol
therapy
for
such
pur-
pose.
In
the
following
the
clinical
examinations
per-
formed
with
a
new
drug
form
of
Paxirasol
will
be
discussed.
Paxirasol
nasal
spray
contains
0.02
g
bromhexine
per
10-g
bottle.
By
one
exposition
0.2
mg
active
substance
is
realeased
from
the
bottle.
Goal
of
the
Study
The
goal
of
the
study
was
the
observation
and
eval-
uation
of
the
clinical
effectivity
of
Paxirasol
nasal
spray,
the
control
of
the
usefulness
of
the
drug
is
the
recommended
indication
field,
and
the
assessment
of
side-effects.
The
indication
fields
of
Paxirasol
nasal
spray
are
dryness
of
nasal
mucosa
and
diseases
accompanied
by
the
cessation
or
notable
decrease
of
nasal
mucus
production
or
nasal
dryness
and
crust
formation.
The
distribution
of
patients
involved
in
the
study
by
sex
is
11
men
and
14
women.
31
H.
Szabadka:
Clinical
Observations
with
Paxirasol
a
Nasal
Spay
The
distribution
by
age
of
the
patients
is
given
in
Table
I.
The
indication
for
the
use
of
Paxirasol
nasal
spray
are
demonstrated
in
Table
II.
In
the
course
of
the
examinations
the
severity
deg-
ree
of
the
symptoms
characteristic
of
the
clinical
condition
and
the
weekly
changes
in
these
symp-
toms
have
also
been
observed
and
registered.
The
examined
symptoms
and
their
severity
degrees
were
recorded
on
the
following
data
sheet:
Mark
the
corresponding
number
with
a
circle!
Paxirasol
nasal
spray
diary
on
the
symptomatic
changes
First
2nd
3rd
week
Feeling
sick
1
no
1
1 1
in
general
2
yes
2 2
2
Catarrh
or
1
no
1
1
1
rhinitis
2
yes
2 2
2
Difficult
nasal
respiration
0
yes
1
occasional
0
0 0
(in
response
to
physical
exercise)
1
1
1
2
several
times
daily
2
2
2
(seemingly
without
reason)
3
continuous
3
3 3
Condition
of
0
normal
nasal
mucosa
1
mucus
layer
of
nasal
mucosa
minimal
but
not
dried
up
1
1
1
2
no
mucus
layer
on
nasal
mucosa,
atrophied
dried
up
2
2
2
3
tough,
dried
tenaciosus
crust
(foetid
or
odorless)
covers
the
nasal
mucosa
3 3
3
Viscosity
of
0
normal
0
0
0
nasal
discharge
1
thin,
watery
"dropping"
1
1
1
2
thick,
dried
up
glue-like
2 2
2
Difficulty
in
1
none
1 1
1
nose-blowing
2
existing
2
2
2
Disturbed
sense
0
none
0
0 0
of
smell
1
occasional
1
1
1
2
continuous
2
2
2
severity
degree
=
0
:
none;
1
:
mild;
2
:
medium
3
:
severe
Among
the
mentioned
symptoms
the
quality
of
the
nasal
discharge
was
assessed
on
the
basis
of
the
opinion
of
the
attend-
ing
physician,
the
other
symptoms
were
evaluated
according
to
the
subjective
opinion
of
the
patients.
Table
I
The
distribution
by
age
of
the
patients
21-30
years
31-40
years
41-50
years
51-60
years
61-70
years
71-80
years
3
patients
6
patients
8
patients
5
patients
2
patients
1
patient
Table
II
Indications
for
the
use
of
Paxirasol
nasal
spray
Number
of
cases
1.
Rhinitis
sicca
acuta
9
patients
2.
Rhinitis
sicca
diffusa
non
foetida
5
patients
3.
Rhinitis
sicca
chronica
foetida
3
patients
4.
Rhinopharyngitis
sicca
4
patients
5.
Exsiccation
following
dialysis
3
patients
6.
Nasal
mucosa
injury,
crusting
following
long-term
nasal
1
patient
intubation
Criteria
of
exclusion
from
the
study
lack
of
co-operation
from
the
part
of
the
patient;
diseases
accompanied
by
disturbed
auditory
function;
hyperplasia
of
the
nasal
mucosa;
side-effects
risking
the
health
of
the
patients;
acute
intercurrent
disease
developing
in
the
course
of
therapy.
Course
of
the
study
1.
Recording
of
data
2.
Recording
case
history
for
finding
the
causative
factor
3.
Local
rhinological
examination
4.
X-ray
examination
of
the
nose
and
sinuses
5.
Laboratory
examinations,
blood
count,
serum
iron,
ESR
6.
Assessment
of
diagnosis
and
severity
degrees
7.
Theree-week
therapy,
as
described
above
8.
Weekly
control,
filling
out
questionnaires,
rhinological
examination
9.
Evaluation
of
data
sheets
after
the
examination
period.
Before
discussing
the
results
of
therapy
the
terms
"acute"
and
"chronic"
diseases
have
to
be
eluci-
dated.
Conditions
in
which
the
complaints
persisted
for
less
than
3
weeks
were
regarded
as
acute
diseases,
those
in
which
more
than
3
weeks
had
elapsed
be-
tween
the
development
of
symptoms
and
the
ap-
pearance
of
the
patient
at our
consultation
and
outset
of
therapy
were
regarded
as
chronic
ones.
Among
our
patients
124
suffered
from
acute
and
11
from
chronic
disease.
32
H.
Szabadka:
Clinical
Observations
with
Paxirasol'
Nasal
Spay
Results
The
changes
in
the
different
symptoms
are
summa-
rized
in
different
tables.
Table
III
demonstrates
the
changes
in
the
general
conditions
of
the
patients.
the
nasal
mucosa,
whereas
on
the
second
week
these
symptoms
persisted
only
in
7
patients.
By
the
end
of
the
third
week
only
4
of
the
examined
patients
complained
still
of
these
symptoms.
The
effect
of
Paxirasol
nasal
spray
on
nasal
respira-
tion
is
summarized
in
Table
V.
Table
III
Table
V
Changes
in
the
General
Condition
i.e.
the
"Feeling
sick"
of
Changes
in
Difficult
Nasal
Respiration
During
the
Use
of
the
Patients
During
Paxirasol
Nasal
Spray
Therapy
Paxirasol
Nasal
Spray
1st
week
2nd
week
3rd
week
Not
feeling
sick
6
20
22
Feeling
sick
19
5
3
Total
25
25
25
As
it
may
be
seen
from
the
table,
19
patients
com-
plained
of
feeling
sick
subjectively,
and
6
patients
did
not
feel
sick
in
spite
of
the
pathological
altera-
tions
observed
on
their
nasal
mucosa.
At
the
end
of
Paxirasol
nasal
spray
therapy
only
3
of
the
19
patients
still
complained
of
discomfort.
By
comparing
the
changes
in
the
symptoms
of
acute
and
chronic
disease
patients
it
may
be
observed
that
Paxirasol
nasal
spray
was
more
effective
in
acute
diseases
(of
less
than
3-week
history)
than
in
chro-
nic
diseases
(of
more
than
3-week
history).
In
this
respect
similar
results
were
obtained
with
Paxirasol
inhalation
spray.
Table
IV
shows
the
changes
in
the
catarrhal
symp-
toms.
Table
IV
Changes
in
Catarrhal
Symptoms
During
the
Use
of
Paxirasol
Nasal
Spray
1st
week
2nd
week
3rd
week
No
catarrhal
symptom
2
18
21
Catarrhal
symptom
exists
23
7
4
Total
number
of
patients
25 25
25
Paxirasol
nasal
spray
significantly
improved
the
catarrhal
symptoms
of
the
patients.
Nevertheless,
the
effect
could
not
be
observed
immediately
but
only
after
some
days,
maybe
a
week.
At
the
onset
of
examination
23
patients
complained
of
sneezing,
nasal
obstruction
or
burning,
stinging
sensation
on
1st
week
2nd
week
3rd
week
No
difficult
nasal
respiration
0
11
16
Occasional
difficult
nasal
respiration
(e.g.
in
response
to
physical
exercise)
6
4
4
Difficult
nasal
respiration
several
times
daily
seemingly
without
reason
11
10
5
Continuous
difficult
nasal
respiration
8
25
25
On
the
basis
of
our
observations
Paxirasol
alleviated
—primarily—the
continuously
manifesting
diffi-
cult
nasal
respiration.
The
symptoms
of
all
patients
(8/25)
suffering
from
difficult
nasal
respiration
were
moderated
or
ceased
by
the
end
of
the
second
week,
but
notable
improvement
was
observed
in
milder
cases
as
well.
Complete
cessation
of
symp-
toms
was
obtained
by
the
end
of
therapy
in
16/25
patients.
The
persistance
of
the
symptoms
of
milder
nasal
obstruction
in
one
part
of
the
patients
may-
-probably—be
explained
by
subjective
reasons.
In
Table
VI
the
changes
in
the
condition
of
nasal
mucosa
are
shown.
Table
VI
Effect
of
Paxirasol
on
the
Pathological
Alterations
of
Nasal
Mucosa
1st
week
2nd
week
3rd
week
Normal
17
20
Mild
alteration
8
7
4
Moderately
severe
alteration
10
1 1
Severe
alteration
7
Total
25
25
25
33
H.
Szabadka:
Clinical
Observations
with
Paxirasol
®
Nasal
Spay
As
it
may
be
seen
in
the
table,
Paxirasol
nasal
spray
proved
to
be
effective
in
severe
and
moderate
pathological
alterations
of
the
nasal
mucosa.
In
4
of
our
patients
the
very
dry,
bleedy,
crusted
mucosal
alteration
developed
very
rapidly.
In
3
cases
this
was
caused
by
exsiccation
following
dia-
lysis,
in
1
case
due
to
long-term
nasal
intubation.
We
keep
continuing
the
examination
of
the
effect
of
Paxirasol
nasal
spray
in
such
dry
nasal
mucosal
al-
terations.
Paxirasol
nasal
spray
therapy
led
to
the
complete
cessation
of
nasal
mucosal
alteration
in
20
of
the
25
patients,
mild
nasal
mucosal
alteration
persisted
in
4,
moderately
severe
condition
in
1
patient.
We
recommended
other
adjuvant
treatments
for
these
patients.
Changes
in
the
viscosity
of
nasal
discharge
are
sum-
marized
in
Table
VII.
Table
VII
Changes
in
the
Viscosity
of
Nasal
Discharge
in
Response
to
Paxirasol
Therapy
1st
week
2nd
week
3rd
week
Normal
viscosity
20
23
Thin,
"dropping"
13
5
2
Thick,
dried
12
Total
25
25
25
Paxirasol
nasal
spray
significantly
improved
the
vis-
cosity
of
nasal
discharge
in
all
patients.
The
visco-
sity
of
nasal
discharge
was
normalized
by
the
second
week
of
therapy
in
20/25
patiens,
by
the
third
week
in
23
of
the
25
patients.
As
a
consequence
the
difficulties
in
nose
blowing
were
moderated
as
well.
Table
VIII
Changes
in
Difficulties
in
Nose
Blowing
During
the
Use
of
Paxirasol
Nasal
Spray
1st
week
2nd
week
3rd
week
No
difficulty
in
nose
blowing
19
23
Difficulty
in
nose
Wowing
25
6
2
Total
25
25
25
Table
IX
Effect
of
Paxirasol
Nasal
Spray
on
Olfaction
1st
week
2nd
week
3rd
week
No
olfactory
disorder
16
22
23
Occasional
olfactory
disorder
7
1
Continuous
olfactory
disorder
2
2
2
Total
25
25 25
The
cessation
or
moderation
of
difficult
nose
blow-
ing
significantly
improved
the
subjective
general
condition
of
the
patients
and
accelerated
the
recov-
ery
process.
Table
IX
shows
the
effect
of
Paxirasol
nasal
spray
on
olfaction.
The
nasal
spray
moderated
or
controlled
the
occa-
sionally
manifesting
olfactory
disorders,
but
it
did
not
influence
two
patients'
complete
anaemia
of
longer
history.
Side-Effects
In
the
course
of
examinations
mild
side-effects
occurred
in
some
patients.
About
50%
(12)
of
the
patients
observed
stinging,
burning
sensation
on
the
nasal
mucosa
on
the
first
2-3
days
of
therapy,
a
number
of
patients
reported
on
increased
sternutatory
stimulus.
In
these
patients
the
3
x
5
puff
daily
dose
was
decreased
to
3
x
1-2
puffs
and
daily
control
examinations
were
performed.
Thereafter
the
dose
was
gradually
increased
again
to
the
therapeutic
level.
These
com-
plaints
ceased
following
a
1-week
therapy
in
all
but
1
patient.
For
this
reason
it
is
recommended
to
inform
the
patient
about
the
possible
side-effects
before
start-
ing
therapy
and
if
such
side-effects
occur
it
is
advis-
ed
to
continue
the
treatment
with
lower
doses
be-
sides
the
close
observation
of
the
patient.
In
two
of
the
25
patients
mild
septal
epistaxis
devel-
oped
following
the
first
treatments
wich
did
not
require
special
therapy.
The
nasal
mucosa
of
both
patients
was
very
dry,
crusty,
predisposed
to
bleed-
ing.
Paxirasol
therapy
was
discontinued
in
both
cases
and
the
application
of
emollient
petrolatum-
type
nasal
ointment
was
started.
After
one
week
treatment
the
use
of
Paxirasol
nasal
spray
could
be
continued
without
the
development
of
side-effects.
34
H.
Szabadka:
Clinical
Observations
with
Paxirasot*
Nasal
Spay
Discussion
Paxirasol
is
used
in
other
countries
under
the
name
of
Bromhexine
in
its
tablet
form.
In
the
examina-
tions
performed
bromhexine
especially
improved
the
discharge
of
secretion
of
the
patients
[8,
10,
3].
The
effectivity
of
bromhexine has
been
questioned
by
some
authors
[14,
29].
The
differences
in
the
material
of
the
different
working
teams
may
be
responsible
for
the
incongruent
opinions.
Brom-
hexine
significantly
improved
the
discharge
of
bronchial
mucus
in
patients
suffering
from
acute
di-
seases
while
it
did
not
influence
the
mucus
discharge
in
severe
chronic
disease
patients.
We
also
observed
a
difference
in
the
healing
ten-
dency
of
acute
and
chronic
cases
when
comparing
the
patients
involved
in
the
present
study
and
treat-
ed
with
Paxirasol
nasal
spray,
especially
in
those
who
suffered
from
rhinitis
sicca.
However,
this
dif-
ference
was
not
so
significant
than
in
the
patients
suffering
from
pharyngitis,
mesophyaryngitis,
and
tracheitis
siccae
and
treated
with
Paxirasol
inhala-
tion
aerosol.
In
the
majority
of
our
patients
discussed
in
the
pre-
sent
study
(23
out
of
25),
both
the
subjective
and
objective
symptoms
(viscosity
of
nasal
discharge,
condition
of
nasal
mucosa)
significantly
improved
and
subsequently
ceased
completely.
This
also
refers
also
to
chronic
cases,
but
in
general
recovery
started
slower
in
these.
The
two
unresponsive
patients
also
suffered
from
chronic
diseases,
in
one
the
symptoms
had
mani-
fested
for
one
and
a
half,
in
the
other
for
5
years.
Summarizing
it
may
be
concluded
that
Paxirasol
nasal
spray
may
successfully
be
used
in
both
acute
and
chronic
diseases
accompanied
by
frequent
dehydration
of
nasal
mucosa.
In
the
former
cases
the
improvement
may
be
expected
as
early
as
in
the
first-second,
in
the
latter
ones
in
the
second-third
weeks
of
therapy.
In
acute
disease
patients
almost
in
every
case,
in
chronic
disease
patients
in
the
majority
of
cases
complete
cessation
of
symptoms
may
be
obtained
with
Paxirasol
nasal
spray
when
applied
in
form
of
monotherapy.
Summary
The
effect
of
Paxirasol
nasal
spray
has
been
exami-
ned
in
25
patients
by
the
open
method.
The
goal
of
the
study
was
to
assess
and
evaluate
the
clinical
effectivity
of
the
product
and
to
observe
the
even-
tual
side-effects.
Among
the
examined
patients
14
were
acute
and
11
chronic
disease
cases.
In
20
of
the
25
patients
treated
with.
Paxirasol
nasal
spray
the
pathological
alteration
of
the
nasal
mucosa
was
con-
trolled,
mild
alteration
persisted
in
4
patients,
and
moderately
severe
condition
in
1
patient.
The
pro-
duct
significantly
improved
the
viscosity
of
nasal
discharge
in
all
of
them.
The
cessation
or
modera-
tion
of
difficult
nose
blowing
improved
the
general
condition
of
the
patients
and
accelerated
recovery.
Occasionally
manifesting
olfactory
disorders
ceased
as
well.
The
treatment
needed
not
be
discontinued
because
of
the
development
of
side-effects.
Considering
the
healing
tendency
difference
could
be
observed
between
the
acute
and
chronic
cases,
especially
in
rhinitis
sicca
patients
who
were
treated
with
Paxirasol
nasal
spray.
In
23
of
the
25
patients
notable
improvement
of
both
the
subjective
and
objective
symptoms
was
observed.
Paxirasol
nasal
spray
is
of
value
in
very
frequently
occurring
diseases
of
the
nasal
mucosa
accompa-
nied
by
dehydration.
In
the
majority
of
acute
disease
patients
the
use of
the
product
as
monother-
apy
may
result
in
complete
cessation
of
symptoms.
Zusammenfassung
Das
Arzneipraparat
Paxirasol
Nasal
Spray
wurde
in
einem
offenen
Therapieversuch
mit
25
Patienten
auf
Wirksamkeit
gepriift.
Ziel
dieser
Untersuchun-
gen
war
eine
Beobachtung
und
Bewertung
der
kli-
nischen
Wirksamkeit
und
der
Nebenwirkungen.
Unter
den
untersuchten
Patienten
litten
14
an
aku-
ter,
und
11
an
chronischer
Erkrankung.
In
20
von
den
insgesamt
25
mit
Paxirasol
Nasal
Spray
behaq-
delten
Patienten
erfolgte
eine
Unterdriickung
der
pathologischen
Nasenschleimhaut
veranderungen,
in
4
anderen
persistierte
eine
gelinde
Veranderung,
und
in
einem
Patienten
blieb
ein
mittelschwerer
Zustand
bestehen.
Das
Priifpraparat
bewirkte
eine
signifikante
Besserung
der
Viskositat
des
Nasen-
schleims
in
alien
behandelten
Patienten.
Das
Unterbleiben
erschwerten
Schneuzens
hatte
zur
Besserung
des
Allgemeinbefindens
beigetragen,
und
beschleunigte
die
Heilung.
In
manchen
Fallen
vorgekommene
Geruchsstorungen
unterblieben
ebenfalls.
Es
kamen
keine
zur
Unterlassung
der
Arzneibehandlung
zwingende
Nebenwirkungen
vor.
35
H.
Szabadka:
Clinical
Observations
with
Paxirasol'
Nasal
Spay
Im
Hinblick
auf
die
Heilungstendenz
waren
Unter-
schiede
zwischen
Erkrankungen
mit
akutem
und
chronischem
Verlauf
zu
erkennen,
insbesondere
bei
den
Paxirasol
Nasal
Spray
erhaltenen
Patienten
mit
Rhinitis
sicca.
In
23
von
den
insgesamt
25
Patienten
war
eine
nennenswerte
Besserung
der
subjektiven
und
objektiven
Beschwerden
zu
er-
zielen.
Paxirasol
Nasal
Spray
ist
ein
hochwirksames
Arz-
neimittel
fiir
die
Behandlung
von
haufig
vorkom-
menden
Erkrankungen
der
Nasenschleimhaut,
begleitet
durch
Dehydration.
In
den
meisten
Fallen
mit
akuter
Erkrankung
erbringt
das
Prafpraparat
als
Alleinmedikament
eine
vollkommene
Aus-
schaltung
der
Krankheitssymptome.
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