Note: Descriptions are shown in the official language in which they were submitted.
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OPSONIN~ IN PERITONEAL__DIALYSIS
Technical Field and Prior Art
Chronic peritoneal dialysis has been a highly
successfu~ means for the treatment of patients with end
stage renal failure. Dialysis solution is passed into
the peritoneal cavity and allowed to dwell for a period
of hours while it engages in dialysis across the membranes
of the peritoneal cavity for removal oE metabolic waste
products. The dialysis solution is then removed from
the peritoneal cavity, and, in the case of continuous
ambulatory peritoneal dialysis, promptly replaced with
another quantity of fresh dialysis solution.
One significant drawback to the various forms of
peritoneal dialysis is that patients who engage in it
are subject to peritonitis. While it has been found
that peritonitis can be handled with antibiotics, i~ is
potentially among the most serious of infections, due to
the sensitivity of the peritoneal cavity to infection.
In accordance with this invention, a ~echnique is
proposed for the suppression of peritonitis and its
symptoms, particularly that peritonitis which takes
place in patients who undergo peritoneal dialysis.
SummarY of the Invention
Various aspects of this invention are as follows:
A peritoneal dialysis solution which comprises
a water solution of physiologically tolerable pH having
physiological salts and an osmotic agent, each in safe
and effective concentrations to effect peritoneal dialysis
when placed in the peritoneal cavity of a patien-t, the
improvement comprising, in combination:
an opsonin for microorganisms dispersed in said
peritoneal dialysis solution in suficient concentration
to suppress symptoms of peritonitis when inserted into
the peritoneal cavity in a peritoneal dialysis procedure.
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A peritoneal dialysis solution which comprises
a water solution of physiologically tolerable pH having
physiological salts and an osmotic agent, each in safe
and effective concentrations, to effect peritoneal
dialysis when placed in the peritoneal cavity of a
patient, the improvement comprising, in combination:
an opsonin for microorganisms comprising at least
one peptidoglycan antibody dispersed in said peritoneal
dialysis solution in a concentration of 0.05 to 10
mg./ml of dialysis solution.
Description of Invention
By this invention, an opsonin for microorganisms is
administered to the peritoneal cavity of a patient in
sufficient dose to suppress the symptoms of peritonitis.
It is known that the peritoneal cavity contains
white cells, particularly those known as peritoneal
macrophages. By this invention, the addition of an
opsonin, for example mixed with the peritoneal dialysis
solution, potentiates the white cell activity in the
peritoneal cavity, causing them to destroy greater
numbers of bacteria and thus to suppress peritonitis
symptoms.
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While opsonins may naturally be found in the
peritoneal cavity, it has been noted that some patients
appear to lack sufficient opsonin concentrations to
effectively suppress peritonitis when exposed to it. The
artificial addition of opsonins to the peritoneal cavity
can be a valuable tool in suppressing the symptoms of
peritonitis, and particularly to prevent its occurrence.
It is believed that the types of opsonins which may be
used in the method of this invention are unlimited,
subject, of course, to the natural restrictions relating
to toxicity, allergic reaction, and the like. Broadly,
the word "opsonin" relates to any agent that modifies
microorganisms to promote white cells to phagocytiæe the
microorganisms, including bacteria, fungi, and the like.
It is believed that a typical opsonin coats or otherwise
attaches itself to the microorganism, and facilitates the
action of the white cell in phagocytizing and typically
destroying it. For example, gamrna globulin, a known
therapeutic blood fraction, is a known opsonin, which is
20 particularly Pffective against gram positive bacteriaO
Complement, which is also a therapeutic blood fraction,
may also be used, being a known opsonin for gram negative
bacteria. Separated components of gamma globulin and
complement may also be used, i.e., specific IgG antibodies
(e.g., peptidoglycan antibodies) or a C3B-containing
component of complement.
The opsonin may be administered to the peritoneal
cavity in any desired way, for example by injection, but
in the case of peritoneal dialysis patients it is
30 preferable to make use of the peritoneal catheter, which
provides communication between the peritoneal cavity and
the exterior, to administer the opsonin. If desired, the
opsonin may be added to the peritoneal dialysis solution
prior to its administration to the peritoneal cavity by
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mixing with the solution just prior to such
administration. In the alternative, the opsonin may be
placed in the solution as it is manufactured so that it is
unnecessary for the user to have to administer extra
5 opsonin, above and beyond that which is provided by the
peritoneal dialysis solution itself.
The peritoneal dialysis solution which contains an
opsonin such as gamma globulin or complement may have the
opsonin present in any desired, safe and effective
10 concentration. For example, gamma globulin or components
thereof may be present in the peritoneal dialysis solution
in a concentration of 0.05 to 10 mg. of dialy~is solution,
preferably no more than 5 mg. per ml. The C3 portion of
the complement may be present in the solution in a
15 concentration of 0.1 to 10 mg. per ml~ of dialysis
solution. It may also be desired for a rnixture of the
above concentrations of gamma globulin and complement to
be present in the peritoneal dialysis solution for
en'nanced effectiveness against both gram positive and gram
20 negative bacteria.
Other possible opsonins may also be provided to the
peritoneal dialysis solution or otherwise administered as
may be desired, for example C-reactive protein or
fibxonectin.
The peritoneal dialysis solution into which the
opsonins are added may be otherwise of conventional
formulation, being of physiologically tolerable pH and
having physiological salts and an osmotic agent, each in
safe and effective concentrations to effect peritoneal
30 dialysis when placed in the peritoneal cavity of a
patient. Typically, from 1 to 5 weight percent glucose
may be present as the osmotic agent, while the ions of the
physiological salts may include sodium, calcium,
ma~nesiurn, chloride, acetate, and lactate, for example, in
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conventional concentrations. Potassium ion as well as
other physiologically compatible ions may also be present
if appropriateO
Description of Drawings
Figure 1 is a perspective view showing a container of
peritoneal dialysis solution in communication with the
peritoneal cavity of a patient, using conventional
equipment.
Descri~tion o~Specific_Embodiment
Referring to the drawing, container 10 of peritoneal
dialysis solution may be of a design which is commercially
available from Travenol Laboratories, Inc. of Deerfield,
Illinois. Container 10 communicates with a transfer set
12, which is also commercially available from the same
company, and communicates with a conventional Tenckhoff
catheter 14 which is permanently implanted in the
peritoneal cavity of a patient 15. As previously stated,
the solution contents of container 10 (typically 2 liters)
can pass into the peritoneal cavity through set 12 and
catheter 14, and the set is closed with clamp 16 so that
the solution is retained therein. The patient can then
fold or roll up the flexible container 10 into a small
package and wear it under his clothes in compact form for
a period of about four hours. Thereafter, in conventional
manner, the patient unfolds container 10, opens catheter
14, and allows the spent dialysis solution to drain back
into container 10. Thereafter he closes container 10 with
a clamp, disconnects it from set 12, and replaces the
connection with a new container of fresh dialysis solution.
A typical peritoneal dialysis solution which may be
utilized in this invention may contain, per 100 ml., 1.5
to ~.25 grams of dextro~e hydrous U.S.P., 500 mg. of
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sodium chloride U.S.P, 448 mg. of sodium lactate, 25.7 gm.
of calcium chloride U.S.P., and 5.08 mg. of ma~nesium
chloride U.S.P. The pH may preferably be about 5.5,
broadly ranging from about p~ 5 to 7.
In accordance with this invention 100 mg. of gamma
globulin per liter of dialysis solution present may be
added to the container 10 by injection syringe 20 through
auxiliary medication port 18, which may be of conventional
design, to mix with the peritoneal dialysis solution
10 present in container 10. Alternatively, 100 mg. per liter
of dialysis solution of the C-3 component of complement
may be added, either as part of whole complement or a
purified fraction thereof. Alternatively, 100 mg. per
liter of the same C-3 component may be added as a further
additive to the solution along with the gamma globulin.
Thereafter, administration of the dialysis solution to
the peritoneal cavity causes peritoneal dialysis to
proceed in ordinary manner, but with the symptoms of
peritonitis being effectively suppressed, since the
presence of opsonins causes greater white cell
phagocytosis and subsequent destruction of any bacteria or
other microorganisms present.
The above has been offered for illustrative purposes
only and is not intended to limit the scope of the
invention, which is ~s defined in the claims below.
