JPS5821611A - Remedy for thrombocytopenia - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a novel method for the treatment of Idiopathic Thrombocytopenic Purpura, (ITP), particularly in children.

ITP is a disease in which the platelet count in the blood is abnormally low, resulting in the blood not clotting normally.

Treatment generally involves administering prednisone, sometimes in combination with immunosuppressants.

Surgical therapy (callus extraction) is also employed in chronic cases.

In early childhood, 85-95 of all cases of ITP are of the acute type, and the remainder are intermittent and chronic. In chronic cases, at a certain rate the disease becomes refractory, in which case there is no longer an adequate response to prednisone and immunosuppressive therapy.

We now show that initial administration of intravenous immunoglobulin (Ig) preparations causes a dramatic increase in platelet levels in both acute and chronic ITP, and that high platelet levels are maintained in most cases with periodic administration. It turns out it can be done.

Accordingly, the present invention provides a method of treating idiopathic thrombocytopenic purpura comprising administering an effective amount of an intravenous form of multivalent, intact immunoglobulin.

Multivalent, intact Ig (e.g. at high pepsin concentrations)
It means an antibody that is not divided and completely retains the structure and function of 7S-IgG antibody. Preferably, the Ig is obtained from the serum fraction by denatured alcohol cryoprecipitation involving mild acidification. Suitable product: 5w1ssRed Cross
Manufactured by and Sa by 5andoz Lid
It is sold under the name ndogl obul in. The in vitro properties of this material were determined by Alvi
ng and Finlayson, eds.
lnmlno: (haracteris-tici
and Uses of Intravenous p
reparation lJ us Dept.

of Health & )I311+ark 5e
rvices l 980: (FDA)-80-9
005pp 201-6 5kbaril and Bar
andon "ln vitro characteri"
zation of -noglobulins fo
Published by rintr@veno+ws useJ.

The initial dose of immunoglobulin is 0.2-0.6 g IgA
C body weight) is preferred, more preferably 0.4g IgA
C body weight) and administered on each day for 1 to 10 days, preferably for 5 consecutive days. Thereafter, the dose is 0.2 to 066 g/day, preferably 0.42 g/day, once every 1 to 6 weeks, or as needed.

The Ig is preferably administered by intravenous infusion in the form of a 2-6% solution, more preferably in sterile saline.
It is administered as a solution.

Suitable injection rates for the 3-ti solution are, for example, 10-20 drops/min for the first 15 minutes, 20-30 drops/min for the next 15 minutes, and 40-50 drops/min thereafter.

Treatment efficacy was monitored by repeated platelet counts;
Dangerously low level of platelet count, e.g. 50X109
//Administer more Ig when it falls below.

In the treatment of chronic ITP, it has been found that the majority of patients are maintained at acceptable platelet levels by this periodic administration. In some cases the beneficial effects are only temporary, in others a complete lull is observed. Treatment of acute ITP shows complete remission in the majority of cases, but a small number of cases show a smaller initial response and require subsequent maintenance of Ig.

No adverse side effects have been observed as a result of Ig treatment, and this treatment can avoid the need for callus extraction and/or immunosuppressive therapy in chronic cases of ITP, and can also avoid the need for multicosteroid therapy in acute cases. It can be avoided.

Next, the present invention will be explained with reference to Examples.

Example 1: Treatment of chronic ITP Intact Ig for intravenous injection (Product name: Sandoglo
bul in) was administered at a dose of 0.4 y/M (body weight) 7 days for 5 consecutive days to all 7 children with chronic ITP. Three children had previously undergone callus removal, two of whom were receiving immunosuppressive drugs and the remainder receiving prednisone. Two of the children who did not undergo callus removal received prednisone; one was resistant to prednisone, and the other had a lull for several years and then relapsed.

Platelet levels were monitored for a period of 70 to 110 days, and 0.
A single dose of 4 f Ig/Kg (body weight) was given as needed.

Platelet levels were <30X109A~>4 in 3 cases
00. x 109/l, and if there are 4 people left, 2
50~350 x 109/l! increased after initial Ig treatment.

Adequate platelet counts were observed to be maintained with only 1 g in all three callus-extracted patients and two prednisone-dependent non-callus-extracted patients. Prednisone-resistant patients responded poorly, whereas patients who relapsed from a lull returned to a lull after initial Ig treatment and did not require further treatment during the observation period.

Example 2: Treatment of Acute ITP 1 g (trade name: Sandoglobulin) was administered in the same manner as in Example 1 to 6 children suffering from acute ITP.

Two of them were receiving prednisone but did not respond to this treatment. The remaining four patients were untreated.

An initial rise in platelet levels of approximately 400×10 9 // or more was observed in 4 cases after Ig administration.

In the remaining two cases, an increase of approximately 150 to 200 x 109// was observed. Four patients with high initial responses had moderately high platelet levels without any further treatment during the observation period, whereas two with low initial responses had 0.4 pI.
Appropriate platelet levels could be maintained by periodic administration of g/Kf.

Patent applicant: Swiss Red Cross Society Patent attorney Aoyama Aoyama and 1 other person

Claims (1)

[Scope of Claims] 1. A therapeutic agent for idiopathic thrombocytopenic purpura, which comprises polyvalent intact immunoglobulin in a form for intravenous injection. 2. The agent of item 1 above, wherein polyvalent, intact immunoglobulins are obtained from the serum fraction by denatured alcohol cryoprecipitation with mild acidification. 3. The agent according to item 2 above, which is in the form of a sterile physiological saline solution.