A Dreval

Digitally signed by A Dreval

DN: CN = A Dreval, C = RU, O =
MONIKI, OU = MONIKI
Reason: I am the author of this
document
Date: 2006.01.19 14:10:14 +03'00'

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hypoglycaemic potency in healthy men', The Lancet, 1980, ii, 398-401).
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diabetes mellitus', Diabetes Care, Vol. 4, No. 2, p. 262-63, March-April 1981).
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'Comparative studies on intermediary metabolism and hormonal counterregulation following
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pork insulin in type I diabetic patients', Diabetes Research and Clinical Practice, 13, 1991, 2936).
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36
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patients with NIDDM', Diabetes, 1995, 44, 272-277).
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ELI LILLY GLENN SELIG,

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82
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84
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(Diabetes Care 1982,p152-160; Diabetes are, 1983, p.43-48; Diabetes Care 1993, p.155-165;
Am.J.Obstet.Gynecol. 1992,p1325-1330; Diabetes Care, December 1999),
2- 4- (Diabetes Res.,1988,p19-20; Oxford University Press
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85
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86
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87
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International Diabetes Federation American Diabetes Association, . , : A Desktop Guide to
Type 1 (Insulin-dependent) Diabetes 1998, International Diabetes Federation ( European Region ), Brussels http://www.staff.ncl.ac.uk/philip.home/t1dg1998.htm#PolicyGroup Advise
(): the use of unmodified ( soluble, regular ) human insulin before each meal, and
human NPH insulin in combination unless ( (, ) , ) : - multiple injection therapy is not wanted by the person with diabetes ( ) - flexibility of life-style is not
important ( ) - insulin secretory capacity is high ( honeymoon
period ) ( , ,
) - insulin analogue therapy is indicated ( see below ) ( , . )
, . , , . , , .
-, : The 1993 Consensus Guidelines were explicit about the knowledge base used.
In an attempt to raise clarity, the current Desktop Guide is more prescriptive. However, we will

88
also be publishing a source document in a major journal; this will go even further than the previous Guidelines in documenting the strength of the recommendations given here. (
1993 . , . ,
, ;
,
)
, , , .
-, 1993 , : 3.2.2 Recommendations for insulin therapy ( ) 3.2.2.1 General advice ( ) - Insulin
preparations of any species may be used; method of manufacture is not clinically relevant. ( ;
) - Insulin preparations should be of adequate purity to avoid
lipoatrophic injection site abnormalities, or other insulin-antibody induced problems. ( , ) Insulin regimens should be composed of available preparations of short- and intermediate-acting
formulations (Table 4). Long-acting formulations (24-h effect) are not generally available at present. ( -
(. 4). (24
) .) - U100 (100 U/ml) concentration insulin
is increasingly used in Europe; further standardization is desirable, but U40 (40 U/ml) insulin is
entirely satisfactory. ( 100 / ;
, 40 /
) - For routine therapy insulin can only be given by the subcutaneous
route; other routes are for special ( surgery , ketoacidosis, CAPD) or experimental (intraperitoneal, nasal) use only. ( ; ( , , ) (, )). Consensus Guidelines for the Management of Insulin-dependent ( Type 1 )
Diabetes European IDDM Policy Group 1993 A detailed guideline, with considerable explana-

89
tion included, which has stood the test of time well. Previously published in Diabetic Medicine
1993; 10: 990-1005
, , .
5 ?
, ,
. , , , 1998 . :
The production of these Guidelines was made possible by the financial support of a consortium of industry partners of the St Vincent Declaration Initiative and IDF (Europe). The members of this consortium are ( ().
): Bayer Corporation, Diagnostics Eli Lilly and Company Glaxo Wellcome
Novo Nordisk Roche Diagnostics Zeneca Pharmaceuticals. Additionally the European Diabetes Policy Group would like to thank Elizabeth Dempsey Becker of Novo Nordisk and Joachim
Thiery of Roche Diagnostics for their organizational assistance and advice, and their companies
for continuing their support of the original guidelines. ( , Elizabeth Dempsey Becker
Joachim Thiery ).
A number of members of the Policy Group, personally or through their employers, hold research contracts with, or provide consultation to, governmental and commercial organizations (
including the sponsors ) with an interest in areas covered by these Guidelines. (
, ,
(
) , )
, ,
.
,
Diabetes Care 25:S112-S115, 2002.
Diabetes Care 25:S112-S115, 2002 Position Statement Insulin Administration American
Diabetes Association Different types and species of insulin have different pharmacological
properties. (
) Human insulin is preferred for use in pregnant women, women considering preg-

90
nancy, individuals with allergies or immune resistance to animal-derived insulins, those initiating
insulin therapy, and those expected to use insulin only intermittently. (
, , , ,
) Insulin type and species, injection technique, insulin antibodies, site of injection, and individual patient response differences can all affect the onset, degree, and duration of insulin activity. ( , , ,
,
) Changing insulin species may affect blood glucose control and should only
be done under the supervision of a health professional with expertise in diabetes. (

, ) Human insulin manufactured using recombinant DNA technology is replacing
insulin isolated from pigs. ( , ) Future
availability of animal insulin is uncertain ( )
, , , , , .
- , !
: BNF No 43, March 2002: All insulin
preparations are to a greater or lesser extent immunogenic in man but immunological resistance
to insulin action is uncommon. Preparations of human sequence insulin should theoretically be
less immunogenic, but no real advantage has been shown in trials. (
, . , , )
( http://www.cochrane.org/cochrane/revabstr/ab003816.htm . 'Human' insulin versus animal insulin in people with diabetes mellitus
(Cochrane Review) ( )
Richter B, Neises G ABSTRACT () A substantive amendment to this systematic re-

91
view was last made on 27 May 2002. Cochrane reviews are regularly checked and updated if
necessary. Background: Human insulin was introduced for the routine treatment of diabetes
mellitus in the early 1980s without adequate comparison of efficacy to animal insulin preparations. First reports of altered hypoglycaemia awareness after transfer to human insulin made
physicians and especially patients uncertain about potential adverse effects of human insulin.
(: 1980
. , .) Objectives: To assess the effects of different insulin species by evaluating their efficacy (in particular glycaemic control) and adverse effects profile
(mainly hypoglycaemia). (: , , , , )
Search strategy: A highly sensitive search for randomised controlled trials combined with key
terms for identifying studies on human versus animal insulin was performed using the Cochrane
Library (issue 2, 2002), Medline (1966 to May, 2002) and Embase (1974 to February, 2002). We
also searched reference lists and databases of ongoing trials. Date of latest search: May 2002.
( : , ,
)
Selection criteria: We included randomised controlled clinical trials with diabetic patients of all
ages that compared human to animal (for the most part purified porcine) insulin. Trial duration
had to be at least one month in order to achieve reliable results on the main outcome paramater
glycated haemoglobin. ( : , , ( ,
).
1 , ) Data collection and analysis: Trial selection as well as
evaluation of study quality was performed by two independent reviewers. The quality of reporting of each trial was assessed according to a modification of the quality criteria as specified by
Schulz and by Jadad. ( : ,
. -

92
Schulz Jadad)
Main results: Altogether 2156 participants took part in the 45 randomised controlled studies that
were discovered through extensive search efforts. Though many studies were of a randomised,
double-blind design, most studies were of poor methodological quality. Purified porcine and
semi-synthetic insulin were most often investigated. No significant differences in metabolic control or hypoglycaemic episodes between various insulin species could be elucidated. Insulin dose
and insulin antibodies did not show relevant dissimilarities. ( : 45 , 2156 .
,
. - . . .) Reviewers' conclusions: A comparison of
the effects of human and animal insulin as well as of the adverse reaction profile did not show
clinically relevant differences. Many patient-oriented outcomes like health-related quality of life
or diabetes complications and mortality were never investigated in high-quality randomised
clinical trials. The story of the introduction of human might be repeated by contemporary launching campaigns to introduce pharmaceutical and technological innovations that are not backed up
by sufficient proof of their advantages and safety. ( : ,
,
. ,

.
). Citation: Richter B, Neises G. 'Human' insulin versus animal insulin
in people with diabetes mellitus (Cochrane Review). In: The Cochrane Library, Issue 3 2002.
Oxford: Update Software.***
.
.
,
,

93
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101
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