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 Доказательная вакцинология. 
Автор Сообщение
Сообщение Доказательная вакцинология.
В одной теме хотелось бы собрать исследования вакцинологов, доказательные на первый взгляд, и наше понимание этих исследований без эмоций, только с позиций науки.

Вот такие вопросы я получил на своём форуме:
http://forum.medicinform.net/index.php? ... entry13883

Вадим, а какие конкретно критерии ЕВМ Вы имеете в виду?
ЕВМ это "добросовестное точное, разумное применение последних данных для принятия решения о лечении конкретного пациента. Практика ЕВМ - это интеграция между индивидуальным клиническим опытом и лучшими результатами внеклинических разработок, почерпнутых из систематических научных разработок"
tutorial of EBM
Каким именно критериям должен соответствовать триал, чтобы вы лично его признали соответствующим ЕВМ?
Ну вот хотя бы:
"определение степени предотвращаемости пневмонии вакцинацией в Гамбии
... По наблюдениям, около 5-10 проц. всех случаев тяжелой пневмонии удетей было вызвано гемофильной палочкой типа В (ГПб). С 1993по 1995 было прведено рандомизированное контролированное исследование с участием 40 тыс. детей, которым вводили либо конъюгированную вакцину, либо плацебо. Это уменьшило количество радиологически подтвержденной пневмонии на 21проц., что было гораздо больше, чем ожидаемое снижение (5-10проц.)
Результаты этого триала были важны не только для Гамбии, но и для остальных стран, так предоставляли очевидные доказательства (they provide a firm basis of evidence) того, что конъюгированная ГПб вакцина подходит для рутинной иммунизации..."

http://www.niaid.nih.gov/dmid/gambia/background.htm#7]
Estimating the Burden of Pneumonia Preventable by Vaccination: the Example of Hib Vaccine in The Gambia
Vaccine trials can provide the most accurate measure of the burden of a disease. Based on observational studies of patients with pneumonia conducted in The Gambia it was expected that about 5-10% of severe pneumonia episodes in infants and young children were likely due to the bacterium, Haemophilus influenzae type B (Hib). Between 1993 and 1995, a randomized controlled trial was conducted in the Western Division of The Gambia in which nearly 40,000 infants were given either Hib conjugate vaccine or placebo. This study design was able to show that vaccination with Hib conjugate vaccine reduced the incidence of radiographic pneumonia by 21%. This reduction in pneumonia cases was substantially greater (21%) than expected (5-10%) on the basis of the observational studies that preceded it. The results of this study were important in The Gambia and elsewhere because they provide a firm basis of evidence that supports the use of this vaccine as a routine immunization. The results of the pneumococcal vaccine trial are expected to be equally or more influential for the decision of whether to use pneumococcal vaccine in the future.


Чт ноя 30, 2006 12:45 am
Сообщение 
Да, уж нечего сказать, здесь и не требуется знаний математики.
Идёт просто подмена понятий - этиологического фактора на морфологический, кстати, не радиологического, а рентгенологического исследования.
Это статья из серии рекламы вакцинации от гриппа - прививайтесь - у Вас не будет гриппа, ОРЗ, поллиноза и улучшится потенция! :x


Чт ноя 30, 2006 1:50 am
Сообщение 
НАЦИОНАЛЬНЫЙ СТАНДАРТ РОССИЙСКОЙ ФЕДЕРАЦИИ. НАДЛЕЖАЩАЯ КЛИНИЧЕСКАЯ ПРАКТИКА.
Предисловие.
Цели и принципы стандартизации в Российской Федерации установлены Федеральным законом от 27 декабря 2002 г. № 184-ФЗ «О техническом регулировании», а правила применения национальных стандартов Российской Федерации – ГОСТ Р 1.0 – 2004 «Стандартизация в Российской Федерации. Основные положения»
Сведения о стандарте.
1. ПОДГОТОВЛЕН Ассоциацией международных фармацевтических производителей (AIPM), Международной конфедерацией обществ потребителей (КонфОП), Российской Академией медицинских наук (РАМН) по собственному аутентичному переводу, указанному в пункте 4
2. ВНЕСЕН Техническим комитетом по стандартизации ТК 450 «Лекарственные средства»
3. УТВЕРЖДЕН Приказом Федерального агентства по техническому регулированию и метрологии от 27 сентября 2005 г. № 232-ст
4. Настоящий стандарт идентичен Руководству по надлежащей клинической практике (Consolidated Guideline for Good Clinical Practice) Международной конференции по гармонизации технических требований к регистрации фармацевтических продуктов, предназначенных для применения человеком (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use; ICH)
При применении настоящего стандарта рекомендуется использовать вместо ссылочных международных стандартов соответствующие им национальные стандарты Российской Федерации
1. ВВЕДЕН ВПЕРВЫЕ.
http://www.cra-club.ru/index.php?option ... &Itemid=97


Чт ноя 30, 2006 3:26 am
Сообщение 
Продолжение дискуссии, прошу желающих подключиться!

Как рентгенологически достоверно можно установить этиологию пневмонии, чтобы потом говорить о снижении заболеваемости? Ситуация идентична «профилактике» гриппа.
Я согласен на обмен информацией – вы мне про пользу вакцинации, я - про вред!
Вот пара резюме из PubMed, с дизайном слабовато, но это только начало:

http://www.ncbi.nlm.nih.gov/entrez/quer ... med_docsum
Vaccine. 2006 Oct 19. Bell's palsy associated with influenza vaccination: Two case reports.
Chou CH, Liou WP, Hu KI, Loh CH, Chou CC, Chen YH.
Department of Family Medicine, Tri-Service General Hospital, Nei-Hu, Taipei, Taiwan, ROC.
The etiology of Bell's palsy is often unknown. We present herein two cases of adults who developed a Bell's palsy following the administration of an influenza vaccine. While the incidence is low, with the widespread recommendation for annual influenza vaccines, patients should be apprised of the possibility of this complication and the benefit of early treatment
http://www.ncbi.nlm.nih.gov/entrez/quer ... med_docsum
Pharmacotherapy. 2006 Nov;26(11):1658-61
Erythema multiforme after meningitis vaccine: patient safety concerns with repeat immunization.
Studdiford J, Oppenheim L, McCann E, Altshuler M.
1 Department of Family and Community Medicine, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania; Jefferson Medical College, Philadelphia, Pennsylvania.
A 20-year-old college student developed an immunologic hypersensitivity reaction, erythema multiforme minor, 1-2 weeks after receiving a meningococcal conjugate vaccine. He had no history of erythema multiforme, nor had he received any other vaccine or drug therapy. The temporal relationship between the development of erythema multiforme and the vaccination suggests that the meningitis vaccine probably was the causal agent. The occurrence of this distinct cutaneous reaction, with the potential for a serious complication such as erythema multiforme major or Stevens-Johnson syndrome on rechallenge, should serve as a warning against repeated booster vaccinations in patients who develop reactions such as this one.


Сб дек 02, 2006 2:51 am
Сообщение 
http://www.ncbi.nlm.nih.gov/entrez/quer ... med_docsum


Pediatr Infect Dis J. 1998 Apr;17(4):294-304
Clinical acceptability and immunogenicity of a pentavalent parenteral combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b conjugate antigens in two-, four- and six-month-old Chilean infants.
Lagos R, Kotloff K, Hoffenbach A, San Martin O, Abrego P, Ureta AM, Pines E, Blondeau C, Bailleux F, Levine MM.
Centro para Vacunas en Desarrollo, Chile, Servicio de Salud Metropolitano Norte, Santiago.
BACKGROUND: In recent years additional parenteral vaccines have been recommended for routine immunization of infants in the US and elsewhere. The ability to administer multiple vaccines as a single injection without unacceptably increasing reactogenicity or decreasing immunogenicity of any component would offer many practical advantages. METHODS: A randomized, open, controlled trial was conducted to assess the tolerance profile and immunogenicity, as well as to identify potential antigenic interferences, resulting from administration of a parenteral combination vaccine for infants. The vaccine contains diphtheria and tetanus toxoids, acellular pertussis antigens (DTaP), enhanced inactivated poliovirus (eIPV) and Haemophilus influenzae type b-tetanus toxoid conjugate (PRP-T). Infants (n=711) were randomly assigned to receive 1 of 5 regimens as the primary series at 2, 4 and 6 months of age, by group: (1) DTaP plus oral polio vaccine (OPV); (2) DTaP plus eIPV (separate injections); (3) DTaP-eIPV combined as a single injection; (4) DTaP-eIPV combined, plus a separate injection of PRP-T; or (5) DTaP-eIPV combined and reconstituting PRP-T, as a single injection. At 3, 5 and 7 months Groups 1, 2 and 3 received PRP-T. At 12 months all infants received a booster dose of DTaP reconstituting PRP-T as a single injection, plus a separate injection of measles, mumps and rubella vaccine. Groups 2, 3, 4 and 5 received OPV at 7 months, and all infants received OPV at 13 months. Serum immune responses were measured to the primary series at 2 and 7 months and to the booster dose at 12 and 13 months. RESULTS: Reaction rates were similar among groups. In the primary series combining eIPV with DTaP decreased geometric mean titers (GMTs) to diphtheria, tetanus and pertussis. In addition concomitant PRP-T (either simultaneous or combined) with DTaP-eIPV lowered anti-PRP and further decreased tetanus GMTs. Nonetheless in 100% of infants protective titers were achieved against diphtheria and tetanus (>0.01 IU/ml each) and against the poliovirus types 1, 2 and 3 after eIPV (Groups 2 to 5); 99% of infants (Groups 4 and 5) had protective titers against PRP (> or = 0.15 microg/ml). After boosting with DTaP/PRP-T decreased GMTs to diphtheria and PRP antigens were observed in the groups that received DTaP and eIPV combined. Nonetheless protective titers to diphtheria, tetanus and PRP occurred consistently. In contrast concomitant PRP-T with DTaP-eIPV enhanced the pertussis GMTs. CONCLUSIONS: We conclude that combined DTaP, eIPV and PRP-T in a single injection is well-tolerated and elicits an acceptable immune response to each component.


Сб дек 02, 2006 2:46 pm
Сообщение 
Замечательная статья не сколько подтверждающая эффективность вакцинации -образование антител, а огромное количество документально подтверждённых осложнений до 72,6%! Наша статистика отдыхает!

J. Pediatr. 1984 Aug;105(2):189-94. DTP reactions and serologic response with a reduced dose schedule. Barkin RM, Samuelson JS, Gotlin LP.
In a double-blind study, infants received standard (0.5 ml) or modified (0.25 ml) doses of DTP vaccine for the primary series of three immunizations administered at 2, 4, and 6 months of age and the booster immunization at 18 months. Side effects and antibody responses were determined in 80 children who completed the primary series and 73 who received the booster. The modified regimen was associated with significantly reduced febrile reactions and behavioral changes after the primary series and booster inoculation: 63.2% of those who received the standard dose had febrile reactions, compared to 42.3% who received the modified dose during the primary series; a similar difference was observed with the booster. Only 47.2% of the reduced dosage recipients demonstrated marked behavioral changes, and 62.4% of the standard vaccine recipients had comparable reactions. An even larger difference (33.3% vs 64.7%) was noted at the time of the booster. The modified vaccine produced a local reaction incidence of 58.5%, compared to 72.6% in the control population during the primary immunization series; no differences were noted in local reactions with the booster dose. All patients had serologic evidence of protective titers against diphtheria and tetanus. After the primary immunization series, 97.6% and 97.3% of the infants given the modified and standard doses, respectively, had pertussis agglutinin titers of greater than or equal to 1:16. One patient who received the standard dosage had a titer of less than 1:16 one month after the booster immunization, whereas all those given the modified dose had titers greater than or equal to 1:16. Geometric mean titers of pertussis agglutinins were higher in the standard vaccine recipients after the primary series, but were similar in the two study groups before and after the 18-month immunization.


Сб дек 02, 2006 6:02 pm
Сообщение 
Нашёл замечательную статью про бесполезность BCG вакцинации!
Am J Respir Crit Care Med. 2000 Oct;162(4 Pt 1):1314-7.
Risk of tuberculosis infection and tuberculous meningitis after discontinuation of Bacillus Calmette-Guerin in Beijing.
Zhang LX, Tu DH, He GX, Ma ZQ, Nagelkerke NJ, Borgdorff MW, Enarson DA, Broekmans JF.
Beijing Research Institute for Tuberculosis Control and Shun-yi Tuberculosis Centre, Beijing, China.
In Beijing, the notification rate of smear-positive tuberculosis (TB) has been below 20 per 100,000 since 1986, and continues to decline. To accurately measure the risk of TB infection in a population in which the results of tuberculin skin testing were not confounded by vaccination with Bacillus Calmette-Guerin (BCG), BCG vaccination at birth was discontinued from 1988 in Shun-yi County. In 1995, the prevalence of TB infection among 12,836 primary school children aged 6 to 7 yr and without BCG scars was 1.4%, giving an estimated annual risk of infection of 0.19% (95% confidence interval: 0.16 to 0.22%). The prevalence of TB infection in children aged 5 to 9 yr in Beijing in 1950 was 46%. The number of cases of tuberculous meningitis did not increase after discontinuation of BCG. We conclude that discontinuation of BCG had no detectable harmful effects, and that control of TB in Beijing has markedly reduced the prevalence of TB infection since 1950.
http://www.ncbi.nlm.nih.gov/entrez/quer ... med_docsum


Вс дек 03, 2006 5:28 am
Сообщение 
Эта статья не отвечает критериям ЕВМ и подтверждает бесполезность DT вакцинации лабораторно – падением титра антител ниже «защитного».
Как определяются критерии «защитных» титров? Очень интересен адъювантный эффект коклюшного токсина, вот бы его в гриппол вместо полиоксидония!

Pediatr Infect Dis. 1986 Jul-Aug;5(4):428-30.
Pediatric diphtheria and tetanus toxoids-adsorbed vaccine: immune response to the first booster following the diphtheria and tetanus toxoids vaccine primary series.
Pichichero ME, Barkin RM, Samuelson JS.
Diphtheria and tetanus toxoids (DT) vaccine should be given to children at 2, 4 and 6 months of age when there are contraindications to the administration of pertussis vaccine. We have previously reported that such children develop protective antitoxin antibody levels to diphtheria and tetanus antigens. This follow-up study evaluates the decay in antitoxin antibody levels and the booster response elicited to DT antigen when a fourth dose is given at approximately 18 months of age. Twenty-three children receiving DT vaccine were compared to 38 receiving diphtheria and tetanus toxoids-pertussis (DTP) vaccine. The prebooster antibody titer to diphtheria and tetanus at approximately 18 months of age had declined below the recommended protective level in one child who had received DT vaccine and in three children who had received DTP. Following the 18-month booster dose of DT and DTP vaccine, all of the children had protective titers to diphtheria and tetanus toxin. These results suggest that the adjuvant effects of pertussis vaccine are not required to achieve adequate immunization to diphtheria and tetanus when currently available DT vaccine is used in early childhood.
http://www.ncbi.nlm.nih.gov/entrez/quer ... med_docsum


Вс дек 03, 2006 5:54 am
Сообщение 
Эта статья тоже не отвечает критериям ЕВМ и подтверждает бесполезность DT вакцинации лабораторно – падением титра антител ниже «защитного».
Scand J Infect Dis. 1987;19(4):445-51.
Determination of tetanus and diphtheria antitoxin content in dried samples of capillary blood: a convenient method applied to infants.
Schou C, Simonsen O, Heron I.
Vaccine Department, State Serum Institute, Copenhagen, Denmark.
To assess the effect of vaccination of infants against tetanus and diphtheria capillary blood was drawn from 51 randomly selected healthy infants 2 years of age. The blood was applied directly to filter paper. In the laboratory the blood dots were eluted in phosphate buffered saline for 2 h at room temperature yielding 100% recovery of antitoxin activity. Serum volume in the blood dots was determined by calculation of dot area or by measuring albumin content in the eluted samples by means of rocket immunoelectrophoresis. These approaches were found to be equally applicable. Concentration of antitoxin to tetanus and diphtheria was assessed with ELISA and in vitro toxin neutralization assay respectively. Mean diphtheria antitoxin concentration was 0.53 IU/ml, and mean tetanus antitoxin concentration 4.1 IU/ml. Low initial immune response to diphtheria vaccination may be responsible for the risk among school children to have antitoxin concentration below protective level (reported elsewhere). In environments where diphtheria is disappearing a lowered vaccination response may be expected.


Вс дек 03, 2006 6:10 am
Сообщение 
Статья вроде бы в стандарте ЕВМ, подтверждающая большое количество осложнений и поощряющая неэтичные опыты над детьми. В резюме не указаны количественные показатели, видимо из-за отсутствия чётких «нормативов» «защитных» титров.

J Infect Dis. 1989 Nov;160(5):832-7.
Evaluation of a new highly purified pertussis vaccine in infants and children.
Edwards KM, Bradley RB, Decker MD, Palmer PS, Van Savage J, Taylor JC, Dupont WD, Hager CC, Wright PF.
Department of Pediatrics (Division of Infectious Disease), Vanderbilt University School of Medicine, Nashville, TN 37232.
Purified acellular pertussis vaccine (12.5 micrograms of lymphocytosis promoting factor [LPF] and 12.5 micrograms of filamentous hemagglutinin [FHA]) was compared with conventional pertussis vaccine in a randomized double-blind study involving 40 children aged 4-6 y, 40 children aged 18-24 mo, and 50 infants. Increases in antibody were significantly greater among recipients of acellular vaccine than among recipients of conventional vaccine for antibodies to LPF in all age groups and for antibodies to FHA in infants and children aged 4-6 y; the increase in FHA antibody was also greater with acellular vaccine among children aged 18-24 mo but not significantly so. Compared with conventional vaccine, acellular vaccine was significantly associated with reduced frequency of leg pain and fretfulness at all ages and less frequent fever and anorexia at some ages. The reduced reaction rates and comparable or enhanced immunogenicity of the acellular vaccine make it an attractive candidate for larger field trials, particularly among infants.
http://www.ncbi.nlm.nih.gov/entrez/quer ... med_docsum

Где помощь единомышленников? Бросил все дела, изучаю вакцинно-антивакцинное дело!


Вс дек 03, 2006 6:58 am
Сообщение 
Статья не отвечает стандартам ЕВМ и подтверждает большое количество осложнений со стороны нервной системы.
Am J Dis Child. 1991 Jul;145(7):734-41.
A comparative trial of the reactogenicity and immunogenicity of Takeda acellular pertussis vaccine combined with tetanus and diphtheria toxoids. Outcome in 3- to 8-month-old infants, 9- to 23-month-old infants and children, and 24- to 30-month-old children.
Kimura M, Kuno-Sakai H, Sato Y, Kamiya H, Nii R, Isomura S, Horiuchi K, Kato T, Deguchi M, Saikusa H, et al.
Department of Pediatrics, Tokai University School of Medicine, Isehara, Japan.
The reactogenicity and immunogenicity of the Takeda acellular pertussis vaccine combined with tetanus and diphtheria toxoids were compared in 139 infants aged 3 to 8 months, 60 infants and children aged 9 to 23 months, and 99 children aged 24 to 30 months. Good antibody responses to pertussis toxin (PT), filamentous hemagglutinin (FHA), and agglutinogens occurred in all age groups after both the third and fourth doses. After the fourth (booster) dose, the mean antibody values in initially seronegative infants vaccinated at 3 to 8 months of age were as follows: anti-PT, 67.8 enzyme-linked immunosorbent assay units (EU) per milliliter; anti-FHA, 149.5 EU/mL; the agglutinin titer was 125.6. The values in initially seronegative children vaccinated at 24 to 30 months of age were as follows: anti-PT, 92.9 EU/mL; anti-FHA, 251.7 EU/mL; the agglutinin titer was 275.8. Reactions following immunization were minimal. Except for drowsiness after the first dose in infants, there were no clinically significant differences in reactions between infants and older children. The findings in this study coupled with the recent demonstration of efficacy of this vaccine in 2-year-old children supports the recent Japanese recommendation to lower the age of immunization with acellular pertussis vaccine combined with tetanus and diphtheria toxoids to 3 months.


Вс дек 03, 2006 7:13 am
Сообщение 
Статья, представляющая чисто научный интерес, подтверждающая неидентичность токсина и анатоксина и адъювантные свойства коклюшного компонента.
J Biol Stand. 1989 Oct;17(4):311-9.
In vitro induction of a diphtheria toxoid specific antibody response in human peripheral blood lymphocytes cultivated in the presence of diphtheria toxoid.
Loggen HG, Kreeftenberg JG.
National Institute of Public Health and Environmental Protection Laboratory for Control of Bacterial Vaccines, Bilthoven, The Netherlands.
In comparison with the presently used potency test for diphtheria vaccine, in vitro examination of the immunogenicity of the vaccine would have great advantages. For this reason in vitro induction of diphtheria toxoid specific antibody synthesis in human peripheral blood lymphocytes cultivated in the presence of diphtheria toxoid was investigated. The results showed that a dose dependent synthesis of diphtheria antibody was induced by adsorbed diphtheria toxoid and combined vaccines containing the diphtheria toxoid component. Plain diphtheria toxoid appeared to be less immunogenic in comparison with adsorbed toxoid. There is some indication that the pertussis component had a stimulating effect on the diphtheria antibody synthesis. In conclusion, these results are promising for in vitro examination of the immunogenicity of diphtheria vaccines. The model will be validated for the routine control of diphtheria vaccine.
http://www.ncbi.nlm.nih.gov/entrez/quer ... med_docsum


Вс дек 03, 2006 7:43 am
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Зарегистрирован: Чт фев 23, 2006 11:06 am
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Где помощь единомышленников? Бросил все дела, изучаю вакцинно-антивакцинное дело!


Дорогой кипучий Вадим! В дни сомнений, в дни тягостных раздумий :D ( и т д )

Я вот что-то совсем перестала врубаться в какие-то ни было статистические расчеты и показатели.. А английский еще не выучила.. Потому простите великодушно за молчание... :oops:


Пн дек 04, 2006 1:37 am
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Зарегистрирован: Вс ноя 19, 2006 11:10 am
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Дорогой кипучий Вадим! В дни сомнений, в дни тягостных раздумий :D ( и т д )



Во дни разлук и тягостных сомнений,
Как нам писал из Франции Тургенев,
Не надо слез и лишних сожалений,
Она уехала с другим купаться в Крым! :) :x


Пн дек 04, 2006 6:42 am
Профиль
Сообщение 
Есть ли соображения по поводу результатов вакцинации грипполом и весенней вспышкой гриппа? Встречал ли кто анализ результатов? Процент охвата вакцинацией по областям, городам и процент заболеваемости?


Вс мар 18, 2007 6:51 am
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