4102. Economical multiple-site intradermal immunisation with human diploid-cell-strain vaccine is effective for post-exposure rabies prophylaxis.
作者: M J Warrell.;K G Nicholson.;D A Warrell.;P Suntharasamai.;P Chanthavanich.;C Viravan.;A Sinhaseni.;M K Chiewbambroongkiat.;X Pouradier-Duteil.;C Xueref.
来源: Lancet. 1985年1卷8437期1059-62页
An economical post-exposure regimen of Mérieux human diploid-cell-strain vaccine (HDCSV) was compared with Semple vaccine (SV), the most widely used vaccine in Asia. 155 patients bitten by animals proved to be rabid received either conventional courses of SV (34 severe and 43 mild cases) or HDCSV, 0.1 ml intradermally, at eight sites on day 0, at four sites on day 7, and at one site on days 28 and 91 (36 severe and 42 mild cases). All severely bitten patients were given equine anti-rabies serum (EARS), 80 IU/kg on day 0. There were no deaths from rabies in either group. Follow-up was 97.5% at 1 year and 93% at 2 years. 88% of patients given HDCSV alone had detectable neutralising antibody on day 7 in contrast to 2% given SV alone. Antibody persisted until 1 year in all sera tested from HDCSV patients in contrast to only 48% of SV sera. The high dose of EARS resulted in pronounced suppression of response to HDCSV. There were no serious systemic side-effects but local side-effects were significantly more common in the SV group. The multiple-site intradermal HDCSV regimen was at least as effective as SV. The amount of HDCSV used was 30% of the conventional dose.
4105. Review of British National Lymphoma Investigation studies of Hodgkin's disease and development of prognostic index.
作者: J L Haybittle.;F G Hayhoe.;M J Easterling.;A M Jelliffe.;M H Bennett.;G Vaughan Hudson.;B Vaughan Hudson.;K A MacLennan.
来源: Lancet. 1985年1卷8435期967-72页
A review of data from the British National Lymphoma Investigation (BNLI) studies of Hodgkin's disease (HD) done over the past 14 years shows (i) that systemic chemotherapy is appropriate for all clinical stages except I and IIA, and that MOPP (mustine, vincristine, procarbazine, and prednisone) courses are substantially more effective than MOP (the same without prednisone) but no better than the less toxic LOPP combinations (where chlorambucil replaces mustine); (ii) that local involved-field irradiation in stages I and IIA HD is as effective as wide-field in terms of both overall and recurrence-free survival; and (iii) that, histologically, nodular sclerosing HD can be divided into grades 1 and 2, the latter containing areas of lymphocyte depletion or numerous pleomorphic Hodgkin's cells. A multivariate analysis of factors influencing prognosis in clinical stages I and IIA disease shows that laparotomy has no significant effect but that age, sex, erythrocyte sedimentation (ESR), the presence or absence of mediastinal involvement and, especially, pathological grade are the most important factors influencing overall survival, while ESR, pathological grade, and stage of disease (I or II) correlate with recurrence-free time. A prognostic "survival" index was developed; an index of greater than 7.5 indicated a poor prognosis and that chemotherapy was perhaps more appropriate than local radiation. Laparotomy is no longer justified as a routine procedure in staging HD, although it may still be useful in special circumstances and in some research investigations.
4106. Hepatitis B immunisation with a reduced number of doses in newborn babies and children.
作者: M Piazza.;L Picciotto.;R Villari.;V Guadagnino.;R Orlando.;L Isabella.;V Macchia.;A M Memoli.;A Vegnente.;A M Borrelli.
来源: Lancet. 1985年1卷8435期949-51页
74 healthy babies born to mothers positive for hepatitis B surface antigen (HBsAg) were randomly divided at birth to receive either HB immunoglobulin and 2 doses of HB vaccine 2 months apart, or HB immunoglobulin and 3 doses of HB vaccine 1 month apart. 80 healthy babies born to HBsAg, anti-HBs, and anti-HB core (c) negative mothers were randomly divided at birth to receive either 2 doses of vaccine 2 months apart or 3 doses 1 month apart. The seroconversion rates and the geometric means of anti-HBs titres were lower in both groups of babies given 2 doses of vaccine than in the groups given 3 doses. 60 pairs of children at risk, aged 1 to 12 years and HBsAg, anti-HBs, and anti-HBc negative, were randomly divided to receive either the 2-dose regimen or the 3-dose regimen. The seroconversion rates and the geometric means of anti-HBs titres were satisfactory in both groups.
4107. Controlled trial of treatment of recurrent spontaneous abortion by immunisation with paternal cells.
作者: J F Mowbray.;C Gibbings.;H Liddell.;P W Reginald.;J L Underwood.;R W Beard.
来源: Lancet. 1985年1卷8435期941-3页
In a paired sequential double-blind trial of immunological treatment of recurrent spontaneous abortion successful outcome of the next pregnancy was significantly more common in women injected with purified lymphocytes prepared from their husbands' blood than in those injected with their own lymphocytes. 17 of 22 women given paternal cells had successful pregnancies, compared with 10 of 27 given their own cells.
4109. Trials of mefloquine in vivax and of mefloquine plus 'fansidar' in falciparum malaria.
Two randomised double-blind trials were conducted to examine the activity and tolerability of mefloquine alone and in combination with sulfadoxine/pyrimethamine (MSP). In one trial mefloquine was compared with chloroquine in 40 patients with Plasmodium vivax malaria and in the other one mefloquine was compared with MSP in 40 patients with P falciparum malaria. The former trial showed that both a single oral dose of 250 mg mefloquine and a single oral dose of 450 mg chloroquine (base) were highly effective in relieving symptoms of malaria and in clearing P vivax parasitaemia. No side-effects and no changes in laboratory variables attributable to the test drugs were observed. The other trial showed that a single oral dose of 750 mg mefloquine and a single oral dose of MSP (750 mg mefloquine plus 3 tablets of 'Fansidar', were equally effective in the treatment of falciparum malaria. 2/4 treatment failures in the mefloquine group and 2/3 treatment failures in the MSP group were due to low plasma drug levels resulting from vomiting soon after ingestion of the tablets. Gametocytes of P falciparum were unaffected by either mefloquine or MSP. 5 patients in each group had side-effects such as vomiting, skin rash, diarrhoea, and transient mental confusion. Mefloquine was well tolerated by patients with glucose-6-phosphate dehydrogenase deficiency or heterozygous haemoglobin E.
4110. Randomised trial of intravenous recombinant tissue-type plasminogen activator versus intravenous streptokinase in acute myocardial infarction. Report from the European Cooperative Study Group for Recombinant Tissue-type Plasminogen Activator.
作者: M Verstraete.;R Bernard.;M Bory.;R W Brower.;D Collen.;D P de Bono.;R Erbel.;W Huhmann.;R J Lennane.;J Lubsen.
来源: Lancet. 1985年1卷8433期842-7页
In a single-blind randomised trial in patients with acute myocardial infarction of less than 6 h duration, the frequency of coronary patency was found to be higher after intravenous administration of recombinant human tissue-type plasminogen activator (rt-PA) than after intravenous streptokinase. 64 patients were allocated to 0.75 mg rt-PA/kg over 90 min, and the infarct-related coronary artery was patent in 70% of 61 assessable coronary angiograms taken 75-90 min after the start of infusion; 65 patients were allocated to 1 500 000 IU streptokinase over 60 min, and the infarct-related vessel was patent in 55% of 62 assessable angiograms. The 95% confidence interval of the differences ranges from +/- 30 to -2% (p = 0.054). Bleeding episodes and other complications were less common in the rt-PA patients than in the streptokinase group. Hospital mortality was identical in the 2 treatment groups. At the end of the rt-PA infusion the circulating fibrinogen level was 61 +/- 35% of the starting value, as measured by a coagulation-rate assay, and 69 +/- 25% as measured by sodium sulphite precipitation. After streptokinase infusion, corresponding fibrinogen levels were 12 +/- 18% and 20 +/- 11%. In the rt-PA group only 4.5% of the fibrinogen was measured as incoagulable fibrinogen degradation products, compared with 30% in the streptokinase group. Activation of the systemic fibrinolytic system was far less pronounced with rt-PA than with streptokinase.
4111. Prevention of pre-eclampsia by early antiplatelet therapy.
102 patients at high risk of pre-eclampsia and/or fetal growth retardation were randomly allocated to treatment with 300 mg dipyridamole and 150 mg aspirin daily from 3 months' gestation onwards (group A) or to the control group (group B, no treatment). Group A was twice as likely as group B to have a normal pregnancy. Pre-eclampsia occurred in 6 patients in group B and none in group A. Major complications (fetal death or severe growth retardation) occurred in 9 patients in group B and none in group A. Platelet count and plasma volume were significantly higher in group A than in group B throughout pregnancy. The treatment did not produce serious adverse effects. Antiplatelet therapy given early in pregnancy to high-risk patients may thus protect against pre-eclampsia and fetal growth retardation.
4112. Controlled trial of tamoxifen as single adjuvant agent in management of early breast cancer. Analysis at six years by Nolvadex Adjuvant Trial Organisation.
来源: Lancet. 1985年1卷8433期836-40页
A randomised controlled trial of tamoxifen as a single adjuvant agent after mastectomy for early breast cancer, reported on at an average follow-up of almost 2 years in 1983, has now been followed up to a maximum of 6 years. 1285 patients aged 75 or less were entered into the trial. Premenopausal women with positive axillary nodes and postmenopausal women with both positive and negative axillary nodes were randomised to receive either tamoxifen 10 mg twice daily for two years or to the untreated control group with systemic therapy reserved until the time of relapse. 46% of the trial population had primary tumour specimens assayed for oestradiol receptor (ER) content. There has been a highly significant prolongation of the disease-free interval in the tamoxifen-treated group followed by a highly significant reduction in death rate, with 45 (34%) fewer deaths observed in the treated group than in the control group. This benefit appeared to be independent of menopausal, nodal, or ER status.
4113. Treatment of active rheumatoid arthritis with slow intravenous injections of thymopentin. A double-blind placebo-controlled randomised study.
作者: M G Malaise.;C Hauwaert.;P Franchimont.;B Danneskiold-Samsoe.;R Bach-Andersen.;D Gross.;H Gerber.;H Gerschpacher.;H Stocker.;K Bolla.
来源: Lancet. 1985年1卷8433期832-6页
41 patients with active rheumatoid arthritis entered a placebo-controlled double-blind randomised study in which 21 received slow intravenous injections (given in fractions over 10 min) of thymopentin (TP-5) 50 mg 3 times a week for 3 consecutive weeks and 20 received placebo in the same way. After 3 weeks of treatment the TP-5 group showed improvement (p less than 0.05 or p less than 0.01) in all but one of the clinical variables tested. There was improvement in the number of joints painful at rest, the number of joints painful on motion, scores for tenderness on pressure and swollen joints, severity of pain on awakening and morning stiffness, and right-hand grip strength; left-hand grip strength remained unchanged. In the placebo group, only morning stiffness improved significantly. The intergroup comparisons showed that thymopentin was significantly better than placebo in reducing tenderness, joint swelling, severity of pain on awakening, and disease activity. 4 weeks after the end of the TP-5 therapy, the improvement was still present although there was a trend towards relapses. No significant modifications occurred in any of the laboratory variables tested and only minor side-effects were experienced by either group.
4114. Reduction in mortality from breast cancer after mass screening with mammography. Randomised trial from the Breast Cancer Screening Working Group of the Swedish National Board of Health and Welfare.
作者: L Tabár.;C J Fagerberg.;A Gad.;L Baldetorp.;L H Holmberg.;O Gröntoft.;U Ljungquist.;B Lundström.;J C Månson.;G Eklund.
来源: Lancet. 1985年1卷8433期829-32页
A randomised controlled trial to investigate the efficacy of mass screening with single-view mammography in reducing mortality from breast cancer was started in Sweden in 1977. 162 981 women aged 40 years or more and living in the counties of Kopparberg and Ostergötland were enrolled in the study and divided at random into 2 groups. Each woman in the study group was offered screening every 2 or 3 years depending on age. Women in the control group were not offered screening. This report is confined to the 134 867 women aged 40-74 years at date of entry. The results to the end of 1984 show a 31% reduction in mortality from breast cancer and a 25% reduction in the rate of stage II or more advanced breast cancers in the group invited to screening. 7 years after the start of the study the excess of stage I cancers in the study group largely outweighs the deficit of advanced cancers.
4116. Prophylactic endoscopic sclerotherapy of oesophageal varices. A prospective controlled study.
Of 109 patients with cirrhosis and endoscopically demonstrated oesophageal varices who had not bled, 56 were treated by sclerotherapy and 53 were treated conservatively. Patients were assigned to one of three categories according to varix size and Child's classification of severity of liver disease. Severity of liver disease increased with varix size. Frequency of haemorrhage in the control group also increased with varix size: haemorrhage occurred from small varices in 35% of patients, from medium varices in 53%, and from large varices in 83%. Prophylactic sclerotherapy diminished the frequency of variceal bleeding and overall mortality: over 25 months, frequency of bleeding was 9% in the therapy group and 57% in the controls, with mortality rates of 23% and 55%, respectively.
4118. Randomised controlled trial of azathioprine withdrawal in autoimmune chronic active hepatitis.
To assess the value of azathioprine in the maintenance therapy of autoimmune chronic active hepatitis a controlled trial of azathioprine withdrawal was carried out in 50 patients who had been maintained in remission on a combination of azathioprine and prednisolone. The patients were randomly allocated to remain on combination therapy (23) or to discontinue azathioprine (27). These 2 groups were comparable at the start of the study. Over a follow-up period of up to 3 years, biochemical and histological relapse occurred in 8 patients in the azathioprine-withdrawal group but in only 1 patient in the combination-therapy group. Cumulative probability of relapse was 32% among the patients in the withdrawal group, compared with 6.0% for those in the combination group.
4119. Paracentesis versus diuretics in the treatment of cirrhotics with tense ascites.
作者: E Quintero.;P Ginés.;V Arroyo.;A Rimola.;F Bory.;R Planas.;J Viver.;J Cabrera.;J Rodés.
来源: Lancet. 1985年1卷8429期611-2页
72 cirrhotics with tense ascites were randomly assigned to treatment with either paracentesis plus intravenous albumin infusion (38 patients) or diuretics (34 patients). Paracentesis was not associated with significant changes in renal function. The clinical course of the disease was similar in the two groups of patients, both during their hospital stay and during follow-up.
|