4841. Double-blind clinical trial of anaesthetic premedication for use in major day surgery.
Three anaesthetic premedication regimens have been compared by double-blind controlled trial in 158 patients undergoing day-case surgery for varicose veins or hernia. Atropine plus droperidol was superior to atropine plus diazepam or atropine alone in lessening nausea and vomiting and in reducing the need for postoperative analgesia.
4842. Treatment of early cancer of the breast: Histological staging and role of radiotherapy.
The clinical progress of 350 patients with early cancer of the breast was reviewed. In a five-year follow-up after simple mastectomy routine postoperative radiotherapy conferred no demonstrable benefit on those with histologically negative lymph-nodes. When the regional nodes were involved in the malignant process, radiotherapy led to an increased mortality in the early stages, but did reduce the incidence of local recurrence.
4843. Controlled trial of 1apha-hydroxycholecalciferol in chronic renal failure.
作者: L Tougaard.;E Sorensen.;J Brochner-Mortensen.;M S Christensen.;P Rodbro.;A W Sorensen.
来源: Lancet. 1976年1卷7968期1044-7页
24 patients with chronic renal failure (glomerular filtration-rate (G.F.R.) 5-25 ml/min) participated in a double-blind placebo-controlled trial of the effects of 1 alpha-hydroxycholecalciferol (1alpha-H.C.C.) 1 mug daily for eleven weeks. This treatment induced significant increases in the intestinal absorption of calcium and in plasma-calcium which reached normal levels within two weeks. It also induced a significant reduction of the raised serum levels of parathyroid hormone. No significant changes were induced in plasma-phosphorus, plasma-alkaline-phosphatase, or in the degree of bone mineralisation as measured by the phosphorus/hydroxyproline ratio in bone. The bone mineral content in the forearm measured by photon absorptiometry decreased to the same extent in the 1alpha-H.C.C. groups and in the placebo group. The fall in G.F.R. over eleven weeks was 2-5 times greater in the 1alpha-H.C.C. group than in the placebo group, but this difference was not significant. It is concluded that 1alpha-H.C.C. treatment in chronic renal failure does not affect the progressive loss of calcium from bone despite normalisation of plasma-calcium.
4844. Radiotherapy in treatment of acute rejection of human renal allografts.
36 patients who received a renal transplant and who subsequently underwent a rejection episode were randomised into two groups. The first group received a standard form of rejection therapy consisting in high doses of steroid drugs, and the second group received in addition 600 rads of radiotherapy to the graft. After three years (minimum follow-up twelve months) the groups were compared with respect to patient and graft survival and level of transplant function. No benefit was obtained by the group receiving radiotherapy.
4845. One drug (phenytoin) in the treatment of epilepsy.
Thirty-one, previously untreated, adult outpatients with idiopathic or focal grand-mal and/or focal minor seizures were treated initially with phenytoin. Serum-phenytoin concentrations were monitored to achieve an optimum range of 10-20 mug/ml if necessary. With a mean duration of follow-up of 14-7 months, only three (10%) patients have required the addition of a second drug, although without the guidance of serum concentrations sixteen (54%) might have been treated with a further drug. In the optimum serum-phenytoin range only 1 grand-mal attack occurred in this series, compared with a mean pre-treatment grand-mal seizure-rate of 1-1/month. Serum phenytoin declined slowly in fourteen (45%) patients. These observations suggest that many epileptic patients could be satisfactorily treated with one drug instead of the polypharmacy which they usually receive.
4846. Prolongation of postoperative disease-free interval and survival in human colorectal cancer by B.C.G. or B.C.G. plus 5-fluorouracil.
作者: G M Mavligit.;J U Gutterman.;M A Burgess.;N Khankhanian.;G B Seibert.;J F Speer.;A V Jubert.;R C Martin.;C M McBride.;E M Copeland.;E A Gehan.;E M Hersh.
来源: Lancet. 1976年1卷7965期871-6页
83 patients with colorectal carcinoma of the Dukes' C class were randomised to receive postoperative adjuvant therapy with B.C.G. alone or in combination with oral doses of 5-fluorouracil (5-F.U.), and have been followed for up to thirty months. Results were compared with carefully selected historical controls who were treated by surgery alone. A statistically significant prolongation of both disease-free interval and overall survival was observed in 50 patients receiving the combination of B.C.G. and 5-F.U. (P=0.03, P=0.01 respectively) as well as in 33 patients receiving B.C.G. alone (P=0.03, P=0.05 respectively). The efficacy of B.C.G.+5-F.U. was independent of the number of tumour-involved lymph-nodes in the surgical specimen. In contrast, B.C.G. given alone appears to be highly effective among 10 patients with 6 or more positive lymph-nodes (P less than 0.04) and ineffective (as yet) among 23 patients with 5 or less positive lymph-nodes. These results suggest that adjuvant immunotherapy, with or without chemotherapy, can improve the prognosis of surgically treated patients with colorectal carcinoma of the Dukes' C class.
4847. Double-blind trial of glycerol therapy in early stroke.
The effects of intravenous glycerol and intravenous dextrose were compared using a double-blind trial in twenty-seven patients with acute stroke. Administration continued for up to 6 days. A standard scoring system was used for neurological evaluation. There was no difference in mortality or in improvement in neurological score between the two groups.
4848. Prediction of azathioprine intolerance in transplant patients.
One cause of transplant rejection is curtailment of immunosuppressive therapy due to leucopenia. To determine those patients most apt to develop leucopenia due to azathiprine the granulocyte response to intravenous injections (i.v.) of hydrocortisone was evaluated in 10 patients who had rejected their grafts at least six month previously. 5 patients who had rejected their grafts with concomitant severe leucopenia had an inadequate response to hydrocortisone, while in the other 5, who had tolerated the drug, the response was similar to that of normal controls. Based on these observations, all the transplant candidates underwent the hydrocortisone stimulation test the results of which were correlated with their subsequent clinical course. All medical decisions were based on events other than the steroid test. 8 leucopenic patients underwent splenectomy. 6 improved their granulocyte response to hydrocortisone and tolerated azathioprine after transplantation. 2 patients who underwent splenectomy and an unoperated leucopenic man were unresponsive to the hydrocortisone test, did not tolerate azatioprine after transplantation and rejected their grafts. 4 candidates with normal responses to i.v. hydrocortisone received transplants uneventfully. In all 13 patients transplanted since the beginning of this study, the hydrocortisone test correctly predicted their tolerance to azathioprine.
4849. Evidence of stem-cell competition in children with malignant disease. A controlled study of hypertransfusion.
In a prospective, randomized controlled study, 30 children who were receiving chemotherapy for malignant disease and who were anaemic and neutropenic, were randomized: 18 to receive transfusion to a Hb of 10-12 g/dl (group A) and 12 to receive moderate hypertransfusion to a Hb of 14-16 g/dl (group B). Children in group B had a significantly more rapid rise in polymorph count, lower incidence of infection, and lower incidence of interruption to chemotherapy. The findings of this study provide evidence for the existence of a common stem cell in human marrow, at least for erythroid and myeloid cell lines, and demonstrate that the concept of "stem-cell competition" derived from animal experiments has a human counterpart which is clinically significant.
4850. Inhibition of frusemide-induced hyperreninaemia by growth-hormone release-inhibiting hormone in man.
In a study of the effect of somatostatin (growth-hormone release-inhibiting hormone) on plasma-renin in healthy volunteers, plasma-renin activity was measured by radioimmunoassay after the intravenous administration of somatostatin and also during frusemide-induced hyperreninaemia. While somatostatin was being given, basal values of renin were unchanged. Injection of frusemide alone produced hyperreninaemia; but, under somatostatin, renin release was inhibited by 45%. The results indicate that somatostatin is a potent inhibitor of renin and exerts its effect independent of sodium excretion, which was unchanged under somatostatin. Conceivably, somatostatin plays an important role in the regulation of endogenous renin release.
4852. A controlled study of therapeutic portacaval shunt in alcoholic cirrhosis.
作者: B Rueff.;D Prandi.;F Degos.;J Sicot.;J D Degos.;C Sicot.;J N Maillard.;R Fauvert.;J P Benhamou.
来源: Lancet. 1976年1卷7961期655-9页
A controlled study of therapeutic end-to-side portacaval shunt was carried out from 1968 to 1971 in 89 patients with alcoholic cirrhosis. Recurrent gastrointestinal bleeding was less common and chronic hepatic encephalopathy was more common in patients with shunts than in patients without shunts. The survival-rate was lower, but not significantly, in patients with shunts. No overall benefit of the operation could be demonstrated in cirrhotic patients with the selection criteria and the type of surgical shunt used in this study.
4853. Psychiatric screening in general practice. A controlled trial.
This study reports the efficacy of the General Health Questionnaire (G.H.Q.) in the secondary prevention of minor psychiatric illness in a primary-care setting. 1093 consecutive attenders at a general practitioner's surgery were screened for minor psychiatric disorder using the G.H.Q. 32% were found to have a conspicuous psychiatric disorder and a further 11% had a hidden psychiatric disorder. The group with hidden disorders were randomly assigned to a treated index group and an untreated control group. The effects of case detection and treatment were beneficial and immediate, with the duration of episode of the disorder being much shorter for patients whose disorder was recognised by the general practitioner. For patients with more severe disorders there are significant differences still demonstrable between the groups one year later; but patients with mild disorders do equally well, some recovering spontaneously but others becoming manifest to the general practitioner over the next year and so receiving treatment. The "detected" group of patients increased their consultations for emotional complaints over the next year, but their total consultation-rate was not increased.
4854. Lithium carbonate in the treatment of thyrotoxicosis. A controlled trial.
Of 24 patients with newly diagnosed thyrotoxicosis, 13 were randomly selected for treatment with methimazole 40 mg per day, and 11 for treatment with lithium carbonate in such doses that the serum lithium lay between 0-5 and 1-3 meq. per litre. The lithium treatment brought about a fall in serum-thyroxine iodine (T4I) of 27.0%, and in the free-thyroxine index (F.T.I.) of 38.1% after 10 days. A comparison of the two patient groups with regard to the fall in F.T.I. after 3 and 10 days showed no statistically significant difference; similarly the calculated confidence limits appeared to exclude any difference of clinical importance. 8 of the 11 patients subjected to lithium treatment had side-effects, so that the general condition, which was already affected by the hyperthyroidism, was worsened. It is concluded that lithium cannot be considered superior to thiocarbamides for the rapid control of thyrotoxicosis.
4856. Efficacy of prophylactic gamma-globulin in preventing non-A, non-B post-transfusion hepatitis.
Of 279 cardiac-surgery patients receiving a mean of twelve transfusions, 47 had significantly increased transaminase concentrations 14 to 180 days postoperatively and 10 were icteric. Preoperatively, each patient randomly received high-titre HbsAb gamma-globulin, normal gamma-globulin, or placebo and was followed at intervals for 9 months. Only 3 patients had serological evidence of hepatitis-B infection. 3 additional patients had serological evidence of cytomegalovirus infection, while none had evidence of hepatitis-A or Epstein-Barr infection. Less icteric hepatitis occurred in patients receiving the gamma-globulin preparations (P = 0-003), and the overall frequency of hepatitis was significantly reduced when compared with recipients of placebo. The protective effects of the two gamma-globulin preparations were not significantly different. Most post-transfusion hepatitis tody is neither viral hepatitis type B nor type A, and its severity and transmission are reduced by pre-transfusion gamma-globulin.
4858. Treatment of ulcerative colitis with oral disodium cromoglycate. A double-blind controlled trial.
Twelve patients with ulcerative protocolitis were treated for six months with each of oral disodium cromoglycate (2 g/day) and placebo in a double-blind cross-over trial. The active drug significantly improved the patients' sense of well-being and the signoidoscopic and rectal biopsy appearances. Orally administered disodium cromoglycate may have a place in the long-term management of colitis.
4859. Menstrual blood-loss with intrauterine devices.
The effect of three intrauterine contraceptive devices (I.U.D.)-Lippes D, Dalkon Shield, and Copper 7-on menstrual blood-loss has been studied serially by objective methods in 279 women. All the women had a minimum of two cycles following delivery, abortion, cessation of lactation, or previous pill or I.U.D. use. All pads and tampons used for two further menstrual cycles before and for 12 cycles after I.U.D. insertion were collected, and the blood-loss was measured by extracting the haemoglobin by conversion to alkaline haematin. Mean menstrual blood-loss increased with all three devices. The amount of loss, the percentage of women losing more than 80 ml, the decline in haemoglobin concentration, and the incidence of anaemia during the 12 cycles following insertion were all greater among users of the Lippes Loop than of the Copper 7 with generally intermediate values for Dalkon Shield users. The mean increases in blood-loss were: for parous women fitted with the Lippes Loop, 48 ml, with the Dalkon Shield, 34 ml, and with the Copper 7, 18 ml; for nulliparae fitted with the small size of Dalkon Shield, 27 ml, and, with the Copper 7, 19 ml.
4860. Levamisole in prevention of recurrent upper-respiratory-tract infections in children.
70 children with chronically relapsing mild-to-severe upper-respiratory-tract infections during autumn and winter participated in a six month double-blind placebo-controlled trial: 38 of them received about 1-25 mg/kg of levamisole twice daily for two consecutive days every week, the others were given placebo. During each of the three trial periods, levamisole proved superior to placebo in that it significantly reduced the number, the duration, and the severity of the infections. Moreover, in the group treated with the higher dose (i.e. greater than 2-5 mg/kg/day), the superiority of levamisole to placebo was much more clear-cut. No drug-related side-effects were reported.
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