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PubMed1988

Single dose versus daily intravenous aminohydroxypropylidene biphosphonate (APD) for the hypercalcaemia of malignancy.

Thirty patients with hypercalcaemia and known malignant disease were randomly allocated to receive 60 mg 3-amino-1-hydroxypropylidene-1,1-bisphosphonate (APD) intravenously as a single dose or as consecutive daily doses of 30 mg (two days) or 15 mg (four days). The rate of infusion was the same for each regimen (7.5 mg/hour). Calcium concentrations fell in all patients and returned to normal in all but two. Relapse of hypercalcaemia occurred after a mean of 21 days in each group. Urinary calcium excretion fell in all groups and symptoms were greatly improved. After relapse patients were retreated with APD (30 mg as a single infusion) and normocalcaemia maintained by regular infusions at two to three week intervals. APD given as a single 60 mg infusion over eight hours together with rehydration is recommended as the initial management of the hypercalcaemia of malignancy, followed by 30 mg APD roughly every two to three weeks to maintain normal or near normal serum calcium concentrations.

Calcium↗

PubMed1983

Medical treatment of biliary duct stones: effect of ursodeoxycholic acid administration.

Twenty-eight patients with radiolucent biliary duct stones without cholangitis and jaundice were randomly allocated into two treatment groups receiving ursodeoxycholic acid 12 mg/kg (group A) or placebo (group B) in three daily doses for 24 months. In group A stones disappeared completely in seven patients and partially in one; placebo administration had no effect on stone size and three patients of group B (only one of group A) went to surgery for complications. Ursodeoxycholic acid treatment did not adversely affect liver function tests, and alkaline phosphatase decreased. Abdominal and biliary colics also became less frequent in the first six months of therapy in group A, but not in the placebo group. The bile was supersaturated with cholesterol in both groups, but decreased significantly only in patients receiving ursodeoxycholic acid even though the lithogenic index remained high. Cholesterol saturation of bile does not seem to be the only factor determining the dissolution of biliary duct stones which sometimes contain cholesterol as the main component.

Adolescent↗

PubMed1981

Treatment of anal fissure by lateral subcutaneous sphincterotomy should be under general anaesthesia.

Seventy-one consecutive patients with acute anal fissure were randomly allocated to treatment by lateral subcutaneous sphincterotomy under either local anaesthesia (n = 34) or general anaesthesia (n = 37). Four months after treatment there were 18 patients with a recurrent or persistent anal fissure, 17 had had local anaesthesia (50 per cent) and only one had a recurrent fissure after general anaesthesia (3 per cent). These results indicate that if lateral subcutaneous sphincterotomy is used for treatment of anal fissure the operation should be performed under a general anaesthetic.

Acute Disease↗

PubMed1991

Comparison of growth retarding effects induced by two different glucocorticoids in prepubertal sick children: an interim long-term analysis.

The low interference with growth expected in child for a cortisol analogue, deflazacort (DFZ), prompted us to verify if DFZ could affect growth less than prednisone (PDN). An interim analysis relative to 27 girls and 38 boys (out of 100 expected) aged 3-12 yrs, after a median period of 14 mo.s is reported. Children with connective tissues (CTD) and glomerular disorders (KD) were randomly allocated to DFZ or PDN. Anthropometric measurements and maturity ratings were performed. Mean daily doses of PDN (or DFZ equivalent), from 0.57 to 0.64 mg/kg (DFZ 0.92 to 0.94 mg/kg) to induce control and from 0.19 to 0.39 mg/kg (DFZ 0.34 to 0.36 mg/kg) to maintain disease under control were given in CTD and KD, respectively. The increase in bone age delay over time was significantly greater than for PDN (-4.0 mo/yr) than DFZ (-1.8 mo/yr) in the overall group. The increases in statural age delay and loss over time were significantly greater than for PDN (-5.9 and -5.9 mo/yr) than DFZ (-2.4 and -2.4 mo/yr), only in children with "taller" midparents. Although doses of DFZ 1.1-1.8 times those of PDN were given, growth retardation in PDN-treated children was nevertheless 2.3-2.5 times that in DFZ-ones.

Age Determination by Skeleton↗

PubMed1983

Adjunctive medroxyprogesterone acetate to radical nephrectomy in category M0 renal cell carcinoma. Preliminary report of a prospective randomized trial.

From July 1979 to December 1981, 83 patients from 6 centers in the Lombardy underwent radical nephrectomy for category M0 renal cell carcinoma. Postoperatively they were randomly allocated to adjunctive medroxyprogesterone acetate (MPA) or to a control group. After the first year of follow-up, the relapse rate was 13% in the controls (5 of 38 evaluable patients) versus 28% in the MPA treatment group (9 of 32). Sex steroid receptors were studied in both the tumor and in the surrounding healthy parenchyma by the dextran-coated charcoal technique in 52 of 70 clinically evaluable patients. There was no significant correlation between receptor studies and the relapse rate. Besides, receptors were more often detected in the healthy than in the neoplastic tissue, and values rarely exceeded 10 fmol/mg protein. Due to the negative trend in the MPA treatment group, the admittance of patients to this study was stopped after 120 patients had been accepted.

Adenocarcinoma↗

PubMed1989

Relationship between Sakita endoscopic stage and duration of treatment for duodenal ulcer healing.

1. Endoscopic staging of peptic ulcer lesions according to Sakita will be a methodological improvement in therapeutic trials provided that the correlation between stages and the time spent in treatment is proved valid. 2. We describe a double-blind controlled randomized trial carried out to determine the efficacy of cimetidine in patients with duodenal ulcer in the H stage of Sakita endoscopic staging. Fifty-two patients with duodenal ulcer (H stage) were randomly allocated to receive either 400 mg cimetidine twice daily (N = 26), or placebo (N = 26) for two weeks; patients with unhealed ulcers continued the same treatment for an additional week. 3. Of the cimetidine-treated patients, 19 (73%) were healed after two weeks and 23 (88.5%) after three weeks of treatment, and of the placebo-treated patients, 8 (31%) were healed after two and 13 (50%) after three weeks. 4. These differences indicate a natural tendency of the H stage lesions to heal faster than reported for the active (stage A) lesions and still faster if treated with cimetidine. These findings, by establishing a relationship between the ulcer stage and the time spent in treatment, may help the physician to treat duodenal ulcer patients and will enable the adoption of an important, uniform criterion for selection of duodenal ulcer patients for therapeutic trials, especially in multicenter trials.

Adult↗

PubMed1990

[Rectoscopy and Hemoccult II in irritable colon. A prospective study].

It was investigated whether Hemoccult-II test (H-II) could reduce the number of colonic examinations in patients with the irritable bowel syndrome, with normal rigid proctoscopic findings. A negative H-II was obtained in 299 patients from general practice and a positive test in nine. Colonoscopy was done in 157 and double contrast barium enema in 142 after random allocation. The nine patients with positive H-II all had colonoscopy. Among the 299 with negative H-II, colonic adenomas were detected in ten and an early cancer in an adenoma in the sigmoid colon; overlooked rectal adenomas were found in three, rectal cancer in one, rectal carcinoid in another and a coecal cancer, which could be palpated, in a third patient. Two patients with colonic cancer and one with adenoma were detected among those with positive H-II. All patients were followed by clinical examination after one year. In conclusion, colonic examination should carry a low priority in patients with symptoms of irritable bowel, negative Hemoccult-II and normal rigid proctoscopic findings performed by an experienced examiner. The investigation confirmed the recommendation of total colonoscopy in patients with a positive H-II and added support for increasing number of endoscopy services in contrast to those of diagnostic radiology, which should be reduced.

Adenoma↗

PubMed1991

Effectiveness of inhaled bronchodilator delivery systems for elderly patients.

A prospective study of inhaler technique using aerosol metered dose inhalers (MDIs), Rotahalers and a breath-activated device (Aerolin Autohaler) was undertaken to assess how effectively elderly patients use their inhalers. Fifty-one patients aged 67-89 years (mean 77.4 years) were enrolled. Peak flow, FEV1 and FVC were recorded, before and after inhalation of 2.5 mg of salbutamol via a nebulizer, to assess the extent of reversible airways obstruction. Inhaler technique was assessed using a scoring system, based on performance in five aspects of inhaler use. Those with poor technique were randomly allocated to an alternative inhaler and reassessed. Twenty-nine of 51 patients demonstrated reversibility in their airways disease. Twenty-one of 47 had poor technique using an MDI and were given Rotahaler or Aerolin devices to use. Ten of 11 given Aerolin Autohalers improved but seven of ten using Rotahaler showed no improvement (p = 0.006). Subsequently, five of these seven were able to improve their technique with the breath-activated autohaler. The breath-activated Aerolin Autohaler is a better delivery system than Rotahalers for inhaled bronchodilators for elderly patients.

Age Factors↗

PubMed1983

Clinical trial of pirprofen in arthrosis of the knee joint: a double-blind comparison with indomethacin.

Thirty-nine patients suffering from arthrosis of the knee were randomly allocated to either pirprofen 400 mg b.i.d. or indomethacin 50 mg b.i.d., the treatment being double-blind. Assessments for pain and joint stiffness were made after 2 and 4 weeks. Both treatments appeared to be equally effective and induced side-effects in a limited number of patients. Similar observations were made in those patients who continued the treatment over longer periods of time.

Anti-Inflammatory Agents, Non-Steroidal↗

PubMed1989

The effectiveness of two test dentifrices on dental plaque formation: a 1-week clinical study.

A 1-week, double-blind clinical study was conducted to compare the effects on plaque formation of two test dentifrices with a placebo dentifrice. Male and female adult subjects received an oral prophylaxis and were randomly allocated to three study groups. The subjects used the dentifrice three times daily and were examined for the presence of plaque after seven days. The results indicated that one of the two test dentifrices, containing 0.3% triclosan, 2% of a copolymer, and 0.76% sodium monofluorophosphate in an insoluble sodium metaphosphate abrasive system, significantly reduced plaque formation by 16% when compared to the placebo dentifrice.

Adult↗

PubMed1989

Residual curarization in the recovery room: atracurium versus gallamine.

Residual curarization in the recovery room was evaluated in 19 patients randomly allocated to two groups with nine and ten patients in each group, respectively. In one group atracurium was used for relaxation, and gallamine was used in the other. Anaesthesia was achieved with thiopental, diazepam, fentanyl and nitrous oxide in oxygen. Mean train-of-four (TOF) ratio in the gallamine and atracurium group was 0.63 and 0.91, respectively. Fifty per cent of the patients in the gallamine group had TOF ratios below 0.70, and none of these patients were able to sustain a head lift for 5 s. All patients in the atracurium group had TOF ratios above 0.70, and all of them were able to lift their head for 5 s. All patients were fully awake when they were evaluated, and no patient had any sign of respiratory difficulty. We conclude that residual curarization in the recovery room remains a problem and that this problem seems to be reduced when muscle relaxants of intermediate duration of action are used for relaxation during operation.

Adult↗

PubMed1989

Polyvalent immune globulin and cytomegalovirus infection after renal transplantation.

To determine whether polyvalent, immune globulin (IgG) prevents cytomegalovirus (CMV) infection after cadaver renal transplantation, 28 patients were randomly allocated to receive 12 weekly infusions of 500 mg/kg of IgG (n = 15) or no treatment (n = 13). Both groups were similar with respect to age, sex, antigen mismatches, number of diabetics, and pretransplant donor/recipient CMV antibody titers. Moderately severe CMV infections occurred in 10 (77%) of 13 control subjects compared with 8 (53%) of 15 IgG-treated patients (not significant). Among those who developed CMV infections, prophylactic IgG had no effect on the severity or duration of fever, leukopenia, or hepatic enzyme elevations. Since none of the IgG-treated patients or control subjects in this study developed life-threatening CMV complications, a beneficial effect of prophylactic IgG in the small number of patients at risk for more severe CMV infections could not be excluded. However, this investigation suggests that the routine, prophylactic administration of polyvalent IgG, to prevent or to ameliorate CMV infection in unselected cadaver renal transplant recipients, is not warranted.

Antibodies, Viral↗

PubMed1989

Immunotherapy with dog and cat extracts in children.

Hypersensitivity to dogs and cats causes asthma in many children. In this open controlled clinical study we wanted to establish whether immunotherapy can be recommended as a supplement to conventional medical therapy in dog- and cat-induced asthma in children. Twenty-seven children with mean age 10 7/12 years and with allergy to dog or cat according to anamnesis, skin prick test (SPT), specific IgE (RAST) and bronchial provocation test (BPT) entered the study. On the basis of age and bronchial sensitivity they were randomly allocated to either immunotherapy with dog or cat extract (active group, n = 14) or conventional medical therapy (control group, n = 13). Immunotherapy comprised subcutaneous injections with an alum-adsorbed depot extract (Alutard-SQ), and a maintenance dose of 100,000 SQ-U or the maximum tolerated dose. Before entering the study and after 9 months' therapy the patients were evaluated by BPT, SPT, RAST - and IgG4 analyses. The active group showed statistically significant change in bronchial tolerance (P less than 0.02), whereas no such change was found in the control group (P greater than 0.05). The change in skin sensitivity was significantly greater in the active group than in the control group (P less than 0.05), whereas no significant differences were found in RAST and IgG4. However, a significant (P = 0.05) increase in IgG4 was seen in the active but not in the control group. Frequency and degree of side effects in this study were acceptable.

Adolescent↗

PubMed1988

Gastric fluid volume and pH in elective inpatients. Part II: Coffee or orange juice with ranitidine.

In order to assess the effect of preoperative oral fluids, with and without ranitidine, on gastric fluid volume and pH 300 elective surgical inpatients, ASA physical status I and II, were randomly allocated to one of six groups. The three ranitidine groups (Groups 4, 5, and 6) are discussed in this paper (Part II), and the three placebo groups (Groups 1, 2, and 3) in Part I. Between two and three hours before the scheduled time of surgery, patients received 150 ml coffee with oral ranitidine 150 mg (Group 4), 150 ml orange juice with oral ranitidine 150 mg (Group 5), or oral ranitidine alone (Group 6). No opiate or belladonna premedication was given. Immediately following induction of anaesthesia a # 18 Salem sump tube was passed and its position in the stomach confirmed by auscultation of insufflated air. The volume of residual gastric fluid, which was aspirated into a 60 ml syringe, was recorded, and its pH was measured. There were no statistically significant differences between groups with respect to volume (Group 4: 14.3 +/- 15.4; Group 5: 14.8 +/- 17.0; Group 6: 9.7 +/- 12.6 ml). The mean pH in all groups was greater than 5.40 (Group 4: 5.65 +/- 2.12; Group 5: 5.41 +/- 2.12; Group 6: 6.21 +/- 1.51).

Adult↗

PubMed1988

A randomized controlled trial of the effect on blood pressure of dietary non-meat protein versus meat protein in normotensive omnivores.

1. A randomized, controlled trial was carried out to examine whether changes in type and amount of dietary protein were responsible for earlier observations of blood-pressure-lowering effects of lacto-ovo-vegetarian diets. 2. Sixty-four subjects were pair-matched for sex, age, weight and sitting systolic blood pressure, and were randomly allocated to receive one of two types of protein supplement: one containing proteins from meat, the other proteins from non-meat sources. The supplements were balanced in terms of other nutrients. Consumption of other meat, poultry or fish was prohibited. 3. Sitting and standing blood pressures, weight, dietary intakes and plasma and urinary electrolytes were measured at regular intervals during the 12 weeks of trial. Urinary 3-methylhistidine was used as a measure of compliance. 4. Fifty subjects completed the trial. There were no statistically significant blood pressure differences between groups either at baseline or at end-of-trial, neither were there any substantive differences in mean blood pressure changes between baseline and end-of-trial. 3-Methyl-histidine excretion was significantly lower in subjects on the non-meat diet. 5. The results suggest that the protein components of the lacto-ovo-vegetarian diet are not responsible for the blood-pressure-lowering effects of that diet.

Adolescent↗

PubMed1990

Single breath versus panting technique in salbutamol delivery through a 750 mL spacing device.

Spacing devices have been widely advocated for asthmatic patients having difficulty actuating metered aerosols and co-ordinating inspiration. Studies have generally supported the slow inspiration/breath hold technique. This requires conscious respiratory control. Such control is often not possible in young children; consequently panting techniques are widely recommended. The panting technique has not been studied. The aim of this study was to compare the bronchodilator effectiveness of panting and the single breath maneuver, each followed by a breath hold, and each at functional residual capacity (FRC), using a Volumatic Space. The study design was a randomly allocated cross-over assessment of bronchodilator response for each technique. The drug dosage was controlled by limiting the inspired volumes of gas (single and cumulative) to the pretested inspiratory capacity. Two hundred micrograms of salbutamol was delivered into the spacer. Twenty-one patients were entered in the study and 15 (mean age +/- SD = 10.9 +/- 3.3 years) completed the protocol. There was no significant difference in bronchodilator response between the two groups. We conclude that the panting and the single breath techniques are equally effective in children of this age group.

Adolescent↗

PubMed1988

Multicentre double-blind comparison of sustained action formulations of tiaprofenic acid and indomethacin in osteoarthritis.

In a randomised double-blind, multicentre, crossover study, the short term efficacy and tolerance of a sustained action preparation of tiaprofenic acid 600 mg once daily was compared with sustained release indomethacin 75 mg once daily in 98 patients with osteoarthritis. After a minimum washout period of 3 days, patients were randomly allocated to receive each treatment in turn for a period of 4 weeks. There were no significant differences between the 2 treatments in the clinical assessments of pain level, duration of morning stiffness, articular index and functional impairment performed at the end of each treatment period. High pain levels on movement were reduced by both treatments, and reduction was also seen in night pain, where initial levels were lower. There was no significant difference between the number of patients who reported side effects on the 2 treatments. 37 patients (39%) reported 49 side effects while taking sustained release tiaprofenic acid, and 35 patients (37%) reported 53 side effects while taking sustained release indomethacin. Daily diary cards showed that both treatments provided improvements in duration of morning stiffness and in pain relief. Thus sustained action tiaprofenic acid and sustained release indomethacin were shown to be equally well tolerated and efficacious.

Adult↗

PubMed1987

Alfentanil or fentanyl for anaesthetic procedures of two hours duration? A double-blind study.

Eighty women undergoing surgery of at least 2-h duration were randomly allocated to receive either alfentanil or fentanyl to supplement a diazepam nitrous oxide/oxygen anaesthetic. Anaesthesia was induced with fentanyl 0.2 mg and diazepam 10-20 mg and continued with nitrous oxide/oxygen. Analgesia was provided by injection of the narcotic using unlabelled ampoules that contained either alfentanil 0.5 mg ml-1 or fentanyl 0.05 mg ml-1. Apart from a marginally higher heart rate when alfentanil was used, there was no significant difference between groups at any time during the operation. Patients woke 2.7 +/- 3.1 min following discontinuation of nitrous oxide and were extubated after 10.3 +/- 7.6 min (alfentanil) and 17.3 +/- 19.0 min (fentanyl) (P = 0.1). However, following alfentanil significantly more patients could be extubated within 20 min to 30 min after completion of the operation (P less than 0.01). The last top-up dose of alfentanil had to be given nearer the end of the operation than the last dose of fentanyl (P less than 0.01). Patients receiving alfentanil needed significantly more (P less than 0.01) post-operative analgesia.

Adjuvants, Anesthesia↗