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PubMed1988

Need for endotracheal intubation and suction in meconium-stained neonates.

In a prospective study, we determined whether routine immediate tracheal aspiration at birth is necessary in meconium-stained but otherwise normal infants delivered vaginally and having a 1-minute Apgar score greater than 8. A total of 572 newborn infants who met these criteria were randomly allocated to one of two groups. All infants underwent oropharyngeal suctioning with a DeLee catheter while the head was still on the perineum. In group I (n = 308) suctioning of the trachea under direct vision was performed instantly at birth; in group II (n = 264) this procedure was not done. There was no mortality among infants in the study, but morbidity, mainly pulmonary and laryngeal disorders, occurred in six of 308 group I infants and in none of the group II infants (P less than 0.025). Immediate tracheal suction is not a harmless intervention, and should be considered superfluous in a vigorous term neonate born with meconium-stained amniotic fluid.

Apgar Score↗

PubMed1989

Sucralfate as maintenance treatment for the prevention of duodenal ulcer recurrence.

Eighty-eight patients with endoscopically proven and healed duodenal or pyloric ulcer were randomly allocated into a double-blind, placebo-controlled, 12-month maintenance trial to determine whether sucralfate, 1 g twice daily, can be used to prevent a recurrence of ulceration. The patients were assessed endoscopically at three, six, and 12 months, or earlier if a symptomatic relapse occurred. Serum aluminum levels were also monitored. Sixteen patients were excluded from the study during the follow-up: nine of 41 in the sucralfate group, and seven of 47 in the placebo group. The groups did not differ with respect to age, sex, or smoking. The cumulative relapse rates in the sucralfate group were 28 percent after three months, 33 percent after six months, and 45 percent after 12 months, as compared with 49 percent (p less than 0.05), 64 percent (p less than 0.01), and 68 percent (p less than 0.05), respectively, in the placebo group. It is concluded that 1 g sucralfate twice daily is more effective than a placebo and is safe for the maintenance treatment of duodenal and pyloric ulcer disease.

Adult↗

PubMed1987

Randomized trial of portacaval shunt, stapling transection and endoscopic sclerotherapy in uncontrolled variceal bleeding.

Seventy consecutive cirrhotic patients with persistent or recurrent variceal bleeding were included in a clinical trial to compare the efficacy and safety of portacaval shunt (PCS) and stapler transection (ST) in patients with low surgical risk, and of stapler transection and endoscopic sclerotherapy (ES) in patients with high surgical risk. To classify the patients into low- and high-risk groups a new scoring system was used, based on an analysis of factors influencing operative mortality in an earlier series of emergency portacaval shunt. Thirty-eight low-risk patients were randomly allocated for treatment with portacaval shunt (19 patients) or stapler transection (19 patients), and 32 high-risk patients for stapler transection (17 patients) or ES (15 patients). The operative mortality of patients treated by PCS was close to that expected according to retrospective data, this indicating that the proposed scoring system is highly discriminant. In low-risk patients, portacaval shunt evidenced greater haemostatic efficacy and fewer complications than stapler transection. However, hepatic encephalopathy during follow-up was more frequent in the portacaval shunt group and there were no significant differences in operative mortality and long-term survival between the two groups. In high-risk patients, stapler transection and sclerotherapy had a similar haemostatic efficacy, operative mortality and long-term survival. However, sclerotherapy occasioned fewer complications than stapler transection. Our results motivate us to recommend stapler transection for low-risk patients and to consider sclerotherapy as an alternative for high-risk patients in the emergency treatment of uncontrolled variceal bleeding.

Clinical Trials as Topic↗

PubMed1982

Comparison of propranolol and hydrochlorothiazide for the initial treatment of hypertension. II. Results of long-term therapy. Veterans Administration Cooperative Study Group on Antihypertensive Agents.

As described in the preceding communication, either propranolol hydrochloride or hydrochlorothiazide were randomly allocated in a double-blind manner to 683 patients with initial diastolic BP in the range of 95 to 114 mm Hg. Of this number, 394 entered the long-term treatment phase. During the subsequent 12 months of long-term treatment, hydrochlorothiazide was more effective than propranolol in controlling BP (mean reductions, -17.5/-13.1 mm Hg with hydrochlorothiazide compared with -8.3/-11.3 with propranolol. After treatment with hydrochlorothiazide, a greater percentage of patients achieved the goal diastolic BP of less than 90 mm Hg (65.5% compared with 52.8% taking propranolol). Also during treatment, fewer patients receiving hydrochlorothiazide required termination as compared with those receiving propranolol; comparative dosage requirements were lower; additional titration during long-term treatment was required less often, and BP remained lower after withdrawal of the active drugs. However, biochemical abnormalities were greater with hydrochlorothiazide. Although not statistically significant, the antihypertensive effects of hydrochlorothiazide were greater in blacks than in whites. Whites, on the other hand, had a greater response to propranolol than blacks, although it was still less than the response of the whites to hydrochlorothiazide.

Adult↗

PubMed1987

Alpha-tocopherol: effect on plasma lipoproteins in hypercholesterolemic patients.

This study was designed to examine the hypothesis that dl-alpha-tocopheryl acetate (vitamin E) increases the level of high-density lipoprotein cholesterol (HDLC) with a concomitant decrease of the ratio of total cholesterol/HDLC and a resultant amelioration of the coronary risk profile. Vitamin E (500 IU/day) or placebo were administered under double-blind randomized allocation to 69 hypercholesterolemic patients for 3 months. Sixty patients completed the study (30 in the active treatment group and 30 in the placebo group). Vitamin E raised the mean level of HDLC from 1.39 +/- 0.38 (SD) to 1.58 +/- 0.41 mmol, a 13.6% increase. This increase significantly (P less than 0.05) exceeded a parallel smaller increase of only 0.05 mmol (3.8%) in the placebo group. As total cholesterol (TC) declined by similar proportions in the vitamin E (7.8%) and placebo (9.4%) groups, a concomitant reduction of 23% in the TC/HDLC ratio was achieved in the vitamin E group, significantly exceeding a 9.1% reduction under placebo. Significant beneficial effects were noted on apolipoprotein (Apo) A (which rose) and Apo B (which declined). An increase of Apo A/Apo B ratio by 17.9% was observed only in the vitamin E group. These results suggest that the oral administration of vitamin E (500 IU/day) is beneficial in hyperlipoproteinemia and offers a potential tool for treating the increased coronary heart disease risk.

Apolipoproteins A↗

PubMed1987

Prolongation of isobaric bupivacaine spinal anesthesia with epinephrine and clonidine for hip surgery in the elderly.

The effects of vasoconstrictors on the duration of isobaric bupivacaine spinal anesthesia are unknown. A prospective controlled study was conducted on 60 ASA class II or III patients aged 75 yr or more who were scheduled for spinal anesthesia for orthopedic hip surgery. The subjects were randomly allocated into three groups. All patients received 15 mg bupivacaine plain solution in 4 ml in the horizontal position. Group I patients received bupivacaine plus 1 ml normal saline; group II patients received bupivacaine plus 0.2 mg epinephrine; group III patients received bupivacaine plus 0.15 mg clonidine. The segmental level of sensory loss was tested using forceps. In one case in group III, anesthesia was unsatisfactory. The time course required for maximal spread of the sensory blockade did not differ in the three groups. No difference was observed between mean highest levels of sensory anesthesia. The mean time to two-segment regression from the highest level was significantly longer in group III than in groups I and II. Mean time for regression to the L2 segment was also significantly longer in groups II and III than in group I. This time tended to increase more with the bupivacaine plus clonidine solution than with the bupivacaine plus epinephrine solution. Significant prolongation of motor block was also associated with the addition of clonidine.

Aged↗

PubMed1979

Randomised comparison of methyldopa and oxprenolol for treatment of hypertension in pregnancy.

Fifty-three pregnant women with moderately severe hypertension were randomly allocated to treatment with methyldopa or oxprenolol. There were no significant differences between the groups in age, height, weight, parity, or stage of gestation at the start of treatment. The outcome of pregnancy was better in the group treated with oxprenolol, with greater maternal plasma volume expansion and placental and fetal growth. No intrauterine deaths occurred in either group, and antepartum fetal distress, detected by oxytocin challenge testing, was evident in only one patient, who received methyldopa. This infant, and one other in the methyldopa group, died in the neonatal period. No neonatal deaths occurred in the oxprenolol-treated group. Even in this small number of patients these results were considerably better than those in untreated women with hypertension of similar severity. Apgar scores in both groups were equivalent at birth, while blood sugar concentrations were higher in the oxprenolol group. Oxprenolol appears to be safe and effective in controlling hypertension during pregnancy. There was no evidence of harmful effects on the fetus, and oxprenolol may offer a selective advantage over methyldopa for fetal growth and wellbeing in utero.

Adult↗

PubMedDate not supplied

Thrombosis prevention with ticlopidine after femoropopliteal thromboendarterectomy.

Fifty patients submitted to thromboendarterectomy in the femoropopliteal district for obstructive arterial disease of the lower limbs, documented angiographically, were randomly allocated to treatment with ticlopidine (500 mg/day) (T) or a placebo (P) in double-blind conditions. The treatment was started as soon as possible after the surgical intervention and was continued for six months or until a clinically evident reocclusion occurred. There were 46 patients available for assessment, 23 in each treatment group both of which were comparable in preoperative characteristics and type of surgery. Doppler ultrasonography at the end of treatment showed three cases of reocclusion of the operated segment in the T group versus six occlusions and seven significant stenoses in the P group (p = 0.003). Clinically, the active treatment significantly reduced the incidence of both acute ischemia during the treatment (four cases, all in the P group) and residual claudication at the end of treatment: in the T group five patients presented persistent or recurrent symptoms versus 16 in the P group (p = 0.001). Hemostatic function tests showed a marked inhibition of platelet activation in the T group. The treatment was well tolerated.

Aged↗

PubMed1988

Endocrine effects of 17 alpha-hydroxyprogesterone caproate during early pregnancy: a double-blind clinical trial.

The clinical and endocrine effects of progestogen therapy in early pregnancy were investigated using a double-blind randomized trial in 64 patients who had a viable fetus at 6 weeks gestation and had an increased risk of miscarriage. The patients were randomly allocated to receive either 17 alpha-hydroxyprogesterone caproate or a placebo between 7 and 12 weeks gestation. Four fetal ultrasonographic variables and 17 maternal endocrine variables were studied in each woman. Only four maternal serum variables (17 alpha-hydroxyprogesterone, prolactin, thyroxin and thyroxin binding globulin) rose significantly. The serum progesterone levels in the hormone supplemented group were on average 20% higher than in the placebo group but the difference was not statistically significant. However, the relation between the progesterone levels and the fetal outcome was not clear. Therefore it is not advisable to prescribe 17-OHP-C during early pregnancy to prevent a miscarriage.

17 alpha-Hydroxyprogesterone Caproate↗

PubMed1988

Effect of preoperative iodine in patients with Graves' disease controlled with antithyroid drugs and thyroxine.

Thirty-four patients with Graves' disease, first rendered euthyroid with antithyroid drugs (ATD) then given supplementary thyroxine (T4), were randomly allocated to three treatment groups. In Group I ATD and T4 were stopped 10 days before partial thyroidectomy and the patients were treated with Lugol's iodine alone. In Group II the patients were treated up to the time of operation with ATD and T4 alone. In Group III ATD and T4 were continued until the day of operation, but the patients also received 10 days' treatment with Lugol's iodine. Analysis of the results showed that pre-operative iodine therapy in patients with Graves' disease, already rendered euthyroid with ATD and T4, made no difference to the vascularity of the gland, operative blood loss or thyroid follicular size. Over a third of patients in Group I, treated with Lugol's iodine alone for 10 days pre-operatively, had subnormal levels of thyroid hormones at the time of operation and this was also the Group in which the complications of partial thyroidectomy tended to occur. It is concluded that the addition of iodine preoperatively is unnecessary in the patient who is already euthyroid on ATD and T4.

Adult↗

PubMed1987

Ticarcillin/clavulanic acid (Timentin) compared to metronidazole/netilmicin in preventing postoperative infection after elective colorectal surgery.

A randomized controlled trial was performed to compare the effectiveness of ticarcillin/clavulanic acid to metronidazole/netilmicin in preventing postoperative infections after elective colorectal surgery. Ninety-two patients were randomly allocated to receive three doses of ticarcillin, 3 g, with clavulanic acid, 100 mg every 8 hours, or three doses of metronidazole, 500 mg, and netilmicin, 80 mg intravenously every 8 hours. All patients received a mechanical bowel preparation with 3 L of Go-lytely solution. There were no operative deaths. Eight patients had wound infections--three in the ticarcillin/clavulanic acid group and five in the metronidazole/netilmicin group. One patient in the ticarcillin/clavulanic acid group had an intra-abdominal abscess. There were two anastomotic leaks, one in each group. Ticarcillin/clavulanic acid and metronidazole/netilmicin appear to be equally effective in preventing postoperative infections after elective colorectal surgery.

Adolescent↗

PubMed1988

Comparison of norfloxacin with cotrimoxazole for infection prophylaxis in acute leukemia. The trade-off for reduced gram-negative sepsis.

A total of 63 neutropenic patients receiving cytotoxic therapy for acute leukemia were randomly allocated to receive norfloxacin (400 mg every 12 hours) or cotrimoxazole (160/800 mg every 12 hours) to prevent bacterial infection. Compliance was more than 95 percent and no adverse effects attributable to the study drugs were observed. The overall incidence of febrile illness (67 percent) was similar between the groups; however, no gram-negative bacillary infections were observed in 31 norfloxacin recipients compared with four of 32 cotrimoxazole recipients. Furthermore, nine norfloxacin recipients had 17 gram-positive bacteremias compared with two in two cotrimoxazole recipients (p = 0.0034). Norfloxacin was more effective than cotrimoxazole for preventing acquisition of aerobic gram-negative bacilli in surveillance cultures. Neither study drug allocation nor the presence of an indwelling central venous catheter influenced outcome among the 42 patients who subsequently received empiric systemic antibiotics for suspected infection. Although gram-positive infection remains an unsolved problem, norfloxacin appears to be a safe, effective, well-tolerated alternative to cotrimoxazole for preventing gram-negative infection in neutropenic patients with acute leukemia.

Acute Disease↗

PubMed1980

Evaluation of heroin maintenance in controlled trial.

Ninety-six confirmed heroin addicts requesting a heroin maintenance prescription were randomly allocated to treatment with injectable heroin or oral methadone. Progress was monitored throughout the next 12 months by research workers operating independently of the clinic. Heroin can be seen as maintaining the status quo, with the majority continuing to inject heroin regularly and to supplement their maintenance prescription from other sources; it was associated with a continuing intermediate level of involvement with the drug subculture and criminal activity. Refusal to prescribe heroin while offering oral methadone constituted a more confrontational response and resulted in a higher abstinence rate, but also a greater dependence on illegal sources of drugs for these who continued to inject. Those offered oral methadone tended to polarize toward high or low categories of illegal drug use and involvement with the drug subculture, and were more likely to be arrested during the 12-month follow-up. There was no difference between the two groups in terms of employment, health, or consumption of nonopiate drugs. Refusal to prescribe heroin resulted in a significantly greater drop out from regular treatment.

Adolescent↗

PubMed1987

[Comparison of the diffusion of ceftriaxone in digestive surgery after a single administration at doses of one and two grams].

Twenty patients undergoing gastrointestinal surgery were randomly allocated to receive either 1 or 2 g of ceftriaxone, a long half-life third generation cephalosporin, as a single dose intravenous prophylaxis on induction of anaesthesia. Plasma and tissue samples were taken 2 hours and analysed with an HPLC procedure. The results of plasma and tissue concentrations of ceftriaxone showed that 1 g dosage was enough for preventing the occurrence of postoperative sepsis. No adverse reaction or side-effects were recorded.

Adult↗

PubMed1983

Effects of immediate breast reconstruction on psychosocial morbidity after mastectomy.

64 women with operable breast cancer were randomly allocated at the time of mastectomy to a group receiving immediate breast reconstruction or to a control group to whom breast reconstruction was offered 12 months later. The objective of the trial was to determine whether immediate breast reconstruction affected the psychosocial morbidity of mastectomy. Immediate reconstruction reduced the psychiatric morbidity assessed 3 months after operation, predominantly in women with unsatisfactory marriages. Women who underwent reconstruction had more freedom of dress and were less likely to be repulsed by their own naked appearance than women who did not undergo reconstruction. Sexual and social morbidity were not affected.

Breast↗

PubMed2001

An automatic incision device for obtaining blood samples from the heels of preterm infants causes less damage than a conventional manual lancet.

OBJECTIVES: To evaluate in a randomised blind study the effect on puncture site lesions of two different incision devices used to obtain blood samples from preterm infants by repeated heel sticks. SETTING: The neonatal intensive care unit at the Hospital for Children and Adolescents and Laboratory, Helsinki University Central Hospital. PATIENTS: A total of 100 preterm infants (birth weight below 2500 g) not previously subjected to heel stick sampling. INTERVENTIONS: The infants were randomly allocated to blood sampling from the heel with either a conventional manual lancet or an automatic incision device. The same type of lancet was used for any given baby throughout the study (2-21 days). MAIN OUTCOME MEASURES: The damage caused by sampling was evaluated using four criteria: bruising of the heel, inflammation of the heel, bruising of either the ankle or the leg, and skin healing at the puncture site. The evaluation was based on photographs presenting typical categories of each outcome. RESULTS: To obtain a sufficient volume of blood, on average 2.6 times more punctures were needed when the conventional manual lancet was used than when the automatic incision device was used. Heels punctured with the lancet had more bruising (100% v 84%) and more signs of inflammation (79% v 53%), and there was more bruising of the ankle or leg (92% v 53%) than when the automatic incision device was used. Skin healed equally rapidly in the two groups. CONCLUSION: The use of an automatic incision device for collecting repeated skin puncture samples from preterm infants is less traumatic than the use of a conventional manual lancet.

Blood Specimen Collection↗

PubMed1987

Ethanolamine oleate is superior to polidocanol (aethoxysklerol) for endoscopic injection sclerotherapy of esophageal varices: a prospective randomized trial.

Thirty-four consecutive patients with liver cirrhosis and esophageal varices were included in a prospective randomized trial done to investigate the efficacy and safety of two sclerosants 5% ethanolamine oleate (EO) and polidocanol (1% Aethoxysklerol [AS]) for use in endoscopic injection sclerotherapy (EIS). Eighteen patients were randomly allocated to the group given EO and 16 to the AS group. These two groups were comparable with regard to age, sex, etiology and severity of the liver disease. The bleeding rate from esophageal ulcers which developed during the course of repeated EIS was significantly (P less than 0.05) higher in the AS group (31.3%, 5/16) than in the EO group (0%, 0/18). In 4 occasions bleeding from the esophageal ulcer could not be controlled with AS. In 3 of these 4 bleeding episodes, EO successfully halted bleeding from esophageal ulcer. In the other patient, a Sengstaken-Blakemore tube was inserted to stop the hemorrhage. The period and number of sessions of EIS for eradication of esophageal varices were significantly (P less than 0.05) shorter in the EO group than the AS group (EO: 4.0 +/- 0.8 [means +/- SD] sessions during 4.7 +/- 1.5 weeks versus AS: 4.8 +/- 1.2 sessions during 5.4 +/- 1.6 weeks). The rate of early mortality did not differ between the two groups. We conclude that 5% ethanolamine oleate seems to be superior to 1% Aethoxysklerol when used for sclerosing esophageal varices.

Clinical Trials as Topic↗

PubMed1987

Comparison of sustained-release with standard tiaprofenic acid in the treatment of rheumatic diseases in general practice.

An open, parallel-group study was carried out to compare the efficacy and tolerance of a sustained-release capsule formulation of tiaprofenic acid at a dosage of 600 mg once daily with standard 300 mg tiaprofenic acid tablets given twice daily. Four hundred and eighty-five general practice patients with rheumatic disease requiring long-term non-steroidal anti-inflammatory drug therapy were included in the analysis. Patients were randomly allocated to receive, in a ratio of 3:1, either 2 X 300 mg sustained-release capsules at night or standard 300 mg tablets twice daily for a treatment period of 3 months. Pain, impairment of function and duration of morning stiffness were assessed at Week 0 (after a 3-day washout period) and at the end of Weeks 4, 8 and 12. Side-effects and compliance were also recorded at the end of Weeks 4, 8 and 12. Eighty-one (16.7%) patients withdrew from the study, with no significant difference in the withdrawal rates for the two treatment groups. Both treatment groups showed significant improvements clinically during tiaprofenic acid treatment; there were no significant differences between the two groups at Weeks 4, 8 or 12, nor were there any significant differences between the two treatment groups in the number of patients reporting side-effects at any of the assessments. In total, 36% of patients reported side-effects during the trial. The results indicate that both formulations are effective, well-tolerated treatments for rheumatic disease in general practice.

Adult↗