[Clinical trial on the effect of buphenine, aminophenazone and diphenylpyraline hydrochloride in treating the common cold in children of 6 to 24 months of age]. / Ensayo clínico sobre el efecto de la bufenina, aminofenazona y el clorhidrato de difenilpiralina en el tratamiento del resfriado común en niños de seis a 24 meses de edad.

INTRODUCTION: Acute respiratory infections are the second leading cause of morbidity in children under 18 years. Several drugs have been used with variable efficacy and safety, trying to reduce the associated symptoms and improve quality of life. OBJECTIVE: To evaluate the efficacy and safety of buphenine, aminophenazone and diphenylpyraline hydrochloride when compared with placebo for the control of symptoms associated with common cold in children 6-24 months of age. MATERIAL AND METHODS: Randomized clinical trial, double blind, placebo controlled, in 100 children < 24 months of any gender, with symptoms associated to common cold. They received the drug under study vs. placebo for seven days. Both groups received acetaminophen. The change on common cold related symptoms were evaluated. Statistic analysis was made with STATA 11.0 for Mac. RESULTS: Fifty-three children were randomized to study drug and forty-seven to placebo. Age of children in each group was similar (12.2 +/- 5.8 months vs. 12.7 +/- 5.8 months, p NS). There were significant differences between groups in relation to rhinorrea and sneezing resolution, with better results in Flumil group and no adverse events observed. CONCLUSIONS: The results in this study indicates that Flumil is a safe and effective drug for control of symptoms present in the common cold in children aged 6-24 months.

Visaline in the treatment of age-related macular degeneration: a pilot study.

Age-related macular degeneration (AMD) is the main cause of a reduction in visual acuity in patients over the age of 65 years. A positive influence of medical treatment (i.e. with vitamins and trace minerals) has been suggested but remains unproven. In this randomized, double-blind study, 20 patients in an early stage of AMD were included. Over a period of 6 months, 9 patients were treated with Visaline and 11 with a placebo. The effect of the treatment was not statistically different between the two groups, admittedly small in number, in terms of visual and retinal acuity, color vision, and contrast sensitivity. Despite the lack of such measureable differences, the patients' own subjective assessments, however, were much better in the Visaline-treated group. Due to the short duration of the observation time, we can not comment on a possible long-term effect.

Increased incidence of bronchopulmonary dysplasia after antenatal administration of indomethacin to prevent preterm labor.

The aim of this randomized study was to compare the neonatal outcome in infants who have been exposed in utero to indomethacin with that in infants exposed to a beta-adrenergic agonist, nylidrin hydrochloride. Eighty pregnant women threatened with preterm labor between 24 and 34 weeks of gestation were enrolled in the study. An intravenous infusion of nylidrin or enterally administered indomethacin was given for a maximum of 72 hours. If preterm labor recurred, all parturient patients were treated with nylidrin. Indomethacin prolonged gestation significantly more than the beta-adrenergic agonist (6.6 weeks vs 4.5 weeks; p = 0.04). Ten of the forty-two infants exposed to indomethacin and 2 of the 45 infants exposed to nylidrin had bronchopulmonary dysplasia (24% vs 5%; p = 0.02). Among the 28 infants delivered within 120 hours after the start of treatment, the incidences of respiratory distress syndrome (82% vs 29%; p = 0.02), bronchopulmonary dysplasia (73% vs 6%; p = 0.0006), and necrotizing enterocolitis or focal intestinal perforation (27% vs 0%; p = 0.03) were higher among those exposed to indomethacin than among those exposed to nylidrin. We infer that administration of indomethacin to pregnant women threatened with premature labor is associated with an increased risk of bronchopulmonary dysplasia in their infants if delivery occurs early.

Urinary excretion of prostacyclin and thromboxane metabolites in threatened preterm labor: effect of indomethacin and nylidrin.

OBJECTIVE: We studied the role of smooth muscle-relaxing prostacyclin and its endogenous antagonist, thromboxane A2, in preterm labor by assessing the urinary output of the breakdown products of prostacyclin (6-keto-prostaglandin F1 alpha and 2,3-dinor-6-keto-prostaglandin F1 alpha) and those of thromboxane A2 (thromboxane B2, 2,3-dinor-thromboxane B2). STUDY DESIGN: Thirty-three women in preterm labor between 25 and 34 weeks of gestation were studied before, during, and after treatment with indomethacin (n = 16) or nylidrin (n = 17). Urinary prostanoid levels were determined by high-performance liquid chromatography followed by radioimmunoassay, and the excretion was expressed as nanograms of prostanoids per millimole of creatinine. Statistical analyses were done by paired and unpaired Student t test, by Spearman's correlation, and by Wilcoxon signed-rank test. RESULTS: Preterm labor was accompanied by a median 32% higher output of prostacyclin and thromboxane A2 metabolites as compared with those in 25 controls. At 8 hours after the start of treatment indomethacin induced maximal drops in 6-keto-prostaglandin F1 alpha (70%), in dinor-6-keto-prostaglandin F1 alpha (60%), in thromboxane B2 (85%), and in dinor-thromboxane B2 (95%) excretion. Within 1 week after the cessation of indomethacin, output of prostacyclin metabolites had recovered to pretreatment values, whereas output of thromboxane A2 metabolites was yet lower than the pretreatment value. Nylidrin induced no change in the output of prostacyclin and thromboxane A2 metabolites. CONCLUSION: Threatened preterm labor is associated with a rise in prostacyclin and thromboxane A2 synthesis. Indomethacin inhibits more thromboxane A2 than does prostacyclin synthesis. These findings may explain the fetal vascular changes during maternal indomethacin treatment.

A randomized double-dummy comparison between indomethacin and nylidrin in threatened preterm labor.

We compared the tocolytic effect of indomethacin and nylidrin in a prospective double-blind trial in which the appearance of the tocolytic treatment (always intravenous infusion and rectal suppositories/oral capsules) was identical to the subjects. Sixty healthy women in imminent preterm labor between 25-34 weeks of singleton gestation were included. Thirty of these women received indomethacin (concomitantly with placebo infusion), with doses as follows: day 1, 100-mg rectal suppository followed by two oral capsules (50 mg) at 8-hour intervals; days 2 and 3, three 50-mg oral capsules each day. Thirty women received intravenous nylidrin (concomitantly with rectal/oral placebo), initiated with the dose of 50 micrograms/minute and continued at the dose of 100-150 micrograms/minute for a maximum of 3 days. Preterm labor was arrested for 24, 48, and 72 hours in 100, 96, and 90%, respectively, of subjects in the indomethacin group, compared with 100, 76, and 73% of women in the nylidrin group; the difference was significant (P less than .05) at 48 hours. Women progressed beyond 37 gestational weeks more commonly (P less than .05) with indomethacin (21 of 30, 70%) than with nylidrin (13 of 30, 43%). Indomethacin treatment was accompanied by maternal side effects 20% of the time, significantly less commonly (P less than .001) than with nylidrin (83%). The neonatal outcome was similar in the two study groups. We conclude from this double-dummy technique trial that indomethacin is more effective and better tolerated than nylidrin in arresting imminent preterm labor.

Maternal plasma corticotrophin-releasing hormone--elevated in preterm labour but unaffected by indomethacin or nylidrin.

The role of corticotrophin-releasing hormone (CRH) in preterm labour was studied in 23 women in preterm labour at between 26 and 33 weeks gestation who were randomly allocated to receive treatment with indomethacin (n = 11) or with nylidrin a beta-sympathomimetic agent (n = 12). Maternal plasma CRH in the preterm group (median 70, range 9-597 pmol/l) before therapy was higher (P less than 0.05) than that in 23 control pregnancies, without uterine contractions, matched for gestational age (median 51, range 4-127 pmol/l). CHR levels determined after 3 and 24 h of treatment showed a 10% decrease in the indomethacin group and 10-20% decrease in the nylidrin group, but these changes were not statistically significant. After cessation of uterine contractions during tocolysis, 12 women proceeded to give birth preterm (less than 37 weeks) and their pretreatment CRH levels (median 195, range 9-597 pmol/l) were higher (P less than 0.05) than those in women whose pregnancy proceeded to term (median 52, range 16-207 pmol/l). In another group of women, full-term labour was not accompanied by any changes in maternal CRH levels. Umbilical plasma CRH levels were 1.1-9.8% of the paired maternal levels and did not rise with advancing gestational age. Nor had the type of delivery (elective caesarean section before labour, or preterm or term vaginal delivery) any effect on fetal CRH levels.(ABSTRACT TRUNCATED AT 250 WORDS)

The effects of indomethacin and a beta-sympathomimetic agent on the fetal ductus arteriosus during treatment of premature labor: a randomized double-blind study.

To study the effect of maternal indomethacin or nylidrine hydrochloride treatment on the fetus ductus arteriosus and the pulmonary artery, 27 women with threatened preterm labor between 24 and 34 weeks' gestation were studied by echocardiography. Fourteen women were treated with indomethacin and 13 with nylidrin. Both systolic and diastolic velocities in the ductus increased after administration of indomethacin indicating constriction in nine fetuses, and exceeded the corresponding velocities in the fetuses of the nylidrin group (p = 0.001). However, there were no changes in pulmonary artery flow velocities (p greater than 0.5). In the indomethacin group, there was a significant linear positive relationship between the gestational age and the change in ductal flow velocity. Three of the nine patients with ductal constriction also had tricuspid regurgitation. These findings indicate that indomethacin, not nylidrin, causes transient constriction of the ductus arteriosus and the constrictive response increases with the gestational age. We recommend echocardiographic surveillance of fetal hemodynamics when prostaglandin synthesis inhibitors are used in the treatment of spontaneous preterm labor.

Catechol-O-methyltransferase activity in red blood cells in threatened preterm labor; effect of indomethacin and nylidrin.

Catecholamines that are released in excess during human labor are inactivated mainly by catechol-O-methyltransferase (COMT). To ascertain whether uterine contractions are associated with changes in COMT activity in red blood cells (RBCs), we studied 25 women with established threat of preterm labor between 25 and 33 weeks of gestation, 25 gestational age-matched control women not experiencing uterine contractions, 25 women who were in term labor, and 25 non-pregnant healthy women. COMT activity in pregnant women without uterine contractions (median 0.3, range 0.1-0.8 pmol/mg/min) was lower (p less than 0.05) than that in non-pregnant control series (median 0.5, range 0.3-0.7 pmol/mg/min). RBCs' COMT activity in women with preterm labor (median 0.6, range 0.2-1.1 pmol/mg/min) was greater (p less than 0.05) than that in pregnant and non-pregnant control women, but similar to that during term labor (median 0.5, range 0.2-1.7 pmol/mg/min). Women with preterm labor were treated with indomethacin (12 women) or nylidrin (13 women). Nylidrin treatment was accompanied by a 35% rise in COMT activity 3 h later, whereas indomethacin caused no significant change. Apart from cessation of uterine contractions during tocolysis, 13 women went into labor before the 37th gestational week, but their pretreatment COMT activity (median 0.7, range 0.2-1.1 pmol/mg/min) did not differ from COMT activity in women whose pregnancy proceeded to term (median 0.5, range 0.3-1.0 pmol/mg/min).(ABSTRACT TRUNCATED AT 250 WORDS)

Clinical experience with the use of peripheral vasodilator in oral disorders.

Conventional therapies practised in the treatment of asymptomatic neuralgia, oral submucous fibrosis and paraesthesic numbness, are empirical and symptomatic in nature. These are usually prolonged and may be inadequate, impractical with complete or incomplete remissions associated with or without relapses. High dosages of drugs administered for longer duration, are also not infrequently without side-effects. With these problems in view, the clinical use of nylidrin hydrochloride a peripheral vasodilator, was experienced for over 10 years. Irrespective of age, sex and status, 97 cases were randomly extracted from the hospital and oral surgery clinical records. The projected sample included 33 cases of asymptomatic neuralgia, 58 cases of oral submucous fibrosis and 6 cases of numbness. Neuralgia, where mean age was 50 years, was treated with nylidrin hydrochloride, vitamin B-complex and carbamazepine. Oral submucous fibrosis where mean age was 38 years, was treated with nylidrin hydrochloride, vitamins A,E,B-complex, iodine, placental extract, local and systemic corticosteroids and physiotherapy. Paraesthesic numbness, following iatrogenic or accidental trauma to the affected nerve, was treated with nylidrin hydrochloride and B-complex therapy. Peripheral vasodilator administered in all 97 cases, initially contained low divided doses, which steadily were increased or decreased as per individual response. There were reportedly no side-effects, except complaints of flushingly warm skin. Supportive therapy with antibacterials, tranquilizers and analgesics, along with minor dental surgery, were given as and when required. The success rate was 72.16% in total, while individually it varied from 84.85% in neuralgia, 62.07% in oral submucous fibrosis and 100% in numbness.(ABSTRACT TRUNCATED AT 250 WORDS)

[Premature cervical ripening--surgical or conservative therapy?]. / Vorzeitige Zervixreifung--operative oder konservative Therapie?

We studied the effect of the cerclage operation as treatment of premature ripening of the cervix in the 15.-35. week of gestation with a retrospective matched pair analysis (n = 142). For each patient in the group treated operatively (n = 71) a patient was selected, who was clinically comparable in parity, gestational age and cervix score at the time of diagnosis but was managed conservatively (n = 71). The study showed that the cerclage operation is not generally advantageous as treatment of premature cervical ripening. Because of the higher perinatal morbidity in the group treated by an operation, the unselected indication for a therapeutical cerclage is questioned. To define indications for cervical cerclage as operative treatment for premature cervical ripening we selected subgroups by history and clinical data treated either operatively or conservatively and evaluated their parameters of gestation, delivery and puerperium as well as the perinatal outcome. We found that the operative treatment was superior to the conservative therapy only in patients with premature cervical ripening before the 25th week of gestation and in patients with an "open cervix" and a history of miscarriage, abortion or premature delivery. The results of this study led to a proposal for the treatment of patients with premature ripening of the cervix, which has to be confirmed by prospective controlled studies.

Buphenine and threatened abortion.

One hundred and seventy patients with threatened abortion have been studied in two groups. Group 1 of eighty-five patients were treated with the uterine muscle relaxant, buphenine hydrochloride. The second group of eighty-five patients were given placebo. Pregnancy continuation was 90.6% in group 1 and 62.3% in group 2. Only three of 22 patients with history of recurrent abortion using buphenine aborted.

[Pulmonary edema under tocolytic therapy]. / Lungenödem unter Tokolysetherapie.

A case of pulmonary edema during tocolytic therapy with beta-mimetic drugs is demonstrated. Isotonic hyperhydration is suspected as the reason favoured by oliguria and hypocalcemia. Diagnostic and therapeutic consequences are discussed.

Acral diagnosis and possibilities of conservative treatment of chronic obstructive vascular diseases.

One of the main problems which confronts a doctor practicing in the angiology field is the decision if a conservative treatment alone is going to be sufficient for a patient or if he has to decide for vascular surgery. Concerning the latter, there should be kept in mind that always an additional conservative therapy is of utmost importance since chronic vascular disease is looked at as a generalized phenomenon and surgical therapy can be used only in limited segments. In order to make a decision whether conservative or surgical therapy should be applied we used the "Nitrate Test"--described in 1968 by Migliorini, Italy and in 1976 by Böhme, Germany--modified and developed it further. Migliorini and Böhme stated that an increased blood flow after nitrate application is useful for the determination whether a patient suffers from a functional or an organic vascular disease.

Beneficial hemorheologic therapy of chronic peripheral arterial disorders with pentoxifylline: results of double-blind study versus vasodilator-nylidrin.

Pentoxifylline (Trental 400 mg coated tablets) and nylidrin HCl 3 mg were compared for clinical efficacy and safety in an 8-week randomized double-blind trial. The study was conducted in patients with peripheral arterial disease (Fontaine stage II or III), with 30 patients receiving pentoxifylline (23 returned for follow-up), and 30 patients receiving nylidrin HCl (24 returned for follow-up). Efficacy was assessed objectively in terms of walking performance (absolute walking time and walking distance on a treadmill ergometer) and by acral plethysmography. The clear improvement shown for both variables was greater and statistically significant (p less than or equal to 0.05) after treatment with pentoxifylline. Laboratory data provided no evidence to suggest any adverse effect of either treatment. Subjective side effects were reported by six patients in the pentoxifylline group and by three patients in the nylidrin HCl group.

[Therapeutic effect of a combination of bufenine and beta-escine as an oral delayed-action drug in obliterating arterial diseases of the lower limbs]. / Azione terapeutica di una associazione bufenina - beta-escina, in preparazione ritardo per os, nelle arteriopatie obliteranti degli arti inferiori.

Reference is made to the clinical and instrumental results observed in 40 subjects with chronic obliterating arteriopathy of the lower limbs treated for 90 days with a projective protocol based on a per os retard combination of bufenine and beta-escine. Attention is drawn to the vasoactive and antioedemigenic activity of the combination, its good tolerance, and easy administration.