This study was conducted to evaluate the effect of ambroxol on preventing the infantile respiratory distress syndrome (IRDS) in preterm birth at the Dept. of Obstetrics and Gynecology of Taegu Catholic Medical Center during the period from Jan. 1996 to Dec. 1996. Total of 68 cases were evaluated including 16 ambroxol group and 52 control group. The result were as follows : 1. In the comparison of preventing IRDS, there was 0 case of IRDS in ambroxol group and 7 cases of IRDS in control group (13.46 %). There was a significant difference between two groups (p<0.05). 2. The side effects of ambroxol after administration were nausea in 5 cases, headache in 3 cases, and chest discomfort in 4 cases, but these were not serious and self controlled. 3. There was no significant difference in neonatal morbidity between two groups (p > 0.05).
Ambroxol* ; Daegu ; Gynecology ; Headache ; Nausea ; Obstetrics ; Premature Birth ; Respiratory Distress Syndrome, Newborn* ; Thorax

This study was conducted to evaluate the effect of antenatal ambroxol administration to the mothers who were imminent preterm delivery on preventing the neonatal respiratory distress syndrome. Forty-two preterm newborn infants who were delivered at Yeungnam University Hospital from January 1996 to December 1997 were divided into two groups, twenty-one ambroxol-treated group and twenty-one control group. Six cases of respiratory distress syndromes developed from 21 ambroxol-treated infants. but thirteen cases of RDS developed from 21 control infants. It indicated significant reduction of occurrence of RDS by antenatal administration of ambroxol (p<0.05). There were no differences in the occurrence of adverse effects of ambroxol in mothers between two groups, ambroxol-treated and control groups. There was also no difference between pre- and post-treatment hematologic and biochemical parameters in ambroxol-treated group. In conclusion, when premature delivery is expected, administration of ambroxol before delivery enhances lung maturation in premature newborn infants and prevents the occurrence of respiratory distress syndromes without significant adverse effects.
Ambroxol* ; Humans ; Infant ; Infant, Newborn ; Lung ; Mothers ; Respiratory Distress Syndrome, Newborn*

Administration, Inhalation ; Ambroxol ; administration & dosage ; Female ; Humans ; Infant, Newborn ; Male ; Pneumonia ; drug therapy ; physiopathology

PURPOSE: Antenatal dexamethasone administration is associated with a significant lowering respiratory distress syndrome (RDS) incidence, but can increase neonatal infection. Ambroxol has been accepted as an alternative treatment to dexamethasone and is of at least equal efficacy but without adverse reaction. The aim of this study was to evaluate the effectiveness of ambroxol versus dexamethasone in RDS incidence and neonatal infection. METHODS: In this study, 30 infants, who received prenatal dexamethasone therapy, were compared retrospectively to 19 infants who received prenatal ambroxol therapy and 45 infants who received placebo during 28 to 34 weeks' of gestation. RESULTS: RDS incidence was comparable in both the dexamethasone (10.0%) and ambroxol (10.5%) groups but higer in the control group (26.6%). The puerperal infection rate in the mothers of these infants was 33.3% in the dexamethasone group, 10.5% in the ambroxol group and 20.0% in the control group. Neonatal infection in the 28 days following delivery was 56.6% in the dexamethasone group, 26.3% in the ambroxol group and 26.6% in the control group. Neonatal infection rate of the dexamethasone group was higher than ambroxol and control groups (P<0.05). When premature rupture of membrane was controlled, the sepsis rate (<28 days) was significantly lower in the ambroxol group than in the dexamethasone group (P<0.05), but puerperal infection and sepsis (<7 days) were not significantly different. CONCLUSOIN: Ambroxol was as effective as the dexamethasone in reducing the RDS incidence. Neonatal and puerperal infection were significantly higher in the dexamethasone group than in the ambroxol group.
Ambroxol* ; Dexamethasone* ; Humans ; Incidence ; Infant ; Membranes ; Mothers ; Pregnancy ; Puerperal Infection ; Retrospective Studies ; Rupture ; Sepsis

In the present study, we investigated whether ambroxol, S-carboxymethyl-L-cysteine, dextromethorphan and noscapine affect mucin release from airway goblet cells. Confluent primary hamster tracheal surface epithelial cells were metabolically radiolabeled and chased for 30 min in the presence of varying concentrations of the above agents to assess the effects on 3H-mucin release. Noscapine stimulated mucin release during 30 min of treatment period in a dose-dependent manner. However, ambroxol, S-carboxymethyl-L-cysteine and dextromethorphan showed no significant effect on mucin release during 30 min of treatment period. We conclude that noscapine can affect mucin release by acting on airway mucin-secreting cells.
Ambroxol* ; Animals ; Carbocysteine* ; Cricetinae ; Dextromethorphan* ; Epithelial Cells ; Goblet Cells* ; Mucins* ; Noscapine*

OBJECTIVE: To establish a biofilm model of Haemophilus influenzae and observe the effect of ambroxol on biofilm of Haemophilus influenzae and bactericidal action. METHOD: Thirty strains of Haemophilus influenzae were isolated from adenoids of children with adenoidal hypertrophy. Two strains which could build stronger biofilms was selected in a 96-well plate. The effect of ambroxol on biofilms were determined by crystal violet, and the structure of biofilms were observed by scanning electron microscope (SEM). The numbers of viable bacterial in biofilm after ambroxol treatmented determined by plate culture count. RESULT: Through crystal violet assay, significant difference (P < 0.01) between the two group after treatment was found when ambroxol concentration reached at 0.25 mg/ml and 0.49 mg/ml. The biofilms was destroyed by SEM. Ambroxol had the positive effect on bacterial killing by plate culture count,and the effect was in a dose dependent. CONCLUSION Ambroxol could destroy the biofilm of Haemophilus influenzae, and had bactericidal function in vitro.
Ambroxol ; pharmacology ; Biofilms ; drug effects ; Child ; Child, Preschool ; Haemophilus influenzae ; drug effects ; Humans ; Microbial Sensitivity Tests

AIMTo develop a near-infrared diffuse reflectance analysis (NIRDRA) method for rapid noninvasive quantitative determination of ambroxol hydrochloride in half-finished product particles and non-blister-packed, blistered tablets.

METHODSAll spectra were measured with a Fourier transform spectrometer equipped with a PbS and a InGaAs detector, an external integrating sphere, a rotating sample cup, and a fibre-optic probe for reflectance measurements. All samples were scanned from 12,000 cm-1 to 4,000 cm-1, and each sample spectrum was obtained as an automatic mean of 64 scans. No spectrum pre-processing method was used, and spectral regions, 4,602-4,247, 12,000-7,498 and 6,102-5,446, 12,000-5,446 cm-1 were selected to develope mathematical models by partial least square method for half-finished product particles and non-blister-packed, blistered tablets samples, respectively.

RESULTSThe optimal rank and mean square error determined for half-finished product particles and non-blister-packed, blistered tablets samples by cross validation method all was 6 and 0.306, 0.972 and 1.492, respectively, the average recovery was 100%, 100% and 102% respectively; and the RSD was 1.17%, 1.70% and 1.78% respectively.

CONCLUSIONResults showed that the NIRDRA method was rapid, simple, noninvasive and sensitive, and it can be applied to assay the content of ambroxol hydrochloride in half-finished product particles non-blister-packed and blistered tablets.

Ambroxol ; administration & dosage ; analysis ; Expectorants ; administration & dosage ; analysis ; Quality Control ; Spectroscopy, Near-Infrared ; methods ; Tablets

Ambroxol ; administration & dosage ; therapeutic use ; Bronchitis, Chronic ; etiology ; therapy ; Bronchoalveolar Lavage ; Humans ; Male ; Middle Aged ; Pneumoconiosis ; complications ; therapy ; Treatment Outcome

BACKGROUND: Erdosteine is a thiol derivative developed for the treatement of chronic obstructive bronchitis, including acute infective exacerbation of chronic bronchitis. Erdosteine has mucomodulating and antioxidant properties and especially exhibits excellent gastrointestinal tolerability. METHODS: The study was conducted as a prospective evaluation, with 2 comparative groups orally treated with erdosteine 300mg (b.i.d.) or ambroxol 30mg (b.i.d.) for 7 days and the design of trial was double-blind. The treatments have been assigned randomly to patients (n= 80) with acute or chronic bronchitis. The primary end-point used to determine efficacy in this study was subjective symptoms including expectorating frequence, expectoration volume, expectorating difficulty, expectoration viscosity, cough intensity and dyspnea. The secondary end-points of efficacy was the result of arterial blood gas analysis and pulmonary function test. Safety was evaluated with adverse drug reactions and laboratory tests monitoring. 61 patients was included in the efficacy analysis, due to the fact that 19 patients drop-out for different reasons. The obtained values have been analyzed with paired t-test, ANOVA test, multivariate t2-test, repeated measures analysis of covariance, two sample t-test, loglinear-logit model analysis, Fisher's exact test. RESULTS: 1) There was no significant difference on demographic data and vital signs between erdosteine and ambroxol treated groups. 2) The comparison between erdosteine and ambroxol treated groups showed no significant difference in improvement of each symptom in spite of the more favorable efficacy obtained with erdosteine. No difference on the contrary was observed for arterial blood gas analysis and pulmonary function test. 3) As safety is concerned, no clinical significant changes in laboratory test and symptom were induced in erdosteine and ambroxol treated group and two patients in ambroxol treated group drop-out for adverse reactions in symptom. 4) In the evaluation of final clinical efficacy, erdosteine improved more effectively patient's overall symptoms {very good effect (11/31), good effect (12/31), moderate effect (6/31), no effect (2/31), aggravation (0/31)) than ambroxol (very good effect (6/30), good effect (14/30), moderate effect (5/30), no effect (4/30), aggravation (2/30)}. And the probability of symptomatic improvement by erdosteine compared to ambroxol was 2.5 times. (p<0.05). CONCLUISON: This study showed that erdosteine was clinically effective and safe drug for treatment of acute and chronic bronchitis.
Ambroxol* ; Blood Gas Analysis ; Bronchitis ; Bronchitis, Chronic* ; Cough ; Drug-Related Side Effects and Adverse Reactions ; Dyspnea ; Expectorants ; Humans ; Prospective Studies ; Respiratory Function Tests ; Viscosity ; Vital Signs

OBJECTIVEAmbroxol induces the synthesis of surfactant in lung alveolar type II cells. Some studies have shown its effectiveness for the prevention of respiratory distress syndrome (RDS) in preterm infants. This study aimed to compare the efficacy of two different ways of ambroxol administration, ie, intravenous injection and atomizing inhalation, for the prevention of RDS in preterm infants.

METHODSA total of 125 preterm infants born between 28-37 weeks of gestation were randomly assigned into three groups: Intravenous and Atomizing ambroxol treatment groups (n=40 each) or Control group (n=45). The Intravenous group was injected with 15 mg/kg of ambroxol through the umbilical vein immediately after birth and then received 30 mg/kg of ambroxol daily for 2 days by intravenous drip. The Atomizing group was administered with 30 mg/kg of ambroxol daily for 2 days by atomizing inhalation immediately after birth. The Control group received no ambroxol treatment. The incidences of RDS and complications as well as the blood gas results 6 hrs after birth were compared among the three groups.

RESULTSThe incidence of RDS was 7.5%, 5.0% and 24.4% in the Intravenous, Atomizing and Control groups respectively. There were no significant differences in the incidence of RDS between the two ambroxol treatment groups. However, the incidence of RDS in the two treatment groups were noticeably lower than in the Control group (P < 0.05). The blood gas results did not show significant differences between the two ambroxol treatment groups but both groups demonstrated improved blood gas results compared with the Control group at 6 hrs after birth (P < 0.05). The incidence of complications, such as pulmonary hemorrhage, respiratory failure, intraranial hemorrhage, in the two ambroxol treatment groups was reduced compared with the Control group (P < 0.05), but there were no differences between the two ambroxol groups.

CONCLUSIONSEarly administration of either intravenous or atomizing ambroxol can produce a positive efficacy for the prevention of RDS in preterm infants. The two different ways of administration seem to result in a similar efficacy in the prevention of RDS.

Administration, Inhalation ; Ambroxol ; administration & dosage ; adverse effects ; pharmacology ; Female ; Humans ; Infant, Newborn ; Infant, Premature ; Injections, Intravenous ; Male ; Pulmonary Surfactants ; metabolism ; Respiratory Distress Syndrome, Newborn ; prevention & control