Is trazodone more effective than clomipramine in major depressed outpatients? A single-blind study with intravenous and oral administration

CNS Spectrums ◽  
2017 ◽  
Vol 24 (02) ◽  
pp. 258-264 ◽  
Author(s):  
Massimiliano Buoli ◽  
Chiara Rovera ◽  
Sara Maria Pozzoli ◽  
Alessio Fiorentini ◽  
Laura Cremaschi ◽  
...  
Keyword(s):  
Oral Administration ◽  
Clinical Judgment ◽  
Rating Scale ◽  
Oral Treatment ◽  
Statistical Significance ◽  
Double Blind ◽  
Treatment Groups ◽  
Potential Benefits ◽  
Hamilton Anxiety Rating Scale ◽  
Intravenous And Oral Administration

ObjectiveSome antidepressants, such as trazodone or clomipramine, can be administered intravenously in patients with major depressive disorder (MDD), with potential benefits compared to the standard oral treatment, but available data about their efficacy are limited. The present study was aimed to compare the effectiveness of trazodone and clomipramine (intravenous [i.v.] followed by oral administration).MethodsSome 42 patients with a diagnosis of MDD according to the DSM–5 were selected and treated with i.v. trazodone or clomipramine according to clinical judgment. The Hamilton Depression Rating Scale, the Hamilton Anxiety Rating Scale, and the Montgomery-Åsberg Depression Rating Scale were administered at baseline, after 2 weeks, and after 6 weeks, as well as after 1 week of intravenous antidepressant administration. Raters were blinded to type of treatment.ResultsNo significant differences were found between treatment groups in terms of effectiveness at endpoint. Borderline statistical significance was found in terms of number of responders in favor of trazodone. In addition, patients treated with trazodone reported fewer total side effects than those treated with clomipramine.ConclusionBoth i.v. trazodone and clomipramine are rapid and effective options for improving depressive symptoms, although trazodone appears to be tolerated better. Further studies with larger samples and double-blind conditions are warranted to confirm our results.

scholarly journals EXPRESS: Efficacy and Safety of Tadalafil in a Pediatric Population with Pulmonary Arterial Hypertension: Phase 3 randomized, Double Blind Placebo-Controlled Study

2021 ◽  
pp. 204589402110249
Author(s):  
David D Ivy ◽  
Damien Bonnet ◽  
Rolf MF Berger ◽  
Gisela Meyer ◽  
Simin Baygani ◽  
...  
Keyword(s):  
Pediatric Patients ◽  
Statistical Significance ◽  
Significance Testing ◽  
Efficacy And Safety ◽  
Phase 3 ◽  
Statistical Significance Testing ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Treatment Groups ◽  
Pulmonary Arterial

Objective: This study evaluated the efficacy and safety of tadalafil in pediatric patients with pulmonary arterial hypertension (PAH). Methods: This phase-3, international, randomized, multicenter (24 weeks double-blind placebo controlled period; 2-year, open-labelled extension period), add-on (patient’s current endothelin receptor antagonist therapy) study included pediatric patients aged <18 years with PAH. Patients received tadalafil 20 mg or 40 mg based on their weight (Heavy-weight: ≥40 kg; Middle-weight: ≥25—<40 kg) or placebo orally QD for 24 weeks. Primary endpoint was change from baseline in 6-minute walk (6MW) distance in patients aged ≥6 years at Week 24. Sample size was amended from 134 to ≥34 patients, due to serious recruitment challenges. Therefore, statistical significance testing was not performed between treatment groups. Results: Patient demographics and baseline characteristics (N=35; tadalafil=17; placebo=18) were comparable between treatment groups; median age was 14.2 years (6.2 to 17.9 years) and majority (71.4%, n=25) of patients were in HW cohort. Least square mean (SE) changes from baseline in 6MW distance at Week 24 was numerically greater with tadalafil versus placebo (60.48 [20.41] vs 36.60 [20.78] meters; placebo-adjusted mean difference [SD] 23.88 [29.11]). Safety of tadalafil treatment was as expected without any new safety concerns. During study period 1, two patients (1 in each group) discontinued due to investigator’s reported clinical worsening, and no deaths were reported. Conclusions: The statistical significance testing was not performed between the treatment groups due to low sample size, however, the study results show positive trend in improvement in non invasive measurements, commonly utilized by clinicians to evaluate the disease status for children with PAH. Safety of tadalafil treatment was as expected without any new safety signals.

scholarly journals Responsiveness of the Scripps Neurologic Rating Scale During a Multiple Sclerosis Clinical Trial

1999 ◽  
Vol 26 (4) ◽  
pp. 283-289 ◽  
Author(s):  
James A. Koziol ◽  
Adriana Lucero ◽  
Jack C. Sipe ◽  
John S. Romine ◽  
Ernest Beutler
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trial ◽  
Rating Scale ◽  
Effect Sizes ◽  
Active Therapy ◽  
Double Blind ◽  
Treatment Groups ◽  
Negative Effect ◽  
The Individual ◽  
Positive Effect

Objective:The Scripps neurologic rating scale (SNRS) is a summary measure of individual components comprising a neurological examination, designed for use in multiple sclerosis (MS). Our objective is to evaluate the responsiveness of the SNRS, within the context of a 2-year, randomized, double-blind crossover study of the efficacy of cladribine for treatment of secondary progressive MS.Methods:Effect sizes were determined for the SNRS and its components, separately for each treatment group (initial placebo, and initial cladribine) over both years of the clinical trial, using a standard random effects model.Results:Individual components tended to show positive effect sizes (improvement) during periods of active therapy in both treatment groups, and negative effect sizes (deterioration) during periods of no active therapy. Summation indices derived from the individual components of the SNRS seemed somewhat more stable than the individual components. The two components mentation and mood, and bladder, bowel, or sexual dysfunction, were rather unresponsive in our clinical trial.Conclusion:Changes in the components of the SNRS over the course of our clinical trial were consistent between the two treatment groups. Most components were moderately responsive; and, the summary SNRS score appropriately summarized the moderate magnitudes of change evinced in the individual components.

Dronabinol or Ondansetron Alone and Combined for Delayed Chemotherapy-Induced Nausea and Vomiting (CINV).

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 5555-5555
Author(s):  
Haresh Jhangiani ◽  
James J. Vredenburgh ◽  
Lou Barbato ◽  
Haichen Yang ◽  
Hwa-Ming Yang ◽  
...  
Keyword(s):  
Treatment Group ◽  
Active Treatment ◽  
Statistical Significance ◽  
Active Treatment Group ◽  
Total Response ◽  
Standard Regimen ◽  
Double Blind ◽  
Treatment Groups ◽  
End Point ◽  
Group D

Abstract This randomized, double-blind, placebo-controlled, parallel-group study of the antiemetic efficacy and tolerability of oral dronabinol (D) alone, D in combination with ondansetron (O), O alone, or placebo (P) in patients receiving moderate to high emetogenic chemotherapy. All patients received dexamethasone 20 mg PO and O 16 mg IV prechemotherapy. Patients receiving D, O, or D+O also received D 2.5 mg before chemotherapy and after chemotherapy on Day 1 (combined active treatment group); group P did not receive D before or after chemotherapy. Day 2: P or fixed doses of 10 mg D, 16 mg O, or D+O were administered. Days 3–5: patients received P or flexible doses of 10–20 mg D, 8–16 mg O, or D+O. Primary efficacy variable was total response (TR=nausea intensity &lt;5 mm on a 100-mm visual analog scale, no vomiting/retching, no rescue antiemetic). Secondary efficacy parameters included nausea status and intensity and episodes of vomiting/retching. Active treatments were compared with each other and P on Days 2–5, and statistical significance was determined if P≤0.05 (unadjusted). Exploratory analyses were conducted post hoc to examine the effect of combined active treatment on Day 1 vs P. 64 patients were randomized and 61 analyzed for efficacy. On Day 1, in the combined active treatment group (n=50), significant improvement vs P (n=13) was observed for TR (79% vs 40%; P=0.024), mean nausea intensity (8 mm vs 31 mm; P=0.029), and absence of nausea (79% vs 38%; P=0.013), respectively. The end point efficacy results (Days 2–5 LOCF) for TR, nausea status/intensity, episodes of vomiting/retching are shown in the Table. On Days 2–5, TR was comparable for groups D and O. The percentage of patients without nausea was significantly greater in all treatment groups vs P. Nausea intensity was significantly reduced by all treatments vs P. The incidence of treatment-emergent AEs was similar among active treatment groups (71%–88%); AE rate in P-treated patients was 50%. Diarrhea and fatigue were the most common AEs (11%). Group D had a low incidence of CNS-related treatment-emergent AEs compared with Groups O and DO. The highest rates of the CNS-related events of dizziness and fatigue were observed in Group DO. Day 1 data suggest that the addition of dronabinol to the standard antiemetic regimen before and after chemotherapy may offer more benefit than the standard regimen alone. Thereafter, the antiemetic effect of D for delayed CINV was comparable with O. Results for D+O were similar to either agent alone. D was well tolerated. Efficacy Results at End Point Measure Units Group D, n=17 Group O, n=14 Group DO, n=17 Group P, n=13 *Cochran-Mantel-Haenszel. ‡Analysis of variance. †P≤ 0.05 vs P Median daily dose mg 20 16 17.5–20 D 12–16 O 0 Total response* % (frequency/n) 54 (7/13) 58† (7/12) 47 (7/15) 20 (2/10) Absence of nausea* % (frequency/n) 71† (10/14) 64† (9/14) 53† (9/17) 15 (2/13) Mean nausea intensity† mm (n) 10.1† (14) 24.0† (14) 14.3† (17) 48.4 (13) Mean vomiting/retching* episodes/day (n) 0.2 (13) 1.3 (12) 0.7 (17) 1.3 (10)

Cyclandelate in the Prophylaxis of Migraine

Cephalalgia ◽  
1996 ◽  
Vol 16 (6) ◽  
pp. 441-447 ◽  
Author(s):  
HC Diener ◽  
M F”h ◽  
C laccarino ◽  
P Wessely ◽  
H Isler ◽  
...  
Keyword(s):  
Statistical Significance ◽  
Platelet Activating Factor ◽  
Baseline Period ◽  
Comparable Efficacy ◽  
Double Blind ◽  
Treatment Groups ◽  
Adverse Experiences ◽  
First Choice ◽  
The Difference ◽  
Better Than

Cyclandelate inhibits calcium-induced contraction of vascular smooth muscle cells, platelet aggregation induced by thrombin, platelet-activating-factor and adenosine, and also suppresses a provoked 5HT release from platelets. This pharmacological profile suggests that cyclandelate may have a potential prophylactic effect in migraine. To test this hypothesis, a double-blind multicentre study was performed in 214 patients to investigate the efficacy and tolerability of cyclandelate compared to placebo and propranolol. After a 4-week baseline period, eligible patients (randomization 3:2:3) were treated for 12 weeks with daily doses of 1.200 mg cyclandelate ( n=81), placebo ( n=55) or 120 mg propranolol ( n=78). The number of migraine attacks (350% responders) and the migraine duration/month were compared based on the difference between baseline and the last 4 weeks of prophylactic treatment. The percentage of patients with a reduction in migraine attacks of 350% treated with cyclancelate (37.0%) or propranolol (42.3%) was not significantly superior to placebo (30.9%; P>0.025). The mean duration of migraine in hours (h) per month decreased in both active treatment groups (cyclandelate: 36.8h, p=0.046; propranolol: 34.4 h, p=0.039) compared to placebo (13.7 h) without reaching statistical significance (alpha/2=0.025). The clinical efficacy of cyclandelate and propranolol was comparable. Adverse experiences were reported by 13 patients (16.0%) treated with cyclandelate, by 5 patients (9.1%) treated with placebo and by 19 patients (24.4%) treated with propranolol. These were drug-related in 7.1% ( n=6) of patients treated with cyclandelate and in 9% ( n=7) of patients treated with propranolol. In summary, cyclandelate has a comparable efficacy to that of propranolol an established drug of first choice in the prophylaxis of migraine. Both drugs were better than placebo, but not significantly so. Both active treatments were well tolerated. ÿ box

Oxypertine (Integrin) in the Treatment of Morbid Anxiety. Report of a New Low Dosage Schedule

1973 ◽  
Vol 1 (6) ◽  
pp. 573-579
Author(s):  
J E Murphy ◽  
J F Donald ◽  
A L Molla
Keyword(s):  
Rating Scale ◽  
Comparative Trial ◽  
Practice Setting ◽  
Onset Of Action ◽  
Double Blind ◽  
Dosage Regime ◽  
Random Manner ◽  
Hamilton Anxiety Rating Scale ◽  
Low Incidence ◽  
Low Dosage

One hundred patients were admitted to a double-blind group comparative trial of two doses of oxypertine (Integrin) in the treatment of morbid anxiety in a general practice setting. The two dosage regimes were 10 mg thrice daily and 5 mg thrice daily respectively, patients being allocated in a random manner to one or other of these. Physicians assessment were made on a modified Hamilton Anxiety Rating Scale on admission and after two and four weeks treatment. A patient's self-rating scale was also carried out on these occasions using a nine item visual analogue scale embracing some symptoms of anxiety states. Eighty-nine completed case records were available for analysis. Each dosage regime brought about a similar and highly significant improvement after both two and four weeks of treatment. In both the magnitude of clinical response and rapidity of onset of action the lower dose regime was found to compare favourably with the higher dosage. Each was well tolerated and associated with a very low incidence of undesirable effects.

Switching from long-term benzodiazepine therapy to pregabalin in patients with generalized anxiety disorder: a double-blind, placebo-controlled trial

2011 ◽  
Vol 26 (4) ◽  
pp. 461-470 ◽  
Author(s):  
Sallie J Hadley ◽  
Francine S Mandel ◽  
Edward Schweizer
Keyword(s):  
Anxiety Disorder ◽  
Generalized Anxiety Disorder ◽  
Rating Scale ◽  
Controlled Trial ◽  
Generalized Anxiety ◽  
Double Blind Study ◽  
Double Blind ◽  
Significant Difference ◽  
Hamilton Anxiety Rating Scale

To evaluate the efficacy of pregabalin in facilitating taper off chronic benzodiazepines, outpatients ( N = 106) with a lifetime diagnosis of generalized anxiety disorder (current diagnosis could be subthreshold) who had been treated with a benzodiazepine for 8–52 weeks were stabilized for 2–4 weeks on alprazolam in the range of 1–4 mg/day. Patients were then randomized to 12 weeks of double-blind treatment with either pregabalin 300–600 mg/day or placebo while undergoing a gradual benzodiazepine taper at a rate of 25% per week, followed by a 6-week benzodiazepine-free phase during which they continued double-blind study treatment. Outcome measures included ability to remain benzodiazepine-free (primary) as well as changes in Hamilton Anxiety Rating Scale (HAM)-A and Physician Withdrawal Checklist (PWC). At endpoint, a non-significant higher proportion of patients remained benzodiazepine-free receiving pregabalin compared with placebo (51.4% vs 37.0%). Treatment with pregabalin was associated with significantly greater endpoint reduction in the HAM-A total score versus placebo (−2.5 vs +1.3; p < 0.001), and lower endpoint mean PWC scores (6.5 vs 10.3; p = 0.012). Thirty patients (53%) in the pregabalin group and 19 patients (37%) in the placebo group completed the study, reducing the power to detect a significant difference on the primary outcome. The results on the anxiety and withdrawal severity measures suggest that switching to pregabalin may be a safe and effective method for discontinuing long-term benzodiazepine therapy.

344 Daridorexant Improves Total Sleep Time (TST) in Insomnia Patients Without Altering the Proportion of Sleep Stages

SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A137-A138
Author(s):  
Gary Zammit ◽  
David Mayleben ◽  
Ingo Fietze ◽  
Scott Pain ◽  
Dalma Seboek Kinter ◽  
...  
Keyword(s):  
Sleep Stage ◽  
Oral Treatment ◽  
Sleep Time ◽  
Sleep Stages ◽  
Dependent Manner ◽  
Treatment Change ◽  
Pivotal Phase ◽  
Double Blind ◽  
Treatment Groups ◽  
Sleep Parameters

Abstract Introduction Daridorexant, a new dual orexin receptor antagonist, improved sleep parameters and daytime functioning in two pivotal Phase 3 trials in patients with insomnia (Trial-1, NCT03545191; Trial-2, NCT03575104); polysomnography data were collected at multiple timepoints from &gt;1,800 patients. We report the effects of daridorexant on TST and sleep stages from both trials. Methods Eligible patients with insomnia (according to DSM-5) were randomized (1:1:1) in Trial-1 (N=930) to daridorexant 25mg, 50mg, or placebo and in Trial-2 (N=924) to daridorexant 10mg, 25mg, or placebo. Oral treatment was administered each night during a 3-month double-blind treatment period. Assessment of TST and sleep stages (non-rapid eye movement [NREM, N]1, N2, N3, REM), measured by polysomnography in sleep laboratory, was performed on two consecutive nights during single-blind placebo run-in (baseline) and Months 1 and 3 (M1 and M3) of double-blind treatment. Change from baseline in TST and sleep stages were exploratory endpoints in both trials. Data for M3 (mean ± standard deviation) are presented as change from baseline. Results Daridorexant dose-dependently increased TST(minutes) from baseline to M3, more than placebo, in Trial-1 (25mg, 55±56; 50mg, 61±53; placebo, 40±56) and Trial-2 (10mg, 37±57; 25mg, 50±53; placebo, 35±56). In both trials, sleep stage proportions were preserved from baseline to M3, with no relevant changes in any group. Baseline time spent in each sleep stage (% of TST) was consistent across groups in both trials (range across treatment groups in both trials: N1:11–13; N2:55–57; N3:11–14; REM:19–20). In Trial-1 (25mg/50mg/placebo), the change from baseline to M3 in % of TST spent in N1(-0.3±4.7/-0.2±5/0.1±5), N2(2±8/1±7/1±7), N3(-2±6/-2±6/-2±6), and REM(1±6/1±5/1±5) was low and numerically similar across treatments. In Trial-2, the change from baseline to M3 in % of TST spent in each sleep stage was consistent with Trial-1, with no effect of dose. Mean changes from baseline (% of TST) for each sleep stage appeared to be independent from increasing TST. Data for 25mg were consistent between trials. Conclusion Daridorexant at any dose, and each more than placebo, increased TST in a dose-dependent manner without affecting the proportion of all sleep stages in patients with insomnia. Support (if any) Funded by Idorsia Pharmaceuticals Ltd.

A Double-Blind, Multicentre Study of Paroxetine and Maprotiline in Major Depression

1996 ◽  
Vol 41 (4) ◽  
pp. 239-244 ◽  
Author(s):  
Ulrich Schnyder ◽  
Annemarie Koller-Leiser
Keyword(s):  
Side Effects ◽  
Major Depression ◽  
Rating Scale ◽  
Similar Efficacy ◽  
Nonsignificant Trend ◽  
Double Blind ◽  
Treatment Groups ◽  
Hopkins Symptom Checklist ◽  
Psychiatric Rating ◽  
Psychiatric Rating Scale

Objective: This study was performed to compare the clinical efficacy, side effects, and safety of paroxetine and maprotiline, the latter being the most frequently prescribed antidepressant in Switzerland. Method: Seventy-one patients (in and outpatients) with major depression were randomly allocated to treatment with paroxetine (20 to 40 mg daily) or with maprotiline (50 to 150 mg daily). Efficacy was measured by means of the Hamilton Psychiatric Rating Scale for Depression, the Montgomery-Asberg Depression Rating Scale, the Clinical Global Impression, and the Hopkins Symptom Checklist. Results: The 2 components showed a similar efficacy. The adverse effect profile was comparable in the 2 treatment groups, although the findings showed a nonsignificant trend pointing in the direction of lower side effects with paroxetine. Conclusion: In the moderate dose regimens tested, the 2 components seemed to be of similar efficacy, with comparable profiles of side effects and safety.

Agomelatine versus escitalopram in major depressive disorders : a randomized double-blind, long term study focusing on sleep satisfaction and emotional blunting

2011 ◽  
Vol 26 (S2) ◽  
pp. 619-619 ◽  
Author(s):  
E. Corruble ◽  
C. Bélaidi ◽  
G.M. Goodwin
Keyword(s):  
Depressive Symptoms ◽  
Depressive Disorders ◽  
Rating Scale ◽  
Statistical Significance ◽  
Controlled Study ◽  
Major Depressive ◽  
Double Blind ◽  
Long Term Study ◽  
Long Term Treatment

The novel antidepressant agomelatine is a MT1/MT2 receptor agonist and a 5HT2c receptor antagonist, whose efficacy is demonstrated in Major Depressive Disorder (MDD) (1). In an international 24-week double-blind randomized controlled study, the effects of agomelatine 25–50 mg/d (n = 164) were compared to those of escitalopram 10-20 mg/d (n = 160) on satisfaction about sleep (Visual Analogic Scale), depressive symptoms (Hamilton Depression Rating Scale (HAM-D)) and emotions in a subset of 45 patients having completed the Oxford Depression Questionnaire (2).Both drugs improved depressive symptoms (mean decrease in HAM-D score from baseline: -19.9 with agomelatine and -19.2 with escitalopram; percentage of remitters: 69.6% with agomelatine and 63.1% with escitalopram, LOCF endpoint) and the satisfaction about sleep. Interestingly, the wellness feeling on waking was more improved with agomelatine as compared to escitalopram (p = 0.025), indicating a better alertness on waking with agomelatine than escitalopram.Moreover, emotional blunting was less frequent with agomelatine as compared to escitalopram: 28% on agomelatine vs 60% on escitalopram felt that their emotions lacked intensity with a trend to statistical significance (p = 0.063) and 16% of patients on agomelatine vs 53% on escitalopram felt that things that they cared about before illness did not seem important any more (p = 0.024). Finally, less patients withdrew due to emergent adverse events with agomelatine (4.3%) as compared to escitalopram (10.6%), (p = 0.029). To conclude, this study shows some potential clinical advantages of agomelatine as compared to escitalopram in the long term treatment of MDD.

scholarly journals Analysis of the intermediate results of the INVENT-1 clinical trial: open-label, randomized, multicenter study

2020 ◽  
pp. 78-79
Author(s):  
O.S. Denysov
Keyword(s):  
Treatment Group ◽  
Oral Administration ◽  
Oral Therapy ◽  
Therapy Group ◽  
Oral Treatment ◽  
Long Term Results ◽  
Intensive Phase ◽  
Pulmonary Tb ◽  
Infusion Group ◽  
Intravenous And Oral Administration

Background. Attempts to treat tuberculosis (TB) with the help of intravenous drugs have been made since the early XX century. However, XXI century medicine recommends treating TB with pills, and invasive anti-TB drugs (ATBD) are rarely used. International expert groups recommend intravenous administration only for critically ill patients or for patients with absorption disorders. Meanwhile, the advantages of intravenous ATBD include direct monitoring of treatment, accurate dosing for each patient, fewer side effects, and avoidance of taking a large number of tablets. Objective. To evaluate the efficacy, safety, and tolerability of intravenous and oral administration of ATBD in the intensive phase of treatment in patients with advanced destructive pulmonary TB with bacterial excretion. Materials and methods. The study involved 318 patients from 9 clinical centres. The total duration of the study was 18 months. Intravenous and oral administration of isoniazid, rifampicin and ethambutol were compared. The intensive phase of the study lasted 2 months, the maintenance phase lasted 4 months. Inclusion criteria were the following: age 18-65 years, diagnosis of pulmonary TB, at least one positive test result for TB mycobacteria, radiological confirmation of lung destruction and advance TB process, in women – negative urine test for pregnancy, informed consent, negative GenXpert MTB/RIF analysis, and verbal consent to abstain from alcohol during the study. Results and discussion. Due to the resistance to 1st line drugs 14 people were excluded from the study, due to the lack of data on culture – 16 people, for other reasons – 7 people. In the infusion treatment group, 52.63 % had disseminated TB, and 47.37 % had infiltrative TB. In the group of tablet treatment disseminated TB occurred in 35.2 % of patients, infiltrative – in 61.8 %, miliary – in 3 %. At 4th visit, the efficacy of abacillation in both treatment groups was comparable: 34.2 % in the infusion group and 35.26 % in the oral treatment group. But as of the 6th visit, the share of abacillation in the infusion group was 57.42 %, and in the oral treatment group – 46.96 %. Analysis of the time needed to achieve a negative result on mycobacterium TB also revealed the benefits of infusions. Thus, up to the 3rd visit this parameter was reached by 15.78 % of the infusion group patients, and by 13.76 % of oral therapy group patients. The total proportion of patients with a negative test for mycobacterium TB and clinical improvement in the infusion group was 60 %, and in the oral therapy group – 52.90 %. In infiltrative TB, 27.8 % of the infusion group and only 9.5 % of the tablet therapy group reached abacillation by the 3rd visit. In disseminated TB, abacillation was achieved up to 3rd visit in 5 % of the infusion group and 8.3 % of the tablet treatment group, however, the total numbers at the end of the study were 45 and 25 %, respectively. Conclusions. 1. Monitoring the patient’s treatment is a cornerstone of TB therapy. 2. There is a tendency to the greater effectiveness of TB treatment using intravenous ATBD in the intensive phase of therapy. 3. It is necessary to analyze the long-term results of treatment and the impact of both treatment regimens on the recurrence of the process.

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