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.

scholarly journals Intrathecal Riluzole for the Treatment of Patients With Amyotrophic Lateral Sclerosis

Neurosurgery ◽  
2019 ◽  
Vol 66 (Supplement_1) ◽  
Author(s):  
Nicholas M Boulis
Keyword(s):  
Amyotrophic Lateral Sclerosis ◽  
Side Effects ◽  
Oral Administration ◽  
Oral Therapy ◽  
Drug Exposure ◽  
Oral Treatment ◽  
Oral Drug ◽  
Systemic Drug Exposure ◽  
Lateral Sclerosis ◽  
Systemic Drug

Abstract INTRODUCTION Oral riluzole is the only approved treatment known to improve survival in patients with amyotrophic lateral sclerosis (ALS), with modest efficacy and dosing limited by hepatic toxicity and asthenia. We postulated that a continuous intrathecal (IT) delivery of low daily doses of riluzole could elevate spinal cord (SC) concentrations well above those achievable with oral treatment alone, without increasing side-effects. METHODS A 6-wk and a 24-wk GLP study were conducted to evaluate the safety of IT riluzole in purpose-bred hound dogs. Oral riluzole, equivalent to 50 mg BID in humans, was administered in combination with one of 3 IT doses given through continuous infusion. Plasma, SC, and brain concentrations of riluzole were measured, along with assessments of safety and tolerability. RESULTS In the 6-wk study, when combining the oral and IT routes, IT infusion significantly increased SC concentrations well above those achieved with oral drug administration alone, without increasing brain concentrations. All IT doses in combination with oral administration were well tolerated by the animals. In the 6-mo study, the lowest dose used in the 6-wk study was dropped and a higher dose was added. This highest dose of IT riluzole was not tolerated by the dogs and yielded SC and brain concentrations significantly higher than achieved in any of our previous studies. CONCLUSION Continuous IT administration of riluzole when combined with oral administration can increase the SC concentration of riluzole above those achievable with oral therapy, without increasing the risk for adverse events associated with systemic drug exposure or off-target side-effects in the brain. Therefore, IT riluzole infusion when used in conjunction with oral therapy may safely enhance lower motor neuron neuroprotection and improve the survival benefit of the drug through enhanced SC delivery, and, with a careful selection of IT doses, it could be implemented in patients with ALS.

scholarly journals Principles and rationale of infusion therapy in tuberculosis

2020 ◽  
pp. 239-240
Author(s):  
T.I. Petrenko
Keyword(s):  
Drug Resistance ◽  
Treatment Group ◽  
Oral Administration ◽  
Intravenous Administration ◽  
Vena Cava ◽  
Medical Community ◽  
Infusion Therapy ◽  
Intravenous Therapy ◽  
Pulmonary Tb ◽  
Number Of Patients

Background. In 2018 7 million new cases of tuberculosis (TB) were registered, which is more than in previous years. Undoubtedly, TB is one of the most important threats to the public health globally. In developing countries, where there are no new TB drugs (TBD) and modern medical services, this threat is even more serious. Intravenous administration is an option to optimize the existing drug regimens, as it is accompanied by increased bioavailability. Objective. To substantiate the rationality of infusion therapy in TB. Materials and methods. Analysis of literature data on this topic; own study involving 106 patients with newly diagnosed infiltrative and disseminated pulmonary TB with bacterial excretion. Results and discussion. The medical community is concerned not only about the increase in the TB incidence, but also about the increase in the number of drug resistance (DR) cases. Improper treatment is one of the causes of DR. In case of oral administration absorption disorders of the drug are possible in people with digestive system diseases, in addition, part of the drug is metabolized by passing through the liver. In contrast, intravenous drugs enter the superior vena cava system, right ventricle, and pulmonary arteries. In a number of patients’ subgroups, it is not possible to achieve a sufficient concentration of drugs in serum when taken orally for various reasons. In particular, these reasons include host organism factors (features of drug metabolism (fast acetylators are more likely to have DR than slow ones), malabsorption, drug clearance, inability of the drug to reach lung tissue) and mycobacteria factors (biofilm formation, drug resistance due to efflux pumps, metabolic status of the bacterium – division phase or sleep phase). These factors are considered to be the consequences of continuous oral administration of TBD. Achieving a high concentration of TBD in the source of infection due to intravenous administration allows to overcome the DR of mycobacteria. In the own study, oral (n=33) and intravenous (n=73) modes of TBD administration were compared. The groups were identical in age, sex, and TB stage. In the intravenous treatment group there was a significantly higher proportion of complete closure of the decay cavities (90.5 % vs. 60.4 % in the oral treatment group; p=0.04), as well as the significantly lower number of toxic reactions (14.3 % vs. 57.9 %; p=0.001) and poor tolerability of treatment (31 % vs. 57.9 %; p=0.04). On the background of intravenous therapy less fluoroquinolone DR was observed. Conclusions. 1. Intravenous therapy in patients with pulmonary TB is more effective than standard in terms of closure of the decay cavities. 2. Intravenous therapy is accompanied by significantly less toxicity and better tolerability. 3. Intravenous TB therapy is less likely to provoke the development of DR.

scholarly journals Pengaruh Suplementasi Vitamin A pada Pengobatan Pasien TB Paru terhadap Percepatan Konversi Dahak pada Fase Intensif Di Wilayah Kerja Puskesmas Kecamatan Medan Kota

2018 ◽  
Vol 16 (2) ◽  
pp. 124
Author(s):  
Alexander Marpaung ◽  
Parluhutan Siagian ◽  
Dina Keumala Sari
Keyword(s):  
Treatment Group ◽  
Vitamin A ◽  
University Students ◽  
Statistical Testing ◽  
Control Group ◽  
Vitamin A Supplementation ◽  
Intensive Phase ◽  
Pulmonary Tb ◽  
Sputum Conversion ◽  
Conversion Time

Background: Indonesia is in the second rank for the most TB (Tuberculosis) cases in the world after India. It is estimated that there are 1 million cases per year in Indonesia. Objective: The objective of the research was to find out the influence of Vitamin A supplementation in the medication of pulmonary TB on the acceleration of sputum conversion time at intensive phase in the Working Area of Puskesmas in Medan Kota Subdistrict. Methods: This research applied clinical testing design with experimental approach and Experimental Quasi method. The samples were 30 newly diagnosed pulmonary TB patients consisting of15 patients in the treatment group and 15 patients in the control group. They were ³18 years old, regularly consumed category I OAT with BMI ³18.5. The statistical data were analyzed by Mann-Whitney statistical testing at reliability rate 95% (p<0.05).        Result: The results of the research on the treatment group discovered that they were mostly 18-27 years old 40.0%, male 73.3%, mostly university students 26.7%, had BTA conversion in the second week 80.0%; and the sputum conversion time was 2.4 weeks in average. The results of the research on the control group demonstrated that they were mostly 18-27 years old 33.3%, male 80.0%, mostly university students and entrepreneurs 20.0%, had BTA conversion in the second week 80%; and the sputum conversion time was 4.1 weeks in average. Vitamin A supplementation in the medication of pulmonary TB patients had some influence on the acceleration of sputum conversion at intensive phase (p= <0.001) < (alpha = 0.05). Conclusion: Vitamin A supplementation in the medication of pulmonary TB patients had some influence on the acceleration of sputum conversion at intensive phase in the Working Area of Puskesmas in Medan Kota Subdistrict

scholarly journals Vitamin A Supplementation in Pulmonary Tuberculosis Patients on Acceleration of Sputum Conversion in Medan City

2019 ◽  
Vol 7 (20) ◽  
pp. 3505-3508
Author(s):  
Dina Keumala Sari ◽  
Alexander Parlindungan Marpaung ◽  
Parluhutan Siagian ◽  
Nurfida Khairina Arrasyid
Keyword(s):  
Treatment Group ◽  
Vitamin A ◽  
University Students ◽  
Control Group ◽  
Vitamin A Supplementation ◽  
Intensive Phase ◽  
Tuberculosis Patients ◽  
Pulmonary Tb ◽  
Sputum Conversion ◽  
Conversion Time

BACKGROUND: Indonesia is in the second rank for the most TB (Tuberculosis) cases in the world after India. It is estimated that there are 1 million cases per year in Indonesia. AIM: To find out the influence of Vitamin A supplementation in the medication of pulmonary TB on the acceleration of sputum conversion time at an intensive phase in the Working Area of Puskesmas in Medan Kota Subdistrict METHODS: This research was Quasi Experiment method. With two groups. The samples were 30 newly diagnosed pulmonary TB patients consisting of of15 patients in the treatment group and 15 patients in the control group. The statistical data were analysed with t independent test, significance 95% (p < 0.05) RESULTS: The treatment group discovered that they were mostly 18-27 years old 40.0%, male 73.3%, mostly university students 26.7%, had BTA conversion in the second week 80.0%; and the sputum conversion time was 2.4 weeks in average. The results of the research on the control group demonstrated that they were mostly 18-27 years old 33.3%, male 80.0%, mostly university students and entrepreneurs 20.0%, had BTA conversion in the second week 80%; and the sputum conversion time was 4.1 weeks in average. Vitamin A supplementation in the medication of pulmonary TB patients had some influence on the acceleration of sputum conversion at the intensive phase (p ≤ 0.001). CONCLUSION: We concluded that Vitamin A in the medication of pulmonary TB patients had some influence on the acceleration of sputum conversion at the intensive phase in the Medan Kota.

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.

Randomized trial of medical compression stockings versus two-layer short-stretch bandaging in the management of venous leg ulcers

Phlebologie ◽  
2009 ◽  
Vol 38 (04) ◽  
pp. 157-163 ◽  
Author(s):  
A. Franek ◽  
L. Brzezinska-Wcislo ◽  
E. Blaszczak ◽  
A. Polak ◽  
J. Taradaj
Keyword(s):  
Drug Therapy ◽  
Randomized Clinical Trials ◽  
Therapy Group ◽  
Long Term Results ◽  
Leg Ulcers ◽  
Compression Stockings ◽  
Venous Leg Ulcers ◽  
Group A ◽  
Group B ◽  
Medical Compression Stockings

SummaryA prospective randomized clinical trial was undertaken to compare a medical compression stockings with two-layer short-stretch bandaging in the management of venous leg ulcers. Study endpoints were number of completely healed wounds and the clinical parameters predicting the outcome. Patients, methods: Eighty patients with venous leg ulcers were included in this study, and ultimately allocated into two comparative groups. Group A consisted of 40 patients (25 women, 15 men). They were treated with the compression stockings (25–32 mmHg) and drug therapy. Group B consisted of 40 patients (22 women, 18 men). They were treated with the short-stretch bandages (30–40 mmHg) and drug therapy, administered identically as in group A. Results: Within two months the 15/40 (37.50%) patients in group A and 5/40 (12.50%) in group B were healed completely (p = 0.01). For patients with isolated superficial reflux, the healing rates at two months were 45.45% (10/22 healed) in group A and 18.18% (4/22 healed) in group B (p = 0.01). For patients with superficial plus deep reflux, the healing rates were 27.77% (5/18 healed) in group A and 5.55% (1/18 healed) in group B (p = 0.002). Comparison of relative change of the total surface area (61.55% in group A vs. 23.66% in group B), length (41.67% in group A vs. 27.99% in group B), width (46.16% in group A vs. 29.33% in group B), and volume (82.03% in group A vs. 40.01% in group B) demonstrated difference (p = 0.002 in all comparisons) in favour of group A. Conclusion: The medical compression stockings are extremely useful therapy in enhancement of venous leg ulcer healing (both for patients with superficial and for patients who had superficial plus deep reflux). Bandages are less effective (especially for patients with superficial plus deep reflux, where the efficiency compared to the stockings of applied compression appeared dramatically low). These findings require confirmation in other randomized clinical trials with long term results.

scholarly journals Six-year trend and risk factors of unsuccessful pulmonary tuberculosis treatment outcomes in Thai Community Hospital

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Sakarn Charoensakulchai ◽  
Chaiyapun Lertpheantum ◽  
Chanapon Aksornpusitpong ◽  
Peeranut Trakulsuk ◽  
Boonsub Sakboonyarat ◽  
...  
Keyword(s):  
Risk Factors ◽  
Community Hospital ◽  
Previous History ◽  
Treatment Quality ◽  
Intensive Phase ◽  
Loss To Follow Up ◽  
Pulmonary Tb ◽  
Tb Treatment ◽  
Monitoring Tools ◽  
Unsuccessful Treatment

Abstract Objective Tuberculosis (TB) is a major cause of morbidity and mortality globally. Despite efforts to eliminate TB in Thailand, the incidence rate has declined slowly. This study aimed to identify the incidence and risk factors of unsuccessful pulmonary TB treatment (failed, died and loss-to- follow up) in a community hospital in Chachoengsao Province, Thailand from 1st January 2013 to 31st December 2019. Results A total of 487 patients were eligible for the study. The incidence of unsuccessful treatment was 21.67/100 population person year. Risk factors of unsuccessful pulmonary TB treatment were unemployment (adjusted hazard ratio (AHR) 3.12, 95%CI 1.41–6.86), HIV co-infection (AHR 2.85, 95%CI 1.25–6.46), previous history of TB (AHR 2.00, 95%CI 1.04–3.81), positive sputum AFB at the end of the intensive phase (AHR 5.66, 95%CI 2.33–13.74), and sputum AFB was not performed at the end of the intensive phase (AHR 18.40, 95%CI 9.85–34.35). This study can be utilized to improve prevention and intervention of TB treatment by strengthening public health system on treatment quality especially TB patient monitoring tools or methods easy for accessing to patients in communities.

scholarly journals Effects of Diabetes Mellitus Induced by Alloxan on the Pharmacokinetics of Metformin in Rats: Restoration of Pharmacokinetic Parameters to the Control State by Insulin Treatment

2008 ◽  
Vol 11 (1) ◽  
pp. 88 ◽  
Author(s):  
Myung G. Lee ◽  
Young H Choi ◽  
Inchul Lee
Keyword(s):  
Diabetes Mellitus ◽  
Oral Administration ◽  
Protein Expression ◽  
Intravenous Administration ◽  
Insulin Treatment ◽  
Pharmacokinetic Parameters ◽  
Mrna Levels ◽  
Altered Pharmacokinetic ◽  
Intravenous And Oral Administration ◽  
Control State

To test the effect of insulin treatment on the pharmacokinetics of metformin in rats with diabetes mellitus induced by alloxan (DMIA rats). The following results were reported from other studies. Metformin was metabolized via hepatic CYP2C11, 2D1, and 3A1/2 in rats. In DMIA rats, the protein expression and mRNA levels of hepatic CYP2C11 and 3A1/2 decreased and increased, respectively. In rat model of diabetes mellitus induced by streptozotocin, the protein expression of hepatic CYP2D1 was not changed. The increase in hepatic CYP1A2, 2B1, and 2E1, and decrease in hepatic CYP2C11 in DMIA rats was returned to the controls by insulin treatment. METHODS. Metformin (100 mg/kg) was administered intravenously and orally to the control rats, DMIA rats, and DMIA rats with insulin treatment for 3 weeks (DMIA rats with insulin). RESULTS. After intravenous administration of metformin to the DMIA rats, the CLR and CLNR of the drug were significantly slower than the controls. After oral administration of metformin to the DMIA rats, the AUC of the drug was also significantly greater than the controls. After intravenous administration of metformin to the DMIA rats with insulin, the significantly slower CLNR of the drug in the DMIA rats was returned to the controls. The altered pharmacokinetic indices observed following intravenous and oral administration of metformin to DMIA rats returned to the control values in the DMIA rats with insulin. CONCLUSIONS. The significantly slower CLNR of metformin in the DMIA rats could be due to the decrease in hepatic CYP2C11 than the controls. The comparable CLNR of metformin between the DMIA rats with insulin and the control rats could be due to restoration of hepatic CYP enzyme changes in DMIA rats to the controls.

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