scholarly journals A Prospective, Randomized Controlled Study for the Efficacy and Safety of the Substitution of Pyrazinamide and Ethambutol With Moxifloxacin During the Intensive Phase of Treatment of Pulmonary Tuberculosis

Author(s):  
Yuqi Shang ◽  
Xi Liu ◽  
Yuanli Chen ◽  
Xiaoqing Luo ◽  
Hongqiong Zhu ◽  
...  

Abstract Background: Moxifloxacin (MFX, M) is currently a second-line antituberculosis drug as initial therapy of pulmonary tuberculosis and one of the main anti-TB drugs in drug-resistant TB, which can kill both intracellular and extracellular Mycobacterium tuberculosis. We started a trial to study the efficacy and safety of the substitution of pyrazinamide and ethambutol with moxifloxacin during the intensive phase of treatment of newly diagnosed susceptive pulmonary tuberculosis. Methods/design: This is a prospective, open, randomized, parallel-controlled, single-center clinical study. The study consists of three phases: a screening period, a treatment period of 6 (or 7) months, and a follow-up period of 1 year. Patients selected for the study will be allocated to the trial group or the control group randomly. The control group will be given six months of a standard regimen(2HRZE/4HR). The trial group will be given a total of six months of treatment with substitution of pyrazinamide and ethambutol with moxifloxacin during the intensive phase(2HRM/4HR). The primary outcome is the rate of adverse outcomes within one year of completion of therapy. The Secondary outcomes include the rate of treatment success at the 2nd, 3rd, 5th and 6th months, the rate of sputum Mtb(Mycobacterium tuberculosis) negative conversion at the 2nd, 3rd, 5th and 6th months, the time of sputum Mtb negative conversion at the 2nd, 3rd, 5th and 6th months, and the number of patients with adverse events within one year of completion of therapy. Comparisons will be performed using two-sided tests with a statistical significance level of 5%.Discussion: This trial will reveal the effectiveness and safety of 2months of use of moxifloxacin instead of pyrazinamide and ethambutol during the intensive phase of treatment for newly diagnosed susceptive pulmonary tuberculosis. If the new regimen including isoniazid, rifampicin and moxifloxacin during the intensive phase of treatment (2HRM/4HR) is no less effective and safe than the standard regimen(2HRZE/4HR), it could be a new alternative treatment for newly diagnosed susceptive pulmonary tuberculosis in the future. Trial registration: ClinicalTrials.gov, NCT04187469. Registered on 5 December 2019.

2021 ◽  
pp. 39-43
Author(s):  
L.D. Todoriko ◽  
O.V. Pidverbetska

OBJECTIVE. To investigate the frequency of malabsorption in newly diagnosed sensitive pulmonary tuberculosis (TB) and to establish the effectiveness of treatment correction in these patients. MATERIALS AND METHODS. In the first stage of the study, 73 patients with new drug-susceptible TB underwent lactulose-mannitol test. Individuals with intestinal permeability index <3 were selected and divided into main group which received injectable forms of isoniazid, rifampicin, ethambutol and oral pyrazinamide and control group which received standard treatment orally. RESULTS. Bacterial excretion stopped in 88.2 % of patients in the main group and in only 61.5 % of patients in the control group. In 46.1 % of cases in the control group treatment failure was diagnosed. The frequency of positive radiological dynamics at the end of the intensive phase of treatment was 64.7 % in the main group versus 30.8 % in the control group. The total efficacy of treatment at the end of the main course of chemotherapy was 88.2 % in the main group against 53.9 % in the control group (p <0.05). CONCLUSIONS. Malabsorption, which requires correction of treatment, occurs in about one-fifth of patients with new TB. Usage of injectable anti-TB drugs in such patients increases the effectiveness of treatment by 34 % (p <0.05).


Author(s):  
Syoof Khowman Alramahy ◽  
Akram Hadi Hamza

This study was carried out to study of some immunological aspects among the pulmonary Tuberculosis patients infected with causative agent, Mycobacterium tuberculosis. A Total of 200 sputum samples were collected from patients attending the consultant Clinic for Chest and Respiratory disease center, Diwaniya. Control group (No=15) also included. According to acid fast stain of sputum, the patients were classified as positive (No=91,45.5%) and negative (No=109,54.5, Lowenstein Jensen medium used for the cultivation of samples, on which 70% of sputum samples where positive culture for this microorganism. The grown microorganism were identified as M. tuberculosis, based on positive A.F.B, Niacin producers ,negative for catlase at 68c. The mean IgG level was l184.053±76.684 mg/100 ml in tuberculosis group compared with 1016.533 ± 44.882 mg/100ml in control group, rendering the statistical difference significant. For IgA and IgM levels, they were at mean of 315.880±38.552 mg/100 ml and 119.527±8.464 mg/100 ml in control group compared with 396.358±38.776 mg/100 ml and 134.207±11.696 mg/100 ml in patients group respectively with significant difference


2021 ◽  
Author(s):  
Steven Lubitz ◽  
Steven J. Atlas ◽  
Jeffrey M. Ashburner ◽  
Ana Lipsanopoulos ◽  
Leila Borowsky ◽  
...  

Background: Undiagnosed atrial fibrillation (AF) may cause preventable strokes. Guidelines differ regarding AF screening recommendations. We tested whether point-of-care screening with a handheld single lead electrocardiogram (ECG) at primary care practice visits increases diagnoses of AF. Methods: We randomized 16 primary care clinics 1:1 to AF screening using a handheld single-lead ECG (AliveCor KardiaMobile) during vital sign assessments, or usual care. Patients included were aged ≥ 65 years. Screening results were provided to primary care clinicians at the encounter. All confirmatory diagnostic testing and treatment decisions were made by the primary care clinician. New AF diagnoses over one-year follow-up were ascertained electronically and manually adjudicated. Proportions and incidence rates were calculated. Effect heterogeneity was assessed. Results: Of 30,715 patients without prevalent AF (n=15,393 screening [91% screened], n=15,322 control), 1.72% of individuals in the screening group had new AF diagnosed at one year versus 1.59% in the control group (risk difference [RD] 0.13%, 95% confidence interval [CI] -0.16,0.42, P=0.38). New AF diagnoses in the screening and control groups differed by age with the greatest effect observed for those aged ≥ 85 years (5.56% versus 3.76%, respectively, RD 1.80%, 95% CI 0.18,3.30). The difference in newly diagnosed AF between the screening period and the prior year was marginally greater in the screening versus control group (0.32% versus -0.12%, RD 0.43%, 95% CI -0.01,0.84). The proportion of individuals with newly diagnosed AF who were initiated on oral anticoagulants was similar in the screening (n=194, 73.5%) and control (n=172, 70.8%) arms (RD 2.7%, 95% CI -5.5,10.4). Conclusions: Screening for AF using a single-lead ECG at primary care visits was not associated with a significant increase in new AF diagnoses among individuals aged 65 years or older compared to usual care. However, screening may be associated with an increased likelihood of diagnosing AF among individuals aged 85 years or older and warrants further evaluation.


2021 ◽  
Vol 1 (2) ◽  
pp. 538-547
Author(s):  
Fitri Zulfa Hayati ◽  
Nurhapipa Nurhapipa ◽  
Nila Puspita Sari

Tuberkulosis Paru merupakan penyakit menular yang disebabkan oleh bakteri Mycobacterium tuberculosis. Kejadian penyakit Tuberkulosis Paru di Puskesmas Rejosari Kota Pekanbaru merupakan kasus tertinggi di kota pekanbaru sebanyak 798 kasus. Tujuan penelitian ini secara umum untuk mengetahui hubungan kondisi fisik rumah dan status gizi dengan insiden penyakit tuberkulosis paru. Penelitian ini adalah analitik kuantitatif dengan pendekatan Case Control. Populasi kasus dalam penelitian ini yaitu seluruh penderita Tuberkulosis Paru. Sampel penelitian yaitu 18 responden kelompok kasus dan 72 responden kelompok kontrol dengan menggunakan teknik Simple random sampling. Lokasi penelitian dilakukan di Wilayah Kerja Puskesmas Rejosari Kota Pekanbaru pada bulan Juli – Agustus 2020. Alat ukur yang digunakan yaitu kuesioner, roll meter, lux meter, dan timbangan berat badan. Analisis data dilakukan secara univariat dan bivariat menggunakan uji Chi Square. Hasil uji statistik hubungan dari setiap variabel semuanya berhubungan dengan insiden penyakit tuberkulosis paru, yaitu variabel luas ventilasi (p = 0,002, OR = 7,857), kepadatan hunian (p = 0,003, OR = 5,500), pencahayaan (p = < 0,05, OR = 8,500), dan status gizi (p = 0,001, OR = 10,818). Diharapkan kepada tim pencegah dan pengendalian penyakit tuberkulosis paru Puskesmas Rejosari meningkatkan penyuluhan atau pemahaman langsung kepada masyarakat penderita TB paru serta membentuk dan melatih kader – kader untuk penanggulangan Tuberkulosis Paru. Diharapkan masyarakat selalu membuka jendela agar udara dan cahaya dapat masuk ke dalam rumah serta menjaga pola makan yang seimbang dan sehat. Pulmonary Tuberculosis is an infectious disease caused by the bacteria Mycobacterium tuberculosis. The incidence of pulmonary tuberculosis in Rejosari Primary Health Center Pekanbaru City is the highest case in Pekanbaru city with 798 cases. The purpose of this study in general was to determine the relationship between the physical condition of the house and nutritional status with the incidence of pulmonary tuberculosis. This research is a quantitative analytic with a Case Control approach. The populations of cases were all patients with pulmonary tuberculosis. The research sample was 18 respondents in the case group and 72 respondents in the control group using the simple random sampling technique. The research location was carried out in the Rejosari Public Health Center, Pekanbaru City in July - August 2020. The measuring instruments used were questionnaires, roll meters, lux meters, and weight scales. Data analysis was performed univariate and bivariate using the Chi Square test. The statistical test results of the relationship between each variable were all related to the incidence of pulmonary tuberculosis, namely the variable area of ventilation (p = 0.002, OR = 7.857), occupancy density (p = 0.003, OR = 5,500), lighting (p =0.05, OR 8.5)and nutritional status (p = 0.001, OR = 10.818). It is hoped that the team for preventing and controlling pulmonary tuberculosis at the Rejosari Community Health Center will increase direct education or understanding to people with pulmonary tuberculosis and form and train cadres to control pulmonary tuberculosis. It is hoped that people will always open windows so that air and light can enter the house and maintain a balanced and healthy diet.


2017 ◽  
Vol 61 (4) ◽  
Author(s):  
Xavier A. Kayigire ◽  
Sven O. Friedrich ◽  
Lize van der Merwe ◽  
Andreas H. Diacon

ABSTRACT Mycobacterium tuberculosis strains with spontaneous mutations conferring resistance to rifampin (RIF) are exceedingly rare, and fixed drug combinations typically prevent augmentation of resistance to single drugs. Fourteen newly diagnosed tuberculosis patients were treated with RIF alone for 14 days, and bacterial loads, including mutation frequencies, were determined. A statistical model estimated that 1% of the remaining viable mycobacteria could be RIF resistant after 30 days of monotherapy. This indicates that temporal and spatial windows of RIF monotherapy due to uneven drug distribution within lung lesions could contribute to the acquisition of resistance to RIF.


2021 ◽  
Vol 9 (1) ◽  
pp. 29-29
Author(s):  
Mehdi Haghdoost ◽  
Parisa Alizadeh Nazmi ◽  
Hamid Owaysee Osquee

Introduction: In developing countries, which is an endemic region in terms of tuberculosis, there is an urgent need for fast, accurate, and inexpensive serological testing. The aim of this study was to determine the diagnostic value of patient serum IgG antibodies by ELISA in the diagnosis of Mycobacterium tuberculosis. Method: This case-control study was performed on patients with pulmonary tuberculosis in 2017-2020. After selecting the case (n = 30) and control (n = 30) subjects according to inclusion criteria, their blood samples were obtained and analyzed in the reference laboratory by standard kits for immunoglobulin G against 16, 36, and 40 kDa antigens of mycobacterium tuberculosis. Results: The mean age of the subjects was 47.07 (15.57%). The majority of participants were 46 (51.1%) women. There was no significant difference between the two groups regarding sex and age. serological examination of patients with pulmonary tuberculosis showed 25 positive results and only 4 of the control group had a positive result. Sensitivity, specificity, positive and negative predictive values of serology test were 83.3%, 86.67%, 86.20% and 87.88% respectively. Conclusion: Despite the acceptable sensitivity of the serologic immunoglobulin G test, according to the statement of World health organization (WHO), it did not possess an acceptable specificity. It is recommended that a a wider range of different antigens to be studied also it is essential to evaluate the diagnostic value of the other immunoglobulins inpatient in different stages of the disease.


1986 ◽  
Vol 11 (2) ◽  
pp. 225-230
Author(s):  
J. C. Y. CHENG ◽  
S. Y. C. HSU ◽  
Y. W. CHONG ◽  
P. C. LEUNG

The potential clinical application of Glutaraldehyde treated bioprosthetic material in the hand as implants to substitute for damaged pulley, tendon or ligament has not been fully explored. This study tries to evaluate the efficacy and safety of the proposed bioprosthetic pulley in an experimental model. One of the digital flexor pulleys of the rabbit’s foot was excised and replaced by a bioprosthetic pulley using a standardized technique. Autogenous tendon graft was used as the control on the opposite foot. Altogether twenty rabbits (40 feet) were included in the study and they were sacrificed at different time intervals up to one year. The retrievals were analysed for flexor tendon adhesions and rupture of the pulley macroscopically. Histological and Electron Microscopy study of the ‘pulley’ and ‘pulley-bone’ junction were also carried out. Results show consistently the progressive creeping substitution of the bioprosthetic material by the rabbit’s own tissue without significant inflammatory reactions. Neither adhesions nor breakage of the pulley were detected, the results comparing favourably with the control group using autografts except for the longer time taken for the substitution process.


Sign in / Sign up

Export Citation Format

Share Document