scholarly journals An Intensified Regimen Containing Linezolid Could Improve Treatment Response in Mycobacterium abscessus Lung Disease

2019 ◽  
Vol 2019 ◽  
pp. 1-5
Author(s):  
Hua Li ◽  
Li Tong ◽  
Jun Wang ◽  
Qingtao Liang ◽  
Yun Zhang ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Lung Disease ◽  
Treatment Response ◽  
Conversion Rate ◽  
Mycobacterium Abscessus ◽  
Sputum Culture Conversion ◽  
Conventional Regimen ◽  
Sputum Conversion ◽  
Culture Conversion

Background. Treatment response for the Mycobacterium abscessus (M. abscessus) lung disease remains far from satisfying. An effective regimen is needed to solve the problem. Methods. We retrospectively reviewed the medical records of all patients with M. abscessus lung disease who received antibiotics regimen at Beijing Chest Hospital Affiliated to Capital Medical University between July 1, 2010, and February 1, 2018. Patients were administered a conventional antibiotics regimen (including macrolide and moxifloxacin, along with an initial 12-week course of low-dose cefoxitin and amikacin) or intensified regimen (including a higher dosage of cefoxitin and linezolid besides conventional drugs), respectively. The time to sputum-culture conversion and proportion of sputum-culture conversion in liquid broth were investigated to evaluate the efficacy and evaluation of safety by performing the classification of adverse events according to the Division of AIDS, National Institute of Allergy and Infectious Disease. Patients were followed for 18 months from baseline. Results. In the conventional regimen group, the sputum conversion rate at 18 months was 29.4% (10/34), and the median time until sputum conversion was 2 months (IQR, 1-2 mo). Furthermore, in the intensified regimen group, the sputum conversion rate was 81.3% (13/16), and the median time until sputum conversion was 1 month (IQR, 1-1 mo). Leukopenia and drug-induced hepatotoxicity occurred more frequently in the intensified regimen group in contrast with the conventional regimen group patients. However, only 1 adverse event in the intensified regimen group was classified as severe adverse event. Conclusions. The intensified regimen could improve sputum conversion of M. abscessus lung disease compared with conventional regimen, but close safety surveillance is necessary to monitor adverse events.

scholarly journals Clofazimine for Treatment of Extensively Drug-Resistant Pulmonary Tuberculosis in China

2018 ◽  
Vol 62 (4) ◽  
Author(s):  
Qingfeng Wang ◽  
Yu Pang ◽  
Wei Jing ◽  
Yufeng Liu ◽  
Na Wang ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Sputum Culture ◽  
Successful Outcome ◽  
Control Group ◽  
Drug Resistant ◽  
Sputum Culture Conversion ◽  
Extensively Drug Resistant ◽  
Experimental Group ◽  
Culture Conversion

ABSTRACT We performed a multicenter, prospective, randomized study to investigate the efficacy and safety of clofazimine (CLO) for treatment of extensively drug-resistant tuberculosis (XDR-TB) in China. Forty-nine patients infected with XDR-TB were randomly assigned to either the control group or the CLO group, both of which received 36 months of individually customized treatment. The primary endpoint was the time to sputum culture conversion on solid medium. Clinical outcomes of patients were evaluated at the time of treatment completion. Of the 22 patients in the experimental group, 7 (31.8%) met the treatment criterion of “cure” and 1 (4.5%) “complete treatment,” for a total of 8 (36.4%) exhibiting successful treatment outcomes without relapse. In the control group, 6 patients (22.2%) were cured and 6 (22.2%) completed treatment by the end of the study. Statistical analysis revealed no significant difference in successful outcome rates between the CLO group and the control group. The average sputum culture conversion time for the experimental group was 19.7 months, which was not statistically different from that for the control group (20.3 months; P = 0.57). Of the 22 patients in the CLO group, 12 (54.5%) experienced adverse events after starting CLO treatment. The most frequently observed adverse event was liver damage, with 31.8% of patients (7/22 patients) in the CLO group versus 11.1% (3/27 patients) in the control group exhibiting this adverse event. Our study demonstrates that inclusion of CLO in background treatment regimens for XDR-TB is of limited benefit, especially since hepatic disorders arise as major adverse events with CLO treatment. (This study is registered with the Chinese Clinical Trial Registry [ChiCTR, www.chictr.org.cn ] under identifier ChiCTR1800014800.)

scholarly journals Multicentre, open label, randomised controlled trial comparing intermittent versus daily treatment for non-cavitary nodular/bronchiectatic Mycobacterium avium complex lung disease with rifampicin, ethambutol and clarithromycin (iREC): study protocol

2019 ◽  
Vol 6 (1) ◽  
pp. e000434 ◽  
Author(s):  
Taku Nakagawa ◽  
Hiroya Hashimoto ◽  
Mitsuaki Yagi ◽  
Yoshihito Kogure ◽  
Masahiro Sekimizu ◽  
...  
Keyword(s):  
Treatment Group ◽  
Lung Disease ◽  
Treatment Regimen ◽  
Mycobacterium Avium ◽  
Drug Combination ◽  
Daily Treatment ◽  
Intermittent Treatment ◽  
Sputum Culture Conversion ◽  
Randomised Controlled ◽  
Culture Conversion

IntroductionStandard treatment for nodular/bronchiectatic Mycobacterium avium complex lung disease (NB MAC-LD), excluding severe-status cases, differs between Japan and other countries. Internationally, three-drug combination intermittent treatment (three times a week administration) with macrolide, ethambutol and rifampicin is recommended, but a daily treatment regimen is recommended in Japan. To date, no randomised controlled study directly comparing intermittent treatment with daily treatment has been performed. The purpose of this study is to investigate the usefulness of intermittent treatment.Methods and analysisA total of 140 patients diagnosed with NB MAC-LD in Japan will be randomly assigned, in a 1:1 ratio, to intermittent treatment group or daily treatment group, and three-drug combination therapy with clarithromycin, rifampicin and ethambutol will be continued for 1 year. The primary endpoint is the proportion of patients requiring modification of the initial treatment regimen. Secondary endpoints are adverse events, sputum culture conversion, time to sputum culture conversion, improvement of chest CT findings, change in health-related quality of life score and development of clarithromycin resistance.Ethics and disseminationThis trial was approved by the National Hospital Organisation Review Board for Clinical Trials (Headquarters). The results of this study will be reported at a society meeting or published in a peer-review journal.

Immune-related adverse events for different age groups using the FDA Adverse Event Reporting System.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e14256-e14256
Author(s):  
Zin Myint ◽  
Ayman Qasrawi ◽  
Richard O'Neal ◽  
Chris Z Thomas ◽  
Susanne M. Arnold ◽  
...  
Keyword(s):  
Adverse Event ◽  
Interstitial Lung Disease ◽  
Adverse Events ◽  
Lung Disease ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Age Groups ◽  
Adverse Event Reporting ◽  
Age Group ◽  
Event Reporting

e14256 Background: Understanding immune-related adverse events (irAEs) for different age groups is crucial in the era of immunotherapy. The aim of our study is to assess the irAE profiles in different age groups (≤65 and > 65 years) for drugs that target PD1/PDL1, CTLA4, and their combination. Methods: Data were obtained from the FDA Adverse Event Reporting System database from Jan 2014 to Sep 2018. We extracted the data based on reported irAEs and reviewed 30 different irAEs including, but not limited to colitis, pneumonitis, interstitial lung disease (ILD), myocarditis and pneumonitis. Cases with missing data, another drug reported with the PD1/PDL1 or CTLA4 combinations, and duplicate cases were excluded. We calculated the reporting odds ratio (ROR) for irAE associated with the use of PD1/PDL1, CTLA4 and combination, respectively. Results: A total of 6197 reported irAEs cases were included: 3140 cases from patients ≤65 years and 3057 from > 65 years old. Colitis was the most common irAEs in both groups. The RORs (95% CI) in patients using CTLA4 alone, PD1/PDL1 alone or the combination were 4.17 (3.47-5.02), 0.6 (0.5-0.72), 1.98 (1.64-2.39) for colitis; 0.21 (0.09-0.52), 2.94 (1.97-4.38), 2.2 (1.46-3.3) for diabetic ketoacidosis; 0.29 (0.09-0.92), 16.5 (6.54-41.9), 0.18 (0.04-0.73) for rheumatoid arthritis in ≤65 age group. In > 65 age group, the RORs (95% CI) in patients using CTLA4 alone, PD1/PDL1 alone or the combination were 4.79 (3.49-6.58), 0.56 (0.4-0.78), 2.84 (2.06-4) for hypophysitis; 0.12 (0.06-0.24), 28.53 (18.5-44), 0.17 (0.1-0.29) for interstitial lung disease (ILD); 0.38 (0.19-0.78), 2.87 (2.01-4.1), 2.41 (1.64-3.54) for myocarditis. When we compared all the studied irAEs between age groups (≤65 and > 65) by ROR, the only statistically significant irAE was ILD. The RORs (95%CI) for ILD associated with PD1/PDL1 in age≤65 and > 65 were 11.3 (7.65-16.8) & 28.53 (18.49-44.02). Conclusions: There was no significant difference between irAEs in different age groups except with ILD, which is more commonly seen in the > 65 age group. The ROR combination irAE profiles provide hypothesis generating information regarding association between irAEs and the use of various immune therapies.

scholarly journals Progression and Treatment Outcomes of Lung Disease Caused by Mycobacterium abscessus and Mycobacterium massiliense

2016 ◽  
Vol 64 (3) ◽  
pp. 301-308 ◽  
Author(s):  
Jimyung Park ◽  
Jaeyoung Cho ◽  
Chang-Hoon Lee ◽  
Sung Koo Han ◽  
Jae-Joon Yim
Keyword(s):  
Lung Disease ◽  
Treatment Outcomes ◽  
Lung Diseases ◽  
Mycobacterium Abscessus ◽  
Progression Rate ◽  
Time To Progression ◽  
Mycobacterium Massiliense ◽  
The Difference ◽  
Bilateral Lung ◽  
Culture Conversion

Abstract Background Mycobacterium abscessus and Mycobacterium massiliense are grouped as the Mycobacterium abscessus complex. The aim of this study was to elucidate the differences between M. abscessus and M. massiliense lung diseases in terms of progression rate, treatment outcome, and the predictors thereof. Methods Between 1 January 2006 and 30 June 2015, 56 patients and 54 patients were diagnosed with M. abscessus and M. massiliense lung diseases, respectively. The time to progression requiring treatment and treatment outcomes were compared between the 2 groups of patients, and predictors of progression and sustained culture conversion with treatment were analyzed. In addition, mediation analysis was performed to evaluate the effect of susceptibility to clarithromycin on treatment outcomes. Results During follow-up, 21 of 56 patients with M. abscessus lung diseases and 21 of 54 patients with M. massiliense lung diseases progressed, requiring treatment. No difference was detected in the time to progression between the 2 patient groups. Lower body mass index, bilateral lung involvement, and fibrocavitary-type disease were identified as predictors of disease progression. Among the patients who began treatment, infection with M. massiliense rather than M. abscessus and the use of azithromycin rather than clarithromycin were associated with sustained culture conversion. The difference in treatment outcomes was partly mediated by the organism’s susceptibility to clarithromycin. Conclusions Progression rates were similar but treatment outcomes differed significantly between patients with lung disease caused by M. abscessus and M. massiliense. This difference in treatment outcomes was partly explained by the susceptibility of these organisms to clarithromycin.

scholarly journals Mycobacterial Characteristics and Treatment Outcomes in Mycobacterium abscessus Lung Disease

2016 ◽  
Vol 64 (3) ◽  
pp. 309-316 ◽  
Author(s):  
Won-Jung Koh ◽  
Byeong-Ho Jeong ◽  
Su-Young Kim ◽  
Kyeongman Jeon ◽  
Kyoung Un Park ◽  
...  
Keyword(s):  
Lung Disease ◽  
Treatment Outcomes ◽  
Antibiotic Treatment ◽  
Mycobacterium Abscessus ◽  
Disease Treatment ◽  
Microbial Characteristics ◽  
Subspecies Level ◽  
Genotypic Analysis ◽  
Sputum Conversion ◽  
Negative Conversion

Abstract Background Treatment outcomes of patients with Mycobacterium abscessus subspecies abscessus lung disease are poor, and the microbial characteristics associated with treatment outcomes have not been studied systematically. The purpose of this study was to identify associations between microbial characteristics and treatment outcomes in patients with M. abscessus lung disease. Methods Sixty-seven consecutive patients with M. abscessus lung disease undergoing antibiotic treatment for ≥12 months between January 2002 and December 2012 were included. Morphotypic and genetic analyses were performed on isolates from 44 patients. Results Final sputum conversion to culture negative occurred in 34 (51%) patients. Compared to isolates from 24 patients with persistently positive cultures, pretreatment isolates from 20 patients with final negative conversion were more likely to exhibit smooth colonies (9/20, 45% vs 2/24, 8%; P = .020), susceptibility to clarithromycin (7/20, 35% vs 1/24, 4%; P = .015), and be of the C28 sequevar with regard to the erm(41) gene (6/20, 30% vs 1/24, 4%; P = .035). Mycobacterium abscessus lung disease recurred in 5 (15%) patients after successful completion of antibiotic therapy. Genotypic analysis revealed that most episodes (22/24, 92%) of persistently positive cultures during antibiotic treatment and all cases of microbiologic recurrence after treatment completion were caused by different M. abscessus genotypes within a patient. Conclusions Precise identification to the subspecies level and analysis of mycobacterial characteristics could help predict treatment outcomes in patients with M. abscessus lung disease. Treatment failures and recurrences are frequently associated with multiple genotypes, suggesting reinfection. Clinical Trials Registration NCT00970801.

scholarly journals Evaluation of Potential Complications of Interstitial Lung Disease Associated With Antiandrogens Using Data From Databases Reporting Spontaneous Adverse Effects

2021 ◽  
Vol 12 ◽  
Author(s):  
Hideki Nawa ◽  
Takahiro Niimura ◽  
Hirofumi Hamano ◽  
Kenta Yagi ◽  
Mitsuhiro Goda ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Adverse Event ◽  
Interstitial Lung Disease ◽  
Drug Use ◽  
Adverse Events ◽  
Lung Disease ◽  
Drug Event ◽  
Therapeutic Effects ◽  
Treat Prostate Cancer ◽  
Using Data

From 2002 to 2018, the number of patients with prostate cancer significantly increased from 679,023 to 1276,106 worldwide. Total prostatectomy (including robot-assisted prostatectomy), radiation therapy, and pharmacological treatment are commonly used to treat prostate cancer. The Chief of the Pharmaceutical Safety Division, that is, the Federation of Pharmaceutical Manufacturers’ Associations of Japan (FPMAJ), recently called for the revision of package inserts for ethical drugs. However, the pathogenesis of interstitial lung disease (ILD), a serious drug-induced adverse effect, remains unclear. Moreover, there have been no large-scale evaluations of potential complications associated with currently used antiandrogens, which are commonly employed to treat prostate cancer. Hence, ILD, as an adverse event, remains poorly understood. Therefore, we conducted a survey of reports in the Japanese Adverse Drug Event Report (JADER) database to investigate the potential association between the reporting of ILD and antiandrogen drug use in clinical practice. The occurrence of ILD was investigated by evaluating the relationship between antiandrogen drug use and ILD. Adverse event signals were detected with reporting odds ratios (RORs), using data from the JADER and FDA Adverse Event Reporting System (FAERS) databases, for the analysis of post-marketing adverse event reports. The JADER was used to examine the time profile of adverse event occurrence for each drug, whereas the FAERS was used to screen cases of unknown adverse events and analyze their trends of occurrence. The analysis of data from both databases revealed the 95% confidence interval lower limits of ROR for bicalutamide and flutamide to be > 1, and adverse event signals were detected following the use of either drug. While caution should be exercised for drugs that are new to the market, we conclude that drugs with similar therapeutic effects that have been in use for a long period should also be re-examined for potential adverse events.

scholarly journals Factors Associated with Acid Fast Bacilli and Sputum Culture Conversion in Patients with Multidrug-Resistant Tuberculosis in Surabaya

2021 ◽  
Vol 4 (2) ◽  
pp. 107
Author(s):  
Naomi Rahmasena ◽  
Isnin Anang Marhana ◽  
Muhammad Yamin Sunaryo Suwandi ◽  
Tutik Kusmiati ◽  
Tuksin Jearanaiwitayakul
Keyword(s):  
Alcohol Consumption ◽  
Multidrug Resistant ◽  
Smoking History ◽  
Sputum Smear ◽  
Sputum Culture Conversion ◽  
Resistant Tuberculosis ◽  
Multidrug Resistant Tuberculosis ◽  
Mdr Tb ◽  
Sputum Conversion ◽  
Culture Conversion

Introduction: Indonesia is a high incidence country of multidrug-resistant tuberculosis. There are approximately 11,000 MDR TB cases, 2.8% of them are new cases and 16% of them are relapse cases. Although guidelines for MDR-TB are frequently designed, medication freely provided, and centers for treatment duly expanded, studies on time to sputum culture conversion have been very limited in Indonesia. Therefore the aim of the study is to identify risk factors that effect on sputum and culture conversion.Methods: Data on short-term regimen for MDR TB in Dr. Soetomo General Hospital from January 1st – December 31st, 2018 were collected with a total sampling approach, and fulfill the inclusion and exclusion. Data were analyzed by computer software IBM SPSS Statistic 24 for windows. Results: Male is more likely to have delayed sputum conversion and culture conversion but no statistical difference is observed (p>0.05). Smoking history is more likely to have delayed sputum and culture conversion but only in sputum smear test shows a significant difference (p≤ 0.05). Alcohol consumption has delay effect on sputum and culture conversion but there is statistically difference in only culture conversion (p<0.05). The high baseline smear test also affects delay the sputum and culture conversion but only in sputum smear reveals a significant effect (p<0.05).Conclusion: In this present study, we identified sex, smoking history, high bacillary loads as significant factors on sputum conversion. In addition, we revealed that alcohol-consumption history is a significant factor affecting on culture conversion.

scholarly journals Spontaneous sputum conversion and reversion in Mycobacterium abscessus complex lung disease

PLoS ONE ◽  
2020 ◽  
Vol 15 (4) ◽  
pp. e0232161
Author(s):  
Kyung-Wook Jo ◽  
Yea Eun Park ◽  
Yong Pil Chong ◽  
Tae Sun Shim
Keyword(s):  
Lung Disease ◽  
Mycobacterium Abscessus ◽  
Mycobacterium Abscessus Complex ◽  
Sputum Conversion
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