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Background: Ending the tuberculosis (TB) epidemic by 2030 is among the health targets of the sustainable development goals. Side effects to anti-TB drugs are common and may lead to reduced compliance to treatment. These adverse effects must be recognized early to reduce associated morbidity and mortality. Objective of this study was to determine the adverse drug reactions (ADR) to anti-tubercular therapy among patients visiting directly observed treatment, short-course (DOTS) centre MIMS, Mandya.Methods: A cross sectional study was conducted at DOTS Centre MIMS, Mandya. TB patients registered at DOTS Centre during the year 2018 were selected for the study. Verbal informed consent was taken from the TB patients and interviewed using pretested semi-structured questionnaire. Data analysis was done using descriptive statistics and chi square test.Results: Among the study population (n=90), 67 (74.4%) experienced ADR among which 47.7% took treatment for ADR and the remaining 52.3% patients were given reassurance. In this study, gastrointestinal manifestations (42.3%) were the most common adverse drug reaction (ADR). Of the TB patients who experienced ADR, 9.0% of them had interrupted ATT, however they completed full course of ATT.Conclusions: A considerable number of TB patients taking ATT experience ADRs and some of them may have to interrupt treatment. However, they need to be counselled or supervised with caution to complete their course of treatment to reduce the chances of treatment default and also reduce the occurrence of drug resistance.
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Tuberculosis (TB) is a major public health problem in India with high morbidity and mortality. As per the World Health Organization guidelines, the Revised National Tuberculosis Control Program introduced daily directly observed treatment, short-course (DOTS) regimen with a fixed-dose combination with weight bands. This study was undertaken to compare the effectiveness of daily DOTS regimen with intermittent regimen and to assess the proportion of adverse drug reactions in both groups. Materials and Methods: A descriptive study was conducted at a peripheral health institute under one of the TB Units in South Bengaluru. Participants registered for treatment during the third and fourth quarter of 2017 were selected using continuous sampling. Data were collected by case record analysis, structured interviews, and telephonic follow-up. Results: The study included 81 participants, with the mean age of 40 ± 16.1 years. Majority of the study participants 55 (67.9%) were male, and majority (38 [46.9%]) belonged to the upper-lower class. Forty-two (51.8%) of the study participants were on intermittent regimen, and 39 (48.1%) were on daily DOTS regimen. There was 100% sputum conversion at the end of treatment under both treatment regimens. A total of 36 (85.7%) participants under intermittent regimen and nine (23%) under daily regimen developed one or the other adverse drug reactions. The treatment success for participants under intermittent regimen was 38 (90.47%) and that for daily regimen was 35 (89.74%). However, there was no statistically significant difference between the two groups. Conclusion: Both daily and intermittent DOTS regimens are equally effective in TB treatment, but adverse drug reactions were more common with the intermittent regimen.
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Background: Studies have shown that the prevalence of psychiatric disorders, particularly depression, is high among tuberculosis (TB) patients, and may adversely affect treatment compliance. A person suffering from TB can develop depression in due course of time owing to a number of factors, namely the long duration of treatment for TB, stigmatization faced by the patient due to the disease and lack of family support to name a few. Objectives: The present study aimed to determine the prevalence of depression and its correlates among TB patients enrolled at a Directly Observed Treatment Short-course (DOTS) center in a rural area of Delhi. Methods: The study was a DOTS center-based, cross-sectional study, among 106 patients of pulmonary and extrapulmonary TB, above 18 years of age. An interviewer-administered questionnaire in Hindi was used to collect basic sociodemographic data and the Patient Health Questionnaire (PHQ)-9 was used for detecting depression. Those with a score of 10 or more were considered to be suffering from depression. Data analysis was done using SPSS licensed version 20. Chi-square was used to test for association between qualitative variables, and a P < 0.05 was considered statistically significant. Results: A total of 106 patients participated in the study, of which 61 (57.5%) were males. The median age was 30 years (inter-quartile range 24� years). Depression was found to be present in 25 (23.6%) participants. A higher proportion of patients with depression were unemployed currently, and also belonged to middle or lower class (P < 0.05). Depression was not found to be associated with religion, gender, marital status, HIV status, presence of diabetes, DOTS category nor with the phase of treatment. Conclusion: Depression among TB patients is common, affecting almost one in four TB patients. Physicians and DOTS providers should have a high index of suspicion for depression when assessing TB patients.
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Mycobacterium kansasii, most virulent of all atypical mycobacteria, causes pulmonary disease identical to the disease caused by Mycobacterium tuberculosis. Early identification of the species and prompt initiation of treatment for M. kansasii is necessary to prevent morbidity and mortality due to this disease. This case series highlights the similarity in the clinical presentation of both M. tuberculosis and M. kansasii and response to direct observation of short‑course chemotherapy with rifampicin, in the management of pulmonary M. kansasii disease. Larger studies are required to evaluate the long‑term effect of short‑course chemotherapy, especially use of moxifloxacin, in the management of pulmonary M. kansasii disease.
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Objective To compare the efficacy and safety of levofloxacin 750 mg for 5 days versus 500 mg for 7‐14 days intravenous (IV ) infusion in the treatment of community‐acquired pneumonia (CAP ) . Methods This study was a multi‐center , randomized , open‐label , non‐inferiority , controlled clinical trial .The CAP patients were randomized to receive levofloxacin 750 mg IV daily for 5 days or levofloxacin 500 mg IV daily for 7‐14 days .The clinical symptoms , laboratory tests , imaging results and microbiology data were collected and compared between the two treatment groups in terms of efficacy and safety .Results A total of 241 patients were enrolled in this clinical trial from 10 study centers .Among these patients ,223 were eligible for full analysis set (FAS) analysis ,including 111 in 750 mg group and 112 in 500 mg group .Of the 223 patients in FAS ,211 were eligible for per‐protocol set (PPS) analysis ,including 107 in 750 mg group and 104 in 500 mg group .Two hundred and forty‐one patients were included in safety set (SS) ,including 121 patients in 750 mg group and 120 in 500 mg group .The median treatment duration was 5 .0 days in 750 mg and 9 .0 days in 500 mg group .The median total dose was 3 750 mg in 750 mg group and 4 500 mg in 500 mg group .The overall efficacy rate was 86 .2% in 750 mg group and 84 .7% in 500 mg group in terms of FAS at visit 4 ,which suggested that the efficacy of 750 mg group was non‐inferior to 500 mg group .Of the 111 FAS patients in 750 mg group ,40 were bacteriological evaluable ,and 41 strains of pathogens were isolated .Forty‐nine of the 112 FAS patients in 500 mg group were bacteriological evaluable ,and 51 bacterial strains were obtained .The bacterial eradication rate was 100% in both groups .The clinical treatment efficacy rate for atypical pathogens was 100% in both groups .In 750 mg group ,the most common clinical adverse drug reactions (ADRs) were injection site adverse reactions including injection site pruritus ,pain and hyperemia .The other common ADRs were insomnia ,nausea ,skin rash .The most common drug‐related laboratory abnormalities were neutrophil percentage decreased , decreased white blood cell (WBC ) count , alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevation .Most of the ADRs were mild in severity and well‐tolerated .The safety profile of the two treatments was comparable in terms of the drug‐related treatment discontinuation and the incidence of ADRs .Conclusions The short‐course regimen of levofloxacin 750 mg IV for 5 days is at least as effective and well tolerated as the long‐course regimen of 500 mg IV for 7‐14 days in treatment of CAP .
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The study was undertaken to assess the effect of various disease related variables on treatment outcome of patients treated under Directly Observed Treatment Shortcourse (DOTS) chemotherapy. The objective of the study is to identify the factors which affect treatment outcome and are responsible for default. This Cross sectional study was carried out at three TUs (Tuberculosis Unit) of Agra city, Uttar Pradesh, India. Two DMCs (designated microscopy centers) were selected randomly from each TU. All the patients from the DOTS centers under these DMCs registered during January to December 2007 were included in the study until the sample size of 900 patients was complete. Treatment cards of these patients were obtained from their respective DMCs after their outcome had been recorded. Chi-square test was used for statistical analysis. 71.6% patients had favorable outcome while 15.1% defaulted. Defaulter were more among category-II (26.4%), pulmonary cases (18.2%) and retreatment cases (28.4% among treatment after default, 18.8% among failure and 42.9% among relapse cases), while 19.4% & 18.3% of patients among sputum positive & negative patients defaulted. Deaths were also more among pulmonary (8.0%), category II (12.3%) & treatment after default cases (11%). Favorable outcome was observed among 80.4% of new patients, 72.8% of category I patients and 85.7% of category III patients. 83.5% of patients with extra pulmonary disease had favorable outcome, while only 67.4% of pulmonary TB patients had favorable outcome. Present study concludes that default to treatment is more among category II patients, retreatment cases and patients with pulmonary disease.
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The study was undertaken to assess the effect of various disease related variables on treatment outcome of patients treated under Directly Observed Treatment Shortcourse (DOTS) chemotherapy. The objective of the study is to identify the factors which affect treatment outcome and are responsible for default. This Cross sectional study was carried out at three TUs (Tuberculosis Unit) of Agra city, Uttar Pradesh, India. Two DMCs (designated microscopy centers) were selected randomly from each TU. All the patients from the DOTS centers under these DMCs registered during January to December 2007 were included in the study until the sample size of 900 patients was complete. Treatment cards of these patients were obtained from their respective DMCs after their outcome had been recorded. Chi-square test was used for statistical analysis. 71.6% patients had favorable outcome while 15.1% defaulted. Defaulter were more among category-II (26.4%), pulmonary cases (18.2%) and retreatment cases (28.4% among treatment after default, 18.8% among failure and 42.9% among relapse cases), while 19.4% & 18.3% of patients among sputum positive & negative patients defaulted. Deaths were also more among pulmonary (8.0%), category II (12.3%) & treatment after default cases (11%). Favorable outcome was observed among 80.4% of new patients, 72.8% of category I patients and 85.7% of category III patients. 83.5% of patients with extra pulmonary disease had favorable outcome, while only 67.4% of pulmonary TB patients had favorable outcome. Present study concludes that default to treatment is more among category II patients, retreatment cases and patients with pulmonary disease.
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Objective: To determine the efficacy of a short course of antibiotics (<4 days) in comparison to a longer course (≥4 days) for the treatment of acute otitis media in children. Data sources: Electronic databases, hand search of reviews, bibliographies of books, abstracts and proceedings of international conferences. Review Methods: Randomized controlled trials of the empiric treatment of acute otitis media comparing antibiotic regimens of <4 days versus ≥4 days in children between four weeks to eighteen years of age were included. The trials were grouped by pharmacokinetic behavior of short-course antibiotics into short-acting antibiotics, parenteral ceftriaxone, and long-acting azithromycin. Results: We reviewed 35 trials, which provided 38 analytic components. Overall, there was no evidence of an increased risk of treatment failure until one month with a short-course of antibiotics (RR=1.06, 95% CI 0.95 to 1.17, P=0.298). Use of short-acting oral antibiotic in shortcourse was associated with a significantly increased risk of treatment failure (RR=2.27, 95% CI: 1.04 to 4.99). There was a slightly increased risk of treatment failure with parenteral ceftriaxone (RR=1.13, 95% CI 0.99 to 1.30). The risk of adverse effects was significantly lower with short-course regimens (RR=0.58, 95% CI: 0.48 to 0.70). Conclusion: There is no evidence of an increased risk of treatment failure with short course of antibiotics for acute otitis media. Among the short-course regimens, azithromycin use was associated with a lower risk of treatment failure while short-acting oral antibiotics and parenteral ceftriaxone may be associated with a higher risk of treatment failure.
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Background: Extra pulmonary TB (EPTB) including tuberculous lymphadenitis is becoming more common probably due to human immuno deficiency virus (HIV) co-infection. While children do experience a high TB related morbidity and mortality, management of TB in children is challenging. The present study was designed to study the treatment outcome of DOTS strategy for pediatric tuberculous lymphadenitis. Objective: To study the efficacy of DOTS strategy for pediatric lymphhnode tuberculosis. Methods: Retrospective analysis of 669 children of lymphnode tuberculosis treated with DOTS strategy over 9½ years. Results: Mean age was 9.8 years with significantly more girls (61.3%) than boys (38.7%) {c2=34.08, P< 0.001 (S)}. Most of the patients were in the age group of 11-14 years (48.0%) followed by 6-10 years(34.5%) and 0-5 years(17.5%) respectively. Cervical tuberculous lymphadenitis (88.2%) was the commonest form for all ages followed by axillary lymphadenitis in 3.3%. TB of other sites was seen in only 57 (8.5%) cases. Out of total 622 (93%) cases of lymphnode TB where fine needle aspiration and/ or excisional biopsy was done, it was positive (84.2%) and negative (15.6%) respectively for AFB/ cytology, while it could not be done in 47 patients due to inaccessible sites. Category I, II and III was started on 15.4%, 7.5% and 77.1% patients respectively. Overall, treatment completion rate was 94.9% and the default rate was 2.2% with a failure rate of 2.5%. Death rate was 0.3%. Conclusion: The study confirms the efficacy of DOTS strategy for pediatric TB lymphadenitis
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The Directly Observed Treatment Shortcourse (DOTS) chemotheraphy as a means to eradicate tuberculosis (TB) has been proven in the past. However, emergence of more resistant and virulent strains increase throughout the years. As response to this trend, the World Health Organization (WHO) had started initiatives which prompted country-specific approaches to stopping TB. In the Philippines, one of the strategies adopted by the Department of Health (DOH) is to empower the community health worker (CHW) to be the treatment partner of a TB patient. The CHW, being the indigenous counterpart of the professional health manpower in communities, remain as an important factor that may affect the treatment process. The main purpose of this study was to explore, understand and describe the lived experience of TB-DOTS treatment partners using a phenomenological approach. A triangulation of methods for data gathering was used to capture the meaning of their experiences: focus group discussions, key informat interviews, and observation. The experiences and practices of the CHW's were explored and documented for a period of six weeks solely devoted to field work. Shared meanings of their joy and pain, as well as their practices, are investigated. As stories were told, four themes have merged: 1) battle against TB as a socioeconomic problem; 2) volunteerism 3) transcending role of the indigenous treatment partner, and; 4) spiritually at work. These led to several assertions which focus on the how and why CHWs make DOTS treatment regimen successful in achieving positive outcomes. This was evident through their constant communication, empowering practices and provision of social support to the patients.
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Humans , Male , Female , Therapeutics , TuberculosisABSTRACT
A significant proportion of global tuberculosis (TB) caseload is contributed by children. Management of pediatric TB especially EPTB is challenging. The present study was designed to study demographic, clinical profile and treatment outcome of DOTS strategy for pediatric tubercular pleurisy. Aim: To study the efficacy of DOTS strategy. Methods: Retrospective analysis of 106 TB pleurisy children treated with DOTS Results: Mean age was 10.8 years (median age 12.2 years) with more females (51.9%) than males (48.1%)c1 2=0.15; P= 0.698 (NS). In the age group of 0-5, 6-10 and 11-14 years, there were 15.1%, 30.2% and 54.7% patients respectively. Fever was the commonest symptom (98.1%) followed by cough (77.4%) and chest pain (55.7%). History of contact could be elicited only in 2/3rd of cases unilateral effusion (61.3%) was commonest, followed by empyema (22.6%), massive effusion and broncho-pleural fistula each in 13.2% cases respectively. Bilateral effusion was seen in 3.8% cases only. Conventional methods (mantoux, radiograph, ultrasound, pleural aspiration) and minimal invasive surgical techniques, percutaneous pleural biopsy were done to arrive at the diagnosis. Diagnosis was made by X-ray Chest in 92.5%, exudative pleural fluid (100%) predominantly lymphocytic in 85.8%, positive AFB smear and culture in 4.7 and 5.7% cases respectively. Category I, II and III was started on 35.9%, 2.8% and 61.3% patients respectively. Overall treatment completion rate was 94.3%, 4.7% default rate, 0.9% failure rate and no deaths. Conclusion: The study confirms early detection by simple tests and ensuring complete treatment using DOTS strategy.
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Background: The RNTCP has envisaged the role of non-governmental organizations (NGOs) in the control of tuberculosis in India, and five schemes have been developed. The RK Mission Free TB Clinic, as an exceptional case, was included under Scheme- 5, known as the ‘tuberculosis unit model’, with additional independent status of a District Tuberculosis Centre (DTC), to provide all RNTCP services. Aim: To assess the performance of the RK Mission Free TB Clinic as a full-fledged independent DTC over a 4-year period from 1999 to 2002. Material and Methods: A total of 5209 patients were initiated on anti-tuberculosis therapy under DOTS during 1999-2002. The yearly data in terms of case detection, follow-up and treatment outcome of new and retreatment cases were compiled. Results: Of the 5209 patients initiated on ATT under DOTS, 4125(79%) were new patients and 1084(21%) were retreatment cases. Of the 4125 new cases, 3049(74%) had pulmonary tuberculosis while 1076(26%) were treated for extra-pulmonary tuberculosis. In the newly detected pulmonary tuberculosis cases, the ratio of smear positive to smear negative patients was 1:0.65. The sputum conversion rates at 3 months in the new smear positive patients were 86% (1999), 85% (2000), 88% (2001) and 91% (2002). The cure and treatment completion rates in the new smear positive patients with pulmonary tuberculosis were 79% and 81% respectively in 1999. These rates were comparable for the years 2000, 2001 and 2002, with the respective values being 83%, 86% and 87%. The treatment completion rates in the new smear negative pulmonary tuberculosis cases as well as in the new extra-pulmonary tuberculosis patients were always greater than 85% in the study period. Conclusion: These results serve as a successful example of an NGO functioning within the parameters of the RNTCP.
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In the early 1960s, the WHO developed a tuberculosis control policy whereby tuberculosis services (including regular and complete treatment of infectious cases) could be integrated into the general medical institutions distributed across a country. This control policy was deemed the best way to effectively reduce the tuberculosis problem within a community.<br><br>In late 1960s, the Philippines successfully developed a National Tuberculosis Program, based on WHO recommendations, that was integrated into the general health services. But due to inadequate management, it was not effectively implemented. The Government of the Philippines requested that the Japanese Government cooperate in improving its effectiveness. So, in 1992 JICA initiated a technical cooperation project in tuberculosis control. The total period of the project is from 1992 to 2007. During the cooperation, the project made major contributions to the introduction and expansion of WHO strategies throughout the country. Among the reasons for its success, the most important was that the Philippines had already developed a primary health care infrastructure throughout the country. In addition, the following factors should also be mentioned: 1) the strong commitment of the Philippine government in tuberculosis control, 2) the JICA project led to the coordination of other international aid agencies, 3) the Research Institute of Tuberculosis (Japan Anti-Tuberculosis Association), which has ample experience in tuberculosis research and international cooperation, was involved in the planning and operation of the project.<br><br>However, the Philippines' governance is still weak at the central, regional and provincial levels. The strengthening of their ability to administrate will be a key factor in the future success of the program.
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Human immunodeficiency virus (HIV) infection and acquired immunodeficiency syndrome (AIDS) have resulted in a resurgence of tuberculosis the world over. Given that the South-East Asia Region of the World Health Organization accounts for nearly 40 per cent of all tuberculosis (TB) cases globally and 18 per cent of the world’s HIV infected also live in this region, the twin challenge of this “cursed duet” seems to be daunting. Treatment of patients coinfected with HIV and TB in India is very difficult especially because there is very little co-ordination between the Revised National Tuberculosis Control Programme (RNTCP) and HIV control. Clinical presentation of TB in early HIV infection resembles that observed in immuno-competent persons. In late HIV infection, the clinical presentation of TB can be atypical. Diagnosis of TB in HIV infected patients may be delayed because of atypical clinical presentation and involvement of inaccessible sites and low sputum smear positivity. Rational management of patients co-infected with HIV and TB in severely resource limited settings involves detailed history taking, thorough physical examination, clinical staging, assessment of CD4+ T-lymphocyte count or total lymphocyte count and institution of antiretroviral drugs and antituberculosis treatment using the directly observed treatment, short-course (DOTS) strategy. HIV infected patients respond well to the standard anti-tuberculosis drug treatment regimens using the DOTS strategy. Thorough knowledge and familiarity regarding the adverse drug reactions and drug-interactions between antiretroviral and anti-tuberculosis drugs is essential for ensuring compliance and successful outcome.
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BACKGROUND: Short-course chemotherapy for 6 months is well established for pulmonary tuberculosis. However, little is known about the efficacy of the short-course chemotherapy for tuberculous pleural effusion. Tuberculous pleural effusion itself may be self-limiting without any treatment, but about two thirds of the patients with tuberculous pleural effusion may subsequently develop pulmonary tuberculosis within 5 years. After completing treatment for tuberculous pleural effusion, prolonged follow-up is necessary for evaluating the efficacy of the treatment There is still no report on the efficacy of 6-month regimens for tuberculous pleural effusion in Korea, where the incidence of tuberculous disease and drug resistance is high. We studied the efficacy of 6 month short-course chemotherapy comparing with 9 month chemotherapy. METHOD: Retrospective study was done through medical record review in 238 patients with tuberculous pleural effusion who admitted to Asan Medical Center during May 1989-May 1993. The diagnosis of tuberculous pleural effusion was made by bacteriologic or histopathologic study. RESULTS: Among 238 patients, 38 patients were dropped out during follow-up period. In 2 patients, second line drugs were prescribed according to known drug resistance results. And, in 23 patients, treatment longer than 9 months was done due to accompanying extrapulmonary tuberculosis or durg resistance. In 8 patients, treatment regimen was changed due to hepatotoxicity. Remaining 167 cases (70.2%) completed the treatment as scheduled ; 6 month chemotherapy in 88 cases and 9 month chemotherapy in 79 cases. In 60 patients (35.9%) with pleural effusion only in chest X-ray finding, sputum smear or culture for M.tu-berculosis was positive in 6 cases (10.0%), and in 63 patients (37.7%) with radiologically inactive pulmonary tuberculosis, sputum smear or culture was positive in 18 cases (28.6%). In 44 patients (26.3%) with radiologically active pulmonary tuberculosis, the sputum smear or culture was positive in 24 cases (54.5%). In 6-month chemotherapy group (n=88), during mean 23 months (range; 1-61months) follow-up period, pulmonary tuberculosis developed in 1 case (1.4%). In 9-month chemotherapy group(n=79), during mean 23 months (range; 3-70months) follow-up period, pulmonary tuberculosis developed in 2 cases (2.5%). All the cases who developed pulmonary tuberculosis also showed active pulmonary tuberculosis on initial chest X-ray before treatment. CONCLUSION: In patients with tuberculous pleural effusion, the incidence of pulmonary tuberculosis after 6 month chemotherapy showed no difference from that after 9 month chemotherapy. Thus, 6 month short-course chemotherapy seems to be an effective treatment for tuberculous pleural effusion.