A study of adverse drug reactions in patients receiving treatment for multidrug-resistant tuberculosis in a tertiary care center

Background: The emergence of multidrug-resistant tuberculosis (MDR-TB) (defined as resistance to at least isoniazid and rifampin) poses a threat to global TB control. Second line drugs are frequently associated with very high rates of unacceptable adverse drug reactions (ADRs), needing frequent interruption and change of regimen. Different studies have stated varying incidence of these adverse effects leading to discontinuation of ATT. Aims and Objectives: This study intends to find out the occurrence of side effects of anti-TB drugs in patients receiving MDR treatment. Material and Methods: The present prospective cross-sectional observational study was carried out at Drug-Resistant TB Center at Govt. Medical College Kota for a period of July 2018 to June 2019. Patients with adverse events after the introduction of treatment of MDR-TB were included in the study. We monitored the patients with adverse events after starting treatment till the patients were admitted and later followed up by recalling the patients at monthly intervals. Results: Out of total 148 patients majority patients (64.81%) were in the young age group (20–39 years) with male: female ratio 2:1. Out of the 148 patients, 112 patients developed at least one or more types of ADR and a total of 15 types of ADR. Gastrointestinal upset was the most common ADR reported (62.16%) followed by joint pain (41.89%) and headache (36.48%). About 60.74% of all ADRs were managed by symptomatic treatment. 32 (21.62%) patients required change of regimen.Twelve patients (8%) discontinued treatment due to adverse reactions. Conclusion: Treatment of MDR-TB with second-line antitubercular drugs is associated with high rate of adverse effects experienced in more than half of patient in this study. Ototoxicity and neuropsychiatric symptoms are major adverse effects lead to important drug withdrawl from the regimen. The health care professionals should be alert during the intensive phase of the treatment, identify symptoms at the earliest and hence help in minimizing morbidity.

Clinical characteristics, serum albumin and eosinophil levels as risk factors for drug induced hepatitis in tuberculosis patients receiving fixed-dose combination anti-tuberculosis drug

Background: Drug-induced hepatitis (DIH) is a side effect of the usage of anti-tuberculosis (TB) drugs, which can cause alteration in treatment regiments and prolonged treatment. This study aim is to identify the risk factors that can be used to predict the occurrenceof DIH on tuberculosis (TB) patients.Methods: This was a case-control study, conducted at Sanglah central general hospital in Denpasar from January to June 2021. Data collection was carried out through the medical records of inpatients and outpatients who received fixed-dose combination anti-TB drug.Results: There were 62 research samples which were divided into 31 samples in the case group and 31 samples in the control group. The clinical manifestations of DIH were vomiting (32.8%), nausea (15.7%), abdominal pain (13.1%), and hepatic encephalopathy (1.3%). Median time to onset of DIH was 18 (Interquartile range: 19) days. Low BMI was a significant risk factor for DIH (AOR=22.4; 95%CI 4.147-121.575; p<0.001). Other clinical characteristic variables such as age, female, extrapulmonary TB, positive HIV status, diabetes mellitus, hypoalbuminemia, and eosinophilia were not proven risk factors for DIH-TB.Conclusions: Low BMI was a significant risk factor for DIH. Other variables such as age, female, extrapulmonary TB, positive HIV status, diabetes mellitus, hypoalbuminemia, and eosinophilia were not risk factors for DIH in TBpatients

Influence of iron deprivation on virulence traits of mycobacteria

ABSTRACT Novel strategies to combat the ever increasing burden of drug resistance in Mycobacterium tuberculosis (MTB) causing tuberculosis (TB) remains a global concern. The ability of MTB to sense and adapt to restricted iron conditions in the hostile environment is essential for their survival and confers the basis of their success as dreadful pathogen. The striking and clinically relevant virulence trait of MTB is its ability to form biofilms and adhere to the host cells. The present study elucidated the effect of iron deprivation on biofilm formation and cell adherence of Mycobacterium smegmatis, a non-pathogenic surrogate of MTB. Firstly, we showed that iron deprivation leads to enhanced cell sedimentation rate and altered colony morphology depicting alterations in cell surface envelope properties. We explored that biofilm formation and cell adherence to polystyrene surface as well as human oral epithelial cells were considerably reduced under iron deprivation both in presence of 2,2 BP (iron chelator) and siderophore mutant Δ011-14 strain. We further investigated that the potency of three first line anti-TB drugs (Isoniazid, Ethambutol, Rifampicin) to inhibit both biofilm formation and cell adhesion were enhanced under iron deprivation in contrast to the drugs when tested alone. Taken together, by virtue of the indispensability of iron for functional virulence traits in mycobacteria, iron deprivation strategies could be further exploited against this notorious human pathogen to explore novel drug targets.

A case study of pharmaceutical care on combined use of anticoagulants and anti-tuberculosis drugs / 中国药学杂志

OBJECTIVE: To find out the essentials of clinical pharmacists' work on making individualized anticoagulation therapy, tailored to patients with deep vein thrombosis and pulmonary tuberculosis, and on its pharmaceutical care. METHODS: The clinical pharmacist participated in one case of individualized anticoagulation therapy and provided pharmaceutical care to one patient with deep vein thrombosis and pulmonary tuberculosis. The patient used to take warfarin, but the treatment was ineffective, therefore the clinical pharmacist tried to find out the reason from such aspects as interactions among genetic polymorphism, anticoagulants and anti-TB drugs, then adjusted the therapy for the patient. RESULTS: A dosage regimen suitable for the patient was formulated, and medication education was carried out to the patient in terms of medication instructions, such as influencing factors on curative effects of warfarin and monitoring of INR, to improve the patient compliance related to anticoagulation therapy. CONCLUSION: Clinical pharmacists should start pharmaceutical service right from making individualized anticoagulation therapy and carrying out pharmaceutical care.

Evaluation of directly observed treatment short courses at a secondary health institution in Ibadan, Oyo State, Southwestern Nigeria

OBJECTIVE@#To evaluate the success rate of tuberculosis intervention programme at a specialist hospital in Ibadan, Nigeria through a retrospective study as well as carry out physicochemical evaluation of anti-tuberculous agents as a way of eliminating drug-related failure.@*METHODS@#The retrospective study involved the use of quarterly tuberculosis central register at the Government Chest Hospital, Ibadan between 1st quarter (2003) to 4th quarter (2009). Relevant data were extracted from these register with the aid of data collection forms. The basic physicochemical analyses of the drugs given to the patients were also carried out using the International Pharmacopoeia methods.@*RESULTS@#All the drugs examined for their physicochemical properties passed the International Pharmacopeia recommended tests. A total number of 1 260 patients enrolled at the hospital were assessed through case notes. This comprises of 59.4% males of which 69.23% new cases were also males. There was a significant (P0.05). Failure rates in all categories were higher in males than females (P>0.05).@*CONCLUSIONS@#More enlightenment and counseling is still required to meet up with the target for TB control.

Características clínicas y sociodemográficas de los casos con tuberculosis resistente en el municipio de Armenia, Quindío (Colombia) / Clinical and socio-demographic characteristics of tuberculosis with antimicrobial resistance in Armenia, Quindio (Colombia)

Objetivo: Analizar los factores sociodemográficos y clínicos de los pacientes con diagnóstico de tuberculosis resistente en el municipio de Armenia durante el período 2006-2009. Métodos: Se realizó un estudio descriptivo y retrospectivo con base en la notificación de pacientes con tuberculosis resistentes durante el período de estudio. Los datos fueron tomados de los registros consignados en las fichas de notificación y las tarjetas individuales de tratamiento categoría IV. Resultados: Entre 2006 y 2009, 678 pacientes ingresaron en el programa de control de la tuberculosis. De ellos, 14 casos (2,0%) fueron resistentes al menos a un medicamento, y entre estos, 7 (50%) fueron multirresistentes. El 21% estuvo asociado a infección por virus de la inmunodeficiencia humana. La tasa de fallecimientos en pacientes con tuberculosis con farmacorresistencia múltiple fue del 71%. Se encontró amplificación de la resistencia en 2 casos, quienes presentaron deterioro en el estado de salud y deceso. Conclusión: La situación en Armenia de resistencia a antituberculosos es de proporción similar a la del resto del país. Se encontraron factores de riesgo conocidos en los casos de resistencia (coinfección con virus de la inmunodeficiencia humana, farmacodependencia, abandono social) en la mayoría de casos, pero también de resistencia primaria y sin factores de riesgo con farmacorresistencia múltiple y una alta mortalidad, lo que llama la atención para mejorar la vigilancia y el control de los casos en tratamiento en la ciudad.

Objective: To analyze the socio-demographic and clinical diagnosis of patients with resistant tuberculosis in the municipality of Armenia in the period 2006-2009. Methods: We performed a retrospective descriptive study based on the notification of patients with resistant tuberculosis during the study period, data were taken from registrations under notification forms and individual treatment cards category IV. Results: 678 patients were admitted to the program of tuberculosis control between 2006 and 2009, 14 cases (2,0%) were resistant to at least one drug and from these cases 7 were multidrug resistant (MDR). In 21% of cases there was co-infection with HIV. The death rate in patients with MDR-TB was 71%. Amplification in resistance was observed in two cases which lead to further deterioration in the health status and death. Conclusion: Armenia has levels of resistance to anti tuberculosis drugs similar to the reported in the rest of Colombia. We found factors already know to be associated with resistance (drug addiction, social abandon, HIV co infection) but there were also cases without these factors and with primary MDR and high mortality, therefore is urgent to improve the public health measures for cases under treatment in this city.

On Inventory Management of Free Anti-TB Drugs in He'nan Province / 中国药房

OBJECTIVE:To evaluate the management of the free anti-TB drugs in He'nan province,and to analyze ex-periences and find out the gap.METHODS:Based on the requirements of the Chinese TB Control Program-Free anti-TB drug management manual,a questionnaire comprised of 17 items was developed and 20 TB drug storerooms at city or county level were randomly sampled for on the spot investigation.RESULTS:Of the total drug storerooms investigated,75% had yearly drug demand plan,but only 35% was up to the standard in inventory control,95% had no expired drug,90% had inventory/supply vouchers and detailed inventory records,only 25% achieved conformity between records and physical counts.The condition of drug storerooms and the storage of drugs were unable to meet the requirement.CONCLUSION:Tuberculosis Control Agency at different levels haven't paid due attention to the management of free anti-TB drugs.The personnel in this agency should raise their drug management responsibility from aspects of saving public belongings and ensuring patients' medication quality.