Standard treatment regimens for multidrug-resistant tuberculosis – analysis of effectiveness

Abstract

Introduction. In recent years, the number of cases of multidrug-resistant tuberculosis (MDR-TB) has been increasing in Ukraine and all over the world.The leading factor in fight against this pathology is the effective treatment of such patients.To increase the effectiveness of treatment of patients with MRI in 2008 unified protocols for the provision of medical care to patients were introduced in Ukraine, which offered standard treatment regimens for such patients, taking into account the individual sensitivity of pathogen to antituberculous drugs. Aim.Analysis of effectiveness of various standard therapy regimens that were used in patients with newly diagnosed pulmonary MDR-TB. Materials and methods. 68 case histories of patients with newly diagnosed pulmonary MDR-TB who were treated in the Kharkov Regional TB Dispensary № 1 in 2009-2014 and received anti-tuberculosis therapy according to current clinical protocols for medical care to patients with chemoresistant TB. All patients were older than 18 years. Patients were divided into two groups. Group I included 49 people who received treatment according to the Order of Ukrainian Ministry of Health № 600 of October 22, 2008. "Standard of medical aid for patients with chemorreistant tuberculosis". Patients from this group received the following standard therapy regimen: 6EZAm(Km)QEt(Pt) / 12-18EZQEt(Pt); 6EZAm(Km)QPAS / 12-18EZQPAS. In addition, 19 patients (38.8%) in group I were treated with isoniazid (H). Thus, in group I there were 2 subgroups: subgroups Ia (with the use of H) - 19 patients and Ib (without using H) - 30 patients, and the effectiveness of treatment in them was analyzed. Another 19 people, group II, received therapy according to the Order of Ukrainian Ministry of Health № 1091 of December 21, 2012. "On approval and introduction of medical and technological documents for standardization of care in tuberculosis" according to the scheme 8ZKm(Am)LfxPt(Et)Cs(Tz,PAS) / 12ZLfxPt(Et)Cs(Tz,PAS). All patients underwent clinical tests (fever, cough, body weight deficit), x-ray (lung destruction, X-ray dynamics) and bacteriological (pathogen detection by smear and cultureon solid and/or liquid media) signs of pulmonary tuberculosis at 2 and 6 months from the beginning of chemotherapy. Results and discussion. After 6 months of treatment, in group II, fewer patients complained of cough (15.8% and 44.9% in groups II and I, respectively); presence of destruction was noted in 47.4% and 67.3% of patients in groups II and I, respectively, indicating healing of cavities in a larger number of patients from group II. Effectiveness of treatment of patients in both groups was almost the same (69.4% and 68.4% in group I and II, respectively), but in the group I there were by 5.9% more deaths, and treatment failure by 4.4% than in group II. To identify possible causes of such differences, we analyzed within group I of subgroups Ia and Ib. Healing of cavities was noted in larger number of patients in group Ib, because the destruction in 6 months of treatment was determined in 56.6% and 84.2% of patients from the subgroups Ib and Ia, respectively. Also, after 6 months of treatment there were more patients with bacterioexcretion detected by both smear microscopy (10.5% and 0%) and culture (21% and 10%) in subgroup Ia than in subgroup Ib, respectively. Effectiveness of treatment was almost the same (68.4% and 70%) in subgroups Ia and Ib, respectively. There were more deaths in subgroup Ib by 18.1% than in group Ia (5.2% and 23.3%, respectively). When comparing groups of patients treated without isoniazid (groups II and Ib), it was established that in group II, after six months of treatment there were by 27.5% patients with cough (15.8% and 43.3% respectively) less than in a smaller patient than in subgroup Ib; also, after 6 months of therapy in this group, there were 9.2% less patients with destruction of lung tissue (47.4% and 56.6% in groups II and Ib, respectively). In addition, at the 2nd month of treatment there was positive X-ray dynamics in more by 10.9% patients in group II than in group Ib (84.2% and 73.3%, respectively). Also, after 2 months of treatment, there were less patients with bacterial excision (detected both microscopically (26.3% and 30%, respectively), and culturally (42.1% and 60%, respectively)) in group II than in group Ib. Effectiveness of treatment of such patients was almost the same (70% and 68,4%, respectively, in groups II and Ib), but the number of deaths was higher in group Ib than in group II (23.3% and 10.5%, respectively). Also in group II there were no treatment failures. Conclusions. Analysis of treatment efficiency criteria for patients with MDR-TB in various standard schemes showed that in group II the schemes were most effective. It should be noted that expressed positive effect of therapy has been already was achieved at the 6th month of treatment, despite the fact that according to the protocol, duration of intensive phase was not less than 8 months. But the additional use of isoniazid had no positive effects, and in general, when comparing the effectiveness of treatment with regimens with its use, patients from this group showed the worst positive dynamics from therapy.