Six-month Regimens Research Articles

Erythema Induratum of Bazin, a Rare Manifestation of Cutaneous Tuberculosis: A Case Report

Background: Erythema induratum of Bazin is a rare manifestation of cutaneous tuberculosis. It may mimic some systemic disorders like sarcoidosis, poly arteritis nodosa, lymphoproliferative disorder, Histoplasmosis, and lupus profundus. Case Presentation: A 38-year young female, diabetic, and hypertensive presented with multiple painful skin lesion over anterior part of her leg for 3 months. These skin lesion used to appear as painful erythematous nodules of variable size and shape over the anterior and lateral aspects of both legs that became ulcerate, healed with hyperpigmentation. On examinations, all of her systemic examinations revealed unremarkable except skin lesion. Punch biopsy from skin lesion revealed lobular panniculitis with granuloma suggestive of erythema induratum and MTB gene Xpert from skin lesion found positive. Thereafter, she was put on anti TB therapy six-month regimens according to the national TB guideline, Bangladesh. After 2 and half months of treatment, her skin lesion disappeared. Conclusion: In a TB prevalent country, erythema induratum should be kept in differential diagnosis along with others. As it is usually underdiagnosed or misdiagnosed because of the absence of typical clinical features of TB, therefore comprehensive investigations like skin biopsy with histopathology, detecting DNA of Mycobacterium tuberculosis by PCR, positive Mantoux test are the cornerstone for confirmatory diagnosis. J MEDICINE 2022; 23: 165-168

Shortened treatment regimens versus the standard regimen for drug-sensitive pulmonary tuberculosis.

Shortened treatment regimens versus the standard regimen for drug-sensitive pulmonary tuberculosis.

Treatment outcomes and factors affecting unsuccessful outcome among new pulmonary smear positive and negative tuberculosis patients in Anqing, China: a retrospective study

BackgroundMonitoring the treatment outcomes of tuberculosis and determining the specific factors associated with unsuccessful treatment outcome are essential to evaluate the effectiveness of tuberculosis control program. This study aimed to assess treatment outcomes and explore the factors associated with unsuccessful outcomes among new pulmonary smear positive and negative tuberculosis patients in Anqing, China.MethodsA nine-year retrospective study was conducted using data from Anqing Center for Diseases Prevention and Control. New pulmonary tuberculosis patients treated with two six-month regimens were investigated. Non-conditional logistic regression was performed to calculate odds ratios and 95% confidence intervals for factors associated with unsuccessful outcomes.ResultsAmong 22,998 registered patients (16,939 males, 6059 females), 64.54% were smear-positive patients. The treatment success rates was 95.02% for smear-positive patients and 95.00% for smear-negative patients. Characteristics associated with an higher risk of unsuccessful treatment among smear-positive patients included aged above 35 years, treatment management model of self-medication, full-course management and supervision in intensive phase, unchecked chest X-ray, cavity in chest X-ray, and miliary shadow in chest X-ray, while normal X-ray was negative factor. Unsuccessful treatment among smear-negative patients was significantly associated with age over 45 years, treatment management model of full-course management, unchecked chest X-ray, presence of miliary shadow in chest X-ray and delay over 51 days.ConclusionsTuberculosis treatment in Anqing area was successful and independent of treatment regimens. Special efforts are required for patients with unsuccessful outcomes.

Shortened treatment regimens versus the standard regimen for drug-sensitive pulmonary tuberculosis

Shortened treatment regimens versus the standard regimen for drug-sensitive pulmonary tuberculosis

Six-month therapy for abdominal tuberculosis.

BackgroundTuberculosis (TB) of the gastrointestinal tract and any other organ within the abdominal cavity is abdominal TB, and most guidelines recommend the same six‐month regimen used for pulmonary TB for people with this diagnosis. However, some physicians are concerned whether a six‐month treatment regimen is long enough to prevent relapse of the disease, particularly in people with gastrointestinal TB, which may sometimes cause antituberculous drugs to be poorly absorbed. On the other hand, longer regimens are associated with poor adherence, which could increase relapse, contribute to drug resistance developing, and increase costs to patients and health providers.ObjectivesTo compare six‐month versus longer drug regimens to treat people that have abdominal TB.Search methodsWe searched the following electronic databases up to 2 September 2016: the Cochrane Infectious Diseases Group Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, Embase (accessed via OvidSP), LILACS, INDMED, and the South Asian Database of Controlled Clinical Trials. We searched the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov for ongoing trials. We also checked article reference lists.Selection criteriaWe included randomized controlled trials (RCTs) that compared six‐month regimens versus longer regimens that consisted of isoniazid, rifampicin, pyrazinamide, and ethambutol to treat adults and children that had abdominal TB. The primary outcomes were relapse, with a minimum of six‐month follow‐up after completion of antituberculous treatment (ATT), and clinical cure at the end of ATT.Data collection and analysisTwo review authors independently selected trials, extracted data, and assessed the risk of bias in the included trials. For analysis of dichotomous outcomes, we used risk ratios (RR) with 95% confidence intervals (CIs). Where appropriate, we pooled data from the included trials in meta‐analyses. We assessed the quality of the evidence using the GRADE approach.Main resultsWe included three RCTs, with 328 participants, that compared six‐month regimens with nine‐month regimens to treat adults with intestinal and peritoneal TB. All trials were conducted in Asia, and excluded people with HIV, those with co‐morbidities and those who had received ATT in the previous five years. Antituberculous regimens were based on isoniazid, rifampicin, pyrazinamide, and ethambutol, and these drugs were administered daily or thrice weekly under a directly observed therapy programme. The median duration of follow‐up after completion of treatment was between 12 and 39 months.Relapse was uncommon, with two cases among 140 participants treated for six months, and no events among 129 participants treated for nine months. The small number of participants means we do not know whether or not there is a difference in risk of relapse between the two regimens (very low quality evidence). At the end of therapy, there was probably no difference in the proportion of participants that achieved clinical cure between six‐month and nine‐month regimens (RR 1.02, 95% CI 0.97 to 1.08; 294 participants, 3 trials, moderate quality evidence). For death, there were 2/150 (1.3%) in the six‐month group and 4/144 (2.8%) in the nine‐month group. All deaths occurred in the first four months of treatment, so was not linked to the duration of treatment in the included trials. Similarly, the number of participants that defaulted from treatment was small in both groups, and there may be no difference between them (RR 0.50, 95% CI 0.10 to 2.59; 294 participants, 3 trials, low quality evidence). Only one trial reported on adherence to treatment, with only one participant allocated to the nine‐month regimen presenting poor adherence to treatment. We do not know whether six‐month regimens are associated with fewer people experiencing adverse events that lead to treatment interruption (RR 0.53, 95% CI 0.18 to 1.55; 318 participants, 3 trials, very low quality evidence).Authors' conclusionsWe found no evidence to suggest that six‐month treatment regimens are inadequate for treating people that have intestinal and peritoneal TB, but numbers are small. We did not find any incremental benefits of nine‐month regimens regarding relapse at the end of follow‐up, or clinical cure at the end of therapy, but our confidence in the relapse estimate is very low because of size of the trials. Further research is required to make confident conclusions regarding the safety of six‐month treatment for people with abdominal TB. Larger studies that include HIV‐positive people, with long follow‐up for detecting relapse with reliability, would help improve our knowledge around this therapeutic question.2 April 2019Up to dateAll studies incorporated from most recent searchAll eligible published studies found in the last search (2 Sep, 2016) were included

Month 2 Culture Status and Treatment Duration as Predictors of Recurrence in Pulmonary Tuberculosis: Model Validation and Update

BackgroundNew regimens capable of shortening tuberculosis treatment without increasing the risk of recurrence are urgently needed. A 2013 meta-regression analysis, using data from trials published from 1973 to 1997 involving 7793 patients, identified 2-month sputum culture status and treatment duration as independent predictors of recurrence. The resulting model predicted that if a new 4-month regimen reduced the proportion of patients positive at month 2 to 1%, it would reduce to 10% the risk of a relapse rate >10% in a trial with 680 subjects per arm. The 1% target was far lower than anticipated.MethodsData from the 8 arms of 3 recent unsuccessful phase 3 treatment-shortening trials of fluoroquinolone-substituted regimens (REMox, OFLOTUB, and RIFAQUIN) were used to assess and refine the accuracy of the 2013 meta-regression model. The updated model was then tested using data from a treatment shortening trial reported in 2009 by Johnson et al.FindingsThe proportions of patients with recurrence as predicted by the 2013 model were highly correlated with observed proportions as reported in the literature (R2 = 0.86). Using the previously proposed threshold of 10% recurrences as the maximum likely considered acceptable by tuberculosis control programs, the original model correctly identified all 4 six-month regimens as satisfactory, and 3 of 4 four-month regimens as unsatisfactory (sensitivity = 100%, specificity = 75%, PPV = 80%, and NPV = 100%). A revision of the regression model based on the full dataset of 66 regimens and 11181 patients resulted in only minimal changes to its predictions. A test of the revised model using data from the treatment shortening trial of Johnson et al found the reported relapse rates in both arms to be consistent with predictions.InterpretationMeta-regression modeling of recurrence based on month 2 culture status and regimen duration can inform the design of future phase 3 tuberculosis clinical trials.

Medical management of genitourinary tuberculosis.

Antimycobacterial chemotherapy is the mainstay of treatment for the majority of patients with genitourinary tuberculosis (GUTB). A large body of evidence from clinical trials suggests that short-course chemotherapy regimens, employing four drugs including rifampicin and pyrazinamide, achieve cure in most of the patients with tuberculosis (TB) and are associated with the lowest rates of relapse. Standard six-month regimens are adequate for the treatment of GUTB. Directly observed treatment, short-course (DOTS) is the internationally recommended comprehensive strategy to control TB, and directly observed treatment is just one of its five elements. DOTS cures not only the individual with TB but also reduces the incidence of TB as well as the prevalence of primary drug-resistance in the community. Corticosteroids have no proven role in the management of patients with GUTB. Errors in prescribing anti-TB drugs are common in clinical practice. Standardized treatment regimens at correct doses and assured completion of treatment have made DOTS the present-day standard of care for the management of all forms of TB including GUTB.

The Comparison of Six-month and Four-month Regimens of Chemotherapy in the Treatment of Smear Positive Pulmonary Tuberculosis

The Comparison of Six-month and Four-month Regimens of Chemotherapy in the Treatment of Smear Positive Pulmonary Tuberculosis

A review of efficacy studies of 6-month short-course therapy for tuberculosis among patients infected with human immunodeficiency virus: differences in study outcomes.

Six-month regimens that include rifampin for the treatment of tuberculosis in patients without human immunodeficiency virus (HIV) infection are recommended because of low percentage of relapses. Whether a similar duration of therapy should be used to treat tuberculosis in HIV-infected patients is unclear. Six studies of patients with HIV-infection and 3 of patients without HIV infection were reviewed and compared. The studies differed in terms of design, eligibility criteria, site of disease, frequency of dosing, dose administration methods, and outcome definitions. Among HIV-infected patients, the following percentages were found: cure, 59.4%--97.1%; treatment success, 34.0%--100%; effective treatment, 29.4%--88.2%; and relapse, 0%--10%. In those without HIV infection, percentages were as follows: cure, 62.3%--88.0%; treatment success, 91.2%--98.8%; effective treatment, 70.6%--83.8%; and relapse, 0%--3.4%. Although the rate of relapse appeared to be higher in some studies of HIV-infected patients with tuberculosis, this review demonstrates the limitation in the use of relapse as the exclusive outcome of interest when comparing studies.

The Role of Pyrazinamide in Tuberculosis Chemotherapy

Pyrazinamide is an antituberculosis drug synthesized in the 1950s and formerly used only as salvage therapy. Recent developments have elevated it to a central role in tuberculosis chemotherapy as the essential addition to isoniazid and rifampin which makes it possible to successfully complete treatment in six months. This is accomplished with no increase in hepatotoxicity. The only substantial side effect of this drug given at the dosage and for the duration used in these six-month regimens is a polyarthralgia which is only bothersome and not sufficient to warrant interruption of therapy. More rarely, acute gout is produced. The early history and pharmacology of this now first line antituberculosis drug are reviewed herein.

Short-course antituberculous chemotherapy for pulmonary and pleural disease: 5 years' experience in clinical practice

One hundred and twenty-four patients have been treated with 6-month regimens for pulmonary and pleural tuberculosis over 5 years; 118 patients have completed treatment as planned. No patient has relapsed of the 109 followed up for 15 months from the end of chemotherapy, or in the remaining nine patients still under observation. Significant drug side effects requiring alteration of treatment occurred in only three patients. Six-month regimens in routine practice are well tolerated and are highly effective.

A controlled trial of six-month and nine-month regimens of chemotherapy in patients undergoing radical surgery for tuberculosis of the spine in Hong Kong

Sixty patients in Hong Kong with a diagnosis of tuberculosis of the thoracic, thoraco-lumbar or lumbar spine were allocated at random to either a 6-month (6M) or a 9-month (9M) regimen of daily isoniazid plus rifampicin, supplemented in all patients by streptomycin twice a week for the first 6 months. All patients had the modified ‘Hong Kong’ operation of radical resection of the lesion and insertion of autologous bone grafts.After exclusions, the main analyses of this report concern observations for 3 years on 51 patients (25 6M, 26 9M). The clinical and radiographic condition of the two series on admission was broadly similar.At 18 months, 19 of the 25 6M and 22 of the 26 9M patients had a favourable status, achieved on the allocated regimen that is, they had no clinical evidence of active diseasa, in particular no sinus or clinically evident abscess and no central nervous system lesions; they were capable of full physical activity and radiographically the lesion was quiescent. At 3 years, 24 patients in each series had a favourable status. Of the remaining three patients, one (9M) was clinically favourable but his spinal lesion was reported not yet quiescent at radiographic assessment. The other two patients (one in each series) had a favourable status in every respect except that they had required modifications of the allocated regimen; both had had a sinus at the site of the operation scar requiring surgical excision, with additional chemotherapy in one (9M). These modifications apart, all 25 6M and 25 of the 26 9M patients had a favourable status at three years.A sinus or clinically evident abscess was present on admission in seven patients (5 6M, 2 9M) and had resolved by 3 months in all seven, although one patient (6M) developed a sinus at the operation site subsequently. A further four patients (1 6M, 3 9M) developed an abscess or sinus for the first time after the start of treatment, but all resolved within 6 months.Two patients (one 6M, one 9M) had a mild paraparesis and one (9M) a cauda equina lesion on admission; all had resolved by 9 months.Radiographic evidence of bony fusion of the affected vertebral bodies had occurred in 36 % of 25 6M and 42 % of 26 9M patients at 6 months, in 44 % and 77 % respectively at 9 months (P=0.03), 68 % and 88 % respectively at 18 months and 100 % in both series at 36 months.In conclusion, in terms of favourable status the 6-month and 9-month shortcourse regimens were equally effective and were at least as successful as the standard 18-month regimen as assessed at 3 years [1]. However, the ‘Hong Kong’ radical operation requires surgical resources which are not available in many areas where tuberculosis of the spine is common.

Six-month Chemotherapy Regimens in Pulmonary Tuberculosis

Six-month Chemotherapy Regimens in Pulmonary Tuberculosis

Preliminary Results of Six-month Regimens Studied in the United States and in Poland

The Tuberculosis Control Division of the Centers for Disease Control is involved with two studies of short-course chemotherapy for pulmonary tuberculosis. One is being carried out in the United States and the other in Poland. All short-course regimens being studied are of six months’ duration, and all include rifampin (R) and isoniazid (I) administered daily or intermittently for the entire duration of treatment. Some regimens also included supplemental drugs. This report presents the results of these short-course regimens 18 months after completion of therapy.

Clinical trial of six-month and four-month regimens of chemotherapy in the treatment of pulmonary tuberculosis: The results up to 30 months

In a study in Singapore, Chinese, Malay and Indian patients with pulmonary tuberculosis received 2 months of daily treatment with streptomycin, isoniazid, rifampicin, and pyrazinamide followed by daily isoniazid, and rifampicin either with pyrazinamide (SHRZ/HRZ) or without it (SHRZ/HR), allocated at random. Both regimens were given for either 6 or 4 months by random allocation. All 330 patients with drug-sensitive tubercle bacilli pretreatment had a favourable bacteriological response during chemotherapy. After chemotherapy none of 78 SHRZ/HRZ patients and only 2 of 80 SHRZ/HR patients treated for 6 months relapsed bacteriologically, but 9 (11 %) of 79 SHRZ/HRZ and 6 (8 %) of 77 SHRZ/HR patients treated for 4 months relapsed. Of 33 patients with bacilli resistant to isoniazid, streptomycin, or both drugs pretreatment, only 1 had an unfavourable response during chemotherapy; none of 9 patients treated for 6 months and 2 of 22 treated for 4 months relapsed bacteriologically after stopping chemotherapy.

Clinical trial of six-month and four-month regimens of chemotherapy in the treatment of pulmonary tuberculosis.

In a study in Singapore, Chinese, Malay, and Indian patients with pulmonary tuberculosis received 2 months of daily treatment with streptomycin, isoniazid, rifampin, and pyrazinamide followed either by daily treatment with isoniazid, rifampin, and pyrazinamide (SHRZ/HRZ regimen) or by daily administration of isoniazid and rifampin (SHRZ/HR regimen) allocated at random. Both regimens were given for either 6 or 4 months by random allocation. All 330 patients with drug-sensitive tubercle bacilli before treatment had a favorable bacteriologic response during chemotherapy. During the first 6 months after the end of chemotherapy, there was only a single bacteriologic relapse among 84 SHRZ/HRZ and 80 SHRZ/HR patients treated for 6 months, but 8 (10 per cent) of 80 SHRZ/HRZ and 4 (5 per cent) of 74 SHRZ/HR patients treated for 4 months relapsed. Of a total of 33 patients with bacilli resistant to isoniazid, streptomycin, or both drugs before treatment, only one had an unfavorable response during chemotherapy, and none of 31 patients relapsed during the first 6 months after stopping chemotherapy. The incidence of adverse reactions was low; 11 (3 per cent) of 397 patients had hepatitis, but not all episodes were attributable to drug toxicity, and one patient had thrombocytopenic purpura.

Five-year assessments of controlled trials of ambulatory treatment, debridement and anterior spinal fusion in the management of tuberculosis of the spine. Studies in Bulawayo (Rhodesia) and in Hong Kong. Sixth report of the Medical Research Council Working Party on Tuberculosis of the Spine

The Journal of Bone and Joint Surgery. British volumeVol. 60-B, No. 2 ArticlesFree AccessFive-year assessments of controlled trials of ambulatory treatment, debridement and anterior spinal fusion in the management of tuberculosis of the spine. Studies in Bulawayo (Rhodesia) and in Hong Kong. Sixth report of the Medical Research Council Working Party on Tuberculosis of the SpinePublished Online:1 May 1978https://doi.org/10.1302/0301-620X.60B2.350883AboutSectionsPDF/EPUB ToolsAdd to FavouritesDownload CitationsTrack CitationsPermissions ShareShare onFacebookTwitterLinked InRedditEmail FiguresReferencesRelatedDetailsCited byHistory of Tuberculosis Spine (Post-ATT Era)28 April 2022Most Reliable Time in Predicting Residual Kyphosis and Stability: Pediatric Spinal TuberculosisAsian Spine Journal, Vol. 12, No. 6Musculoskeletal Tuberculosis27 April 2017Musculoskeletal TuberculosisMicrobiology Spectrum, Vol. 5, No. 2Tuberculosis TreatmentA PROSPECTIVE STUDY TO ASSESS EFFICACY OF DIRECTLY OBSERVED TREATMENT SHORT - COURSE INTERMITTENT REGIME IN DIFFERENT STAGES OF SPINAL TUBERCULOSIS13 February 2015 | Journal of Evidence Based Medicine and Healthcare, Vol. 2, No. 7Surgical outcome of anterior versus posterior surgical approach for thoracic and lumbar Pott′s diseaseThe Egyptian Orthopaedic Journal, Vol. 49, No. 2The Michel Benoist and Robert Mulholland Yearly European Spine Journal Review: a survey of the “surgical and research” articles in the European Spine Journal, 20133 January 2014 | European Spine Journal, Vol. 23, No. 1One-stage posterior transforaminal lumbar debridement, 360° interbody fusion, and posterior instrumentation in treating lumbosacral spinal tuberculosis22 May 2013 | Archives of Orthopaedic and Trauma Surgery, Vol. 133, No. 8Surgical treatment of acute TB spondylitis: indications and outcomes16 August 2012 | European Spine Journal, Vol. 22, No. S4Posterior approach in thoracolumbar tuberculosis: a clinical and radiological review of 67 operated cases15 December 2012 | MUSCULOSKELETAL SURGERY, Vol. 97, No. 1Efficacy of directly observed treatment short-course intermittent regimen in spinal tuberculosisIndian Journal of Orthopaedics, Vol. 46, No. 2Efficacy of extended DOTS category I chemotherapy in spinal tuberculosis based on MRI-based healed statusIndian Journal of Orthopaedics, Vol. 46, No. 6Lumbar Fusion in the Treatment of Infections and TumorsSeminars in Spine Surgery, Vol. 23, No. 4The chemotherapy of osteo-articular tuberculosis with recommendations for treatment of childrenJournal of Infection, Vol. 62, No. 6Infections of the SpineTuberculosis TreatmentRoutine surgery in addition to chemotherapy for treating spinal tuberculosis25 January 2006 | Cochrane Database of Systematic Reviews, Vol. 41Diagnosis of tuberculous vertebral osteomyelitis (TVO) in a developed country and literature review19 April 2005 | Spinal Cord, Vol. 43, No. 9Surgery as an adjunct to chemotherapy for treating spinal tuberculosis20 October 2003Pott’s disease after heart transplantation: a case reportTransplantation Proceedings, Vol. 35, No. 4Single stage decompression, anterior interbody fusion and posterior instrumentation for tuberculous kyphosis of the dorso-lumbar spine20 August 2001 | Spinal Cord, Vol. 39, No. 8Growth Changes of Solidly Fused Kyphotic Bloc After Surgery for TuberculosisSpine, Vol. 22, No. 10A 25-Year-Old Man With Back Pain and an Abnormal Chest RadiographChest, Vol. 109, No. 2Osteomyelitis of the cervical spineTuberculosis of the SpineA controlled trial of six-month and nine-month regimens of chemotherapy in patients undergoing radical surgery for tuberculosis of the spine in Hong KongTubercle, Vol. 67, No. 4 Vol. 60-B, No. 2 Metrics History Published online 1 May 1978 Published in print 1 May 1978 InformationCopyright © 1978, The British Editorial Society of Bone and Joint Surgery: All rights reservedPDF download