Systematic Review of Survival Analysis in Leprosy Studies-Including the Following Outcomes: Relapse, Impairment of Nerve Function, Reactions and Physical Disability.
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SUBMITTER: Barbosa CC
PROVIDER: S-EPMC9566694 | biostudies-literature | 2022 Sep
REPOSITORIES: biostudies-literature
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Systematic Review of Survival Analysis in Leprosy Studies-Including the Following Outcomes: Relapse, Impairment of Nerve Function, Reactions and Physical Disability.
Barbosa Celivane Cavalcanti CC Bezerra Gilberto Silva Nunes GSN Xavier Amanda Tavares AT Albuquerque Maria de Fátima Pessoa Militão de MFPM Bonfim Cristine Vieira do CVD Medeiros Zulma Maria de ZM Souza Wayner Vieira de WV
International journal of environmental research and public health 20220926 19
Leprosy is a public health problem in South American, African and Oceanian countries. National programs need to be evaluated, and the survival analysis model can aid in the construction of new indicators. The aim of this study was to assess the period of time until the outcomes of interest for patients with or exposed to leprosy by means of survival analysis surveys. This review researched articles using the databases of PubMed, Science Direct, Scopus, Scielo and BVS published in English and Por ...[more]
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Project description:ImportanceThe World Health Organization (WHO) 2016-2020 Global Leprosy Strategy aims to reinvigorate efforts to control leprosy and avert leprosy disability to less than 1 per million population.ObjectiveTo systematically identify clinical factors associated with physical disability in patients with leprosy.Data sourceSearches were conducted in Scopus, PubMed, and Web of Science databases to identify studies published from January 23, 1988, to May 23, 2018, using the keywords leprosy and physical disability and related terms.Study selectionStudies that evaluated patients using the WHO leprosy disability grading system and reported the number of patients with and without disability by clinical characteristics were included.Data extraction and synthesisThe odds ratio (OR) was used as a measure of association between the clinical features and physical disability. Summary estimates were calculated using random-effects models.Main outcomes and measuresThe primary outcome was physical disability according to the WHO disability classification. The association between clinical features and physical disability was evaluated.ResultsThe search identified 2447 reports. After screening titles and abstracts, 177 full-text articles were assessed for eligibility, and 32 studies were included in the systematic review; 24 of the 32 studies included sex information (39 571 patients), of whom 24 218 (61.2%) were male. Male patients with leprosy were more likely to have physical disability than female patients with leprosy (pooled OR, 1.66; 95% CI, 1.43-1.93; I2, 81.3%; P < .001). Persons with multibacillary leprosy were 4-fold more likely to have physical disability than those with paucibacillary leprosy (pooled OR, 4.32; 95% CI, 3.37-5.53; I2, 88.9%, P < .001). Patients having leprosy reactions were more likely to have disability (pooled OR, 2.43; 95% CI, 1.35-4.36; I2, 92.1%; P < .001). Patients with lepromatous leprosy experienced 5- to 12-fold higher odds of disability.Conclusions and relevanceThis systematic review and meta-analysis confirms the association between the presence of physical disabilities and male sex, multibacillary leprosy, leprosy reactions, and lepromatous presentation. These findings can guide the development of targeted interventions for early identification of individuals at greater risk of developing physical disabilities and education campaigns to promote early consultation to institute treatment for leprosy reactions and prevent physical disability.
| S-EPMC6686771 | biostudies-literature
Project description:Many studies have focused on multidrug therapy (MDT) for multibacillary (MB) leprosy and rarely on long-term outcome of paucibacillary (PB) leprosy having recommendation of therapy for 6 months fixed duration therapy for PB patients. Studies on measuring risk of disability are rare. The present study is to assess the cure; default, relapse and disability in a prospective cohort of PB leprosy during follow-up of >4 years after treatment. Prospective. Primary in our field area of Agra District. 920 PB leprosy patients entered the study, 621 completed treatment, 599 followed finally including 271 males, no ethnic differentiation, patients of all age groups except for children below 5 years and old persons above 70 years were not included. 6 months fixed duration MDT as recommended by WHO. Treatment completion, cure, relapse and development of disability based on clinical assessment by well-experienced doctors. Data have been analysed using SPSS software, risk is computed as incidence per 100 person-years (PY) and test of significance used. Study reports 91% cure rate. Incidence of relapse was 1.3/100 PY with no significant variation by age, sex, delay in detection, patches and nerves. Crude incidence of disability was 2.2% and varied significantly by age and nerve thickening but not by sex, number of patches, nerves and delay in treatment. Incidence of disability was 0.50/100 PY in treatment completed and 0.43 among defaulters. The study concludes that relapses do occur after MDT treatment but at the level of 1-2%, incidence of disability remains low (<1/100 PY) in PB leprosy. Low incidence of relapse and disability suggests that 6 months therapy is quite effective. However, further improvement may help to improve its efficacy. Longer follow-up may add to efficacy measures.
| S-EPMC3425897 | biostudies-literature
Project description:BackgroundType 1 leprosy reaction, also known as "reversal reaction", is related to cellular immune responses to Mycobacterium leprae antigens. The risk factors that trigger type 1 leprosy reactions are poorly understood. Leprosy with concurrent tetanus is rare, and there are no publicly available reports of a leprosy patient infected with tetanus that induced type 1 leprosy reactions.Case presentationA 56-year-old Chinese Han female presented to our hospital with symptoms of erythematous plaques and pain over her left upper limb for 2 days and foreign object sensation in her throat for 3 days. The patient had a 6-year history of leprosy. Type 1 leprosy reactions were initially considered, followed by treatment with methylprednisolone. Two days later, the patient's symptoms were aggravated, with neck muscle tension and difficulty in opening her mouth, and the erythematous plaques had spread over most of her left upper limb. After further careful examinations, we confirmed the diagnosis of tetanus with concurrent type 1 leprosy reactions. The patient was given anti-tetanus treatment for 12 days and anti-leprosy reaction treatment for 4 months; the diseases were eventually controlled.ConclusionsThis report suggests that tetanus infection may be a trigger for type 1 leprosy reactions.
| S-EPMC6004287 | biostudies-literature
Project description:BackgroundThe ILEP Nerve Function Impairment in Reaction (INFIR) is a cohort study designed to identify predictors of reactions and nerve function impairment (NFI) in leprosy.Aim of the studyAntibodies to mycobacteria, nerve components and serum cytokine were measured as potential markers for their possible association with reactions and NFI.Patients and methods303 newly diagnosed leprosy patients from two centres in North India were enrolled. Antibodies to PGL-1, LAM (IgG1 and IgG3), ceramide, S100 and TNFα levels were measured using ELISA techniques.ResultsS-100, PGL IgG and IgM antibody levels were lowest in patients with BT leprosy and highest in patients with lepromatous leprosy. LAM IgG1 and LAM IgG3 antibody levels were highest in patients with BL leprosy. Ceramide antibody levels were not correlated with type of leprosy. Levels of all the antibodies tested and TNF α were lowest in patients with only skin reaction. PGL IgM antibody levels were elevated in patients with skin reactions and NFI. Old sensory NFI is associated with significant elevation of PGL IgG, LAM IgG and S100 antibody levels.ConclusionThese results reveal that the antibody response to mycobacterial antigens, nerve antigens and cytokines are in a dynamic flux and could collectively contribute to NFI in leprosy. The association of multiple markers with old NFI may indicate the contribution of different pathological processes.
| S-EPMC3050910 | biostudies-literature
Project description:Traumatic physical injury can result in many disabling sequelae including physical and mental health problems and impaired social functioning.To assess the effectiveness of psychosocial interventions in the prevention of physical, mental and social disability following traumatic physical injury.The search was not restricted by date, language or publication status. We searched the following electronic databases; Cochrane Injuries Group Specialised Register, CENTRAL (The Cochrane Library 2009, Issue 1), MEDLINE (Ovid SP), EMBASE (Ovid SP), PsycINFO (Ovid SP), Controlled Trials metaRegister (www.controlled-trials.com), AMED (Allied & Complementary Medicine), ISI Web of Science: Social Sciences Citation Index (SSCI), PubMed. We also screened the reference lists of all selected papers and contacted authors of relevant studies. The latest search for trials was in February 2008.Randomised controlled trials that consider one or more defined psychosocial interventions for the prevention of physical disability, mental health problems or reduced social functioning as a result of traumatic physical injury. We excluded studies that included patients with traumatic brain injury (TBI).Two authors independently screened the titles and abstracts of search results, reviewed the full text of potentially relevant studies, independently assessed the risk of bias and extracted data.We included five studies, involving 756 participants. Three studies assessed the effect of brief psychological therapies, one assessed the impact of a self-help booklet, and one the effect of collaborative care. The disparate nature of the trials covering different patient populations, interventions and outcomes meant that it was not possible to pool data meaningfully across studies. There was no evidence of a protective effect of brief psychological therapy or educational booklets on preventing disability. There was evidence from one trial of a reduction in both post-traumatic stress disorder (PTSD) and depressive symptoms one month after injury in those who received a collaborative care intervention combined with a brief psycho-educational intervention, however this was not retained at follow up. Overall mental health status was the only disability outcome affected by any intervention. In three trials the psychosocial intervention had a detrimental effect on the mental health status of patients.This review provides no convincing evidence of the effectiveness of psychosocial interventions for the prevention of disability following traumatic physical injury. Taken together, our findings cannot be considered as supporting the provision of psychosocial interventions to prevent aspects of disability arising from physical injury. However, these conclusions are based on a small number of disparate trials with small to moderate sample sizes and are therefore necessarily cautious. More research, using larger sample sizes, and similar interventions and patient populations to enable pooling of results, is needed before these findings can be confirmed.
| S-EPMC3428876 | biostudies-other
Project description:Leprosy reactions are acute inflammatory episodes that complicate the course of a Mycobacterium leprae infection and are the major cause of leprosy-associated pathology. Two types of leprosy reactions with relatively distinct pathogenesis and clinical features can occur: type 1 reaction, also known as reversal reaction, and type 2 reaction, also known as erythema nodosum leprosum. These acute nerve-destructive immune exacerbations often cause irreversible disabilities and deformities, especially when diagnosis is delayed. However, there is no diagnostic test to detect or predict leprosy reactions before the onset of clinical symptoms. Identification of biomarkers for leprosy reactions, which impede the development of symptoms or correlate with early-onset, will allow precise diagnosis and timely interventions to greatly improve the patients' quality of life. Here, we review the progress of research aimed at identifying biomarkers for leprosy reactions, including its correlation with not only immunity but also genetics, transcripts, and metabolites, providing an understanding of the immune dysfunction and inflammation that underly the pathogenesis of leprosy reactions. Nevertheless, no biomarkers that can reliably predict the subsequent occurrence of leprosy reactions from non-reactional patients and distinguish type I reaction from type II have yet been found.
| S-EPMC8568883 | biostudies-literature
Project description:BackgroundThe geographical overlap of HIV (human immunodeficiency virus) and leprosy infection has become increasingly frequent and worrying, bringing many clinical issues. Peripheral neuropathy is very frequent in leprosy because of the predilection of its etiologic agent by Schwann cells of the peripheral nervous system, and it also affects individuals with HIV as one of the most common neurological manifestations.Methodology/principal findingsThe present study compared a cohort of 63 patients diagnosed with leprosy and coinfected with HIV with a cohort of 64 patients with leprosy alone, who were followed at the outpatient clinic of the Nucleus of Tropical Medicine of the Federal University of Pará, Brazil. We observed that HIV-coinfected leprosy patients presented greater odds of overall peripheral nerve damage (nerve function impairment-NFI) than patients with leprosy alone. More sensitive damage was observed, especially in patients coinfected with multibacillary forms. Leprosy patients coinfected with HIV presented higher chances of motor damage with improvement over time using multidrug therapy (MDT) and highly active antiretroviral therapy (HAART), along with a greater extent of damage and occurrence of neuritis. The data suggest that in addition to patients presenting possible damage caused by leprosy, they also had a greater damage gradient attributable to HIV disease, but not related to HAART because most of these patients had been on the treatment for less than a year. Neuritis was treated with prednisone at doses recommended by the WHO, and coinfected patients had the highest rate of clinical improvement in the first 60 days.Conclusions/significanceThe clinical characteristics of the two diseases should be considered in leprosy patients coinfected with HIV for better diagnosis and treatment of peripheral neuropathy. We suggest that new simplified assessment tools that allow the evaluation of the NFI of these patients be developed for use in the service.
| S-EPMC6066254 | biostudies-literature
Project description:BackgroundLeprosy Type 1 reactions are difficult to treat and only 70% of patients respond to steroid treatment. Azathioprine has been used as an immune-suppressant and we tested its efficacy in treating leprosy T1R.MethodologyRandomised controlled trial adding azathioprine to steroid treatment for leprosy reactions. This trial was conducted in four leprosy hospitals in India. Patients with a new leprosy Type 1 reaction affecting either skin or nerve were recruited. They were given a 20 week course of oral prednisolone either with placebo or azathioprine 50mg for 24, 36 or 48 weeks. Outcomes were measured using a verified combined clinical reaction severity score (CCS) and the score difference between baseline and end of study calculated. An intention to treat analysis was done on the 279 patients who had an outcome.Principal findings345 patients were recruited, 145 were lost due to adverse events, loss to follow up or death. 36% needed extra steroids due to a recurrence of their skin and/or nerve reaction. 76% of patients had improvements in their CCS the end of the study, 22% had no change and 1.1% deteriorated. Adding azathioprine to steroid treatment did not improve CCS. So the improvements were attributable to treatment with steroids. We analysed the skin, sensory and motor scores separately and found that skin improvement contributed most with 78.9% of patients having skin improvement, azathioprine treatment for 48 weeks improved sensory scores it also improved motor scores but so did treatment with prednisolone alone. We identified significant adverse effects attributable to steroid treatment. When azathioprine and Dapsone were given together significant numbers of patients developed significant anaemia.ConclusionsAzathioprine is not recommended for the treatment of leprosy reactions and does not improve steroid treatment. Recurrent reactions are a major challenge. We have also identified that 65% of patients with sensory and 50% with motor nerve damage do not improve. Future studies should test giving azathioprine in the treatment of nerve damage and giving a higher dose for 48 weeks to patients. These findings highlight the difficulty in switching off leprosy inflammation and the need for better treatments for reactions and nerve damage. There is also a research need to identify patients who have recurrences and optimize treatments for them. Patients with recurrences may benefit from combined treatment with steroids and azathioprine. We have also shown that significant numbers of patients treated with steroids develop adverse effects and this needs to be highlighted in leprosy programmes. Research is needed to identify patients who do not respond to steroid treatment and develop alternative treatments for them.Trial registrationClinicalTrials.gov This trial was registered with the Indian Council of Medical research clinical Trial register as a clinical trial Number-REFCTRI/2016/12/007558.
| S-EPMC5373510 | biostudies-literature
Project description:BackgroundWhile prednisolone is commonly used to treat recent nerve function impairment (NFI) in leprosy patients, the optimal treatment duration has not yet been established. In this "Treatment of Early Neuropathy in Leprosy" (TENLEP) trial, we evaluated whether a 32-week prednisolone course is more effective than a 20-week course in restoring and improving nerve function.MethodsIn this multi-centre, triple-blind, randomized controlled trial, leprosy patients who had recently developed clinical NFI (<6 months) were allocated to a prednisolone treatment regimen of either 20 weeks or 32 weeks. Prednisolone was started at either 45 or 60 mg/day, depending on the patient's body weight, and was then tapered. Throughout follow up, NFI was assessed by voluntary muscle testing and monofilament testing. The primary outcome was the proportion of patients with improved or restored nerve function at week 78. As secondary outcomes, we analysed improvements between baseline and week 78 on the Reaction Severity Scale, the SALSA Scale and the Participation Scale. Serious Adverse Events and the need for additional prednisolone treatment were monitored and reported.ResultsWe included 868 patients in the study, 429 in the 20-week arm and 439 in the 32-week arm. At 78 weeks, the proportion of patients with improved or restored nerve function did not differ significantly between the groups: 78.1% in the 20-week arm and 77.5% in the 32-week arm (p = 0.821). Nor were there any differences in secondary outcomes, except for a significant higher proportion of Serious Adverse Events in the longer treatment arm.ConclusionIn our study, a 20-week course of prednisolone was as effective as a 32-week course in improving and restoring recent clinical NFI in leprosy patients. Twenty weeks is therefore the preferred initial treatment duration for leprosy neuropathy, after which likely only a minority of patients require further individualized treatment.
| S-EPMC5643133 | biostudies-literature
Project description:BackgroundLeprosy is a chronic infectious disease that affects the peripheral nerves, leading to neurological damage and physical disability. This study analyzed the temporal trend in the rate of new leprosy cases with grade 2 physical disability in Brazil and identified spatial clusters of risk for physical disability.MethodsThis is an ecological study of all new cases of leprosy with grade 2 physical disability (G2D) at diagnosis between 2001 and 2022 in Brazil, macro-regions, states and municipalities. Data were extracted from the National System of Notifiable Diseases and the Brazilian Institute of Geography and Statistics. Sociodemographic and clinical variables such as age, sex, race/colour, education and clinical form of the disease were analyzed, as well as the rate of new cases of leprosy with grade 2 physical disability at the time of diagnosis per million inhabitants. Data analysis was divided into three stages: 1- Descriptive analysis of the socio-demographic and clinical profile; 2- Time series analysis: In this stage, the joint-point regression model was used; 3- Spatial analysis, using global and local Moran statistics.ResultsThere were 50,466 new cases of leprosy with G2D during the period studied, 97.4% aged > 14 years, 70.2% male, 45.7% brown, 87.6% with low education, 90.2% multibacillary and 47.5% dimorphic clinical form. There was a downward trend in the detection of leprosy with physical disability grade 2, with an average annual reduction of 2.8% (13.6/1 million in 2001 and 9.1/1 million in 2022). The southeast, south and north regions showed a downward trend. A total of 14 states and 4 capitals showed a decrease in the rate, the most significant being Roraima (-11.0%/year). Tocantins was the only state with an upward trend (3.2%/year). 635 (14.1%) municipalities were in the high-high quadrant. These municipalities belong to 12 Brazilian states and accounted for 30% (n = 15,139) of all cases recorded in the country over the 22 years analyzed.ConclusionsThese results suggest an overall decrease in the detection of leprosy with physical disability in Brazil and highlight geographical disparities in the occurrence of leprosy disability. Interventions to promote early diagnosis should be targeted at areas with the highest rate of new cases with grade 2 disability.
| S-EPMC11883925 | biostudies-literature