RESUMO
Background: Clavicle fracture (CF) is the tenth most prevalent fracture, accounting for an annual incidence of 37/10,000. This systematic review highlights the factors contributing to the nonunion union of the clavicular fracture. Method: A systematic search was conducted using three web-based databases up to August 12, 2022, for conducting qualitative analysis. Articles were screened for relevance, and only studies that met inclusion criteria based on PECOS; P (patients): participants diagnosed with clavicular fracture; E (exposure): nonunion, C (control): not applicable; O (outcomes): factors contributing to nonunion or delayed union; S (studies): trials and observational studies. The Newcastle-Ottawa Scale was used to assess the quality of the cohort studies. The Cochrane risk of bias tool was used to assess the bias in randomized control trials. Results: Ten studies were selected after the final literature search. Two thousand seven hundred and sixty-six adult participants who were radiologically and clinically diagnosed with nonunion clavicular fracture were included to pool the qualitative results. Fall was the most dominant cause of clavicular fracture, followed by road traffic collisions. Open reduction was widely used to treat nonunion correction. The qualitative results suggested a prominent correlation of nonunion with advancing age, female gender, high energy trauma, high Disabilities of the Arm, Shoulder, and Hand Score, smoking, fracture displacement, clavicular shortening, the callus on radiography, and fracture movement. The mid-shaft fracture was the most dominant type of fracture in the included studies; highly associated with nonunion in comparison to medial or lateral CF. The previous history of operation was an independent factor contributing to nonunion. Conclusion: The results of this systematic review suggested the predictors contributing to nonunion in the CF. Demographic factors such as advancing age with female gender are at higher risk of developing clavicular nonunion. Smoking was the most dominantly highlighted environmental factor contributing to nonunion. Diaphyseal or midshaft fracture was the most common site for nonunion. Therefore, we suggested that patients with the predictors mentioned above require special attention to prevent nonunion of the CFs. More studies should be conducted on this subject to assess the factors that pose a risk associated with the nonunion of the bone for better clinical management and outcomes of the fracture.
RESUMO
BACKGROUND: Multiple Sclerosis (MS) is a chronic debilitating neurological disease affecting young adults. The disease involves immune-mediated demyelination of nerve fibers and neurons that leads to disruption of brain-body communication, leading to permanent nerve damage. MS-associated retrovirus envelope protein (MSRV-Env) has been detected in the blood and lesions of MS patients, and its role is suggested in the pathogenesis of MS. Temelimab is a humanized IgG4 monoclonal antibody (mAb) that targets the MSRV-Env protein and neutralizes its action. Several clinical trials have been conducted to evaluate the effectiveness of the drug in MS. MATERIALS AND METHODS: A systemic search was conducted from electronic databases (PubMed/Medline, Cochrane Library, and Google Scholar) from inception to 11th sept 2021. All statistical analysis was conducted in Review Manager 5.4.1. Studies meeting inclusion criteria were selected. Those studies were selected which compared Temelimab therapy to inactive control. The primary outcome of interest was drug safety and efficacy; information about immunogenicity was also included. Random-effect model was used to pool the studies, and the result was reported in the risk ratio (RR) with corresponding 95% Confidence interval (CI). RESULTS: Phase I, Phase II-a and Phase II-b trials demonstrate the safety and effectiveness of Temelimab. Our analysis showed statistically non-significant Risk Ratio (RR) of Adverse events in Temelimab group than that in placebo group (1.01 [0.70,1.46]; p-value = 0.94; I2 = 0%) . Considering the effect of Temelimab on brain lesions, pooled result showed statistically significant Risk Ratio (RR) of brain lesions in placebo group than that in Temelimab group (0.75 [0.69,0.81), p-value < 0.00001, I2 = 0% CONCLUSION: Qualitative and quantitative analysis of the trials assessing the safety and efficacy of Temelimab demonstrate that the drug is safe as well as favourable for use in MS patients.
