The promising development of the microneedle (MN) drug delivery system has prompted its clinical application as a substitute for traditional hypodermic injection needles. In addition to the satisfactory MN technology design for various application prospects, safety issues during MN use are increasingly an important consideration. This review aims to gather data from published literature regarding safety evaluations on MNs in relation to pain, skin irritation, in vivo degradation, as well as storage stability. By analyzing the existing testing methods and the safety performance of MNs, the description of MN safety is updated as painless, minimally invasive, and stable during storage. However, the development of MNs that can degrade in a human body should be addressed to accelerate clinical applications.
Background: Our study aimed to develop a clinical prediction model to evaluate the possibility of CD4 þ /CD8 þ ratio restoration in HIV-positive individuals.Methods: About 1980, HIV/AIDS patients initiated with antiretroviral treatment from 1 January 2013, to 30 December 2016, at Beijing Ditan Hospital and achieved persistent virological suppression during the 4 years follow-up were included in this study. Multivariate Cox proportional regression analysis was used to identify the independent risk factors and establish a predictive model. The model's performance was assessed using the area under the receiver operating characteristic and calibration plots.Results: Overall, after 4 years of treatment, a total of 455 individuals (22.98%) restored their CD4 þ /CD8 þ ratio (!1). The area under the receiver operating characteristic was 0.782 and 0.743 in the deriving and validation cohort, respectively. The ultimate model included five indexes: age at AIDS diagnosis, albumin, and syphilis status, and baseline CD4 þ and CD8 þ values. A nomogram further visualized the model, and the calibration plots indicated high agreement of predicted and observed outcomes.
Conclusion:Our prediction model might be practical and easily applied to recognize HIV/AIDS individuals most likely to benefit from modern antiretroviral therapy.
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