The Russian FIS and FSS represent reliable and valid tools for efficient quantification and monitoring of fatigue severity and its clinical impact in MS. EDSS and anxiety are important contributors to fatigue severity in MS.
There was a decrease in numbers of Escherichia coli with normal enzymatic activity, which was replaced by atypical forms of E. coli, Enterobacter spp. and fungi of the genus Candida, and, during treatment with GA, by atypical forms of E. coli, Proteus spp., Parvimonas micra. These differences indicate the effect of the therapy on the intestinal microbiota composition.
The article introduces ethical, clinical and scientific aspects of a medicinal drugs research, as well as particularities of conducting of clinical researches
on a multiple sclerosis. The article presents major regulatory document on conduction of clinical researches of medicines in the Russian Federation.
Patients with multiple sclerosis (MS) are at high risk for transition to secondary progressive MS (SPMS). To date, there has not been a sufficiently effective therapy for SPMS. Siponimod is a selective sphingosine-1-phosphate types 1 and 5 receptor modulator that has been shown to be more effective than placebo in slowing the progression of disability in patients with SPMS in the international phase III (EXPAND) clinical trial. This review analyzes data on the pathophysiology of MS progression, the features of the mechanism of action of siponimod, the efficiency and safety of its use, including those by the results of the EXPAND study. The latter studied the efficacy of siponimod by the time to 3-month confirmed disability progression (3M-CDP) and also assessed other clinical and radiological parameters. The analysis included data on 1,651 patients with SPMS from 31 countries. In the patients who received siponimod, the risk of 3M-CDP decreased by an average of 21% compared with those who took placebo. The administration of siponimod positively affected the speed of cognitive processes. Mild adverse events associated with liver failure, hypertension, and upper respiratory tract infections were more common in the siponimod group. Siponimod did not pose a higher risk for developing malignant neoplasms. The drug reduces the risk of disability progression in patients with SPMS and has a favorable safety profile.
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