Siromos's treatment of IBM is forward-looking in its efficacy and safety

Inclusive myositis is the most common type of myocarditis in patients over 50 years of age.
, classical immunosuppressants are ineffective in treating myositis, so far there are no recommendations for drug treatment.
use of sirolimus after organ transplantation can block the proliferation of effect T cells while retaining regulating T cells and inducing autophagy, all of which are damaged in patients with enshaled myositis.
the study was designed to assess the efficacy of Siromos for enculation myositis.
photo source: The Lancet Rheumatology about inclusion of body myositis (IBM) is a skeletal myocarditis disease characterized by muscle mass or a tube-like filamental filament enshulation in the core of the muscle, which is a type of idypathic myopathy.
the cause of the disease is not clear and may be related to cytotoxic T-cell primary mediatation, viral infection and genetic factors.
clinical manifestations of the disease are muscle weakness and muscle atrophy in the forearms and forearm flexion muscles (wrist flexos, finger flexion muscles).
1, Epidemiology 1.1 Infectious non-communicable.
1.2,12.1 Data show that the incidence rate in South Korea, South America, the Middle East and the Southern Mediterranean region is lower than in northern Europe, North America and Australia.
1.2.2 data show that the age of onset of IBM is 10 to 80 years old, the maximum age of onset can reach 87 years old, the vast majority of patients are over 50 years of age.
are more likely to develop the disease than older men, with a gender ratio of 3:1.
2, etopath 2.1 basic etoxicity 2.1.1 cytototoxic effect examination found that the immersed inflammatory cells have ogeneous restrictions, suggesting that the incidence of inclusive myocarditis (IBM) and cytotoxic T-cell primary mediatation.
2.1.2 "Alheimer-like proteins" are present in muscle fibers in patients with protein build-up, including β-starch protein, β-type starch preloom protein, abnormal phosphate tau protein, α-1 Anticoagulant proteases, lipoproteins E, ubibin, and cell carbide proteins, it is speculated that muscle fibers produce too many β-class starch prebiotoproteins, which are cut to produce abnormal β-class starch proteins in muscle fiber accumulation and toxic effects on muscle fibers.
2.1.3 No bubble muscle fibers show an increase in nitro tyrosine, suggesting that NO-induced oxidative stress also played a role in the occurrence of disease.
2.1.4 Changes in muscle biopsies in patients with viral infection reverse transcription virus infection and post-polio syndrome can be very similar to IBM, and there is speculation that the disease is related to viral infections.
2.1.5 Genetic factors may also play a role in the occurrence of diseases, including myocarditis and HLA-DR3, 8.1MHC ancestors deverage height.
was a randomized, double-blind, placebo-controlled Phase 2b trial that recruited patients aged 45-80 with confirmed ensepathic myositis.
test highlights the difficulty of selecting the appropriate outcome indicator as the primary endpoint for patients with ensepathic myocarditis.
in our study, the main endpoint of knee stretching intensity was caused by several factors.
first, this variable was the most easily changed in the natural history study of 16 patients.
second, the main purpose of muscles is to produce strength, so we believe that the efficacy of Siromos therapy can first be detected by changes in strength measurement and then translated into improvements in motor function.
, the relationship between muscle strength and function is nonlinear, and sensitivity to changes in two dimensions is different between patients, depending on the clinical state.
subjects were randomly divided into two groups (1:1) and received cylomos (2 mg, 1/day, oral) or placebo.
end point is a change in maximum autonomous isosotre knee stretching at 12 months.
end of the second period has 6 months of strength changes, and 12:6 minutes walk distance, hand ethnosopathic knee flexion and elbow flexion, forced lung capacity.
: The participants signed up for a flowchart (in the course of the experiment, four patients in the Siromos group were discontinued due to severe mouth ulcers, aseptic pneumonia, renal insufficiability, and edema of the lower extremities).
) We screened a total of 285 patients, 44 of whom were randomly assigned to the Siromos group or the placebo group (22 each).
researchers observed no significant difference between the two groups in terms of the relative percentage change in the maximum autonomous isostress stretching intensity of the knee from baseline to 12 months.
as for the secondary endpoint, there was no significant change in the muscle fat ratio of the other muscle groups (grip strength, elbow bending and stretching, or knee bending), IBMWCI, IBMFRS, and lower limb muscle fat.
the researchers found significant differences in the advantages of the Siromos group compared to the control group in terms of HAQ-DI, forced lung capacity, thigh fat ratio, and six-minute walking distance.
10 patients in the Siromos group had severe adverse reactions, compared with 6 in the control group.
four patients in the Siromos group were treated for adverse reactions (severe mouth ulcers, sterile pneumonia, renal insufficiability and lower limb edema) and recovered after discontinuation of treatment.
showed that mouth ulcers were the most common side effect and were mildly moderate in 10 patients. figure
: Changes in the baseline relationship between the Siromos group and the placebo group, in summary, based on measurements of the maximum autonomous isometre extension strength and other muscle strength of the knee joint, found no evidence to support the effective treatment of Ceredigion myositis in the Siromos group, and the risk of side effects was relatively high.
, however, the study provided sufficient evidence that Siromos was useful in some secondary outcomes and that a multi-center Phase III trial could be conducted to further assess the safety and effectiveness of Siromos.
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