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Recently, the researchers examined the efficacy of adding bellemu monoantin to the standard treatment of mycophenolic acid or cyclophosphamide-thiopental in patients with active lupus nephritis.
in this Phase III, multi-country, multi-center, randomized, double-blind, placebo-controlled study, adult patients with active lupus nephritis from 21 countries were involved in mycophenolate or cyclophosphamide-thiopental On the basis of standard treatment, intravenous belimu monoantigen (10 mg per kilogram of body weight) or placebo was randomly administered for 104 weeks, and the main endpoint of the study was improved renal function after treatment (defined as the ratio of urine protein to creatinine. 7, renal cyspheric filtration rate (eGFR) is not less than 20% of the pre-treatment value or 60 ml/min/1.73 m2, and no resuscitation treatment is used), the secondary endpoint is complete kidney Functional improvement (ratio of urine protein to creatinine, eGFR is not less than 10% before treatment or 90 ml/min /1.73 m2, no rescue treatment is used).
a total of 448 patients were involved in the study, including 224 in the Bailey wood monoantigen group and 224 in the placebo group.
In week 104, patients in the Bellewood monoantion group had significantly higher post-treatment improvement in renal function (43% vs. 32%; advantage ratio of 1.6) and full renal function improvement rate (30% vs 20%; advantage ratio of 1.7) significantly higher than that of the placebo group.
, the risk of kidney-related events or death was lower than in the placebo group (risk ratio 0.51).
safety events were not found in the belimu monoantial group, which differed in mortality and risk of kidney events between the two groups.
study concluded that for patients with active lupus nephritis, the addition of belliesum monoantin on the basis of standard treatment of mycophenolate or cyclophosphamide-thiopental significantly improved kidney function and reduced the risk of kidney-related events or death.
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