ABSTRACT
BACKGROUND: Severe fever with thrombocytopenia syndrome (SFTS) is an emerging viral hemorrhagic fever with high fatality rates. The blockade of pro-inflammatory cytokines presents a promising therapeutic strategy. METHODS: We conducted a randomized clinical trial at the 154th hospital, Xinyang, Henan Province. Eligible patients with severe SFTS disease were randomly assigned in a 1:2 ratio to receive either a single intravenous infusion of tocilizumab plus usual care; or usual care only. The primary outcome was the clinical status of death/survival at day 14, while secondary outcomes included improvement from baseline in liver and kidney damage and time required for hospital discharge. The efficacy of tocilizumab plus corticosteroid was compared to those receiving corticosteroid alone. The trial is registered with the Chinese Clinical Trial Registry website (ChiCTR2300076317). RESULTS: 63 eligible patients were assigned to the tocilizumab group and 126 to the control group. The addition of tocilizumab to usual care was associated with a reduced death rate (9.5%) compared to those received only usual care (23.0%), with an adjusted hazard ratio (aHR) of 0.37 (95% confidence interval [CI], 0.15 to 0.91, P = 0.029). Combination therapy of tocilizumab and corticosteroids was associated with a significantly reduced fatality (aHR, 0.21; 95% CI, 0.08 to 0.56; P = 0.002) compared to those receiving corticosteroids alone. CONCLUSIONS: A significant benefit of reducing fatality in severe SFTS patients was observed by using tocilizumab. A combined therapy of tocilizumab plus corticosteroids was recommended for the therapy of severe SFTS.
Subject(s)
Adrenal Cortex Hormones , Antibodies, Monoclonal, Humanized , Drug Therapy, Combination , Severe Fever with Thrombocytopenia Syndrome , Humans , Antibodies, Monoclonal, Humanized/therapeutic use , Antibodies, Monoclonal, Humanized/administration & dosage , Male , Female , Middle Aged , Severe Fever with Thrombocytopenia Syndrome/drug therapy , Severe Fever with Thrombocytopenia Syndrome/mortality , Adrenal Cortex Hormones/therapeutic use , Adrenal Cortex Hormones/administration & dosage , Aged , Treatment Outcome , Hospitalization/statistics & numerical data , China , AdultABSTRACT
OBJECTIVE: To clone heavy-chain and light-chain variable region (VH and VL) gene of mouse-anti-human CD71 monoclonal antibody (mAb). METHOD: One-step method was used to extract total RNA, and a set of oligonucleotide primers were designed to amplify the cDNAs with reverse transcriptase-polymerase chain reaction (RT-PCR), and the resultant products were respectively cloned into PMD18-T vector and their sequences analyzed. RESULTS: The PCR product obtained with the oligonucleotide primers for the variable region of mouse immunoglobulin heavy chain was about 350 bp and that with oligonucleotide primers for the light chain was about 320 bp, and their DNA sequences were determined. CONCLUSION: The length of the cloned heavy chain variable region was 348 bp, belonging to mouse heavy-chain subgroup II(A); the light-chain variable region was 336 bp that belongs to mouse kappa light-chain subgroup II.