ABSTRACT
Tocilizumab has been reported to attenuate the "cytokine storm" in COVID-19 patients. We attempted to verify the effectiveness and safety of tocilizumab therapy in COVID-19 and identify patients most likely to benefit from this treatment. We conducted a randomized, controlled, open-label multicenter trial among COVID-19 patients. The patients were randomly assigned in a 1:1 ratio to receive either tocilizumab in addition to standard care or standard care alone. The cure rate, changes of oxygen saturation and interference, and inflammation biomarkers were observed. Thirty-three patients were randomized to the tocilizumab group, and 32 patients to the control group. The cure rate in the tocilizumab group was higher than that in the control group, but the difference was not statistically significant (94.12% vs. 87.10%, rate difference 95% CI-7.19%-21.23%, P = 0.4133). The improvement in hypoxia for the tocilizumab group was higher from day 4 onward and statistically significant from day 12 (P = 0.0359). In moderate disease patients with bilateral pulmonary lesions, the hypoxia ameliorated earlier after tocilizumab treatment, and less patients (1/12, 8.33%) needed an increase of inhaled oxygen concentration compared with the controls (4/6, 66.67%; rate difference 95% CI-99.17% to-17.50%, P = 0.0217). No severe adverse events occurred. More mild temporary adverse events were recorded in tocilizumab recipients (20/34, 58.82%) than the controls (4/31, 12.90%). Tocilizumab can improve hypoxia without unacceptable side effect profile and significant influences on the time virus load becomes negative. For patients with bilateral pulmonary lesions and elevated IL-6 levels, tocilizumab could be recommended to improve outcome.
Subject(s)
Humans , Antibodies, Monoclonal, Humanized , COVID-19/drug therapy , SARS-CoV-2 , Treatment OutcomeABSTRACT
Objective To investigate the clinical efficacy of vancomycin cement spacer in the treatment of bone infection after calcaneal fracture.Methods A retrospective case series study was conducted to analyze the clinical data of 31 patients with bone infection after calcaneal fracture admitted to First Affiliated Hospital of Army Medical University from February 2012 to August 2016.There were 24 males and seven females,aged 20-59 years,with an average of 43 years.There were 11 patients with infection at the left foot,17 patients at the right foot,and three patients at both feet.Two patients were accompanied with skin and soft tissue defects.The duration of bone infection was 0.25-40 years,with an average of 6.5 years.After thorough debridement,the vancomycin cement spacer was used to fill the bone defect.Limb reconstruction with autogenous bone graft was performed after 6-8 weeks.After the operation,white blood cell count (WBC),erythrocyte sedimentation rate (ESR),C-reactive protein (CRP) and interleukin-6 (IL-6) were recorded.The clinical manifestations of the affected limb (redness,swelling,heat,pain and sinus formation) and X-ray films (lateral position and axial position) were observed.The American Foot and Ankle Surgery Association's hind foot (AOFAS-AH) score was used to assess the postoperative limb function.Wound healing and complications were recorded.Results The patients were followed up for 14-42 months,with an average of 20.5 months.At postoperative 1 month,WBC was decreased from preoperative (10.9 ± 5.2) × 109/L to (8.4 ± 2.7) × 109/L,and ESR decreased from preoperative (27.5 ±25.5)mm/h to (6.21 ±3.20)mm/h,CRP decreased from preoperative (11.4 ± 9.3) mg/L to (3.3 ± 1.8) mg/L,and IL-6 decreased from preoperative (7.3 ± 5.2) ng/L to (4.3 ± 2.2) ng/L (all P ＜ 0.05).Three patients who had sinus after operation received vancomycin cement spacer treatment for a second time and were not seen relapse of sinus afterwards.The cure rate of bone infection was 91％ (28/31).X-ray films were regularly reviewed at 1,3,6,and 12 months after surgery and showed good bone cement position.Sinus tract appeared in the affected limbs of three patients after operation,and no recurrence was found after the vancomycin cement spacer treatment again.The cure rate of bone infection was 91％ (28/31).The AOFAS-AH score improved from preoperative (38.4 ± 3.7) points to (50.2 ± 7.4) points at postoperative 1 month and to (65.5 ± 2.9) points at postoperative 6 months (P ＜ 0.05).Four patients with postoperative foot pain received autologous bone grafting and the pain was relieved.All patients were seen with wound healing at postoperative 0.5-3 months (mean,1.5 months) and returned to work.Conclusions The vancomycin cement spacer is a simple and effective method for bone infection after calcaneal fracture.Autologous bone grafting can be performed after the operation,which can promote wound healing and preserve limb function.