ABSTRACT
Objective:To retrospectively analyze clinical efficacy and safety of omalizumab in the treatment of chronic urticaria (CU) in southern Zhejiang, China.Methods:A retrospective observational study was conducted on CU patients who received omalizumab treatment at the First Affiliated Hospital of Wenzhou Medical University from January 1st, 2018 to August 1st, 2021. Through the outpatient follow-up visits, the disease activity, condition control, and quality of life were evaluated using the 7-day urticaria activity score (UAS7) , urticaria control test (UCT) , and dermatology life quality index (DLQI) . In addition, changes in disease condition, recurrence after withdrawal, and adverse events were assessed. Independent-sample t test was used for intergroup comparisons of normally distributed measurement data, Wilcoxon signed-rank sum test or Kruskal-Wallis H test was used for comparisons of non-normally distributed measurement data, and chi-square test or Fisher′s exact test was used for comparisons of enumeration data. Results:A total of 252 CU patients with poor response to antihistamines were included, with a baseline UCT score of 5.0 ± 2.4 points, a UAS7 score of 25.6 ± 6.2 points, and a DLQI score of 17.5 ± 4.7 points; among them, 204 (81.0%) were treated with omalizumab at an initial dose of 300 mg, and 48 (19.0%) with omalizumab at an initial dose of 150 mg. At the end points (12.0 ± 1.4 months after the start of treatment) , an overall control rate of 90.3% (224/248) was achieved after the omalizumab treatment; concretely, 137 (55.2%) patients achieved complete control (UCT = 16 points) , 87 (35.1%) achieved partial control (12 points ≤ UCT < 16 points) , and 24 (9.7%) showed no response (UCT < 12 points) , while 10 with partial response shifted to complete control after dose increase. During the treatment period, recurrence occurred in 50 patients (36.5%) , of whom 32 patients opted for retreatment with omalizumab, and then 30 (93.8%) achieved partial or complete control. Adverse events were reported in 8 patients (3.2%) , and all were mild or moderate.Conclusion:Omalizumab was effective in the real-world treatment of CU, and could improve patients′ quality of life, with a favorable safety profile.
ABSTRACT
Objective@#To evaluate the value of T cell spot test of tuberculosis infection(T-SPOT.TB) and inflammatory indicators for diagnosis of active tuberculosis in patients with fever of unknown origin (FUO). @*Methods@#Patients with FUO in Tongji Hospital from Jan 1st 2014 to Feb 28th 2015 were retrospectively enrolled, and general condition, laboratory examination including T-SPOT.TB, blood routine test, procalcitonin (PCT), high sensitivity C-reactive protein (hs-CRP), erythrocyte sedimentation rate (ESR), lactate dehydrogenase (LDH), serum ferritin (SF) and final diagnosis were collected and analyzed. @*Results@#A total of 395 hospitalized patients with FUO were retrospectively enrolled into this study, among which there were 36 (9.11%) confirmed active tuberculosis (including 7 pulmonary cases and 29 extra-pulmonary cases), 189 (47.85%) bacterial infections, 50 (12.66%) viral infections, 4 (6.32%) fungal infections, 20 (5.06%) neoplastic diseases, 51(12.91%) autoimmune diseases, 25 (6.32%) other diseases. While 20 (5.06%) patients remained un-diagnosed. The sensitivity of T-SPOT.TB for the diagnosis of active TB in patients with FUO was 80.56% (95%CI: 63.43%-91.20%), and the specificity was 83.57% (95%CI: 79.23%-87.16%). The positive predictive value was 32.95% (95%CI: 23.52%-43.89%), and the negative predictive value was 97.72% (95%CI: 95.16%-99.00%). There were significant differences in positive LDH levels (187[141, 255] U/L vs 209[160, 343] U/L) and SF levels (296.2[191.3, 494.8] g/L vs 528.1[281.1, 1 022.0] μg/L) between active tuberculosis group and bacterial infection group (χ2=77.692, H=13.442, H=16.142, all P<0.05). The combination of T-SPOT.TB and multiple inflammatory indicators obtained most valuable efficiency (AUC=0.866) for TB diagnosis. Similarly, there were significant differences in positive ESR (31[15, 78] mm/1 h vs 10[6, 19] mm/1 h), ratio of neutrophil granulocytes ([71.17±12.59]% vs [57.08±20.38]%) between active tuberculosis group and viral infection group (H=32.797, F=6.171, all P<0.05). The combination acquired most valuable efficiency (AUC=0.929). @*Conclusions@#For patients with FUO, T-SPOT.TB combined with inflammatory indicators are valuable for the diagnosis of active tuberculosis.