目的：據統計，約有八成的患者感染新冠肺炎後為輕、中度感染，但若個案具有 懷孕、高齡、多重共病等重症風險因子，則會提高病症惡化的機率。中和性抗體能有 效降低此類病人的重症率，本研究欲探討此類藥物於本土病人之使用狀況。
方法：以回溯性分析 2021 年 6 月至 7 月，使用中和性抗體（casirivimab/imdevimab 或 bamlanivimab/etesevimab）治療的個案為對象，從電子病歷系統收集病人的基礎 資料、病程相關資料、實驗室數值及治療後的臨床反應，以進行藥物使用分析評估。
結果：本研究共收入 19 位個案 (casirivimab/imdevimab: 16; bamlanivimab/ etesevimab: 3)，女性占 10 位 (52.6%)，疾病嚴重度方面輕度占 16 例 (84.2%)，中度 占 3 例 (15.8%)，平均年齡為 62.2 歲，發病日至給藥日之平均時間為 4.1 天，其中 14 位個案於確診時的 SARS-CoV-2 PCR cycle threshold (Ct) value < 30 (73.7%)。個案 的重症風險因子以高齡 (57.9%)、心血管疾病 (52.6%)、body mass index ≥ 30 kg/m2 (21.1%) 與糖尿病 (21.1%) 為主。所有個案接受治療後病情均獲改善且未惡化為重 度。SARS-CoV-2 PCR 治療前的 Ct 值也於治療後明顯提高 (mean difference: 7.8; 95% confidence interval: 5.4–10.2; p < 0.001)。期間計有9件不良反應 (47.4%)，均為輕度，其中以發燒較為常見 (2/9)。
結論：本研究提供了中和性抗體於本土個案的治療經驗，顯示此類藥物能有效降低重症率與死亡率，並具有良好的安全性。因中和性抗體對於不同變異株的療效仍有 待觀察，故臨床團隊需審慎注意國內流行變異株趨勢，以選擇較適當的治療方案。
Objective: Most of the patients with COVID-19 infection were mild to moderate in disease severity. Patients with risk factors such as pregnancy, old age, and comorbidity, may deteriorate and/or quickly to severe disease stage. We aimed to investigate the role of SARS-CoV-2 neutralizing antibodies in those cases in Taiwan.
Methods: We retrospectively reviewed the medical records of patients infected with COVID-19 receiving casirivimab/imdevimab or bamlanivimab/etesevimab from June to July 2021 at the Far-Eastern Memorial Hospital.
Results: 19 patients were reviewed (10 females). 84.2% of the patients had mild COVID-19 symptoms. The mean age of the patients was 62.2 years. The patients received an infusion of neutralizing antibodies within a median of 4.1 days after the onset of symptoms. Moreover, 73.7% of patients’ baseline SARS-CoV-2 PCR cycle threshold (Ct) value were < 30 (73.7%). The most common risk factors were old age (57.9%), cardiovascular disease (52.6%), and obesity (21.1%). None of the patients had progressed to severe disease stage or occurred in death. The SARS-CoV-2 PCR Ct values were raised significantly after infusion (mean difference: 7.8; 95% CI: 5.4–10.2; p < 0.001). Nine adverse events were noted, and all of them were defined as mild and selflimited.
Conclusions: SARS-CoV-2 neutralizing antibodies reduced the risk of severe COVID-19 disease or death and had an acceptable safety profile for use in high-risk populations. Healthcare providers should continue to monitor the reports of identified viral variants of importance in the local region and to choose the confidential option of neutralizing antibodies for these patients.
Submited for publication: 2021.10.14; Accepted for publication: 2022.3.15
