Bansal Vikas, Mahapure Kiran S, Mehra Ishita, Bhurwal Abhishek, Tekin Aysun, Singh Romil, Gupta Ishita, Rathore Sawai Singh, Khan Hira, Deshpande Sohiel, Gulati Shivam, Armaly Paige, Sheraton Mack, Kashyap Rahul
Department of Anaesthesiology and Critical Care Medicine, Mayo Clinic, Rochester, MN, United States.
Senior Resident, Department of Plastic Surgery, KAHER J. N. Medical College, Belgaum, India.
Front Med (Lausanne). 2021 Apr 9;8:624924. doi: 10.3389/fmed.2021.624924. eCollection 2021.
With a scarcity of high-grade evidence for COVID-19 treatment, researchers and health care providers across the world have resorted to classical and historical interventions. Immunotherapy with convalescent plasma (CPT) is one such therapeutic option. A systematized search was conducted for articles published between December 2019 and 18th January 2021 focusing on convalescent plasma efficacy and safety in COVID-19. The primary outcomes were defined as mortality benefit in patients treated with convalescent plasma compared to standard therapy/placebo. The secondary outcome was pooled mortality rate and the adverse event rate in convalescent plasma-treated patients. A total of 27,706 patients were included in the qualitative analysis, and a total of 3,262 (2,127 in convalescent plasma-treated patients and 1,135 in the non-convalescent plasma/control group) patients died. The quantitative synthesis in 23 studies showed that the odds of mortality in patients who received plasma therapy were significantly lower than those in patients who did not receive plasma therapy [odds ratio (OR) 0.65, 95% confidence interval (CI) 0.53-0.80, < 0.0001, = 15%). The mortality benefit remains the same even for 14 trials/prospective studies (OR 0.59, 95% CI 0.43-0.81, = 0.001, = 22%) as well as for nine case series/retrospective observational studies (OR 0.78, 95% CI 0.65-0.94, = 0.01, = 0%). However, in a subgroup analysis for 10 randomized controlled trials (RCTs), there was no statistically significant reduction in mortality between the CPT group compared to the non-CPT group (OR 0.76, 95% CI 0.53-1.08, = 0.13, = 7%). Furthermore, the sensitivity analysis of 10 RCTs, excluding the study with the highest statistical weight, displayed a lower mortality rate compared to that of non-CPT COVID-19 patients (OR 0.64, 95% CI 0.42-0.97, = 0.04, = 0%). The observed pooled mortality rate was 12.9% (95% CI 9.7-16.9%), and the pooled adverse event rate was 6.1% (95% CI 3.2-11.6), with significant heterogeneity. Our systemic review and meta-analysis suggests that CPT could be an effective therapeutic option with promising evidence on the safety and reduced mortality in concomitant treatment for COVID-19 along with antiviral/antimicrobial drugs, steroids, and other supportive care. Future exploratory studies could benefit from more standardized reporting, especially in terms of the timing of interventions and clinically relevant outcomes, like days until discharge from the hospital and improvement of clinical symptoms.
由于缺乏关于新冠病毒病（COVID-19）治疗的高质量证据，世界各地的研究人员和医疗服务提供者纷纷采用经典和传统的干预措施。使用康复期血浆进行免疫治疗（CPT）就是这样一种治疗选择。我们系统检索了2019年12月至2021年1月18日发表的文章，重点关注康复期血浆在COVID-19治疗中的疗效和安全性。主要结局定义为接受康复期血浆治疗的患者与接受标准治疗/安慰剂治疗的患者相比，在死亡率方面的获益情况。次要结局为康复期血浆治疗患者的合并死亡率和不良事件发生率。共有27706例患者纳入定性分析，共有3262例患者死亡（2127例接受康复期血浆治疗的患者，1135例未接受康复期血浆治疗/对照组患者）。23项研究的定量综合分析表明，接受血浆治疗的患者死亡率显著低于未接受血浆治疗的患者[比值比（OR）0.65，95%置信区间（CI）0.53 - 0.80，P < 0.0001，I² = 15%]。即使在14项试验/前瞻性研究中（OR 0.59，95% CI 0.43 - 0.81，P = 0.001，I² = 22%）以及9项病例系列/回顾性观察研究中（OR 0.78，95% CI 0.65 - 0.94，P = 0.01，I² = 0%），死亡率获益情况依然如此。然而，在10项随机对照试验（RCT）的亚组分析中，CPT组与非CPT组相比，死亡率并无统计学显著降低（OR 0.76，95% CI 0.53 - 1.08，P = 0.13，I² = 7%）。此外，排除统计权重最高的研究后，对10项RCT进行的敏感性分析显示，与未接受CPT的COVID-19患者相比，死亡率较低（OR 0.64，95% CI 0.42 - 0.97，P = 0.04，I² = 0%）。观察到的合并死亡率为12.9%（95% CI 9.7 - 16.9%），合并不良事件发生率为6.1%（95% CI 3.2 - 11.6%），存在显著异质性。我们的系统评价和荟萃分析表明，CPT可能是一种有效的治疗选择，在与抗病毒/抗菌药物、类固醇及其他支持性治疗联合用于COVID-19治疗时，在安全性和降低死亡率方面有可靠证据。未来的探索性研究可能会受益于更标准化的报告，特别是在干预时机和临床相关结局方面，如出院天数和临床症状改善情况。
