Meher Bikash Ranjan, Padhy Biswa Mohan, Das Smita, Mohanty Rashmi Ranjan, Agrawal Kanhaiyalal
Associate Professor, Department of Pharmacology, All India Institute of Medical Sciences, Bhubaneswar, Odisha.
Additional Professor, Department of Pharmacology, All India Institute of Medical Sciences, Bhubaneswar, Odisha.
J Assoc Physicians India. 2020 Dec;68(12):35-43.
Though Convalescent plasma therapy (CPT) is being used for management of COVID-19, the evidence is still equivocal. So, we carried out this study to evaluate the currently available data to provide evidence about CPT in COVD-19 patients. RCTs and observational studies with sample size with more than 5 were included in the analysis. Out of 196 studies, 12 studies were selected for systematic review and meta-analysis was carried out for 6 studies having a control arm. For dichotomous values, risk ratio (RR) and 95% confidence interval was expressed.
All-cause mortality, clinical improvement by day 7 and viral detection by day 7 were the defined outcome measures before starting of data extraction.
For 6 studies (2 RCTs and 4 observational studies) with 474 patients, the overall pooled RR for all-cause mortality was 0.61 (95%CI: 0.37 to 0.99. P= 0.04). Only RCTs and only observational studies for all-cause mortality showed pooled RR of 0.60 (95% CI: 0.33 to 1.10, P=0.10) and 0.48 (95% CI: 0.17 to 1.36, P= 0.17) respectively. There was risk of bias in the studies due to randomization process and confounding. Sensitivity analysis was carried out only for observational studies. The overall pooled RR for clinical improvement by day 7 and viral detection by day 7 were 1.12 (95%CI: 0.96 to 1.31, P=0.16) and 0.19 (95%CI: 0.09 to 0.60, P < 0.0001).
Though the review suggests modest utility of CPT in reducing all-cause mortality, improving clinical outcome, and early viral clearance, it should be interpreted cautiously.
尽管恢复期血浆疗法（CPT）正用于新冠病毒病（COVID-19）的治疗，但证据仍不明确。因此，我们开展了这项研究，以评估现有数据，为COVID-19患者使用CPT提供证据。分析纳入了样本量大于5的随机对照试验（RCT）和观察性研究。在196项研究中，选择了12项进行系统评价，并对6项设有对照组的研究进行了荟萃分析。对于二分变量，采用风险比（RR）和95%置信区间表示。
在开始提取数据前，将全因死亡率、第7天的临床改善情况和第7天的病毒检测作为既定的结局指标。
对于6项研究（2项RCT和4项观察性研究）中的474例患者，全因死亡率的总体合并RR为0.61（95%CI：0.37至0.99，P = 0.04）。仅RCT和仅观察性研究的全因死亡率合并RR分别为0.60（95%CI：0.33至1.10，P = 0.10）和0.48（95%CI：0.17至1.36，P = 0.17）。由于随机化过程和混杂因素，研究存在偏倚风险。仅对观察性研究进行了敏感性分析。第7天临床改善情况和第7天病毒检测的总体合并RR分别为1.12（95%CI：0.96至1.31，P = 0.16）和0.19（95%CI：0.09至0.60，P < 0.0001）。
尽管该综述表明CPT在降低全因死亡率、改善临床结局和早期病毒清除方面有一定作用，但应谨慎解读。
