Shi Shihua, Wang Fei, Chen Bonan, Pan Jie, Luo Dan, Pei Caixia, Huang Demei, Wang Xiaomin, Wang Yilan, Shen Zherui, Li Weihao, Wu Yongcan, He Yacong, Wang Zhenxing
Department of Geriatric, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.
Department of Epidemiology and Public Health, Swiss Tropical and Public Health Institute, Basel, Switzerland.
Front Pharmacol. 2022 Aug 25;13:779942. doi: 10.3389/fphar.2022.779942. eCollection 2022.
Although increasing clinical trials studying Shenfu injection (SFI) comprising panaxoside 0.8 mg/ml extracted from Panax ginseng C.A. Mey. and aconitine 0.1 mg/ml extracted from Debeaux for elderly patients with severe pneumonia on biomarkers associated with COVID-19 progression are emerging, there is no evidence-based evaluation for the effect of SFI on elderly severe pneumonia. To evaluate the effect of SFI on elderly patients with severe pneumonia providing hints for treating critical COVID-19, we conducted a systematic review and meta-analysis. Nine databases, namely, PubMed, EMBASE, Web of Science, Science Direct, Google Scholar, Wanfang, Chongqing VIP Database, CNKI, and SinoMed were used to search clinical trials reporting the effect of SFI as an adjuvant for elderly severe pneumonia on outcomes of interest. Primary outcomes were total effective rate, Acute Physiology and Chronic Health Evaluation (APACHE) II score, mortality, and safety. Secondary outcomes were predictors associated with COVID-19 progression. Duplicated or irrelevant articles with unavailable data were excluded. Cochrane Collaboration's tool was used to evaluate the risk of bias by two reviewers independently. All data were analyzed by Rev Man 5.4. Continuous variables were shown as weighted mean difference (WMD) or standard mean difference (SMD) with 95% confidence intervals (95% CI), whereas dichotomous data were calculated as the risk ratio (RR) with 95% CI. We included 20 studies with 1, 909 participants, and the pooled data showed that compared with standard control, SFI could improve the total effective rate (RR = 1.25, 95% CI = 1.14-1.37, and = 689), APACHE II score (WMD = -2.95, 95% CI = -3.35, -2.56, and = 809), and predictors associated with COVID-19 progression (brain natriuretic peptide, creatine kinase, stroke volume, cardiac output, left ventricular ejection fraction, cardiac index, sE-selectin, von Willebrand factor, activated partial thromboplastin time, platelet counts, D-Dimer, procalcitonin, and WBC count). SFI may reduce mortality (RR = 0.52, 95% CI = 0.37-0.73, and = 429) and safety concerns (RR = 0.29, 95% CI = 0.17-0.51, and = 150) for elderly severe pneumonia. SFI as an adjuvant may improve the total effective rate, APACHE II score, gas exchange, and predictors associated with COVID-19 progression, reducing mortality and safety concerns for elderly patients with severe pneumonia.
尽管越来越多关于参附注射液（SFI）的临床试验正在开展，该注射液含有从人参中提取的0.8毫克/毫升人参皂苷和从附子中提取的0.1毫克/毫升乌头碱，用于研究其对患有严重肺炎的老年患者与新冠病毒疾病进展相关生物标志物的影响，但目前尚无基于证据的评估来证实参附注射液对老年重症肺炎的疗效。为了评估参附注射液对老年重症肺炎患者的疗效，为治疗危重型新冠病毒疾病提供线索，我们进行了一项系统评价和荟萃分析。我们使用了九个数据库，即PubMed、EMBASE、Web of Science、Science Direct、Google Scholar、万方、重庆维普数据库、中国知网和中国生物医学文献数据库，以检索报告参附注射液作为老年重症肺炎辅助治疗药物对感兴趣结局影响的临床试验。主要结局指标为总有效率、急性生理与慢性健康状况评分系统（APACHE）II评分、死亡率和安全性。次要结局指标为与新冠病毒疾病进展相关的预测指标。排除重复或不相关以及数据不可用的文章。由两名评价员独立使用Cochrane协作网工具评估偏倚风险。所有数据均采用Rev Man 5.4进行分析。连续变量以加权均数差（WMD）或标准化均数差（SMD）及95%置信区间（95%CI）表示，而二分类数据则计算为风险比（RR）及95%CI。我们纳入了20项研究，共1909名参与者，汇总数据显示，与标准对照相比，参附注射液可提高总有效率（RR = 1.25，95%CI = 1.14 - 1.37， = 689）、APACHE II评分（WMD = -2.95，95%CI = -3.35，-2.56， = 809），以及与新冠病毒疾病进展相关的预测指标（脑钠肽、肌酸激酶、每搏输出量、心输出量、左心室射血分数、心脏指数、可溶性E选择素、血管性血友病因子、活化部分凝血活酶时间、血小板计数、D - 二聚体、降钙素原和白细胞计数）。参附注射液可能降低老年重症肺炎的死亡率（RR = 0.52，95%CI = 0.37 - 0.73， = 429）和安全问题（RR = 0.29，95%CI = 0.17 - 0.51， = 150）。参附注射液作为辅助治疗药物可能提高总有效率、APACHE II评分、气体交换以及与新冠病毒疾病进展相关的预测指标，降低老年重症肺炎患者的死亡率和安全问题。
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