Mazina N K, Sheshunov I V, Mazin P V, Mazin V P, Kovalenko A L, Zaplutanov V A
Kirov State Medical University, Ministry of Health of Russia, Kirov, Russia.
Institute of Toxicology, Federal Biomedical Agency of Russia, Saint Petersburg, Russia.
Ter Arkh. 2017;89(11):84-92. doi: 10.17116/terarkh2017891184-92.
The authors carried out a systematic review and subsequent meta-analysis of randomized clinical trials evaluating the efficacy of the immunomodulator agent cycloferon as tablets in adults and children with viral respiratory diseases. A total estimate of its clinical efficacy was obtained in terms of compared heterogeneous groups and response variables. The data published in 16 articles were used to calculate the formal parameters of the clinical efficacy of cycloferon (increased absolute and relative benefits, odds ratio (OR); the number of patients needed to be additionally treated with cycloferon to achieve a favorable outcome or to prevent a poor outcome in one patient, etc.). High heterogeneity hampered the unequivocal interpretation of results; however, combining the compared homogeneous groups in the meta-analysis (with adjustments for fixed and random effects) increased the statistical power of the investigation. In children aged 6 to 18 years, the OR for the positive effect of the drug (no new cases after its preventive administration) was 5.3 (95% confidence interval (CI), 4.8-5.9), heterogeneity test, χ = 249.5; p=0.000...; I = 94.8% (95% CI, 92.7-96.3%). This suggested the heterogeneity of clinical trial data and extrapolated this estimate to medical practice. The use of cycloferon in adults to treat acute respiratory viral infection enhanced their chances of enduring the disease in a mild form and avoiding serious complications: the OR for positive outcomes was 9.7 (95% CI, 7.0-13.0), while the effect was more homogeneous than in children (heterogeneity test, χ = 7.4; p=0.061...; I = 59.4% (95% CI, 0-86.5). Thus, the use of cycloferon to treat and prevent acute viral respiratory infections showed a more than 5-fold increase in the probability of avoiding the disease or enduring the latter in a mild form.
作者对评估免疫调节剂环磷酰胺片对成人和儿童病毒性呼吸道疾病疗效的随机临床试验进行了系统评价和后续的荟萃分析。通过比较异质性组和反应变量,获得了其临床疗效的总体估计。利用16篇文章中发表的数据计算环磷酰胺临床疗效的形式参数(增加的绝对和相对益处、优势比(OR);为使一名患者获得良好结局或预防不良结局而需要额外使用环磷酰胺治疗的患者数量等)。高度异质性妨碍了对结果的明确解释;然而,在荟萃分析中合并比较的同质组(对固定效应和随机效应进行调整)提高了研究的统计效力。在6至18岁的儿童中,该药物预防给药后产生阳性效应(无新病例)的OR为5.3(95%置信区间(CI),4.8 - 5.9),异质性检验,χ = 249.5;p = 0.000...;I² = 94.8%(95%CI,92.7 - 96.3%)。这表明临床试验数据存在异质性,并将该估计值外推至医疗实践。在成人中使用环磷酰胺治疗急性呼吸道病毒感染增加了他们以轻症形式耐受疾病并避免严重并发症的机会:阳性结局的OR为9.7(95%CI,7.0 - 13.0),而该效应比儿童中的效应更具同质性(异质性检验,χ = 7.4;p = 0.061...;I² = 59.4%(95%CI,0 - 86.5)。因此,使用环磷酰胺治疗和预防急性病毒性呼吸道感染显示,避免患病或以轻症形式耐受疾病的概率增加了5倍以上。