摘要
目的系统评价大剂量甲泼尼龙治疗儿童难治性支原体肺炎(RMPP)的疗效和安全性。方法计算机检索PubMed、EMbase、Cochrane Library、中国学术期刊全文数据库(CNKI)、中国生物医学文献数据库(CBM)和维普中文期刊全文数据库(VIP)和万方数据库,检索年限均为数据库建库至2020年2月,搜集大剂量[>2 mg/(kg·d)]甲泼尼龙静脉滴注对比常规剂量[1~2 mg/(kg·d)]治疗中国儿童RMPP的临床对照研究(RCTs),提取数据后采用RevMan 5.3软件进行系统评价。结果共纳入13个RCTs,1 017例患儿,涉及甲泼尼龙剂量≤10 mg/(kg·d)和>10 mg/(kg·d)。Meta-分析结果显示:(1)大剂量组临床有效率(RR=1.12,95%CI=1.07~1.16)显著高于对照组(P<0.01),亚组分析显示≤10 mg/(kg·d)剂量组临床有效率(RR=1.03,95%CI=0.99~1.08)与常规剂量组比较无显著差异(P=0.18);>10 mg/(kg·d)组临床有效率(RR=1.20,95%CI=1.12~1.28)显著优于常规剂量组(P<0.01)。(2)大剂量组退热时间(MD=-1.82,95%CI=-2.06^-1.57)、咳嗽消失时间(MD=-1.57,95%CI=-1.91~1.23)、肺部啰音消失时间(MD=-1.58,95%CI=-1.86^-1.31)和肺部阴影消失时间(MD=-5.30,95%CI=-7.84^-2.76)均显著小于常规剂量组(P<0.01)。(3)≤10 mg/(kg·d)剂量组的肺部阴影吸收率显著优于常规剂量组(RR=1.32,95%CI=1.05~1.65,P=0.02)。(4)大剂量组C反应蛋白水平(MD=-5.08,95%CI=-5.95^-4.21)显著小于常规剂量组(P<0.01)。(5)大剂量组不良反应发生率与常规剂量组相当(RR=1.30,95%CI=0.99~1.71,P=0.06)。亚组分析显示≤10 mg/(kg·d)组的不良反应发生率(RR=0.99,95%CI=0.70~1.41,P=0.97)与常规剂量组比较无显著性差异;而>10 mg/(kg·d)组不良反应发生率(RR=2.05,95%CI=1.30~3.25,P<0.01)显著大于常规剂量组。结论大剂量甲泼尼龙能显著提高儿童RMPP的临床疗效,缩短临床症状改善时间,降低炎性因子水平,其中≤10 mg/(kg·d)是较佳剂量,在此剂量下未增加不良反应发生率。
Objective To ystematically evaluate the efficacy and safety of high-dose methylprednisolone in the treatment of refractory mycoplasma pneumoniae pneumonia(RMPP) in children. Methods The databases PubMed, EMbase, The Cochrane Library, CNKI, CBM, VIP and Wanfang Data were searched for controlled trials(RCTs) of high-dose methylprednisolone [> 2 mg/(kg·d)] vs regular dose [1—2 mg/(kg·d)] in the treatment of RMPP in children from Database building to February of 2020. After data extraction, Meta-analysis was performed by RevMan5.3 software. Results A total of 13 RCTs involving 1 107 patients were included. The results of Meta-analysis showed that:(1) The clinical effective rate in high-does group was significantly greater than that in the control group(RR = 1.12, 95%CI = 1.07 to 1.16, P < 0.01). Subgroup analysis showed that the clinical effective rate of [ ≤10 mg/(kg·d)] group(RR = 1.03, 95%CI = 0.99 to 1.08) had no significant difference compared with the regular dose group(P =0.18), and [>10 mg/(kg·d)] group(RR = 1.20, 95%CI = 1.12 to 1.28) was significantly greater compared with the regular dose group(P < 0.01);(2) High-dose group in fade time(MD =-1.82, 95%CI =-2.06 to-1.57), cough disappearing time(MD =-1.57,95%CI =-1.91 to-1.23), pulmonary rales disappearing time(MD =-1.58, 95%CI =-1.86 to-1.31) and pulmonary shadow disappearing time(MD =-5.30, 95%CI =-7.84 to-2.76) were significantly shorten than the regular-dose group(P < 0.01).(3) The lung shadow absorption rate of the high-dose group [≤ 10 mg/(kg·d)] had significantly higher than the regular-dose group(RR =1.32, 95%CI = 1.05 to 1.65, P = 0.02).(4) The CRP level in high-does group(MD =-5.08, 95%CI =-5.95 to-4.21) were significantly lower than that in the regular-dose group(P < 0.01).(5) Rate of ADR in the high-dose group was similar to that in the regular-dose group(RR = 1.30, 95%CI = 0.99 to 1.71, P = 0.06), subgroup analysis showed the rate of ADR of [≤ 10 mg/(kg·d)]group(RR = 0.99, 95%CI = 0.70 to 1.41, P = 0.97) had no difference with regular-dose group, but [ > 10 mg/(kg·d)] group(RR =2.05, 95%CI =1.30 to 3.25, P < 0.01) was significantly higher than the regular-dose group. Conclusion High-dose methylprednisolone can significantly improve the clinical efficacy of RMPP in children, shorten the time to improve clinical symptoms, reduce the level of inflammatory factors, and not increase the incidence of adverse reactions, of which [≤10 mg/(kg·d)] is the optimal dose.
作者
赵丹
郑蕾芳
程红斌
汪丽丽
胡东懿
ZHAO Dan;ZHENG Leifang;CHENG Hongbin;WANG Lili;HU Dongyi(Department of Pediatrics,Huangshi Central Hospital of Edong Medical Group,Huangshi 435000,China;Department of Pediatrics,Huangshi Maternal and Child Health Hospital of Edong Medical Group,Huangshi 435000,China)
出处
《药物评价研究》
CAS
2020年第11期2311-2318,共8页
Drug Evaluation Research
基金
黄石市医药卫生科研项目(2016-11)。
作者简介
第一作者:赵丹,男,本科,主治医师,研究方向为儿科临床研究。Tel:(0714)6265321 E-mail:danzhao669@aliyun.com;通信作者:郑蕾芳,女,本科,主管护师,研究方向为儿科护理、循证医学。E-mail:897974567@qq.com。
