Ermers Marieke J J, Rovers Maroeska M, van Woensel Job B, Kimpen Jan L L, Bont Louis J
Department of Paediatric Infectious Diseases, Wilhelmina Children's Hospital, University Medical Centre Utrecht, PO Box 85090, 3508 AB Utrecht, Netherlands.
BMJ. 2009 Mar 31;338:b897. doi: 10.1136/bmj.b897.
To determine whether early initiated anti-inflammatory therapy with prolonged high dose inhaled glucocorticoids influences the occurrence and severity of recurrent wheeze after respiratory syncytial virus related lower respiratory tract infections.
Randomised double blind placebo controlled trial.
Paediatric departments of 19 Dutch clinical centres.
243 previously healthy infants (126 boys, 117 girls) aged less than 13 months and admitted to hospital with respiratory syncytial virus infection.
200 mug extra fine hydrofluoroalkane (HFA) beclometasone dipropionate twice daily or matched placebo administered by a pressurised metered dose inhaler and a spacer during the first three months after hospital admission.
The primary outcome was the number of days with wheeze in the year after the three month intervention period.
Of the 243 eligible infants, 119 were randomised to receive beclometasone and 124 to receive placebo. No significant difference was found in the number of days with wheeze between the two groups (total days, 1761/33 568 in the beclometasone group v 2301/36 556 in the placebo group, P=0.31) and the proportion of infants with wheeze did not differ between the groups (61% in the beclometasone group v 62% in the placebo group, P=0.90). In the predefined subgroup of infants who did not need mechanical ventilation (n=221), beclometasone reduced the number of days with wheeze by 32% (relative reduction in total days, 1315/30 405 in the beclometasone group v 2120/33 149 in the placebo group, P=0.046). This reduction was most pronounced during the first six months of the follow-up year after intervention. The proportion of infants with wheeze did not differ between the groups (59% in the beclometasone group v 60% in the placebo group, P=0.89).
Early initiated high dose extra fine HFA beclometasone to infants during the first three months after hospital admission for respiratory syncytial virus infection has no major effect on recurrent wheeze. The general use of such treatment during lower respiratory tract infection with respiratory syncytial virus should not be advocated.
Current Controlled Trials ISRCTN12352714.
确定早期开始使用延长疗程的高剂量吸入糖皮质激素进行抗炎治疗是否会影响呼吸道合胞病毒相关下呼吸道感染后反复喘息的发生及严重程度。
随机双盲安慰剂对照试验。
荷兰19个临床中心的儿科部门。
243名既往健康、年龄小于13个月且因呼吸道合胞病毒感染入院的婴儿（126名男孩，117名女孩）。
入院后前三个月，每日两次使用200微克的超细微粒氢氟烷烃（HFA）二丙酸倍氯米松，或通过压力定量吸入器及储物罐给予匹配的安慰剂。
主要观察指标为三个月干预期后一年内喘息的天数。
在243名符合条件的婴儿中，119名被随机分配接受倍氯米松治疗，124名接受安慰剂治疗。两组之间喘息天数无显著差异（倍氯米松组总计1761/33568天，安慰剂组为2301/36556天，P = 0.31），两组中出现喘息的婴儿比例也无差异（倍氯米松组为61%，安慰剂组为62%，P = 0.90）。在预先定义的无需机械通气的婴儿亚组（n = 221）中，倍氯米松使喘息天数减少了32%（总计天数的相对减少，倍氯米松组为1315/30405天，安慰剂组为2120/33149天，P = 0.046）。这种减少在干预后随访年的前六个月最为明显。两组中出现喘息的婴儿比例无差异（倍氯米松组为59%，安慰剂组为60%，P = 0.89）。
呼吸道合胞病毒感染入院后前三个月对婴儿早期开始使用高剂量超细微粒HFA倍氯米松对反复喘息无重大影响。不建议在呼吸道合胞病毒引起的下呼吸道感染期间普遍使用这种治疗方法。
当前对照试验ISRCTN12352714。
