Zhang Linjie, Prietsch Sílvio O M, Axelsson Inge, Halperin Scott A
Faculty of Medicine, Federal University of Rio Grande, Rua Visconde Paranaguá 102, Centro, RioGrande, RS, Brazil.
Cochrane Database Syst Rev. 2012 Mar 14(3):CD001478. doi: 10.1002/14651858.CD001478.pub5.
Routine use of whole-cell pertussis (wP) vaccines was suspended in some countries in the 1970s and 1980s because of concerns about adverse effects. Following such action, there was a resurgence of whooping cough. Acellular pertussis (aP) vaccines, containing purified or recombinant Bordetella pertussis (B. pertussis) antigens, were developed in the hope that they would be as effective, but less reactogenic than the whole-cell vaccines.
To assess the efficacy and safety of acellular pertussis vaccines in children.
We searched the Cochrane Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 4) which contains the Cochrane Acute Respiratory Infections Group's Specialised Register, MEDLINE (1950 to December week 4, 2011), EMBASE (1974 to January 2012), Biosis Previews (2009 to January 2012), and CINAHL (2009 to January 2012).
We selected double-blind randomised efficacy and safety trials of aP vaccines in children up to six years old, with active follow-up of participants and laboratory verification of pertussis cases.
Two review authors independently extracted data and assessed the risk of bias in the studies. Differences in trial design precluded a meta-analysis of the efficacy data. We pooled the safety data from individual trials using a random-effects meta-analysis model.
We included six efficacy trials with a total of 46,283 participants and 52 safety trials with a total of 136,541 participants. Most of the safety trials did not report the methods for random sequence generation, allocation concealment and blinding, which made it difficult to assess the risk of bias in the studies. The efficacy of multi-component (≥ three) vaccines varied from 84% to 85% in preventing typical whooping cough (characterised by 21 or more consecutive days of paroxysmal cough with confirmation of B. pertussis infection by culture, appropriate serology or contact with a household member who has culture-confirmed pertussis), and from 71% to 78% in preventing mild pertussis disease (characterised by seven or more consecutive days of cough with confirmation of B. pertussis infection by culture or appropriate serology). In contrast, the efficacy of one- and two-component vaccines varied from 59% to 75% against typical whooping cough and from 13% to 54% against mild pertussis disease. Multi-component acellular vaccines are more effective than low-efficacy whole-cell vaccines, but may be less effective than the highest-efficacy whole-cell vaccines. Most systemic and local adverse events were significantly less common with aP vaccines than with wP vaccines for the primary series as well as for the booster dose.
AUTHORS' CONCLUSIONS: Multi-component (≥ three) aP vaccines are effective and show less adverse effects than wP vaccines for the primary series as well as for booster doses.
20世纪70年代和80年代，由于担心不良反应，一些国家暂停了全细胞百日咳（wP）疫苗的常规使用。采取这一行动后，百日咳疫情有所反弹。于是研发了含有纯化或重组百日咳博德特氏菌（B. pertussis）抗原的无细胞百日咳（aP）疫苗，希望其效果与全细胞疫苗相同，但反应原性更低。
评估无细胞百日咳疫苗在儿童中的疗效和安全性。
我们检索了Cochrane对照试验注册库（CENTRAL）（《Cochrane图书馆》2011年第4期），其中包含Cochrane急性呼吸道感染小组的专业注册库、MEDLINE（1950年至2011年12月第4周）、EMBASE（1974年至2012年1月）、生物学文摘数据库（2009年至2012年1月）和护理学与健康领域数据库（2009年至2012年1月）。
我们选择了针对6岁以下儿童的aP疫苗双盲随机疗效和安全性试验，对参与者进行积极随访，并对百日咳病例进行实验室核实。
两位综述作者独立提取数据并评估研究中的偏倚风险。试验设计的差异使得无法对疗效数据进行荟萃分析。我们使用随机效应荟萃分析模型汇总了各个试验的安全性数据。
我们纳入了6项疗效试验，共46283名参与者，以及52项安全性试验，共136541名参与者。大多数安全性试验未报告随机序列生成、分配隐藏和盲法的方法，这使得难以评估研究中的偏倚风险。多组分（≥三种）疫苗预防典型百日咳（以连续21天或更长时间的阵发性咳嗽为特征，通过培养、适当的血清学检查或与有培养确诊百日咳的家庭成员接触确诊B. pertussis感染）的疗效在84%至85%之间，预防轻度百日咳疾病（以连续7天或更长时间的咳嗽为特征，通过培养或适当的血清学检查确诊B. pertussis感染）的疗效在71%至78%之间。相比之下，单组分和双组分疫苗预防典型百日咳的疗效在59%至75%之间，预防轻度百日咳疾病的疗效在13%至54%之间。多组分无细胞疫苗比低效全细胞疫苗更有效，但可能不如高效全细胞疫苗有效。对于初次接种系列以及加强剂量，大多数全身和局部不良事件在aP疫苗组中比在wP疫苗组中明显少见。
多组分（≥三种）aP疫苗在初次接种系列以及加强剂量时均有效，且比wP疫苗不良反应少。
