Kulkarni P S, Phadke M A, Jadhav S S, Kapre S V
Serum Institute of India Ltd., 212/2 Hadapsar, Pune 411028, India.
Vaccine. 2005 Nov 16;23(46-47):5286-8. doi: 10.1016/j.vaccine.2005.05.029. Epub 2005 Jun 13.
The study by da Cunha et al. published in 2002 reported that MMR vaccine containing L-Zagreb mumps strain manufactured by Serum Institute of India Ltd. caused a high incidence of aseptic meningitis (AM) from routine surveillance during two mass immunization campaigns (MIC) conducted in 1998 in two states in Brazil. Since the results were contrary to those in India, Egypt and Bahamas, a critical analysis of the study was done. Several inconsistencies were found in the study, which undermined the conclusions drawn. Two similar studies from Brazil reported similar results. Review of these studies and those done on the vaccine from Zagreb, Croatia showed that in no study the L-Zagreb mumps virus has been isolated from cerebrospinal fluid (CSF) of an AM case. Isolation of the vaccine virus is necessary for definite causal association of AM with the vaccine. There is no such evidence to causally link MMR vaccine containing L-Zagreb mumps strain with AM.
达库尼亚等人于2002年发表的研究报告称,印度血清研究所生产的含L-萨格勒布腮腺炎毒株的麻腮风疫苗,在1998年于巴西两个州开展的两次大规模免疫运动(MIC)的常规监测中,引发了无菌性脑膜炎(AM)的高发病率。由于结果与印度、埃及和巴哈马的情况相反,因此对该研究进行了批判性分析。研究中发现了几处不一致之处,这削弱了所得出的结论。来自巴西的两项类似研究报告了类似结果。对这些研究以及对来自克罗地亚萨格勒布的该疫苗所做研究的回顾表明,在任何研究中,均未从无菌性脑膜炎病例的脑脊液(CSF)中分离出L-萨格勒布腮腺炎病毒。要确定无菌性脑膜炎与该疫苗之间存在因果关联,必须分离出疫苗病毒。没有证据表明含L-萨格勒布腮腺炎毒株的麻腮风疫苗与无菌性脑膜炎之间存在因果联系。