摘要
目的 调查临床使用的严重急性呼吸综合征 (severeacuterespiratorysyndrome,SARS)预防药物的有效性和安全性 ,为前瞻性临床试验设计提供临床数据。 方法 回顾性问卷调查山西省 2个主要SARS定点医院中与SARS患者密切接触的医护人员 ,了解其SARS暴露危险度及相应预防措施 (药物和非药物 ) ,根据预防药物使用情况分为蚯蚓核酸酶和蛋白酶 (earthworm’snucleasesandprotease ,ENP)组、干扰素组和空白对照组。比较各组间暴露危险因素差异、可疑隐性感染率和不良反应出现率。 结果 3组采用的SARS非药物预防措施一致性较好 ,但 3组间暴露强度的差异有统计学意义 ,对预防药物临床有效性评价结果可能有影响。ENP组、干扰素组和空白对照组可疑隐性感染率分别为 4 .5 %、4 .5 %和 9.9% ,但其差异无统计学意义 ;不良反应率分别为 19.6 %、13.6 %和 0 % ,但前两组间差异无统计学意义 ,且两组症状都较轻。 结论 ENP组、干扰素组可疑隐性感染率较空白对照组明显降低 ,提示该两种药物对预防SARS可能有效。ENP与干扰素的不良反应率相当 ,症状均较轻 ,证实其临床安全性与体外实验结果一致。但本研究混杂因素较多 ,特别由于组间暴露危险因素分布不均 ,影响结果的论证强度 ,仅供下一步前瞻性临床试验设计参考。
Objective To investigate the clinical effectiveness and adverse event of preventive medicine for severe acute respiratory syndrome(SARS), and provide clinical data for designing prospective clinical trial. Method Retrospective study on medical staffs , that were exposed to SARS patients, was conducted in two main SARS designated hospitals to obtain information such as SARS exposure risk and preventive measures (medical and others). According to the type of preventive medicine, they were assigned to earthworm’s nucleases and protease(ENP) group, interferon group and blank control group respectively. Exposure risk, suspected sub-clinical infection rate and adverse event rate were compared between the three groups. Results Non-medical preventive measures used in each group were consistent, but the exposure intensity to risk factors between groups was statistically different, which biased the evaluation of clinical effectiveness of preventive medicine. The rate of suspected sub-clinicalinfection in earthworm’s nucleases and protease(ENP) group, interferon group and control group were 4.5%, 4.5%, and 9.9% (P>0.05), respectively; and adverse event rate were 19.6%, 13.6%(P>0.05), and 0%, respectively. Conclusions Suspected sub-clinical infection rate in ENP group, interferon (INF) group were lower than that in control group, which indicated that these two medicines might be effective in preventing SARS. Adverse event rate in ENP group was similar to that of interferon group, and the symptoms were mild in both groups, which was in accordance with the result of in vitro experiments. ENP spray is a kind of biological preparation; further purification may reduce its adverse event rate. However, because there had excessive confounding factors, especially because of the unequal of exposure risk between three groups, the results of this study can only provide insights to design prospective clinical trial in the future.
出处
《中国循证医学杂志》
CSCD
2003年第4期287-293,共7页
Chinese Journal of Evidence-based Medicine
