当代医学
噹代醫學
당대의학
CHINA CONTEMPORARY MEDICINE
2014年
29期
115-116
,共2页
张延炀%肖占沛%王长双%马雅婷%路明霞%张肖肖
張延煬%肖佔沛%王長雙%馬雅婷%路明霞%張肖肖
장연양%초점패%왕장쌍%마아정%로명하%장초초
结核菌素纯蛋白衍生物%结核病%结核菌素试验%安全性
結覈菌素純蛋白衍生物%結覈病%結覈菌素試驗%安全性
결핵균소순단백연생물%결핵병%결핵균소시험%안전성
TB-PPD%Tuberculosis%Tuberculin test%Safety
目的：评价结核菌素纯蛋白衍生物（TB-PPD）的临床安全性。方法随机选取50例健康志愿者，对其皮内注射0.1 mL TB-PPD 试剂，注射结束后分别于30 min、24 h、48 h、72 h和7 d观察其不良反应发生率，评价其安全性。结果不良反应主要表现为发热、接种部位疼痛、硬结等，未发现严重不良反应。结论 TB-PPD具有较好的临床安全性。
目的：評價結覈菌素純蛋白衍生物（TB-PPD）的臨床安全性。方法隨機選取50例健康誌願者，對其皮內註射0.1 mL TB-PPD 試劑，註射結束後分彆于30 min、24 h、48 h、72 h和7 d觀察其不良反應髮生率，評價其安全性。結果不良反應主要錶現為髮熱、接種部位疼痛、硬結等，未髮現嚴重不良反應。結論 TB-PPD具有較好的臨床安全性。
목적：평개결핵균소순단백연생물（TB-PPD）적림상안전성。방법수궤선취50례건강지원자，대기피내주사0.1 mL TB-PPD 시제，주사결속후분별우30 min、24 h、48 h、72 h화7 d관찰기불량반응발생솔，평개기안전성。결과불량반응주요표현위발열、접충부위동통、경결등，미발현엄중불량반응。결론 TB-PPD구유교호적림상안전성。
Objective To evaluate the safety of TB-PPD in humans. Methods A randomized clinical trial was conducted in 50 healthy volunteers. The subjects were intradermal injected with TB-PPD (0.1 mL). The adverse events following immunization (AEFIs) were observed after 30 minutes, 24 hours, 48 hours, 72 hours and 7 days of inoculation. Safety was evaluated by observing adverse reaction after inoculation. Results The main AEFIs were fever, local pain and scleroma. There were no other severe AEFIs. Conclusion The TB-PPD has good safety.
