Mydlak G, Scharkoff H
Z Erkr Atmungsorgane. 1986;167(1-2):52-7.
Despite declining incidence of tuberculosis in developed countries importance of tuberculin testing has not subsided. Previous investigations of the equivalence of 7 tuberculin preparations from 6 countries to RT 23 have shown differences in the diagnostic value of the tuberculin preparations. The smallest rates of negative skin-reactions in cases with bacteriologically confirmed tuberculosis were found with the hungarian tuberculin PPD-5 TU (HU 5 TU) and RT 23. The national tuberculin PPD Dessau 2 TU showed highest rates of non-reactors in tuberculous patients. In 400 cases of active bacteriologically confirmed tuberculosis further investigations were carried out to compare biologic equivalence of RT 23, HU 5 TU, tuberculin PPD Dessau 2 TU and the test-preparation PPD Dessau 5 TU with and without Tween addition and 7.5 TU without Tween. The results showed that with increase of antigen concentration to 5 TE or 7.5 TU the smaller reactions of 6 to 10 mm could be strengthened with a small, statistically not significant, increase of the mean value of reaction size but no increase of larger reactions of more than 20 mm. The rate of false negative reactions decreased using the test-preparation PPD 7.5 TU. The results allow to recommend the production of a national tuberculin preparation with higher antigen concentration biologically equivalent to RT 23 or HU 5 TU.
尽管发达国家结核病发病率呈下降趋势,但结核菌素试验的重要性并未减弱。先前对来自6个国家的7种结核菌素制剂与RT 23等效性的研究表明,这些结核菌素制剂的诊断价值存在差异。在细菌学确诊的结核病病例中,匈牙利结核菌素PPD - 5 TU(HU 5 TU)和RT 23的皮肤阴性反应率最低。德国德绍结核菌素PPD 2 TU在结核病患者中的无反应率最高。对400例细菌学确诊的活动性结核病患者进一步开展研究,比较RT 23、HU 5 TU、德国德绍结核菌素PPD 2 TU以及添加和未添加吐温的德国德绍PPD 5 TU试验制剂和未添加吐温的7.5 TU的生物学等效性。结果显示,随着抗原浓度增加到5 TU或7.5 TU,6至10毫米的较小反应可通过反应大小平均值的小幅增加(统计学上无显著意义)得到增强,但超过20毫米的较大反应无增加。使用试验制剂PPD 7.5 TU时假阴性反应率降低。这些结果有助于推荐生产一种抗原浓度更高、生物学上等同于RT 23或HU 5 TU的国家结核菌素制剂。