2IU和5IU结核菌素纯蛋白衍生物同体双臂皮肤试验结果分析

Comparative analysis of the skin test responses using 2IU and 5IU tuberculin purified protein derivatives performed respectively on two arms of same body

目的比较分析2IU和5IU结核菌素纯蛋白衍生物的皮肤试验结果的关系,为合理使用这两种规格试剂提供参考依据。方法选择北京市西城区和昌平区的结核病定点医疗机构的初诊患者,在知情同意下对其左、右臂分别用5IU和2IU的结核菌素纯蛋白衍生物(purified protein derivative of tuberculin,TB-PPD)进行结核菌素皮肤试验(tuberculin skin test,TST),对其结果比较分析。结果444名初诊患者5IU和2IU的同体双臂TST结果比较分析显示,皮肤反应硬结平均直径差异有统计学意义(Z=-17.21,P<0.01),差值中位数为3 mm;筛查结核感染时,分别选择5IU≥10 mm和2IU≥5 mm的判断标准一致性最高(Kappa值为0.83);筛查预防性治疗对象时,分别选择5IU≥15 mm和2IU≥10 mm的判断标准(或有双圈、水疱、淋巴管炎)的一致性最高(Kappa值为0.82);局部不良反应(双圈、水疱、淋巴管炎等)发生率5IU的(43.0%)高于2IU的(30.4%),差异有统计学意义(χ^(2)=78.68,P<0.001)。结论用TB-PPD进行TST筛查结核菌感染及预防性治疗对象,2IU和5IU分别选择不同的皮肤反应硬结平均直径判断标准,可达到高度一致的结果。

Objective The tuberculin skin test(TST)result of 2IU and 5IU purified protein derivative of tuberculin(TB-PPD)were compared and analyzed to provide evidence for rational use of these two kinds of reagents.Methods Patients who first visited designated tuberculosis medical institutions in Xicheng district and Changping district of Beijing were selected to receive TST with 5IU on the left and 2IU on the right arms,respectively,after informed consent was signed.The result were compared and analyzed.Results Comparative analysis of TST skin responses in 444 patients showed that the difference in the average diameter of induration between 5IU and 2IU were significant(Z=-17.21,P<0.01).The median difference value of the two agents were 3 mm.When screening for tuberculosis infection,the maximum consistency(Kappa value 0.83)was obtained when the average diameter of skin reaction induration were≥10 mm in 5IU group and≥5 mm in 2IU group,respectively.When screening subjects for preventive treatment,the average diameter of skin reaction induration were≥15 mm in 5IU group and≥10 mm in 2IU group(or blister,double-loop,lymphangitis)respectively,with the highest consistency(Kappa value 0.82).The incidence of local adverse reactions(blister,double-loop,or lymphangitis)with 5IU(43.0%)was higher than that with 2IU(30.4%),and the difference was statistically significant(χ^(2)=78.68,P<0.001).Conclusions TB-PPD was used for TST screening in tuberculosis infection and preventive treatment.The highly consistent result could be achieved by different criteria of mean diameter of skin reaction induration with 2IU and 5IU respectively.