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目的确定中国人血清游离轻链(sFLC)的正常值,评价 sFLC 在多发性骨髓瘤(MM)患者的诊断、疗效判断中的临床意义。方法自动免疫比浊法检测63例健康人 sFLC 水平,确定其正常参考区间。采用同样方法检测72例 MM 患者不同疾病阶段的 sFLC 水平,通过与传统的 M 蛋白检测方法的比较来评价 sFLC 的临床意义。结果 (1)健康人 sFLC-κ、sFLC-λ的95%参考区间分别为(9～29)mg/L、(15～34)mg/L,sFLC-κ/λ比值的中位值为0.59,100%参考区间为0.27～2.49。(2)初治 MM 患者中,κ增高的 MM(κ-MM)患者的 sFLC-κ、sFLC-λ的95%参考区间分别为(53～14 100)mg/L、(0～97)mg/L,sFLC-κ/λ比值中位值为10.27;λ增高的MM(λ-MM)患者的sFLC-κ、sFLC-λ95%参考区间分别为(9～117)mg/L、(205～6875)mg/L,sFLCκ/λ比值中位值是0.005。MM患者 sFLC-κ、sFLC-λ的95%参考区间与健康人间无交叉重叠。96.4%(26/27)初治 MM 患者的sFLCκ/λ比值异常。(3)健康人 sFLC-κ、sFLC-λ均与年龄呈正相关(P 值分别为0.031、0.01),而sFLCκ/λ比值与年龄无相关性(P=0.861)。初治 MM 患者年龄与 sFLC-κ、sFLC-λ浓度及 sFLCκ/λ比值间均无相关性(P 分别为0.287、0.408、0.471)。(4)对于初治患者,检测κ克隆时比浊法与免疫固定法的敏感性和特异性分别是100% vs 73.7%和100% vs 44.4%;检测λ克隆时比浊法与 IFE 法的敏感性和特异性分别是100% vs 68.8%和100% vs 58.3%。对于治疗后达完全缓解的 MM 患者比浊法仍可以检测到单克隆 M 蛋白的存在。结论首次获得了一个中国人 sFLC-κ、sFLC-λ及 sFLCκ/λ的正常参考区间。自动免疫比浊法检测 sFLC 可以提高 MM 患者的初诊时的阳性率和疗效判断准确率。
Objective To determine the normal value of serum sFLC in Chinese and to evaluate the clinical significance of sFLC in the diagnosis and treatment of multiple myeloma (MM). Methods The levels of sFLC in 63 healthy volunteers were detected by automatic immunoturbidimetry and their normal reference intervals were determined. The same method was used to detect sFLC levels in 72 MM patients at different stages of disease. The clinical significance of sFLC was evaluated by comparison with traditional M protein detection methods. Results The 95% reference intervals of sFLC-κ and sFLC-λ were (9-29) mg / L and (15-34) mg / L, respectively. The median sFLC-κ / λ ratio was 0.59 , 100% reference interval is 0.27 ~ 2.49. (2) The 95% reference intervals of sFLC-κ and sFLC-λ in newly diagnosed MM patients were (53 ~ 14 100) mg / L, (0 ~ 97) mg / L and the median sFLC-κ / λ ratio was 10.27. The sFLC-κ and sFLC-λ95% of the patients with elevated λ (MM) were 9 to 117 mg / L, 6875) mg / L, with a median sFLCK / λ ratio of 0.005. The 95% reference interval for sFLC-κ and sFLC-λ in MM patients did not overlap with healthy subjects. In 96.4% (26/27) patients with untreated MM, sFLCκ / λ ratio was abnormal. (3) There was a positive correlation between sFLC-κ and sFLC-λ in healthy subjects (P = 0.031,0.01, respectively), while there was no correlation between sFLCκ / λ and age (P = 0.861). The age of newly diagnosed MM patients had no correlation with sFLC-κ, sFLC-λ and sFLCκ / λ ratios (P = 0.287,0.408,0.471, respectively). (4) The sensitivity and specificity of nephelometry and immunostaining assays for kappa clones in naive patients were 100% vs 73.7% and 100% vs 44.4%, respectively; for turbidimetric and IFE assays at λ clones Sensitivity and specificity were 100% vs 68.8% and 100% vs 58.3%, respectively. The turbidimetric method could still detect the presence of monoclonal M protein in MM patients who achieved complete remission after treatment. Conclusion For the first time, we obtained a normal reference interval of sFLC-κ, sFLC-λ and sFLCκ / λ in Chinese. Autoimmunoturbidimetric detection of sFLC can improve the positive rate of MM patients at the time of first diagnosis and efficacy to determine the accuracy.