查看更多>>摘要：目的 探讨单克隆丙种球蛋白（M蛋白）在临床就诊患者中的特点与分布规律。 方法 选择2012年1月至2021年12月在复旦大学附属中山医院就诊并进行毛细管区带电泳的936 171例患者（男508 449例，女427 722例），筛选出异常条带的14 945例患者作为研究对象，男10 173例，女4 772例，年龄21~102（65±13）岁。按年龄分为21~30岁（168例）、31~40岁（405例）、41~50岁（1 326例）、51~60岁（3 068例）、61~70岁（4 985例）、71~80岁（3 288例）、81~90岁（1 519例）、≥91岁（186例）共8组。收集14 945例检出异常条带患者的诊断结果，按有无肿瘤分为肿瘤组（5 196例）和非肿瘤性组（9 749例）。回顾性分析不同性别、年龄和疾病组中异常条带分布情况。14 945例患者中，4 988例进行了免疫固定电泳试验，排除336例阴性和412例双克隆条带反应，以具有单克隆免疫球蛋白（M蛋白）反应的4 240例患者为研究对象，男2 794例，女1 446例，年龄21~102（67±12）岁。按年龄分为21~30岁（18例）、31~40岁（91例）、41~50岁（364例）、51~60岁（862例）、61~70岁（1 455例）、71~80岁（904例）、81~90岁（486例）、≥91岁（60例）共8组，收集患者的诊断结果与免疫球蛋白（Ig）分型（IgA-κ、IgA-λ、IgG-κ、IgG-λ、IgM-κ、IgM-λ、κ、λ）结果，回顾性分析M蛋白在不同性别、年龄和疾病组的分布情况。 结果 在936 171例患者中，电泳图谱表现出异常条带者为14 945例，检出率为1.60%；其中，男性和女性异常条带检出率分别为2.00%（10 173/508 449）和1.12%（4 772/427 722），差异有统计学意义（P<0.01）。不同年龄组间的异常条带检出率差异有统计学意义（P<0.01）；其中，≥91岁组异常条带检出率最高为5.98%，男女检出比1.67∶1。14 945例异常条带中，51~60、61~70、71~80岁患者分别占20.53%（3 068例）、33.36%（4 985例）和22.00%（3 288例），各年龄组间差异均有统计学意义（χ2=115.82，P<0.01）。肿瘤组中检出异常条带前3位者为浆细胞瘤1 123例，淋巴瘤289例，白血病49例，浆细胞瘤电泳图谱异常条带检出率为89.92%（1 123/1 249），高于淋巴瘤、白血病患者［分别为6.73%（289/4 296）和6.40%（49/766），P均<0.01］。4 240例M蛋白阳性患者中，51~60、61~70、71~80岁分别占20.33%（862/4 240）、34.32%（1 455/4 240）和21.32%（904/4 240），各年龄组间差异有统计学意义（P<0.01）；M蛋白分型结果在不同性别人群中均为IgG-κ型占比最高，男性32.28%（902/2 794），女性34.30%（496/1 446）；在21~30、31~40、41~50岁年龄组中，IgG-λ型占比最高，分别为38.89%（7/18）、36.26%（33/91）、34.07%（124/364）；而在51~60、61~70、71~80、81~90、≥91岁年龄组中，均为IgG-κ型占比最高，分别为33.87%（292/862）、34.16%（497/1 455）、31.53%（285/904）、34.57%（168/486）、28.33%（17/60），不同性别组及各年龄组比较差异均有统计学意义（P均<0.01）。M蛋白阳性的肿瘤患者中，浆细胞瘤占比最高14.22%（603/4 240），其次为淋巴瘤6.30%（267/4 240）；非肿瘤疾病中，M蛋白血症占比最高7.24%（307/4 240），其次是肺部感染5.47%（232/4 240）。 结论 毛细管区带电泳异常条带检出率会随年龄的增长而提高，且同年龄组中，男性异常条带检出率高于女性；不同的恶性肿瘤疾病在毛细管区带电泳中也会出现异常条带，但仍以血液系统的肿瘤为主。M蛋白阳性结果中，61~70岁年龄段人群占比最高；M蛋白类型以IgG型最多见；21~50岁年龄段中，IgG-λ型占比最高；>50岁年龄段中，IgG-κ型占比最高；M蛋白阳性的诊断中，排前3位的疾病均为血液系统疾病，分别为浆细胞瘤、M蛋白血症及淋巴瘤。 Objective To investigate the characteristics and distribution of monoclonal gammopathy in clinical patients. Methods A total of 936 171 patients (508 449 males and 427 722 females) who received capillary zone electrophoresis in Zhongshan Hospital Affiliated to Fudan University from January 2012 to December 2021 were selected, from which 14 945 patients with abnormal bands were screened as the study subjects, including 10 173 males and 4 772 females and the age 21-102 (65±13) years old. According to the age, patients were divided into 8 groups: 21-30 years old (168 cases), 31-40 years old (405 cases), 41-50 years old (1 326 cases), 51-60 years old (3 068 cases), 61-70 years old (4 985 cases), 71-80 years old (3 288 cases), 81-90 years old (1 519 cases), and≥91 years old (186 cases). The diagnostic results of the 14 945 patients with abnormal bands were collected and were divided into tumor group (5 196 cases) and non-tumor disease group (9 749 cases) according to the presence of tumor. The distribution of abnormal bands in different gender, age, and disease groups were retrospectively analyzed. Among the 14 945 patients, 4 988 cases underwent immunofixation electrophoresis, excluding 336 negative cases and 412 cases of double clonal bands reaction, and 4 240 patients with monoclonal immunoglobulin (M protein) reaction were selected as the study subjects, including 2 794 males and 1 446 females aged 21-102 (67±12) years old. They were divided into 8 groups according to the age: 21-30 years old (18 cases), 31-40 years old (91 cases), 41-50 years old (364 cases), 51-60 years old (862 cases), 61-70 years old (1 455 cases), 71-80 years old (904 cases), 81-90 years old (486 cases), and≥91 years old (60 cases). The diagnostic results and immunoglobin subtypes (IgA-κ, IgA-λ, IgG-κ, IgG-λ, IgM-κ, IgM-λ, κ, λ) of patients were collected, and the distribution of monoclonal gammopathy in different gender, age and disease groups were retrospectively analyzed. Results Among 936 171 patients, 14 945 cases showed abnormal bands in electropherograms with a detection rate of 1.60% the detection rates of abnormal bands in males and females were 2.00% (10 173/508 449) and 1.12% (4 772/427 722), respectively, with a statistically significant difference (P<0.01). There was a significant difference in the detection rate of abnormal bands among different age groups (P<0.01) among them, the highest detection rate of abnormal band in group of ≥91 years old was 5.98%, and the ratio of male to female was 1.67∶1. Among the 14 945 cases of abnormal bands, patients aged 51-60, 61-70 and 71-80 accounted for 20.53% (3 068 cases), 33.36% (4 985 cases) and 22.00% (3 288 cases), respectively, and the differences among the age groups were statistically significant (χ2=115.82, P<0.01). In the tumor group, the top 3 tumors with abnormal bands were plasmacytoma with 1 123 cases, lymphoma with 289 cases, and leukemia with 49 cases. The detection rate of abnormal bands in electropherograms of plasmacytoma was 89.92% (1 123/1 249), which was higher than that in lymphoma and leukemia [6.73% (289/4 296) and 6.40% (49/766), respectively,P<0.01]. Among 4 240 patients with positive M protein, the proportion of 51-60, 61-70 and 71-80 years old patients were 20.33% (862/4 240), 34.32% (1 455/4 240) and 21.32% (904/4 240), respectively, and the differences among age groups were statistically significant (P<0.01). The results of M protein types showed that the proportion of IgG-κ type was the highest in both genders, with 32.28% (902/2 794) in males and 34.30% (496/1 446) in females. In the 21-30, 31-40, and 41-50 age groups, the proportion of IgG-λ was the highest, which were 38.89% (7/18), 36.26% (33/91) and 34.07% (124/364) in these groups respectively. However, the proportions of IgG-κ were the highest in either of the 51-60, 61-70, 71-80, 81-90 and ≥91 years old groups, which were 33.87% (292/862), 34.16% (497/1 455), 31.53% (285/904), 34.57% (168/486), 28.33% (17/60), respectively, and the differences among all age groups and gender groups had statistical significance (P<0.01). Among patients with positive M protein in the tumor group, plasmacytoma accounted for 14.22% (603/4 240), followed by lymphoma 6.30% (267/4 240) among non-tumor diseases, M proteinemia accounted for the highest proportion (7.24%, 307/4 240), followed by pulmonary infection (5.47%, 232/4 240). Conclusions The detection rate of abnormal bands in capillary zone electrophoresis may increase with age, and is higher in males than in females in the same age group different malignant tumor diseases can also show abnormal bands in capillary zone electrophoresis, but they are still mainly hematological tumors. Among the positive results of M protein, 61-70 years old group accounts for the highest proportion the most common type of monoclonal gammopathy is IgG type in the age group of 21-50 years, the proportion of IgG-λ type is the highest in the group of >50 years old, the proportion of IgG-κ type is the highest in the diagnosis of positive monoclonal gammopathy, the top 3 diseases are all hematological diseases, including plasmacytoma, monoclonal gammopathies and lymphoma.
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