1.上海中医药大学附属岳阳中西医结合医院,上海市虹口区甘河路110号 ,200437
2.上海中医药大学附属市中医医院
yongmingz@sohu.com;18930568162
收稿:2021-08-11,
修回:2021-11-25,
纸质出版:2022-02-17
移动端阅览
李捷凯,鲍计章,朱文伟等.消瘤方加减治疗化疗后正虚痰凝型弥漫大B细胞淋巴瘤60例临床观察[J].中医杂志,2022,63(04):349-355.
LI Jiekai,BAO Jizhang,ZHU Wenwei,et al.Modified Xiaoliu Formula (消瘤方) for Treatment of 60 Cases of Diffuse Large B-cell Lymphoma after Chemotherapy with Healthy Qi Deficiency and Phlegm Coagulation Pattern[J].Journal of Traditional Chinese Medicine,2022,63(04):349-355.
李捷凯,鲍计章,朱文伟等.消瘤方加减治疗化疗后正虚痰凝型弥漫大B细胞淋巴瘤60例临床观察[J].中医杂志,2022,63(04):349-355. DOI: 10.13288/j.11-2166/r.2022.04.010.
LI Jiekai,BAO Jizhang,ZHU Wenwei,et al.Modified Xiaoliu Formula (消瘤方) for Treatment of 60 Cases of Diffuse Large B-cell Lymphoma after Chemotherapy with Healthy Qi Deficiency and Phlegm Coagulation Pattern[J].Journal of Traditional Chinese Medicine,2022,63(04):349-355. DOI: 10.13288/j.11-2166/r.2022.04.010.
目的
2
观察消瘤方加减对化疗后正虚痰凝型弥漫大B细胞淋巴瘤(DLBCL)患者生活质量、肿瘤负荷情况及机体免疫的影响。
方法
2
收集化疗4~6个疗程结束临床评估为完全缓解或不确定的完全缓解的DLBCL患者60例,随机分为对照组与治疗组各30例。两组患者均遵医嘱随访观察定期复查,入组后每个月进行1次随访。治疗组在此基础上予消瘤方加减口服,2周为1个疗程,共治疗6个疗程。对比两组患者治疗前后中医症状积分、生活质量(EORTC-QLQ-C30)评分、KPS评分、肿瘤负荷指标[包括乳酸脱氢酶(LDH)、β2-微球蛋白(β2-MG)]、免疫球蛋白[包括免疫球蛋白M(IgM)、免疫球蛋白G(IgG)、免疫球蛋白A(IgA)]水平,并判定中医证候疗效、生活质量疗效,计算复发率。
结果
2
治疗组中医证候疗效总有效率为96.67%,明显优于对照组的33.3%,差异有统计学意义(
P
<0.05)。治疗组无复发,对照组复发率为16.67%,差异有统计学意义(
P
<0.05)。治疗组生活质量疗效中好转率(80.00%)高于对照组(13.33%),治疗组恶化率(0)低于对照组(6.67%,
P
<0.01)。与本组治疗前比较,治疗后治疗组疲倦、恶心呕吐、气促、失眠、食欲不振、便秘评分,中医症状积分,LDH、β2-MG水平均明显降低,社会功能、情绪功能、躯体功能、角色功能、总体健康状况评分,IgA、IgG、IgM水平均明显升高(
P
<0.05);对照组中医症状积分明显降低(
P
<0.05),其余指标差异均无统计学意义(
P
>0.05),两组各指标差值比较差异均有统计学意义(
P
<0.05)。
结论
2
消瘤方加减可以有效改善化疗后正虚痰凝型DLBCL患者中医证候,提高生活质量及机体免疫力,有效降低肿瘤负荷指标,并可减少复发。
Objective
2
To observe the effect of Modified
Xiaoliu Formula
(消瘤方) on quality of life, tumor burden and body immunity of diffuse large B-cell lymphoma (DLBCL) patients with healthy
qi
deficiency and phlegm coagulation pattern after chemotherapy.
Methods
2
Sixty DLBCL patients who have been evaluated as complete remission (CR) or uncertain complete remission (CRU) after chemotherapy (4 to 6 treatment courses) were randomly divided into control group and MXF group, with 30 cases in each group. All the patients were required to take follow-up appointment once a month after enrollment. In addition, the patients in the treatment group were given
Xiaoliu Formula
orally, for six courses with two weeks as a course. The traditional Chinese medicine (TCM) symptoms scores, European Organization for Research and Treatment of Cancer quality of life questionnaire core 30 (EORTC-QLQ-C30) scores, Karnofsky performance status (KPS) scores, tumor burden indicators including lactate dehydrogenase (LDH), β2-microglobulin (β2-MG), and immunoglobulin levels including immunoglobulin M (IgM), immunoglobulin G (IgG), immunoglobulin A (IgA) were measured before and after the treatment and compared between groups; the effective rates regarding TCM symptoms and quality of life, as well as the recurrence rate were assessed.
Results
2
The effective rate regarding TCM symptoms in the MXF group was 96.67%, significantly better than 33.3% in the control group, with significant differences(
P
<0.05). No patient relaps in the treatment group, while the recurrence rate was 16.67% in the control group (
P
<0.05). The improvement rate regarding quality of life was 80.00% in the treatment group, higher than 13.33% in the control group; and the deterioration rate was 0.00%, lower than 6.67% of the control group (
P
<0.01). After treatment, scores of fatigue, nausea, vomiting, shortness of breath, insomnia, loss of appetite and constipation, level of LDH and β2-MG decreased significantly, while scores of social function, emotional funtion, physical function, role function and overall health status, as well as level of IgA, IgG, IgM increased significantly (
P
<0.05). In the control group, scores of TCM symptom decreased after treatment (
P
<0.05), while changes of other indexes was not significant (
P
>0.05), and the differences within each group was significantly different (
P
<0.05).
Conclusion
2
Xiaoliu Formula
can effectively improve the TCM symptoms, quality of life, and body immunity of DLBCL patients with healthy
qi
deficiency and phlegm coagulation pattern after chemotherapy, and can reduce tumor burden indicators and recurrence of DLBCL.
LI S , YOUNG KH , MEDEIROS LJ . Diffuse large B-cell lymphoma [J]. Pathology , 2018 , 50 ( 1 ): 74 - 87 .
LIU Y , BARTA SK . Diffuse large B-cell lymphoma: 2019 update on diagnosis,risk stratification, and treatment [J]. Am J Hematol , 2019 , 94 ( 5 ): 604 - 616 .
COIFFIER B , SARKOZY C . Diffuse large B-cell lymphoma: R-CHOP failure-what to do? [J]. Hematology Am Soc Hematol Educ Program , 2016 ,2016( 1 ): 366 - 378 .
BARTLETT NL , WILSON WH , JUNG SH , et al . Dose-adjusted EPOCH-R compared with R-CHOP as frontline therapy for diffuse large B-Cell lymphoma: clinical outcomes of the phase III Intergroup Trial Alliance/CALGB 50303 [J]. J Clin Oncol , 2019 , 37 ( 21 ): 1790 - 1799 .
王永敏 , 郑雪梅 , 刘英 , 等 . 益髓补肾方对恶性淋巴瘤化疗后免疫功能的影响 [J]. 现代中西医结合杂志 , 2017 , 26 ( 27 ): 3014 - 3016 .
王永敏 , 郑雪梅 , 刘英 , 等 . 益髓补肾方改善恶性淋巴瘤化疗患者相关性贫血及对免疫功能的影响 [J]. 中国实验方剂学杂志 , 2017 , 23 ( 19 ): 188 - 193 .
杜美莲 , 周永明 . 周永明教授治疗恶性淋巴瘤经验 [J]. 辽宁中医药大学学报 , 2013 , 15 ( 3 ): 103 - 104 .
李军民 , 管忠震 , 沈悌 , 等 . 中国弥漫大B细胞淋巴瘤诊断与治疗指南(2013年版) [J]. 中华血液学杂志 , 2013 , 34 ( 9 ): 816 - 819 .
陈锐深 . 现代中医肿瘤学 [M]. 北京 : 人民卫生出版社 , 2003 : 729 .
中华人民共和国卫生部 . 中药新药临床研究指导原则 [M]. 北京 : 中国医药科技出版社 , 1995 : 329 - 381 .
孙燕 . 内科肿瘤学 [M]. 北京 : 人民卫生出版社 , 2001 : 996 .
张素平 . 昆藻逆瘤汤加味治疗初治弥漫大B细胞淋巴瘤(气郁痰凝型)的临床疗效观察 [D]. 郑州 : 河南中医药大学 , 2018 .
连粉红 . 抑瘤消核方联合R-CHOP方案治疗弥漫大B细胞淋巴瘤的临床研究 [D]. 兰州 : 甘肃中医药大学 , 2019 .
孙振球 , 徐勇勇 . 医学统计学 [M]. 4版 .北京: 人民卫生出版社 , 2014 : 575 .
国家药典委员会 . 中华人民共和国药典 [M]. 北京 : 中国医药科技出版社 , 2015 : 1088 .
GIESINGER JM , LOTH FLC , AARONSON NK , et al . Thresholds for clinical importance were established to improve interpretation of the EORTC QLQ-C30 in clinical practice and research [J]. J Clin Epidemiol , 2020 , 118 : 1 - 8 . doi: 10.1016/j.jclinepi.2019.10.003 http://dx.doi.org/10.1016/j.jclinepi.2019.10.003 .
方杰 , 王琼 , 江瑞 , 等 . 加用利妥昔单抗对B细胞非霍奇金淋巴瘤患者免疫系统的影响 [J]. 中国药业 , 2015 , 24 ( 14 ): 61 - 62 .
NOLTE S , LIEGL G , PETERSEN MA , et al . General population normative data for the EORTC QLQ-C30 health-related quality of life questionnaire based on 15,386 persons across 13 European countries, Canada and the Unites States [J]. Eur J Cancer , 2019 , 107 ( 11 ): 153 - 163 .
0
浏览量
0
下载量
1
CSCD
关联资源
相关文章
相关作者
相关机构
京公网安备11010102007558号