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1.郑州澍青医学高等专科学校,郑州 450064
2.河南省人民医院,郑州 450003
3.河南中医药大学 第三附属医院,郑州 450008
潘思影,讲师,从事妇科肿瘤方向研究工作, E-mail:psy23685@163.com
刘俊保,博士,主任医师/教授,从事中医防治肿瘤的研究工作, E-mail:hjh1563783@163.com
收稿日期:2020-07-17,
网络出版日期:2020-09-15,
纸质出版日期:2021-03-05
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潘思影,张丹,王秀芬等.定坤丹辅助治疗对子宫内膜癌术后放化疗患者的影响[J].中国实验方剂学杂志,2021,27(05):111-116.
PAN Si-ying,ZHANG Dan,WANG Xiu-fen,et al.Effect of Dingkundan in Adjuvant Treatment of Patients with Radiotherapy and Chemotherapy After Endometrial Carcinoma Operation[J].Chinese Journal of Experimental Traditional Medical Formulae,2021,27(05):111-116.
潘思影,张丹,王秀芬等.定坤丹辅助治疗对子宫内膜癌术后放化疗患者的影响[J].中国实验方剂学杂志,2021,27(05):111-116. DOI: 10.13422/j.cnki.syfjx.20201233.
PAN Si-ying,ZHANG Dan,WANG Xiu-fen,et al.Effect of Dingkundan in Adjuvant Treatment of Patients with Radiotherapy and Chemotherapy After Endometrial Carcinoma Operation[J].Chinese Journal of Experimental Traditional Medical Formulae,2021,27(05):111-116. DOI: 10.13422/j.cnki.syfjx.20201233.
目的
2
观察定坤丹辅助治疗子宫内膜癌(EC)术后放化疗患者临床症状、生活质量、免疫功能及预后的影响研究。
方法
2
采用随机按数字表法,将168例患者分为对照组82例和观察组86例。对照组脱落、失访4例,剔除3例,最终完成75例,观察组脱落、失访5例,剔除4例,最终完成77例。两组术后根据危险因素进行给予近距离腔内放疗、盆腔外照射、化疗等措施。对照组口服八珍丸,1丸/次,2次/d;观察组口服定坤丹,7 g/次,2次/d。两组疗程均为治疗4个月,并进行长期随访。治疗前、治疗后2和4个月进行气血两虚证评分;记录放、化疗的毒性反应,比较3级及以上急性和晚期膀胱、直肠放射性损伤的发生率,比较3度及以上化疗药物毒性反应的发生率;检测治疗前后T淋巴细胞亚群(CD3
+
,CD4
+
,CD8
+
,CD4
+
/CD8
+
);进行治疗前后欧洲生命质量协作组癌症核心量表(EORTC QLQ-C30)评价;检测治疗前后癌胚抗原125(CA125),人附睾蛋白4(HE4),Dickkopf相关蛋白1(DKK1),血管内皮生长因子(VEGF),基质金属蛋白酶-9(MMP-9)和转化生长因子-
β
1
(TGF-
β
1
)水平;每3个月随访1次,记录病情进展(复发/转移)情况。
结果
2
观察组在治疗后2和4个月的气血两虚证积分均低于对照组(
P
<
0.01);观察组3级及以上膀胱和直肠的急性放射反应和晚期放射损伤的发生率均低于对照组(
P
<
0.05);观察组3度以上化骨髓抑制、消化道毒性、神经毒性的发生率均低于对照组(
P
<
0.05);观察组EORTC QLQ-C30量表的5个功能维度和整体生存质量评分均高于对照组(
P
<
0.01),3个症状维度评分均低于对照组(
P
<
0.01);观察组CD3
+
,CD4
+
,CD4
+
/CD8
+
均高于对照组,CD8
+
低于对照组(
P
<
0.01);观察组CA125,HE4,DKK1,VEGF,MMP-9和TGF-
β
1
均低于对照组(
P
<
0.01);观察组病情进展率为18.18%(14/77),低于对照组的33.33%(25/75)(
χ
2
=4.572,
P
<
0.05)。
结论
2
定坤丹辅助治疗EC术后放化疗患者,可减轻气血两虚证症状和放射治疗和化疗导致的毒副反应,提高了生活质量和免疫功能,抑制了肿瘤标志物和肿瘤生长因子的表达,改善了肿瘤的进展,从而改善了预后。
Objective
2
To observe the effect of Dingkundan in adjuvant treatment of clinical symptoms, quality of life, immune function and prognosis of patients with radiotherapy and chemotherapy after endometrial carcinoma (EC) operation.
Method
2
Patients were divided into control group (82 cases) and observation group (86 cases) according to random number table. A total of 75 patients in control group completed the study (4 patients fell off or lose visit, and 3 patients were eliminated), while 77 patients in observation group completed the study (5 patients fell off or lose visit, and 4 patients were deleted). After operation, patients got brachytherapy, external pelvic irradiation and chemotherapy. Patients in control group got Bazhenwan, 1 pill/time, 2 times/day, and those in observation group got Dingkundan, 7 g/time, 2 times/day. The course of treatment lasted for 4 months, and long-time follow-up data was recorded. Before treatment, and at the second and fourth month after treatment, deficiency of Qi and blood was scored. Toxic reactions after radiotherapy and chemotherapy were recorded, and incidence rate of acute and advanced radiation injury of bladder and rectum and toxicity of chemotherapeutic drugs at grade 3 or above grade 3 level were compared. And levels of T lymphocyte subsets (CD3
+
, CD4
+
, CD8
+
and CD4
+
/CD8
+
) were detected, European collaborative quality of life Cancer Core Scale (EORTC QLQ-C30) was evaluated, and expressions of pce125 (CA125), epididymis protein 4 (HE4), Dickkopf-related protein-1 (DKK1), vascular endothelial growth factor (VEGF), matrix metalloproteinase-9 (MMP-9) and transforming growth factor-
β
1
(TGF-
β
1
) were tested before and after treatment. The follow-up was made for every three months, and the progression (recurrence/metastasis) of patients was recorded.
Result
2
Scores of deficiency of Qi and blood in observation group were lower than those in control group at the second and fourth week after treatment (
P
<
0.01). Incidence rates of acute and advanced radiation injury of bladder and rectum and toxicity of chemotherapeutic drugs at grade 3 or above grade 3 level and incidence rates of bone marrow suppression, gastrointestinal toxicity, neurotoxicity were lower than those in control group (
P
<
0.05). Five functional dimensions and overall quality of life score based on EORTC and QLQ-C30 in observation group were higher than those in control group (
P
<
0.01), and scores of three symptom dimensions were lower than those in control group (
P
<
0.01). Levels of CD3
+
, CD4
+
and CD4
+
/CD8
+
were higher than those in the control group (
P
<
0.01), and CD8
+
was lower than those in the control group (
P
<
0.01). Levels of CA125, HE4, DKK1, VEGF, MMP-9 and TGF-
β
1
were lower than those in the control group (
P
<
0.01). The disease progression rate in observation group was 18.18% (14/77), which was lower than 33.33% (25/75) in control group (
χ
2
=4.572,
P
<
0.05).
Conclusion
2
In adjuvant treatment of patients with radiotherapy and chemotherapy after EC operation, Dingkundan can reduce the symptoms of Qi and blood deficiency syndrome and side effects caused by radiotherapy and chemotherapy, improve the quality of life and immune function, inhibit the expression of tumor markers and tumor growth factor, delay the progression of tumor and improve the prognosis.
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