十全大补汤干预围手术期气血两虚型乳腺癌患者转移性生物标志物的随机双盲对照研究
Intervention of Shiquan Dabu Decoction on metastatic biomarkers in breast cancer patients with syndrome of qi and blood deficiency during perioperative period: A double-blinded randomized controlled trial
- 上海中医药大学学报 2021年35卷第6期 页码：31-36
- 作者机构：
1.上海中医药大学附属普陀医院中医肿瘤科（上海 200062）
- 作者简介：
杨玉雪，女，硕士，医师，主要从事中西医结合治疗乳腺癌的临床研究
袁旭，主治医师；E-mail：eraft@163.com
- 基金信息：上海市普陀区科技创新基金（卫生）项目(ptkwws201715)
DOI：10.16306/j.1008-861x.2021.06.005
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杨玉雪, 谢曼丽, 陈彬, 等. 十全大补汤干预围手术期气血两虚型乳腺癌患者转移性生物标志物的随机双盲对照研究[J]. 上海中医药大学学报, 2021,35(6):31-36.
YANG Yuxue, XIE Manli, CHEN Bin, et al. Intervention of Shiquan Dabu Decoction on metastatic biomarkers in breast cancer patients with syndrome of qi and blood deficiency during perioperative period: A double-blinded randomized controlled trial[J]. Academic Journal of Shanghai University of Traditional Chinese Medicine, 2021,35(6):31-36.
杨玉雪, 谢曼丽, 陈彬, 等. 十全大补汤干预围手术期气血两虚型乳腺癌患者转移性生物标志物的随机双盲对照研究[J]. 上海中医药大学学报, 2021,35(6):31-36. DOI： 10.16306/j.1008-861x.2021.06.005.
YANG Yuxue, XIE Manli, CHEN Bin, et al. Intervention of Shiquan Dabu Decoction on metastatic biomarkers in breast cancer patients with syndrome of qi and blood deficiency during perioperative period: A double-blinded randomized controlled trial[J]. Academic Journal of Shanghai University of Traditional Chinese Medicine, 2021,35(6):31-36. DOI： 10.16306/j.1008-861x.2021.06.005.
摘要
目的：,2,观察十全大补汤对围手术期气血两虚型乳腺癌患者转移性生物标志物的影响。,方法：,2,采用随机双盲对照研究方法，纳入81例拟行乳腺癌改良根治术的患者，随机分为治疗组41例和对照组40例。所有患者均行乳腺癌改良根治术治疗，术后给予西医常规治疗。治疗组患者于术前第3天起给予十全大补汤颗粒剂口服治疗，对照组患者给予安慰剂颗粒剂口服，仅手术当天停服，两组疗程均为14 d。比较两组患者的中医证候总积分及中医证候疗效；术前第3天及术后第3天、第7天，检测患者的血清白介素（IL）-6、IL-8、IL-10、C反应蛋白（CRP）水平，并检测患者的CD3+、CD8+T淋巴细胞及自然杀伤细胞（NK细胞）百分比；术后第1天、第4天、第7天，测量并比较两组患者手术切口引流液的质量。,结果：,2,研究过程中，治疗组1例患者脱落，最终治疗组40例、对照组40例患者纳入统计分析。①中医证候：术后第7天，治疗组患者的中医证候总积分较术后第1天明显降低（,P,<,0.05），且治疗组患者的总积分低于对照组（,P,<,0.05）；术后第7天，治疗组患者的中医证候疗效总有效率为52.5%，对照组为22.5%，治疗组的疗效优于对照组（,P,<,0.05）。②免疫指标：术后第3天、第7天，治疗组患者的CD3+T淋巴细胞及NK细胞百分比较术前明显升高（,P,<,0.05），且治疗组患者的CD3+T淋巴细胞及NK细胞百分比高于对照组（,P,<,0.05）。③炎症指标：术后第3天、第7天，治疗组患者的IL-6水平较术前明显降低（,P,<,0.05）；术后第7天，对照组患者的IL-6水平较术前亦明显降低（,P,<,0.05）；且术后第3天、第7天，治疗组患者的IL-6水平低于对照组（,P,<,0.05）。术后第7天，治疗组患者的IL-8水平较术前明显降低（,P,<,0.05），且明显低于对照组（,P,<,0.05）。术后第3天、第7天，两组患者的CRP水平较术前均明显升高（,P,<,0.05）；而术后第7天，治疗组患者的CRP水平明显低于对照组（,P,<,0.05）。④术后引流液质量：术后第4天、第7天，治疗组患者手术切口引流液质量较对照组明显减少（,P,<,0.05）。,结论：,2,十全大补汤干预围手术期气血两虚型乳腺癌患者，能够有效改善患者的临床证候，抑制术后炎症反应及血管生成，提高患者的免疫功能。
Abstract
Objective:,2,To observe the effects of Shiquan Dabu Decoction on metastatic biomarkers in breast cancer patients with syndrome of qi and blood deficiency during perioperative period.,Methods:,2,A randomized double-blinded controlled study was performed.A total of 81 breast cancer patients undergoing modified radical mastectomy were enrolled, and randomly divided into the treatment group(41 cases) and control group(40 cases) .All patients were treated with modified radical mastectomy for breast cancer, and treated with conventional western medicine after operation.The patients in the treatment group were orally treated with Shiquan Dabu Decoction granules from the 3rd day before operation, and the patients in the control group were orally treated with placebo granules.The granules were only stopped on the day of operation, and the treatment course of both groups was 14 days.The total score of Chinese medical syndrome and the efficacy of Chinese medical syndrome were compared between the two groups.On the 3rd day before operation and the 3rd and 7th days after operation, the serum levels of interleukin(IL) -6, IL-8, IL-10 and C-reactive protein(CRP) were detected, and the percentages of CD3+, CD8+T lymphocytes and natural killer cells(NK cells) were detected.On the 1st, 4th and 7th days after operation, the mass of surgical incision drainage fluid was measured and compared between the two groups.,Results:,2,During the study, one patient in the treatment group shed off, finally 40 patients in the treatment group and 40 patients in the control group were included for the statistical analysis.①Chinese medical syndrome: On the 7th day after operation, the total score of Chinese medical syndrome in the treatment group was significantly decreased compared with that on the 1st day after operation(,P,<,0.05), and the total score of the treatment group was lower than that of the control group(,P,<,0.05) .On the 7th day after operation, the total effective rate on Chinese medical syndrome was 52.5% in the treatment group and 22.5% in the control group, and the efficacy of the treatment group was better than that of the control group(,P,<,0.05) .②Immune indexes: On the 3rd and 7th days after operation, the percentages of CD3+T lymphocytes and NK cells in the treatment group were significantly increased compared with those before operation(,P,<,0.05), and the percentages of CD3+T lymphocytes and NK cells in the treatment group were higher than those in the control group(,P,<,0.05) .③Inflammatory indicators: On the 3rd and 7th days after operation, the level of IL-6 in the treatment group was significantly decreased compared with that before operation(,P,<,0.05) .On the 7th day after operation, the level of IL-6 in the control group was also significantly decreased compared with that before operation(,P,<,0.05) .And on the 3rd and 7th days after operation, the level of IL-6 in the treatment group was lower than that in the control group(,P,<,0.05) .On the 7th day after operation, the level of IL-8 in the treatment group was significantly decreased compared with that before operation(,P,<,0.05), and was significantly lower than that in the control group(,P,<,0.05) .On the 3rd and 7th days after operation, the level of CRP in both groups was significantly increased compared with that before operation(,P,<,0.05) ; while on the 7th day after operation, the level of CRP in the treatment group was significantly lower than that in the control group(,P,<,0.05) .④The mass of postoperative drainage fluid: On the 4th and 7th days after operation, the mass of surgical incision drainage fluid in the treatment group was significantly less than that in the control group(,P,<,0.05) .,Conclusion:,2,The intervention of Shiquan Dabu Decoction can effectively improve the clinical syndrome, inhibit the postoperative inflammatory response and angiogenesis, and enhance the immune function of breast cancer patients with syndrome of qi and blood deficiency during perioperative period.
关键词
乳腺癌围手术期气血两虚型十全大补汤转移性生物标志物随机双盲对照试验
Keywords
breast cancerperioperative periodsyndrome of qi and blood deficiencyShiquan Dabu Decoctionmetastatic biomarkerdouble-blinded randomized controlled trial
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