| 引用本文:左政1,2，李文辉3，陈德滇3，刘德权3，聂建云3，朱勉生2,4，鞠丽雅5，Jean-Pierre Armand5,Mahasti Saghatchian5,Caroline Barry5,Bernard Asselain5，李云芬3，王炜宇8，刘亮先6，宋冉7，黄梅6，包雄英1，王玲玲1，王英浩1，严梅3，李春香3，王常安3，刘莉娟3，袁恺1，马琼3，马瑞敏3，陈春信4，Mathieu Noel4.时空针灸灵龟八法干预乳腺癌术后化疗疲劳国际临床试验预试验方案的可行性分析[J].世界中医药,2019,(08):. |
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| 时空针灸灵龟八法干预乳腺癌术后化疗疲劳国际临床试验预试验方案的可行性分析 |
| Feasibility Analysis on Space-time Acupuncture Program of Eight Methods of Sacred Tortoise in the Intervention of Postoperative Chemotherapy Fatigue in Breast Cancer |
| 投稿时间：2019-06-15 |
| DOI：10.3969/j.issn.1673-7202.2019.08.007 |
| 中文关键词: 针灸 时空针灸灵龟八法 乳腺癌CRF 可行性分析 |
| English Keywords:Acupuncture Space-time acupuncture of eight methods of sacred tortoise Breast cancer CRF Program security analysis |
| 基金项目:云南省院士(专家)工作站—朱勉生专家工作站项目(云科合发［2016］4号)；云南省重点研发计划项目（国际科技合作）（2018IA059） |
| 作者 | 单位 | | 左政1,2，李文辉3，陈德滇3，刘德权3，聂建云3，朱勉生2,4，鞠丽雅5，Jean-Pierre Armand5,Mahasti Saghatchian5,Caroline Barry5,Bernard Asselain5，李云芬3，王炜宇8，刘亮先6，宋冉7，黄梅6，包雄英1，王玲玲1，王英浩1，严梅3，李春香3，王常安3，刘莉娟3，袁恺1，马琼3，马瑞敏3，陈春信4，Mathieu Noel4 | 1 云南中医药大学针灸推拿康复学院,昆明,650500； 2 北京中医药大学,北京,102488； 3 云南省肿瘤医院,昆明,650106； 4 时空针灸研究院,巴黎，75013； 5 欧洲精准医学平台,巴黎，75013； 6 昆明市中医院，昆明，650051； 7 昆明圣约翰康复医院,昆明,650033； 8 北京博识科技有限公司,北京,100023 |
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| 中文摘要: |
| 目的：乳腺癌癌因性疲乏（CRF）在乳腺癌中普遍存在，并且可以发生在乳腺癌治疗的各个阶段，对CRF进行有效干预已成为乳腺癌患者顺利进行术后化疗的重要条件。时空针灸是朱勉生教授在古代按时取穴方法基础上吸纳欧洲医学文化理念总结出来的一种新针法。本预试验旨在通过法国专家设计的严格的随机对照临床试验方案探讨时空针灸灵龟八法干预乳腺癌CRF的安全性及可行性。方法：按照纳排标准入组有效病例40例，按照2:1:1比例随机分成3组：时空针灸灵龟八法组20例、非经非穴针灸组10例、空白对照组（单纯辅助化疗治疗）10例。在辅助化疗全过程中，针灸组每周接受一次针刺治疗。40例入组患者在T1：基线、T2：表阿霉素+环磷酰胺（EC）4个周期后、T3：紫杉醇4个周期后、T4：化疗后1个月这4个时间点进行量表测评及外周血检测。本预试验40例已全部出组。本文从试验的可行性、安全性等方面对时空针灸灵龟八法试验方案进行评价，为下一步临床试验提供经验和依据。结论：本试验方案可操作性强、安全，患者依从性好。针灸方案贯穿了中医望闻问切的诊断方法、“辨证论治”的理念、“因时、因地、因人”及“治病求本”的治疗原则，实现了中医个体化治疗同临床试验规范化要求的紧密结合。 |
| English Summary: |
| Cancer-ralated fatigue(CRF)of breast cancer is common in breast cancer and can occur in all stages of breast cancer treatment.Whether the effective intervention of CRF can be operated has become an important guarantee for breast cancer patients to maintain the smooth progress of postoperative chemotherapy.Space-time acupuncture is a new acupuncture method summarized by Professor Zhu Miansheng on the basis of an ancient method of acupoint selection in line with time and the absorption of European medical culture.According to Professor Zhu Miansheng's long-term clinical experience and preliminary clinical observation，the space-time acupuncture of eight methods of sacred tortoise(SAEMST)for breast cancer CRF intervention has strong clinical operability and a good application prospect，and the curative effect is relatively positive，which can effectively improve the fatigue and other symptoms caused by the tumor itself or tumor treatment，and improve the quality of life of patients.This project aims to explore the effectiveness，safety and feasibility of the SAEMST for the intervention of breast cancer CRF through a strict experimental design.Methods:A total of 40 patients adopting early-stage chemotherapy after breast cancer operation in Yunnan Cancer Hospital from March 2018 to May 2019 were selected as research objects，and they were randomly divided into 3 groups：SAEMST group，acupuncture of non-meridian and non-acupoint(ANN)group，and blank control group(simple adjuvant chemotherapy treatment).According to the ratio of 2:1:1，there were 20 cases in the SAEMST group，10 cases in the ANN group，and 10 cases in the blank control group.The 3 groups of patients were enrolled and underwent relevant operations.During the whole process of adjuvant chemotherapy，except the blank control group，the other 2 groups received acupuncture treatment once a week.Scale assessments and peripheral blood tests were performed at 4 time points.T1：baseline; T2：after 4 cycles of epirubicin+cyclophosphamide(EC); T3：after 4 cycles of taxol; and T4：the end of 1 month after the chemotherapy.At present，all the patients in this project are out of the groups.This paper evaluates the experimental program of SAEMST from aspects of feasibility，safety and effectiveness of the experiment，so as to provide experience and evidence for the further clinical trial in the next step.Conclusion:This program has strong operability，with good patient compliance，as well as safe and effective clinical operation.This acupuncture program runs through the diagnosis methods of inspection，listening and smelling，inquiring and pulse-taking and palpation，the concept of “ syndrome differentiation and treatment”，the treatment principles of “depending on time，place and person” and “treatment aming at its root causes” in traditional Chinese medicine(TCM)，and realizes the organic combination of TCM individualized treatment with the requirements of clinical trial standardization，which is repeatable in clinical trials and treatment. |
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