| 标题： | 乳腺癌内分泌治疗骨不良事件的中医证候诊断标准 |
| title： | Diagnostic Criteria for Traditional Chinese Medicine Syndromes of Bone-related Adverse Events in Breast Cancer Endocrine Therapy |
| 版本： | 原创版 |
| version： | Original |
| 分类： | 标准 |
| classification： | Standard |
| 领域： | 诊断 |
| field： | Diagnosis |
| 国家和地区： | 中国 |
| Country and region： | China |
| 指南使用者： | 中医师、西医师、中西医结合医师 |
| Guide users： | Physicians of traditional Chinese medicine, western medicine, and integrated traditional Chinese and western medicine |
| 证据分级方法： | 采用推荐意见分级的评估、制定及评价（grading of recommendations assessment, development and evaluation, GRADE）系统对证据级别及其推荐级别进行分类。考虑中医证候等内容的特殊性，将结合专家认可度做调整。 |
| Evidence grading method： | Grading of recommendations assessment, development and evaluation（GRADE）. And considering the special nature of TCM syndromes and the importance of expert recognition, adjustments will be made in conjunction with the level of expert endorsement. |
| 制定单位： | 上海市中医药学会乳腺病分会，上海中医药大学附属龙华医院 |
| Formulating unit： | Shanghai Association of Traditional Chinese Medicine for Breast Diseases, and Longhua Hospital Affiliated with Shanghai University of Traditional Chinese Medicine. |
| 注册时间： | 2024-09-07 |
| Registration time： | |
| 注册编号： | PREPARE-2024CN435 |
| Registration number： | |
| 指南制订的目的： | 我国激素受体阳性的乳腺癌患者约占所有患者的 2/3，此类患者应接受内分泌治疗，常用药物以他莫昔芬（TAM）和第三代芳香化酶抑制剂（AI）等为代表，内分泌治疗的期限为 5 年，部分可延长至10年。而卵巢功能抑制 （OFS）联合AI的绝经前患者生存情况亦受关注。乳腺癌术后内分泌治疗期相关不良反应被广泛关注，尤其是骨不良事件。针对骨关节酸胀、活动不利、疼痛甚至骨折的发生，中医药具有明确疗效。中医药与现代医学内分泌治疗协同应用可以发挥各自优势，取长补短，为改善内分泌治疗的依从性降低，提升患者生活质量提供了重要帮助。 但目前尚无相关标准就乳腺癌内分泌治疗骨不良事件的中医证候诊断进行论述，而中医在辨证论治理论体系的指导下明确这一标准十分重要。制定出严谨规范的循证医学证据，规范乳腺癌内分泌治疗期改善骨相关不良事件的中医证候标准，为中医、西医、中西医结合医师提供标准化的治疗方案奠定基础。 |
| Purpose of the guideline： | Breast cancer patients with positive hormone receptors account for about two-thirds of all patients in our country. Such patients should receive endocrine therapy, with common drugs represented by tamoxifen (TAM) and third-generation aromatase inhibitors (AI). The duration of endocrine therapy is 5 years, and some can be extended to 10 years. The survival of premenopausal patients with ovarian function suppression (OFS) combined with AI is also of concern. Adverse reactions related to postoperative endocrine therapy for breast cancer, especially bone adverse events, have attracted widespread attention. In response to symptoms such as bone and joint soreness, poor mobility, pain, and even fractures, traditional Chinese medicine has distinct therapeutic effects. The perfect integration of traditional Chinese medicine with modern endocrine therapy can exert their respective advantages, complement each other, and provide important help for improving compliance with endocrine therapy and enhancing the quality of life for patients. However, there are currently no standards discussing the diagnosis of traditional Chinese medicine syndromes for bone adverse events during endocrine therapy for breast cancer, and it is very important to clarify this standard under the guidance of the theory system of syndrome differentiation and treatment in traditional Chinese medicine. Formulate rigorous and standardized evidence-based medical evidence, standardize the traditional Chinese medicine syndrome standards for improving bone-related adverse events during the endocrine therapy period of breast cancer, and lay the foundation for standardized treatment plans for traditional Chinese medicine practitioners, Western medicine practitioners, and integrated medicine practitioners. |
