中医外治法治疗产后身痛的临床证据图谱分析

Analysis on Clinical Evidence Map of External Treatment of Traditional Chinese Medicine for Postpartum Musculoskeletal Pains

摘要:

目的：运用证据图谱系统分析中医外治法治疗产后身痛的临床研究现状，明确当前领域证据缺口与发展方向。方法：系统梳理2015年1月—2025年7月中、英文数据库的89篇文献［随机对照试验（RCTs）79篇、非随机对照实验（n-RCTs） 7篇、观察性研究1篇、Meta分析1篇、指南1篇］，分析中医外治法治疗产后身痛的临床证据分布特征。结果：①研究热度在2020年达顶峰后呈波动式下降，样本量集中在60～90例、干预周期以10～30天为主。②干预措施共54种，分为4类，以单一中医外治法（41.4%） 最常见，其中灸法（26.4%） 应用最广。③仅30篇文献明确中医证型，且证型表述混杂，标准不一；其中气血两虚型占比最高（8.0%），与温针灸关联最集中，其余证型均存在同一证型对应多种治法的情况，虽各治法均有临床疗效，但证型与治法的匹配无规范标准、选择零散。④结局指标以临床疗效（83.9%） 和疼痛（75.9%） 为主，心理状况、生活质量等指标关注不足。⑤方法学质量亟待提升，RCTs存在随机方法、分配隐藏不规范及盲法实施困难等问题，n-RCTs存在样本量估算、随访时间等不足，Meta分析主要在研究方案注册、发表偏倚及异质性分析解释存在问题，指南在临床应用性方面存在不足。结论：中医外治法治疗产后身痛虽有一定优势，但现有研究质量普遍不高，证型与治法匹配无规范标准，结局评价指标单一。未来需聚焦研究设计标准化、证型与治法匹配规范化，完善多维结局评价体系，为临床提供更高级别的循证证据。

Abstract:

Abstract： Objective： To systematically analyze the clinical research status of external treatment of traditional Chinese medicine for postpartum musculoskeletal pains by using the evidence map system，and to clarify the evidence gap and development direction in the current research field. Methods： A systematic review of 89 articles [79 on randomized controlled trials （RCTs），7 non-randomized controlled trials （n-RCTs），1 observational study，1 metaanalysis， and 1 guideline] in Chinese and English databases from January 2015 to July 2025 was conducted to analyze the clinical evidence distribution characteristics of external treatment of traditional Chinese medicine for postpartum musculoskeletal pains. Results：① The research heat showed a fluctuating decline after reaching its peak in 2020. The sample size mostly ranged from 60 to 90 cases， and the intervention period was mainly from 10 to 30 days. ② There were 54 kinds of intervention measures， which were divided into 4 categories. Single external treatment of traditional Chinese medicine （41.4%） was the most common，of which moxibustion （26.4%） was the most widely used. ③ Only 30 articles clearly defined traditional Chinese medicine syndrome types， and the expressions of syndrome types were mixed and the standards were different. Among them， dual deficiency of qi and blood type accounted for the highest proportion （8.0%），which was mostly related to warm needle moxibustion. All other syndrome types had the situation that one single syndrome type corresponds to multiple therapeutic methods. Although each method showed clinical efficacy，no standardized criteria exist for matching syndrome types to therapies，leading to scattered therapy selection. ④ The outcome indicators were mainly clinical efficacy （83.9%） and pain （75.9%）， and indicators such as psychological status and quality of life were not paid enough attention. ⑤ The methodological quality needed to be improved urgently. RCTs had problems such as random methods，non-standard allocation concealment，and difficulty in implementing blind methods. n-RCTs showed deficiencies in areas such as sample size estimation and follow-up time. Meta-analysis mainly had problems in research program registration，publication bias，and heterogeneity analysis and interpretation. There were also deficiencies in the clinical application of the guidelines. Conclusion： Although the external treatment of traditional Chinese medicine has certain advantages in treating postpartum musculoskeletal pains， the quality of existing research is generally not high， there are no standardized criteria for the matching of syndrome types and therapeutic methods，and the outcome evaluation index is single. In the future，it is necessary to focus on the standardization of research design，syndrome type and treatment matching，and the improvement of multidimensional outcome evaluation system，thus providing higher-level evidence-based evidence for clinical practice.