目的：研究中药当归芍药散对外周血T淋巴细胞转录因子GATA-3和T-bet mRNA表达的影响，初步探讨其用于治疗不明原因反复自然流产的可能性。方法：体外分离提取11例志愿者外周血单核细胞，在含有或不含当归芍药散的培养液中培养24h，用实时定量PCR技术检测GATA-3和T-bet mRNA的表达。结果：用10 μg/mL浓度当归芍药散处理后,单核细胞中GATA-3 mRNA的含量与对照组比较显著增高（P＜0.05)。当归芍药散处理细胞后，T-bet mRNA的表达水平呈降低趋势，当浓度为100 μg/mL时，与对照组比较有显著性差异（P＜0.05)。结论：当归芍药散可上调转录因子GATA-3 mRNA的表达或下调T-bet mRNA的表达,从而可能通过调节Th2/Th1平衡向Th2偏移、对于Th1反应异常增强的不明原因反复自然流产有一定的治疗潜能。
Objective To define an objective evaluation model for metadata integrity of randomized controlled trials (RCTs) in traditional Chinese medicine (TCM), and to evaluate the data integrity of RCT reports published in TCM journals. Methods Retrieving Chinese medicine RCT literature and extracting data, using the metadata specification list and customized evaluation model defined in the project "Intelligent Construction and Application Demonstration of the Evidence System of Chinese Medicine Dominant Diseases" to analyze RCTs from the perspective of data integrity. Results A metadata interface specification and an objective evaluation model for RCT metadata integrity were proposed. A total of 37 361 articles of 10 diseases from 1986 to 2020 were evaluated. Among them, 6 743 reports failed to meet the basic requirements of metadata specifications. The proportion of reports with no missing required items was between 73% and 97%. "tcm_disease" and "num_drop_total" had a greater impact on completeness for the required items. The reporting rates of the items in the "age_sd" and "history_sd" in the "group" section, and "dosage", "dosage_form" and "dosage_freq" in the "interventions" section were low. The average score of RCT report was 71.39 points. Conclusions There is room for improvement in the integrity of RCT data in TCM, and data reporting is urgently required to be standardized. The metadata specification and completeness objective evaluation model proposed in this study can provide references for improving the data integrity of clinical trial reports of TCM.