目的：研究中藥當歸芍藥散對外周血T淋巴細胞轉錄因子GATA-3和T-bet mRNA表達的影響，初步探討其用于治療不明原因反復自然流產的可能性。方法：體外分離提取11例志愿者外周血單核細胞，在含有或不含當歸芍藥散的培養液中培養24h，用實時定量PCR技術檢測GATA-3和T-bet mRNA的表達。結果：用10 μg/mL濃度當歸芍藥散處理后,單核細胞中GATA-3 mRNA的含量與對照組比較顯著增高（P＜0.05)。當歸芍藥散處理細胞后，T-bet mRNA的表達水平呈降低趨勢，當濃度為100 μg/mL時，與對照組比較有顯著性差異（P＜0.05)。結論：當歸芍藥散可上調轉錄因子GATA-3 mRNA的表達或下調T-bet mRNA的表達,從而可能通過調節Th2/Th1平衡向Th2偏移、對于Th1反應異常增強的不明原因反復自然流產有一定的治療潛能。
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.