Decoction piece is the basic unit of traditional Chinese medicine(TCM) prescriptions, and it is also the main material basis for clinical efficacy of TCM. The clinical efficacy of TCM decoction pieces is very important for the overall efficacy of TCM prescriptions. However, the current quality evaluation of TCM decoction pieces mainly focuses on the amount of intrinsic substances and compositions. The basic researches such as toxicology and pharmacology are deeply, but lacking with the evidences from clinical evaluation. Therefore, the current decoction pieces quality evaluation system is difficult to objectively reflect the clinical effect of traditional Chinese medicine, forming the only componential theory or blindly pursuing the large volume and heavy weight of medicine materials. The quality standard of Chinese decoction pieces is biased,with concerns that "TCM will die from Chinese medicine". Therefore, this paper proposes that it is urgent to clinically evaluate the TCM decoction pieces,and regard the clinical evaluation as a starting point and a foothold for the quality evaluation of TCM decoction pieces, based on the origin identification, origin evaluation, product evaluation, content evaluation, and harmful substance detection as an auxiliary support. Finally a new quality evaluation system for TCM decoction pieces with a clinical evaluation as the core is formed, which is composed of six steps, aiming to promote the quality improvement of TCM decoction pieces. Of course, because there is no mature experience in the clinical evaluation of TCM decoction pieces, the quality evaluation system has some challenges such as complex processes and high cost, but it is essential for maintaining the quality of medicinal materials and life safety. Therefore, it is of importance and urgency to construct and implement the quality evaluation system.
Drugs, Chinese Herbal ; standards ; Medicine, Chinese Traditional

Objective: To investigate the value of T2 map and synthetic T2WI generated by T2 mapping in evaluating the histological type, pathological classification and depth of myometrial invasion of endometrial carcinoma (EC). Methods: Seventy-three patients with pathologically proven EC diagnosed at the First Affiliated Hospital of Zhengzhou University from December 2019 to December 2021 and 42 healthy volunteers were enrolled in the study. All subjects underwent conventional MRI, diffusion weighted imaging (DWI) and T2 mapping sequence for the pelvic cavity to test the T2 values and the apparent diffusion coefficient (ADC) of the focus nidus of the patients and the normal endometrium of the volunteers. The T2 and ADC values of EC vs normal endometrium, and those of different histological types and pathological grades were compared. The receiver operating characteristic (ROC) curves were constructed to evaluate the diagnostic performance of T2 and ADC values in determining the pathological type and classification of EC. In addition, two radiologists used synthetic T2WI combined with T2 map and conventional T2WI combined with DWI, respectively, to evaluate the depth of myometrial invasion, and compared the imaging results with the results of pathological diagnosis to evaluate the diagnostic efficacy of the two methods in determining the depth of myometrial invasion. Results: The T2 and ADC values of endometrial carcinoma were 85.0 (80.8, 92.5) ms and 0.71 (0.64, 0.77) ×10(-3) mm(2)/s, respectively, which were significantly lower than those of normal endometrium [147.4 (123.4, 176.7) ms and 1.46 (1.26, 1.76)×10(-3) mm(2)/s, respectively; both P<0.05]. The T2 values of endometrioid carcinoma (EA) [84.1 (79.5, 88.7) ms] were significantly lower than those of non-EA [98.8 (92.1, 102.8) ms; P<0.05]. There was no significant difference in ADC values between EA and non-EA (P=0.075). The T2 values of G1, G2 and G3 groups in EA were 89.1 (84.4, 94.4) ms, 83.6 (80.9, 86.2) ms, and 76.5 (71.4, 80.3) ms, respectively. There were significant differences in the T2 values between G1 vs G2, G1 vs G3, and G2 vs G3 groups, respectively (all P<0.017). Significant difference was also found in the ADC values between the G1 and G3 groups (P<0.017). The area under the ROC curve (AUC) of T2 values in distinguishing EA from non-EA was 0.867. The AUC of T2 values, ADC values and their combination in predicting high-grade EA was 0.888, 0.730 and 0.895, respectively. The accuracy of synthetic T2WI+ T2 map and conventional T2WI+ DWI in the diagnosis of deep myometrial invasion was 78.1% and 79.5%, respectively, with no significant difference (P>0.05). Conclusions: T2 mapping has great potential in preoperative evaluation of EC. The quantitative T2 value can be used in the diagnosis, pathological classification and grading of EC. The combination of synthetic T2WI and T2 map may be helpful to determine the depth of myometrial invasion.
Female ; Humans ; Neoplasm Invasiveness/pathology* ; Endometrial Neoplasms/diagnostic imaging* ; Diffusion Magnetic Resonance Imaging/methods* ; Magnetic Resonance Imaging/methods* ; ROC Curve ; Retrospective Studies

Objective: To investigate the value of T2 map and synthetic T2WI generated by T2 mapping in evaluating the histological type, pathological classification and depth of myometrial invasion of endometrial carcinoma (EC). Methods: Seventy-three patients with pathologically proven EC diagnosed at the First Affiliated Hospital of Zhengzhou University from December 2019 to December 2021 and 42 healthy volunteers were enrolled in the study. All subjects underwent conventional MRI, diffusion weighted imaging (DWI) and T2 mapping sequence for the pelvic cavity to test the T2 values and the apparent diffusion coefficient (ADC) of the focus nidus of the patients and the normal endometrium of the volunteers. The T2 and ADC values of EC vs normal endometrium, and those of different histological types and pathological grades were compared. The receiver operating characteristic (ROC) curves were constructed to evaluate the diagnostic performance of T2 and ADC values in determining the pathological type and classification of EC. In addition, two radiologists used synthetic T2WI combined with T2 map and conventional T2WI combined with DWI, respectively, to evaluate the depth of myometrial invasion, and compared the imaging results with the results of pathological diagnosis to evaluate the diagnostic efficacy of the two methods in determining the depth of myometrial invasion. Results: The T2 and ADC values of endometrial carcinoma were 85.0 (80.8, 92.5) ms and 0.71 (0.64, 0.77) ×10(-3) mm(2)/s, respectively, which were significantly lower than those of normal endometrium [147.4 (123.4, 176.7) ms and 1.46 (1.26, 1.76)×10(-3) mm(2)/s, respectively; both P<0.05]. The T2 values of endometrioid carcinoma (EA) [84.1 (79.5, 88.7) ms] were significantly lower than those of non-EA [98.8 (92.1, 102.8) ms; P<0.05]. There was no significant difference in ADC values between EA and non-EA (P=0.075). The T2 values of G1, G2 and G3 groups in EA were 89.1 (84.4, 94.4) ms, 83.6 (80.9, 86.2) ms, and 76.5 (71.4, 80.3) ms, respectively. There were significant differences in the T2 values between G1 vs G2, G1 vs G3, and G2 vs G3 groups, respectively (all P<0.017). Significant difference was also found in the ADC values between the G1 and G3 groups (P<0.017). The area under the ROC curve (AUC) of T2 values in distinguishing EA from non-EA was 0.867. The AUC of T2 values, ADC values and their combination in predicting high-grade EA was 0.888, 0.730 and 0.895, respectively. The accuracy of synthetic T2WI+ T2 map and conventional T2WI+ DWI in the diagnosis of deep myometrial invasion was 78.1% and 79.5%, respectively, with no significant difference (P>0.05). Conclusions: T2 mapping has great potential in preoperative evaluation of EC. The quantitative T2 value can be used in the diagnosis, pathological classification and grading of EC. The combination of synthetic T2WI and T2 map may be helpful to determine the depth of myometrial invasion.
Female ; Humans ; Neoplasm Invasiveness/pathology* ; Endometrial Neoplasms/diagnostic imaging* ; Diffusion Magnetic Resonance Imaging/methods* ; Magnetic Resonance Imaging/methods* ; ROC Curve ; Retrospective Studies