OBJECTIVE To construct a comprehensive evaluation system for oral Chinese patent medicines in children that is compatible with pediatric physiological characteristics and the features of traditional Chinese medicine （TCM）， and provide a basis for the selection， pharmaceutical management， and medical insurance procurement of oral Chinese patent medicines in children.METHODS According to the Guidelines for the Management of Comprehensive Clinical Evaluation of Drugs （ 2021 Trial Edition ） and related policy documents and literatures， six first-level indicators were determined： safety， efficacy， suitability， economy， accessibility， and innovation. An initial indicator pool was constructed through literature retrieval， policy text analysis， and semi-structured expert interviews. A preliminary survey using a 5-point Likert scale was conducted to determine the primary indicator list. Two rounds of Delphi expert consultation were carried out. The analytic hierarchy process （AHP） was used to determine the weights and scores of indicators at all levels， and the methodological quality of the questionnaire and reliability were evaluated. Five oral Chinese patent medicines for pediatric respiratory diseases were selected for empirical evaluation. Two independent blinded reviewers scored the medicines， and the Kappa value was calculated to evaluate inter-rater consistency.RESULTS Both rounds of Delphi consulting had 21 experts， with a positive coefficient of 100% and an authoritative coefficient of 0.89. The Kendall’s W coefficients of concordance for the first and second rounds of Delphi expert consultation were 0.812 and 0.856， respectively （ P ＜0.01）. The consistency ratios of all AHP judgment matrices ranged from 0.032 to 0.087 （all ＜0.10）. The Cronbach’s α coefficient was 0.847. A comprehensive evaluation system for oral Chinese patent medicines in children was established， comprising 6 first-level indicators， 25 second-level indicators， and 78 third-level indicators. The weights of the first-level indicators were 0.32， 0.24， 0.16， 0.13， 0.10 and 0.05， respectively， for safety， effectiveness， suitability， economy， accessibility and innovation. The empirical evaluation showed that Xiao’er chiqiao qingre granules obtained the highest comprehensive score （90.8 points）， followed by Xiao’er feire kechuan oral liquid （86.3 points）， Ertong qingfei oral liquid （82.8 points）， Xiao’er xiaoji zhike oral liquid （82.0 points）， and Jinzhen oral liquid （81.5 points）. The inter-rater consistency Kappa value was 0.91.CONCLUSIONS The comprehensive evaluation system for oral Chinese patent medicines in children constructed in this study， includes 12 pediatric-specific third-level indicators and integrates key evaluation points of both traditional Chinese and Western medicine. It demonstrates good consistency and reliability， with good operability and reproducibility.

Objective To explore the expressions of Smad4 and estrogen receptor (ER) and their interrelation,and the relationship with the clinicopathological features of breast cancer.Methods The immunohistochemical SP method was used to detect the expressions of Smad4 and ER in 50 case of invasive cancer,12 cases of carcinoma in situ and 15 cases of normal breast tissues.The differences in different clinical stages,differentiation degrees and nodal metastases were analyzed.The correlation between Smad4 and ER was explored.Results The positive expression rate of Smad4 in invasive cancer was 52.00％,which lower than that in normal breast tissue (93.33％),with a significant difference (x2 =8.329,P =0.004),positive expression rates of ER were 60.00％ and 40.00％ respectively,with no significant difference (x2 =1.868,P =0.172).The positive expression rates of Smad4 in carcinoma in situ and invasive cancer were 75.00％ and 52.00％ respectively,with no significant difference (x2 =2.082,P =0.149).The positive expression rates of ER were 58.33％ and 60.00％ respectively,with no significant difference (x2 =0.011,P =0.916).The positive expression of Smad4 was related to the TNM stage (x2 =6.392,P =0.011) and the lymph node metastasis (x2 =6.738,P =0.009),but it was not associated with the histologic grade (x2 =0.542,P =0.462).The positive expression of ER was related to the lymph node metastasis (x2 =4.133,P =0.042) and histologic grade (x2 =5.357,P =0.021),but it was not associated with the TNM stage (x2 =1.159,P =0.282).There was positive correlation between Smad4 and ER in breast cancer tissue (r =0.263,P =0.032).Conclusion Smad4 is expressed at lower level in breast cancer than in normal breast tissue.The expressions of Smad4 and ER are related to the different clinicopathological features of breast cancer with positive correlation.

Objective To summarize the experience of adjuvant therapy for primary hepatocellular carcinoma. Methods 316 cases of operable hepatocellular carcinoma were divided into three groups. Only hepatectomy were performed in group one (21 8cases).Preopemtive adjuvant TACE were done in group two (52 cases). Preoperative adjuvant TACE and postoperative trans-portal vein chemotherapy were done in group three (46 cases), which was named hepatectomy sequencing two vessel therapy. Results 1, 3 and 5 year survival rote were 51.2 %, 30.0 % and 20.5 % respectively in group one, 57.2 %, 43.0 % and 31.5 % in group two, 84.0 %, 62.5 % and 51.0 % in group three. The postoperative disease-free survival rate in group three was significantly higher than that in group one and group two (P ＜0.05). Conclusion Hepatectomy sequencing two vessels therapy in perioperative period might improve the survival rate, which can prevent and delay the incidence of recurrence and may improve the effect of liver resection.