The field of post-marketing benefit-risk assessment for traditional Chinese medicine（TCM） is still in its nascent stage， lacking a universally accepted and cohesive evaluation framework and standards. This study presented a strategy developed for the benefit-risk assessment of post-marketing of TCM， and explored the critical techniques and specific implementation steps involved in the assessment process. Initially， appropriate qualitative assessment frameworks and quantitative analysis models were selected for the integrated qualitative and quantitative benefit-risk assessment. Subsequently， key technologies were outlined， including the establishment of a benefit-risk indicator system， the assignment of indicator weights， and the definition of criteria attributes. Furthermore， the implementation steps were elaborated， which involved defining decision-making issues， data collection， evaluation methodologies， variability factors， and sensitivity analysis. Finally， a case study of the benefit-risk assessment of a TCM injection for hepatitis B treatment was conducted to validate the feasibility of the proposed strategy. The objective of this research was to provide theoretical support and practical references for the development of a comprehensive post-marketing benefit-risk assessment system for TCM.

ObjectiveTo construct the evidence body for revision of safety information on package inserts of Chinese patent medicines in post-marketing by taking Xiaoke'an capsules as an example， so as to provide reference for the revision of instructions of Chinese patent medicines in post-marketing. MethodThe construction of the evidence body was guided by the theory of traditional Chinese medicine（TCM） and the Technical Guiding Principles for Revision of Safety Information Items in Instructions for TCMs After Marketing， and 8 categories and 25 specific items were taken as the main body of the evidence body， and information inclusion， integration， screening and improvement were carried out， then expert demonstrations were conducted， and finally modifications were made based on the opinions of the Center for Drug Evaluation to complete the revision of the safety information in the instructions of Xiaoke'an capsules. Result［Adverse reactions］ of Xiaoke'an capsules was revised to "monitoring data show that the following adverse reactions can be seen with this product：individual hypoglycemic reaction reports". ［Contraindications］ was revised to "contraindicated for those allergic to this product and its ingredients". ［Precautions］ was revised to "（1）pregnant women should use with caution， （2）elderly people should consult a physician， （3）people with spleen deficiency and dampness， spleen and stomach deficiency and cold， or those who eat less and have diarrhea should use with caution， （4）this product contains ginseng， should not be taken at the same time with TCM prescriptions or patent medicines containing veratrum and Wulingzhi， （5）pay attention to monitoring blood sugar during medication， （6）if any other discomfort occurs during medication， you should seek medical attention in time". The warning was revised to "use with caution by pregnant women， and pay attention to regular monitoring of blood sugar". ConclusionIn accordance with the content and process of the evidence body for the revision of safety information in the instructions， the revision of the safety information in the instructions of Xiaoke'an capsules has been completed， providing a strong basis for the rational and safe use of medication in the clinic.

Objective:To evaluate the value of bedside ultrasound in evaluating volume responsiveness of patients with septic shock.Methods:A total of 102 patients with septic shock admitted to ICU of the First Affiliated Hospital of Hebei North University from April 2018 to February 2021 were selected. Patients were divided into response group and non-response group according to the value of stroke volume increase (ΔSV) after volume loading test (VE), and the hemodynamic parameters before and after VE were compared between the two groups. Pearson correlation was used to analyze the relationship between ΔSV and hemodynamic indexes. Receiver operating characteristic (ROC) curve was drawn to analyze the sensitivity and specificity of each hemodynamic index in evaluating volumetric reactivity in patients with septic shock.Results:Of the 102 patients, 54 responded and 48 did not. Before VE, the distensibility index of inferior vena cava (ΔIVC 1), espiratory variability index of inferior vena cava (ΔIVC 2), respiratory variability of aortic peak velocity (ΔVpeak AO), brachial artery maximum velocity variability (ΔVpeak BA) and respiratory rate of peak flow velocity of femoral artery (ΔVpeak CFA) in response group were higher than those in non-response group (all P<0.05), but there was no statistical significance in heart rate (HR), mean arterial pressure (MAP) and central venous pressure (CVP) between 2 groups (all P>0.05). After VE, the HR, ΔIVC 1, ΔIVC 2, ΔVpeak AO, ΔVpeak BA and ΔVpeak CFA in response group were significantly decreased, while MAP and CVP were significantly increased (all P<0.05). The CVP was significantly decreased in the non-response group ( P<0.05), while other indexes were not significantly changed. Before VE, the ΔIVC 1, ΔIVC 2, ΔVpeak AO, ΔVpeak BA and ΔVpeak CFA were positively correlated with ΔSV ( r=0.589, 0.647, 0.697, 0.621, 0.766; all P<0.05). There was no correlation between CVP and ΔSV ( r=-0.345, P>0.05). Before VE, the area under the curve of ΔIVC 1, ΔIVC 2, ΔVpeak AO, ΔVpeak BA and ΔVpeak CFA were all >0.7, indicating high sensitivity and specificity. Conclusions:Bedside ultrasound monitoring ΔIVC, ΔVpeak AO, ΔVpeak BA and ΔVpeak CFA can better evaluate the volume response of patients with septic shock, and can provide a reference basis for clinical fluid resuscitation treatment.

Objective To ummarized the clinical characteristics of lactic acidosis combined with hypoglycemic coma,diabetic ketoacidosis and hyperkalemia,so to improve the physician's treatment ability by summary the clinical feature of lactic acidosis combined with hypoglycemic coma,diabetic ketosis and hyperkalemia.Methods Analyzed the clinical characteristics and disease development of one case with lactic acidosis combined with hypoglycemic coma,diabetic ketoacidosis and hyperkalemia,and reviewed literature.Results The patient had hypoglycemia and acidosis at the same time due to taking phenformin and glibenclamide.After 2 days,the patient was better through correcting acidosis,intravenous fluid therapy,lowering blood potassium and controlling blood glucose.Conclusion Because acidosis caused the potassium transfer from intracellular to extracellular,the latter leads to hyperpotassemia,lactic acidosis caused by phenformin should be treated with intravenous fluid therapy,correcting acidosis.

Objective To investigate the mechanism of liposome PGE1 on the survival of the expanded flap.Methods The minipigs were set up as an animal model.They were divided into 2 groups.The expanded flaps (8 cm ×2 cm) were designed and elevated on the back of an minipig.An image analysis technology was used to evaluate the survival rate of the expanded flap,while realtimePCR technique was used to investigate the molecular mechanism.Results The survival area of the expanded flap in the Lipo PGE1 group was significantly enlarged (P＜0.01) compared with the control group.The VEGF,iNOS and Ang-1 gene expression decreased,but TGF-β1 gene expression increased.But there was no significant difference between two groups (P＞0.05).Conclusions The Lipo PGE1 could promote survival rate of the expanded flap,but the mechanism does not involve the regulation of VEGF,iNOS,Ang-1 and TGF-β1 gene expression.

Objective To evaluate the accuracy of Gallina nomogram in predicting seminal vesicle invasion (SVI) in prostate cancer.Methods From January 2009 to December 2011,89 patients with prostate carcinoma underwent open retropubic or laparoscopic radical prostatectomy.Complete data of preoperative serum prostate specific antigen (PSA),clinical stage,biopsy Gleason score,percentage of positive biopsy cores,pelvic MRI and pathological report of prostatectomy specimen were collected,and all the patients met the inclusion criteria of Gallina nomogram,2001 Partin tables and 2007 Partin tables.Postoperative pathological results were respectively compared with MRI and the incidence of SVI predicted by the three tools,and the sensitivity,specificity and accuracy of MRI in predicting SVI were calculated.The receiver operating characteristics curves were performed to test the predictive accuracy of SVI of each tool.Results The incidences of organ-confined disease,capsule invasion,SVI and lymph node metastasis were 58.4％,16.9％,22.5％,and 2.2％,respectively.The sensitivity,specificity and accuracy of MRI in predicting SVI was 45.0％ (9/20),71.0％ (49/69) and 65.2％ (58/89),respectively.The area under the curve (AUC) for SVI disease prediction of 2001 Partin tables,2007 Partin tables and Gallina nomogram was 0.712,0.711 and 0.801,respectively.Conclusions The sensitivity of MRI in predicting SVI is poor,the specificity and accuracy are common.All the predictive tools have a reasonable value for SVI (AUC ＞ 0.7),and Gallina nomogram is superior to two versions of Partin tables in predicting SVI.

Objective To investigate the influence of the liposome PGE1 on the ischemia-reperfusion injury of the expanded flap.Methods The minipigs were set up as an animal model.They were divided into 2 groups.The expanded flaps (8 cm × 2 cm ) was designed and elevated on the back of the minipigs.An image analysis technology was used to evaluate the survival rate of the expanded flap,while a biochemistry method was used to detect the concentrations of malondialdehyde (MDA),myeloperoxidase (MPO) and microvessel density (MVD) in the tissue.Skin tempreture was measured after the drug administration.Results The survival area of the expanded flap in the Lipo PGE1 group was significantly enlarged (P＜0.05),compared with the control group.The MPO and MDA concen tration in the tissue was statistically different between two groups (P＜ 0.05),but there was no difference of the MVD concentration between two groups.The skin temperature was higher in the Lipo PGE1 group.Conclusions The Lipo PGE1 could promote survival rate in the expanded flap and protect it from ischemic injury.

Objective To investigate the classification and surgical management of patients with palpebral bags. Methods A total of 200 cases with palpebral bags who underwent surgical treatment between May 2003 to August 2008 were retrospectively analyzed. The palpebral bags were classified according to skin flaccidness, bulging of excessive orbital septum fat and tarsus relaxation. The postoperative cosmetic results were also assessed. Results Of the 200 treated cases, the postoperative cosmetic results were assessed as very satisfactory in 178 (89 % ) cases, as satisfactory in 18 (9 % ) cases, and as dissatisfactory in4 (2 % ) cases. Conclusion Patients with palpebral bags should be treated with different surgical methods according to their different types.

Objective To summarize the clinical characteristics of 15 cases of Poland's syndrome and to explore the suitable treatment strategies. Methods A retrospective study of 15 adult patients with Poland's syndrome was conducted and the related literature was reviewed. According to the development of pectoralis muscles and breast, chest deformities were classified into 2 grades: mild and severe. Mild form was limited to absence of partial pectoralis major muscle, with variable hypoplasia of other minor components (such as the size of breast and the size and position of the nipple-areola complex), leading to a mild chest wall asymmetry. Severe form was characterized by absence or severe hypoplasia of the pectoralis major muscle and mammary gland with an evident chest wall asymmetry. Combined with gender, adult patients were divided into 4 types: female mild, female severe, male mild, and male severe. Each type had its own treatment strategies based on its anatomic features: silicone implant insertion for female mild type;latissimus dorsi muscular flap transposition and silicone implant insertion for female severe type;fat injection for male mild type;latissimus dorsi muscular flap transposition for male severe type of the patients. From 2003 to 2008, 15 adult cases were admitted to our ward, aged from 16 to 34 years.The case number of each type was 6, 6, 2 and 1, respectively. One severe female patients rejected any surgical interventions;the others were all treated as the above. Results Follow-up periods ranged from 6 months to 4 years. This series had got satisfactory results with good breast symmetry and natural texture. All the latissimus dorsi muscular flaps survived well. No postoperative complications, such as implant capsular contracture or implant displacement, were observed. Conclusion The manifestations of Poland's syndrome are extremely varied. This classification method is simple but useful, which could effectively direct the individualized treatment for the complete and adequate rehabilitation. Latissimus dorsi muscular flap, pedicled or free transplanted, pulsing silicone implant in females, are the first choices for severe chest deformations of this syndrome.

Objective To evaluate the method for vaginal treconstruction with muscle sparing verti-cle rectus abdominis myocutaneous flap(MS-VRAM flap). Methods From September 2006 to April 2008, MS-VRAM flaps were used for vaginal reconstruction in 9 patients (20 to 35 years old), ancl all ca-ses were congenital absence of vagina. Before operation, the inferior epigastrie arteries were detected by the Doppler and the flaps based on the perforators ranged from 6 cm×20 cm. MS-VRAM flaps were ele-vated and then transferred to reconstruct the vagina. Results All 9 cases of MS-VRAM flaps survived completely. No complications occurred at donor site of abdominal wall. With 2-12 months' follow-up, the patients were satisfied with the results. Conclusion Despite technical difficulties in elevating the MS-VRAM flap, the flap is a good choice for vaginal reconstruction.