Objective:To explore the improvement of the quality standard of Ginkgo Leaf Extract and Dipyridamole Injection and conduct safety tests including abnormal toxicity test,allergic reaction test,hemolysis and coagulation test.Methods:Ginkgo Leaf Extract and Dipyridamole Injection from 3 different manufactures(A,B and C)were tested respectively through abnormal toxicity test and acute toxicity test in mice,active systemic anaphylaxis test in guinea pigs and hemolysis test in vitro.Five mice were used in each batch for abnormal toxicity test according to the abnormal toxicity test method in general notice of the Chinese Pharmacopoeia 2020 Volume Ⅳ(1141),and 50 mice were selected in each batch for acute toxicity test to determine the median lethal dose(LD50)or maximum tol-erable dose(MTD)of Ginkgo Leaf Extract and Dipyridamole Injection,which were used to establish the method of abnormal toxicity experiment.The anaphylaxis of Ginkgo Leaf Extract and Dipyridamole Injection was evaluated by active systemic anaphylaxis test in guinea pigs,which was used to establish the method of allergic test.The hemoly-sis test of Ginkgo Leaf Extract and Dipyridamole Injection was studied by conventional tube method in vitro(macro-scopic observation)and improved hemolysis method in vitro(spectrophotometric method),which were used to establish the method of hemolysis and coagulation test.Results:① In manufacture A,the results of abnormal toxicity test were showed that LD50 was20.8 mL·kg-1and MTD was 16.5 mL·kg-1.No death or abnormal reac-tions were observed in mice tested for abnormal toxicity of 2 manufactures(B and C),and MTD was 50 and 40 mL·kg-1,respectively.②The no-observed-adverse-effect dose of Ginkgo Leaf Extract and Dipyridamole Injec-tion from 3 manufactures to guinea pig intravenous was 0.83 mL·kg-1,and no allergic reaction symptoms were observed when Ginkgo Leaf Extract and Dipyridamole Injection was diluted 4 times to challenge the sensitized guinea pigs(equivalent to human clinical dosage).③Differences were observed in the hemolytic effects of Ginkgo Leaf Extract and Dipyridamole Injection from 3 manufactures,but no obvious hemolytic reaction occurred when it was diluted 1.2 times(equivalent to 5%of the maximum clinical concentration).Conclusion:It is recommended to add abnormal toxicity test,allergic reaction test,hemolysis and coagulation test in the quality standard of Ginkgo Leaf Extract and Dipyridamole Injection as safety test items to control the risk.The proposed method is diluting Ginkgo Leaf Extract and Dipyridamole Injection by 5 times,4 times and 1.2 times to perform abnormal toxicity test,allergic reaction test,hemolysis test and coagulation test respectively.

Objective:To explore the improvement of the quality standard of Ginkgo Leaf Extract and Dipyridamole Injection and conduct safety tests including abnormal toxicity test,allergic reaction test,hemolysis and coagulation test.Methods:Ginkgo Leaf Extract and Dipyridamole Injection from 3 different manufactures(A,B and C)were tested respectively through abnormal toxicity test and acute toxicity test in mice,active systemic anaphylaxis test in guinea pigs and hemolysis test in vitro.Five mice were used in each batch for abnormal toxicity test according to the abnormal toxicity test method in general notice of the Chinese Pharmacopoeia 2020 Volume Ⅳ(1141),and 50 mice were selected in each batch for acute toxicity test to determine the median lethal dose(LD50)or maximum tol-erable dose(MTD)of Ginkgo Leaf Extract and Dipyridamole Injection,which were used to establish the method of abnormal toxicity experiment.The anaphylaxis of Ginkgo Leaf Extract and Dipyridamole Injection was evaluated by active systemic anaphylaxis test in guinea pigs,which was used to establish the method of allergic test.The hemoly-sis test of Ginkgo Leaf Extract and Dipyridamole Injection was studied by conventional tube method in vitro(macro-scopic observation)and improved hemolysis method in vitro(spectrophotometric method),which were used to establish the method of hemolysis and coagulation test.Results:① In manufacture A,the results of abnormal toxicity test were showed that LD50 was20.8 mL·kg-1and MTD was 16.5 mL·kg-1.No death or abnormal reac-tions were observed in mice tested for abnormal toxicity of 2 manufactures(B and C),and MTD was 50 and 40 mL·kg-1,respectively.②The no-observed-adverse-effect dose of Ginkgo Leaf Extract and Dipyridamole Injec-tion from 3 manufactures to guinea pig intravenous was 0.83 mL·kg-1,and no allergic reaction symptoms were observed when Ginkgo Leaf Extract and Dipyridamole Injection was diluted 4 times to challenge the sensitized guinea pigs(equivalent to human clinical dosage).③Differences were observed in the hemolytic effects of Ginkgo Leaf Extract and Dipyridamole Injection from 3 manufactures,but no obvious hemolytic reaction occurred when it was diluted 1.2 times(equivalent to 5%of the maximum clinical concentration).Conclusion:It is recommended to add abnormal toxicity test,allergic reaction test,hemolysis and coagulation test in the quality standard of Ginkgo Leaf Extract and Dipyridamole Injection as safety test items to control the risk.The proposed method is diluting Ginkgo Leaf Extract and Dipyridamole Injection by 5 times,4 times and 1.2 times to perform abnormal toxicity test,allergic reaction test,hemolysis test and coagulation test respectively.

Objective:To explore the repair effect of resveratrol combined with Schwann cell-like cells(SCLCs)dif-ferentiated from adipose-derived stem cells(ADSCs)on sciatic nerve injury in rats.Methods:ADSCs were primarily cultured and induced to differentiate into SCLCs.Cell morphology was observed by scanning electron microscopy.West-ern Blot method was used to detect the expressions of S100 calcium-binding protein β(S100β),p75 neurotrophin receptor(p75NTR),and glial fibrillary acidic protein(GFAP).Rats were randomly divided into Control group(Con-trol),Schwann cell-like cell group(SCLCs),resveratrol group(Res),and resveratrol+Schwann cell-like cell group(Res+SCLCs).Eight weeks after the successful establishment of the sciatic nerve injury model,the sciatic nerve func-tion index(SFI)of each group was detected by footprint experiment;the mechanical withdrawal threshold(MWT)was measured by von Frey filament stimulation needle;The wet weight ratio(WR)of the tibialis anterior muscle was deter-mined by weighing method;Western Blot and RT-qPCR methods were used to detect the expressions of neurotrophin-3(NT-3),nerve growth factor(NGF),insulin-like growth factor-1(IGF-1),and brain-derived neurotrophic factor(BDNF)at the injury site.Results:After 8 days of induction of ADSCs,the cells had elongated poles and increased extracellular components;S100β,p75NTR,and GFAP proteins were highly expressed.After treatment with SCLCs,Res,and Res+SCLCs,the SFI and WR of the treatment groups were significantly better than those of the Control group(P＜0.05);the MWT of rats in the Res+SCLCs group and SCLCs group was reduced(P＜0.05).Western Blot re-sults showed that the expressions of NT-3,IGF-1,NGF,and BDNF proteins in rats in the Res+SCLCs group were higher than those in other groups(P＜0.05);The expressions of NT-3,NGF,and BDNF proteins in rats in the SCLCs group were higher than those in the Control group(P＜0.05);the expressions of NT-3 and NGF proteins in rats in the Res group were higher than those in the Control group(P＜0.05).RT-qPCR results showed that the expressions of NT-3,IGF-1,NGF,and BDNF mRNA in rats in the Res+SCLCs group were highly expressed;the expressions of NT-3,IGF-1,NGF,and BDNF mRNA in rats in the SCLCs group were higher than those in the Control group(P＜0.05);The expressions of IGF-1 and NGF mRNA in rats in the Res group were higher than those in the Control group(P＜0.05).Conclusion:Res combined with SCLCs differentiated from ADSCs has a good repair effect on sciatic nerve inju-ry in rats.

Objective To establish a method for bacterial endotoxin test of flumazenil bulk drug.Methods According to the bacterial endotoxin test(BET)method in general rule 1143 in the Chinese Pharmacopoeia(2020 Edition,VolumeⅣ),flumazenil was dissolved with dimethyl sulfoxide(DMSO)and diluted with BET water.The gel-clot method and kinetic turbidimetric assay were used to carry out the interference test and endotoxin recovery test.Results Flumazenil was dissolved with DMSO to 10 mg·mL-1,and then diluted 100 times or more by BET water,which has no interference effects on the bacterial endotoxin test.Conclusion The BET method established in this study can be used to control the quality of flumazenil by performing bacterial endotoxin tests.

Objective: To observe the acute hypotensive effect of compound coenzyme for injection on cats,and to establish a method for examination of depressor substance.
Methods: Ten batches of compound coenzyme for injection and histamine depressor substance were compared by cat blood pressure method to determine the limit value of depressor substance test method. According to the limit value, 22 batches of samples were tested for depressor substance.
Results: The limit of compound coenzyme for injection was 3 IU·kg^-1 (calculated by coenzyme A). Two batches of 22 batches of compound coenzyme for injection did not meet the requirements.
Conclusion: The method of compound coenzyme for injection is feasible according to the proposed limit value. It is suggested that the quality standard of compound coenzyme for injection should be added with the examination of depressor substance.

【Objective】 To investigate the main causes of blood donor deferral in domestic blood center. 【Methods】 The causes of donor deferral were classified into 12 categories as previous medical history, drug use, alcohol consumption, menstrual period, underweight, abnormal blood pressure, abnormal body temperature, abnormal hemoglobin (Hb), lipemic blood, positive hepatitis B surface antigen (HBsAg), elevated alanine aminotransferase (ALT) and others according to the comparison indicators of Asia-Pacific Blood Network (APBN) and the national standard Blood Donor Health Examination Requirements. The relevant data of the top 3 causes of donor deferral, voluntarily reported by the members of Practice Comparison Working Group of China’s Mainland Blood Collection and Supply Institutions from 2014 to 2019, were collected and a histogram was generated. 【Results】 The median donor deferral rate of 20 domestic blood centers from 2014 to 2019 was 12.14%, with the lowest at 0.18% and highest at 32.32%, respectively. The top three causes for donor deferral were elevated ALT, abnormal Hb and abnormal blood pressure in year 2014, 2015, 2018 and 2019; elevated ALT, lipemic blood and abnormal blood pressure in 2016; elevated ALT, abnormal Hb, and lipemic blood in 2017. 【Conclusion】 The main causes of donor deferral were elevated ALT, abnormal Hb, abnormal blood pressure and lipemic blood.

Objective:To summarize the effect of Chinese Children′s Cancer Group (CCCG) Wilms tumor (WT)-2015 protocol.Methods:This was a prospective study. CCCG-WT-2015 protocol was revised on the basis of the CCCG-WT-2009 protocol. Clinical data of 288 children diagnosed with newly diagnosed kidney neoplasms in fourteen pediatric centers between September 2015 to December 2018 were summarized. The age of onset, distribution of pathological subtypes, staging, curative effect and prognostic factors of these children were analyzed. Kaplan-Meier method was used for survival curve and Log-Rank method was used for univariate analysis.Results:Among 288 cases with kidney neoplasms, there were 261 cases of WT, including 254 cases (97.3%) with favorable histology (FH) WT and 7 cases (2.7%) with unfavorable histology WT (UFHWT). The 3 year events free survival (EFS) rate for FHWT and UFHWT were (88.9±2.1)% and (80.0±17.9)%, which were better than that in WT-2009 (81.2% and 71.7%). In the 96 cases of stage Ⅲ/Ⅳ FHWT with indications for radiotherapy, 76 cases received radiation, another 20 cases received M protocol chemotherapy (cyclophosphamide, etoposide, gentamycin, vincristine and adriamycin) instead of radiation. The 3 year EFS rate for these two groups were (84.7±4.3)% and (84.7±8.1)%(χ 2=0.015, P=0.902). There were 22 renal clear cell sarcoma and 5 malignant rhabdoid tumor, 3 year EFS rate of them was (94.4±5.4)% and (20.0±17.9)%. Univariate analysis was performed for age, gender, pathological type, stage, whether rupture occurred during operation, whether complete remission (CR) occurred at the end of treatment and radiotherapy. Pathological types (χ 2=44.329, P<0.01) and failure to achieve CR at the end of the treatment (χ 2=49.459, P<0.01) were independent factor for predicting survival. Conclusion:Compared with CCCG-WT-2009, treatment of renal tumors in CCCG-WT-2015 study yielded good survival outcome, which can be further applied.

BACKGROUND: Silk fibroin, the main component of silk fibroin biofilm, is a natural protein, but it is still a heterologous protein to the body. Its immunogenicity/toxicity is an important factor in determining the development prospects. OBJECTIVE: To evaluate the toxicity of absorbable silk fibroin biofilm and its degradation products on the rat immune system by muscle implantation experiments in rats. METHODS: Ten Wistar rats from Beijing Weitong Lihua Experimental Animal Technology Co., Ltd. were implanted with a long strip of 1 mm× 10 mm in the right gluteal muscle to observe the implant absorption and determine the implantation cycle. Seventy-two Wistar rats were assigned into control and experimental groups (n=36/group, 18 in either sexes) . A long strip of 1 mm×10 mm was implanted into the rat right gluteal muscle in the experimental group, and the control group received no implantation. Some of the rats were taken for histological examination and calculate the organ/weight ratio, at 26 weeks postoperatively. The spleen lymphocyte proliferation ability, NK cell activity, cell classification of T lymphocytes, and levels of interleukin 2 and tumor necrosis factor α were detected. Another part of the animals was taken for macrophage phagocytosis of erythrocytes cell capacity and antibody producing cell count. RESULTS AND CONCLUSION: (1) Silk fibroin biofilm was completely absorbed after implanted into the rat muscle for 26 weeks. (2) In female or male Wistar rats, the immune organs in the experimental group showed no significant changes in the appearance, weight and histological examination. There were no significant differences in the hematological indexes (hemoglobin, red blood cell count, hematocrit, blood platelet count and white blood cell count and classification) , spleen lymphocyte proliferation, NK cell activity, the ratio of T lymphocytes and their subpopulations, and the levels of interleukin 2 and tumor necrosis factor α had no significant differences between two groups (P> 0.05) . (3) In female or male Wistar rats, the macrophage phagocytosis of chicken erythrocytes cell capacity and antibody producing cell count showed no significant differences between two groups (P> 0.05) . (4) These results indicate that silk fibroin biofilm causes no immunosuppression or immunostimulation on immune organs, immune cells and immune molecules (cytokines) of rats.

The Asian Society of Gynecologic Oncology International Workshop 2018 on gynecologic oncology was held in the Ajou University Hospital, Suwon, Korea on the 24th to 25th August 2018. The workshop was an opportunity for Asian doctors to discuss the latest findings of gynecologic cancer, including cervical, ovarian, and endometrial cancers, as well as the future of fertility-sparing treatments, minimally invasive/radical/debulking surgery, radiotherapy, chemotherapy, targeted therapy, and immunotherapy. Clinical guidelines and position statement of Asian countries were presented by experts. Asian clinical trials for gynecologic cancers were reviewed and experts emphasized the point that original Asian study is beneficial for Asian patients. In Junior session, young gynecologic oncologists presented their latest research on gynecologic cancers.
Antineoplastic Agents ; Asian Continental Ancestry Group ; Drug Therapy ; Education ; Endometrial Neoplasms ; Female ; Gyeonggi-do ; Humans ; Immunotherapy ; Korea ; Ovarian Neoplasms ; Radiotherapy ; Uterine Cervical Neoplasms

OBJECTIVE: To present the surgical outcomes of advanced epithelial ovarian cancer (AEOC) since the implementation of a personalized approach and to validate multiple predictive models for R0 resection. METHODS: Personalized strategies included: 1) Non-invasive model: preoperative clinico-radiological assessment according to Suidan criteria with a predictive score for all individuals. Patients with a score 0–2 were recommended for primary debulking surgery (PDS, group A), or otherwise were counseled on the choices of PDS, neoadjuvant chemotherapy (NAC, group B) or staging laparoscopy (S-LPS). 2) Minimally invasive model: S-LPS with a predictive index value (PIV) according to Fagotti. Individuals with a PIV < 8 underwent PDS (group C) or otherwise received NAC (group D). Intraoperative assessment (with Eisenkop, peritoneal cancer index [PCI], and Aletti scores) and surgical results were prospectively collected. RESULTS: Between September 2015 and August 2017, 161 pathologically confirmed epithelial ovarian cancer patients were included. A total of 52 (32.3%) patients had a predictive score of 0–2, and 109 (67.7%) patients had a score ≥ 3. Among these individuals, 41 (25.5%) patients received S-LPS. Finally, 110 (68.3%) patients underwent PDS (A+C), and 51 (31.7%) patients received NAC (B+D). The R0 resection rates in PDS and NAC patients were 56.4% and 60.8%, respectively. The area under the curve (AUC) of Suidan criteria was 0.548 for group (A+C). The AUC of Fagotti score was 0.702 for group C. The AUC of Eisenkop, PCI, and Aletti scores were 0.808, 0.797, and 0.524, respectively. CONCLUSION: The Suidan criteria were not effective in these AEOC patients. S-LPS was helpful in decision-making for PDS and should be endorsed in the future.
Area Under Curve ; Cohort Studies* ; Drug Therapy ; Humans ; Laparoscopy ; Ovarian Neoplasms* ; Prospective Studies* ; Research Design ; Triage*