Threatened abortion is a common disease of obstetrics and gynecology and one of the diseases responding specifically to traditional Chinese medicine （TCM）. The China Association of Chinese Medicine organized experts in TCM obstetrics and gynecology， Western medicine obstetrics and gynecology， and pharmacology to deeply discuss the advantages of TCM and integrated Chinese and Western medicine treatment as well as the medication plans for threatened abortion. After discussion， the experts concluded that chromosome， endocrine， and immune abnormalities were the key factors for the occurrence of threatened abortion， and the Qi and blood disorders in thoroughfare and conception vessels were the core pathogenesis. In the treatment of threatened abortion， TCM has advantages in preventing miscarriages， alleviating clinical symptoms and TCM syndromes， relieving anxiety， regulating reproductive endocrine and immune abnormalities， personalized and diversified treatment， enhancing efficiency and reducing toxicity， and preventing the disease before occurrence. The difficulty in diagnosis and treatment of threatened abortion with traditional Chinese and Western medicine lies in identifying the predictors of abortion caused by maternal factors and the treatment of thrombophilia. Recurrent abortion is the breakthrough point of treatment with integrated traditional Chinese and Western medicine. It is urgent to carry out high-quality evidence-based medicine research in the future to improve the modern diagnosis and treatment of threatened abortion with TCM.

OBJECTIVE To establish a quantitative analysis model for the contents of tussilagone， moisture， ethanol-soluble extract and total ash in Farfarae Flos based on near-infrared spectroscopy （NIRS）， providing a new idea for the rapid quality evaluation of Farfarae Flos and its preparations. METHODS Referring to the 2020 edition of the Chinese Pharmacopoeia， the contents of the main quality control indexes tussilagone， moisture， ethanol-soluble extract and total ash in 130 batches of Farfarae Flos from 19 producing areas were determined by HPLC， drying method， hot dip method and ash assay， respectively. The NIRS data information of the medicinal herbs of Farfarae Flos was collected， and then NIRS combined with the partial least squares method was used to establish the individual quantitative analysis models of the above quality control indexes in the samples， and the predictive model of the NIRS content was obtained after sample validation with validation set. RESULTS The range for the contents of tussilagone， moisture， ethanol-soluble extract and total ash in 130 batches of Farfarae Flos were 0.051 4%-0.103 5%， 7.75%-10.93%， 20.17%-31.12%， and 7.68%-12.10%， respectively. The internal cross-validation coefficients of determination （R2） of the established models for the quantitative analysis of tussilagone， moisture， ethanol-soluble extract and total ash in Farfarae Flos were 0.985 8， 0.968 4， 0.973 4， 0.988 0， respectively； the root mean square errors of calibration （RMSEC） were 0.001 54， 0.187， 0.478， 0.127， respectively； the root mean square errors of prediction （RMSEP） were 0.001 81， 0.212， 0.543， 0.149， respectively； RMSEP/RMSEC were 1.175 3， 1.133 7， 1.136 0 and 1.173 2， respectively， which were all within a reasonable range （1＜RMSEP/RMSEC≤1.2）. The mean absolute errors between the true and model-predicted values of the above four quality control indexes in the validation set of samples were －0.000 36， 0.061 43， 0.144 00， and 0.010 43， respectively，and the mean predicted recoveries were 99.65%， 100.72%，100.66%， and 100.15%， respectively. CONCLUSIONS The established NIRS quantitative analysis model has high stability and reliable results， which can be used for the rapid batch prediction of the content of relevant quality control indexes in Farfarae Flos.

Objective:To compare the accuracy of 11 ultrasound parameters prediction formulas for fetal body mass,and to explore the effect of gestational weight gain(GWG)on the accuracy of ultrasound prediction of fetal body mass.Methods:A total of 502 single and full-term postpartum women who gave birth from August 2020 to December 2020 at Jinshan Hospital,Fudan University were collected.The gestational weight gain,fetal ultrasound measurement indicators within 7 days before delivery,and newborn birth weight were calculated and analyzed.The accuracy of multiple ultrasound prediction formulas were calculated and analyzed.According to the criteria for weight gain during pregnancy,the reasonable weight gain during pregnancy was 12.5-18.0 kg for singleton pregnancies with pre-pregnancy(body mass index)BMI<18.5 kg/m2,11.5-16.0 kg for those with BMI 18.5-24.9 kg/m2,7.0-11.5 kg for those with BMI 25.0-29.9 kg/m2,and 5.0-9.0 kg for those with BMI≥30.0 kg/m2.The cases were divided into the group with insufficient GWG(125 cases),the normal group(202 cases),and the group with too much GWG(175 cases)to analyze the effect of different GWG on the accuracy of ultrasound pre-diction of fetal body mass.Results:Among the 11 ultrasound parameter formulas for predicting fetal body mass,the HadlockⅢformula predicted fetal body mass with an absolute error of 186.64±149.28 g and a relative error of(5.52±4.18)%,which was the smallest error among 11 prediction formulas,with a statistically significant difference(P<0.05).The absolute and relative error compliance rates were 72.31%,86.25%,respectively,both of which were the highest,and the difference was statistically significant(P<0.05).When the HadlockⅢformula was used to predict birth weight in the insufficient GWG group,the normal group,and the group with too much GWG,the absolute errors were 190.23±136.69 g,148.12±99.39 g,228.54±189.57 g,and the relative errors were(5.95±4.25)%,(4.40±2.78)%,(6.49±5.09)%,respectively,and the differences were statistically significant(P<0.05).Conclusions:The accuracy of Hadlock Ⅲ formula in predicting fetal body mass is better than that of other formulas,but its accuracy can be affected by GWG,and it is necessary to consider multiple as-pects when estimating fetal body mass in clinical practice.

We developed a method for accurate quantification of the intact virus particles in inactivated avian influenza virus feedstocks. To address the problem of impurities interference in the detection of inactivated avian influenza virus feedstocks by direct high performance size exclusion chromatography (HPSEC), we firstly investigated polyethylene glycol (PEG) precipitation and ion exchange chromatography (IEC) for H5N8 antigen purification. Under the optimized conditions, the removal rate of impurity was 86.87% in IEC using DEAE FF, and the viral hemagglutination recovery was 100%. HPSEC was used to analyze the pretreated samples. The peak of 8.5-10.0 min, which was the characteristic adsorption of intact virus, was analyzed by SDS-PAGE and dynamic light scattering. It was almost free of impurities and the particle size was uniform with an average particle size of 127.7 nm. After adding antibody to the IEC pretreated samples for HPSEC detection, the characteristic peak disappeared, indicating that IEC pretreatment effectively removed the impurities. By coupling HPSEC with multi-angle laser scattering technique (MALLS), the amount of intact virus particles in the sample could be accurately quantified with a good linear relationship between the number of virus particles and the chromatographic peak area (R²=0.997). The established IEC pretreatment-HPSEC-MALLS assay was applied to accurate detection of the number of intact virus particles in viral feedstocks of different subtypes (H7N9), different batches and different concentrations, all with good applicability and reproducibility, Relative standard deviation < 5%, n=3.
Animals ; Reproducibility of Results ; Influenza A Virus, H7N9 Subtype ; Influenza in Birds ; Chromatography, Gel ; Virion ; Lasers

Objective To explore the safety and efficiency of sequential operation of Tirelizumab combined with chemotherapy in neoadjuvant therapy for locally advanced esophageal cancer.Methods A retrospective analysis was conducted on 60 patients with locally advanced esophageal cancer admitted to Renmin Hospital of Wuhan University from August 2018 to June 2022.The immunotherapy combined with chemotherapy sequential surgery patients were selected as the observation group(29 cases)and the chemotherapy sequential surgery patients were selected as the control group(31 cases)according to the treatment method.The study aimed to analyze whether there were differences in efficacy and safety between the two groups.Results There are 28 patients with R0 resection in the observation group,and 14 case reached ORR.In the control group,29 cases were resected with R0,and 7 cases reached ORR.The proportion of ORR patients in the observation group was significantly higher than that in the control group,which was statistically significant(P＜0.05).There were 9 patients with pCR in the observation group and 2 patients with pCR in the control group,and the proportion of pCR patients in the two groups was significantly different(P＜0.05).There were no significant differences between the two groups for preoperative and postoperative adverse events.Conclusion Immune checkpoint inhibitors combined with chemotherapy sequential surgery are safe and reliable in patients with locally advanced esophageal cancer,with significant short-term efficacy,and long-term efficacy remains to be observed.

Objective To summarize the clinical experience in the treatment of postoperative upper gastrointestinal cancer of esophageal cancer.Methods The clinical data of 16 patients with postoperative upper gastrointestinal malignancies treated in our hospital from January 2018 to June 2022 were retrospectively analyzed.Results All the 16 patients successfully completed the operation,and no perioperative death occurred.The cumulative length of hospitalization was 18-38 days.After operation,2 cases of pulmonary infection,1 case of respiratory failure,and 1 case of cervical anastomotic fistula were cured after conservative treatment.All patients could eat normally during postoperative follow-up,and no tumor recurrence and metastasis was found.Conclusion For patients with recurrent upper gastrointestinal cancer after esophageal cancer surgery,if the lesion is relatively limited,surgical treatment is reliable and an optional treatment plan.

This paper aims to detect the antigens in porcine circovirus type 2 (PCV2) vaccines by high-performance size-exclusion chromatography (HPSEC) coupled with multi-angle laser light scattering (MALLS). With purified inactivated PCV2 and PCV2 virus-like particles (VLP) as references, two inactivated vaccines (a and b) and two VLP vaccines (c and d) for PCV2 from four manufacturers were analyzed by HPSEC-MALLS after demulsification. The antigen peaks in HPSEC-MALLS were identified by PCV2 antigen test strips, Western blotting and transmission electron microscope (TEM). The repeatability and linearity of the method were investigated. The results showed the virus antigens in the two inactivated vaccines were eluted at about 13.3 min in HPSEC. The molecular weight of these antigens was 2.61×10⁶ (±4.34%) Da and 2.40×10⁶ (±2.51%) Da, respectively, as calculated by MALLS. The antigen peaks of the two VLP vaccines also appeared at 13.3 min and the molecular weight was 2.09×10⁶ (±2.94%) Da and 2.88×10⁶ (±11.85%) Da, respectively, which was close to the theoretical molecular weight of PCV2. Moreover, an antigen peak of VLP vaccine c was observed at 11.4 min and the molecular weight was 4.37×10⁶ (±0.42%) Da. The antigen was verified to be the dimer of VLP by TEM. Vaccine d and purified Cap VLP antigens were tested repeatedly, and the RSD of the peak area (n=3) was all < 1.5%, indicating that the method was repeatable. The purified VLP were diluted in serial and tested for linearity. The result suggested good linear relationship between the peak area of VLP or VLP aggregates and the protein concentration of the sample with R² of 0.999 and 0.997, respectively. Thus, the method met the requirement for quantification and aggregate analysis. This method is accurate and efficient in in vitro quality evaluation and improvement of PCV2 vaccine.
Animals ; Antibodies, Viral ; Capsid Proteins ; Chromatography, Gel ; Circoviridae Infections/prevention & control* ; Circovirus ; Lasers ; Swine ; Vaccines, Inactivated ; Vaccines, Virus-Like Particle ; Viral Vaccines

Immunotherapy is becoming an effective and less invasive strategy that can be applied to the treatment of various malignancies. Lentiviral vectors (LVs) have shown great potential in immunotherapy as they can stably integrate relatively large foreign DNA, and effectively transduce dividing and non-dividing cells. Clinical application needs high quality LVs, and therefore strict quality control of the final products is necessary to ensure their purity, efficacy and safety. The quantitative detection of LVs is among the key parts of product development and quality control. In this paper, the existing methods for quantitative detection of LVs are summarized, including fluorescence activated cell sorter (FACS), P24 enzyme-linked immuno sorbent assay (P24 ELISA), real-time fluorescence quantitative polymerase chain reaction (RT-qPCR), nanoparticle tracking analysis (NTA), tunable resistive pulse sensing(TRPS) and virus counter(VC).Their advantages and disadvantages are listed, and future development and challenges are discussed.
Genetic Vectors/genetics* ; Humans ; Immunotherapy ; Lentivirus/genetics* ; Neoplasms ; Transduction, Genetic

Objective:To observe the clinical efficacy of Danzhi Sangqin decoction in the treatment of premenstrual acne with liver and lung stagnation.Methods:Sixty patients with liver and lung stagnation premenstrual acne diagnosed and treated in the Department of Dermatology of Shaoxing Central Hospital from July 2016 to November 2018 were selected in the research.They were divided into the control group( n=28) and treatment group( n=32) by random number table method.The treatment group was treated with self-made Danzhi Sangqin decoction, and the control group was orally treated with isotretinoin capsules and vitamin B6.The two groups were treated for 1 week.The clinical efficacy and the incidence of adverse reactions were compared between the two groups. Results:In the treatment group, 18 cases were markedly effective, 11 cases were effective, and 3 cases were ineffective, and the total effective rate was 90.6%(29/32). In the control group, 16 cases were significantly effective, 10 cases were effective, and 2 cases were ineffective, and the total effective rate was 92.9%(26/28). There was no statistically significant difference in the total effective rate between the two groups( P>0.05). The incidence of adverse reactions in the treatment group was 3.1%(1/32), which was significantly lower than that in the control group [21.4%(6/28)], the difference was statistically significant(χ 2=6.281, P<0.05). Conclusion:The clinical efficacy of Danzhi Sangqin decoction in the treatment of premenstrual acne with liver and lung stagnation is similar to that of isotretinoin capsules, but the incidence of adverse reactions is low.

Objective:To investigate the characteristics and clinical significance of lymph node metastasis of peripheral non-small cell lung cancer(NSCLC) with diameter ≤ 2 cm; to explore the possibility of regional mediastinal lymphadenectomy.Methods:Collect all patients’ data with peripheral NSCLC ≤2 cm from January 2017 to August 2018 in our hospital, there was no previous history of other malignant tumors. All patients underwent lobectomy, segmentectomy, or wedge resection, and mediastinal lymphadenectomy , and comprehensive analysis was performed based on pathological findings and clinical features.Results:Among the peripheral NSCLC with a diameter of ≤ 2 cm, metastatic degree and rate of mediastinal lymph nodes were low(0.67% and 1.87%, respectively). The lymph nodes metastatic rate of pGGO, mGGO and solid nodule were 0, 1.18% and 4.92%, respectively. The 11th group of lymph node metastasis was positively correlated with the solid components of lymph nodules( P=0.024). While lymph node metastasis had no significant correlation between gender, age, smoking history, size, location, and tumor type. The metastasis of the 11th group of lymph nodes was positively correlated with the 2nd, 3rd, 4th and 6th lymph nodes( P=0.014, Kappa value 8.406). Conclusion:For the operation of pGGO patients, mediastinal lymphadenectomy was not necessary, or maybe N1 lymph nodes sampling was enough. For the operation of mGGO or solid nodules, the surgeon can determine the lymphadenectomy scope according to the 11th-group lymph nodes frozen pathology result. If positive, the extent of lymph node dissection should be appropriately expanded; If negative, the lymph node dissection can be skipped, so as to reduce the complications.