OBJECTIVE:To establish a method for the determination of related substances in Lovastatin tablet. METHODS:HPLC was performed on the column of Waters XTerra? MS C18 with mobile phase A of 0.01%Phosphoric acid solution and B of acetonitrile(gradient elution)at a flow rate 1.0 ml/min,column temperature was 40 ℃,the detection wavelength was 238 nm,and the injection volume was 10 μl. RESULTS:The impurity components were well separated in principal components;the linear range of lovastatin was 17.5-700 μg/ml(r=0.9999);RSDs of precision,stability and reproducibility tests were lower than 1%;recov-ery was 99.30%-100.67%(RSD=0.4%,n=9). CONCLUSIONS:The method is reproducible with good durability and high preci-sion,and can be used for the quality control of Lovastatin tablet.

Objective To examine the prevalence ofHelicobacter pylori in Shanghai and relevant risk factors, evaluate the resistance proifle ofH. pylori isolates to antibiotics used in ifrst-line therapy in two hospitals in Shanghai.MethodsH. pylori were isolated from the biopsy samples of gastric mucosa collected from September 2013 to January 2015. Antimicrobial susceptibility test was performed by E-test method for 131H. pylori strains to 4 antibiotics, clarithromycin, metronidazole, amoxicillin and tetracycline. Results A total of 955 patients receiving gastroscopy were enrolled. And 248 (26.0%)H. pylori strains were isolated from the biopsy samples of gastric mucosa. Overall, 14.5%, 64.1%, 0 and 0.8% of the strains were resistant to clarithromycin, metronidazole, amoxicillin and tetracycline, respectively. Resistance to two drugs was found in 10.7%(14/131) of the strains, and majority (92.8%, 13/14) of which were resistant to clarithromycin and metronidazole.Conclusions The prevalence ofH. pylori in gastric mucosa is rather lower compared with the data reported previously. It is associated with the sex, age and clinical outcome of patients, however, antibiotic resistance profile is not related to these factors.H. pylori eradication therapy should be individualized according to the results of susceptibility test in Shanghai.

Non-small cell lung cancer (NSCLC) accounts for 85% of total cases of lung cancer, which has the highest incidence and mor-tality in China. Most patients with lung cancer present with advanced stage disease at the time of diagnosis. With the limited develop-ment of cytotoxic chemotherapy for NSCLC therapy, median overall survival in patients receiving platinum-based doublet chemothera-py has been less than one year in several trials. To date, anti-angiogenesis agents combined with chemotherapy, small molecule tyro-sine kinase inhibitors (TKI) and immune checkpoint inhibitors were commonly applied in NSCLC instead of purely chemotherapy, which makes a great breakthrough in NSCLC therapy. This review summarizes and discusses the application of anti-angiogenic therapy in ad-vanced NSCLC.

Objective To investigate the prevalence and pattern of androgenetic alopecia (AGA) in Shanghai through a community-based survey. Methods A cluster sampling survey was done among the residents in Beixinjing Community, Changning District, Shanghai. All the subjects were asked to fill a questionnaire to provide their general information, including sex, age, native place, physical status, life habit, family history, etc. The diagnosis of AGA was made by dermatologists. To determine the pattern of hair loss,Norwood-Hamilton classification system and Ludwig classification system were used for male AGA and female AGA, respectively. All the data were statistically analyzed by EpiData and SPSS11.5 software. Results Totally, 7056 subjects completed the questionnaire, including 3519 males and 3537 females, and the response rate was 72.5%. AGA was diagnosed in 809 patients, consisting of 701 males aging from 19 to 91 years (mean 64.16±11.9 years) and 108 females aging from 35 to 91 years (mean 70.46±18.89 years). The standardized prevalence (SP) was 9.47% in total, 15.73% in males and 2.73% in females; the difference was significant between males and females (χ2=356.00, P<0.001). A family history of AGA was observed in 52.7% of all subjects including 391 (55.78%) males and 35 (32.41%) females. Type Ⅲ vertex involvement was the most common type in men aging from 20 to 70 years old, and type Ⅵ in those over 70 years old. Grade Ⅰ and Ⅱ predominated in female AGA. Conclusions The results of this survey indicate that the prevalence of AGA is remarkably higher in men than that in women. Furthermore, the prevalence is steadily increased with advancing age in Shanghai.

Objective:To explore the perception and perceived characteristics of risk of diabetes in people at high risk of diabetes under different glycemic states, and to provide a reference for clinicians to develop targeted risk interventions.Methods:Descriptive phenomenology research method was used to conduct semi-structured interviews with 17 diabetes high-risk persons selected by purpose sampling from August 2020 to January 2022 in the Health Management Center of General Hospital of Northern Theater Command. Data was transcribed and analyzed using Colaizzi ′s method. Results:Different glycemic states led to different themes for extraction. Each distilled 3 themes, normoglycemia including ignoring the existence of risk and creating doubt, risk perception relies on individual feelings, and demonstrate a positive attitude towards their risk control capabilities; initial diagnosis of dysglycemia including perceive the severity of the risk and express fear, mediated by health professionals and a strong desire to learn, accept by high-risk status and self-reflection on lifestyle; persistent glycemic impairment including tend to ignore risks to avoid undue stress and anxiety, determined based on experience and information, laissez-faire attitude or positive change. The differences among the 3 categories were mainly reflected in attitudes, emotions, perceived predisposing factors and risk control.Conclusions:It is still necessary to strengthen the education on diabetes prevention awareness and risk factors. And blood glucose can be considered as a classification guideline for targeted education.

Objective To discuss the pathological and clinical characteristics,treatments and prognosis of schwannoma of the kidney.Methods Two cases of schwannoma of the kidney in our hospital were reviewed with clinicopathological data and their follow-up.The related literatures were reviewed.The first case was a male patient,28 years old,complained about paroxysmal abdominal pain with nausea over 2 weeks.The physical exam found a 10 cm,qualitative hard,poor activity,tenderness mass in kidney region.MRI preoperative diagnosis was right renal cell carcinoma with renal vein and inferior vena cava tumor thrombus formation.The second patient,female,53 years old,the mass on upper right kidney was found occasionally.It was diagnosed as adrenal pheochromocytoma before operation,laparoscopic resection of right renal hilum mass and right partial adrenectomy plus right nephrectomy were performed.There was no tumor recurrence in the follow-up.Results The abdominal aortography and double renal arteriography were done and right renal artery embolization and inferior vena cava filter were allocated.Then right radical nephrectomy and inferior vena cava tumor thrombus removal were carried out on the first patient.The first malignant and the second benign renal schwannoma patient showed significant difference in pathological presentations.Their immunohistochemistry also showed great diversity.Malignant renal schwannoma was significantly stained by Ki-67 ＞ 40％,S-100 was negative.Ki-67 in benign neurilemmomas was about 2％,and S-100 in benign renal schwannoma was positive.Conclusions Schwannoma of the kidney is rare with a favorable prognosis.The golden standard of diagnosis is pathology.Surgical resection has become the first choice for treatment.Recurrence and malignant transformation would happen after the surgery so that all the patients should be followed up.

Objective To summary the pathological and clinical characteristics,treatments and prognosis of malignant renal perivascular epithelioid cell tumor (PEComa).Methods Between August 2013 and June 2017,8 cases of malignant renal PEComa were analysed respectively.Of all the patients,there were 4 males and 4 females,aged 27-65 years with the average of 46.3 years old.Three cases were detected in routine examination occasionally,three cases complained of intermittent back pain with fever,one presented with swollen and painful right hand and right foot,and one case presented with hematuria.CT or MRI examinations indicated the malignant lesions before the surgery.Clinical staging was performed with 2 cases of T1N0M0,1 case of T1 N0M1,2 cases of T2N0M0,1 case of T3M0M0,and 2 cases of T4N0M1.Three cases underwent radical nephrectomy,1 case underwent radical nephrectomy plus renal artery embolization,2 cases underwent partial nephrectomy,and 2 cases underwent nephrectomy plus inferior vena cava tumor thrombectomy.One case was treated with ifosfamide plus epirubicin after operation due to multiple distant metastases and 1 case was treated with oxaliplatin before the sugery because of excessive tumor diameter.None of the rest received any adjuvant therapy.Results Postoperative histopathological examination showed multiple nodules in reddish gray and yellow color,with soft texture and partial incomplete capsule.Microscopically,there were large atypical cell components,some of which were spindle shaped,with disordered cell arrangement,some of which were associated with a large amount of necrotic tissue,and abundant light eosinophil cytoplasm.Tissue components can be found thick-wall blood vessels,smooth muscle-like cells,and adipose tissue.Immunohistochemistry showed 4 cases were positive of HMB-45,4 of Melan-A,7 of SAM.Seven cases were negative of CK,6 of S-100 75％ (6/8) and Ki67 (10％-70％).Two cases died of multiple metastases (lung,bone,liver),1 case survived with tumor recurrence,with a follow-up from 14 to 60 months (mean 29 months).Conclusions Primary malignant renal PEComa is rare in practice with relative large diameter.The diagnosis depends on pathological findings,and radical nephrectomy is the first choice of treatment.It is easy to recur and metastasize after the operation.

Objective To investigate the efficacy and safety of Nocardiarubra cell wall skeleton (N-CWS) bladder irrigation in prevention of recurrence after transurethral resection for the treatment of non-muscle invasive bladder cancer (NMIBC).Methods The clinical data of patients with NMIBC treated by N-CWS and epirubicin collected between October 2013 and November 2018 at the First Affiliated Hospital of Zhengzhou University were retrospectively analyzed.All patients underwent TURBT.Among the 118 NMIBC patients,the average age was (65.1 ± 1 1.9) years,and the sex ratio (male/female) was 1.9∶1 (77/41).Patients were divided into two group:N-CWS group (n =55) and epirubicin group (n =63) according to different instillation regimens.N-CWS was given as an instillation of 800 μg in 50 ml of saline and maintained in the bladder for 2 h in the N-CWS group.Epirubicin was given as an instillation of 50 mg in 50 ml of saline and maintained in the bladder for 1 h in the epirubicin group.In the N-CWS group,mean agewas (64.9 ± 12.1) years and 37 (67.3％) were male.Multiple tumors were present in 17 (69.1％) patients.Tumor size was ≤3 cm in 49(89.1％) and 7(12.7％) had a history of NMIBC.Stage was Ta and T1 in 36(65.5％) and 19(34.5％),respectively.Grade 1,Grade 2 and Grade 3 were the primary grades in 38(69.1％),13(23.6％) and 4(7.3％),respectively.Low risk,intermediate risk and high risk were present in 14 patients(25.5％),16 (29.1％) and 25 (45.5％),respectively.In the epirubicin group,mean age was (65.3 ± 11.2) years and 40(63.5％)were male.Multiple tumors were present in 19(30.2％) patients.Tumor size was ≤3 cm in 56(88.9％) and 11 (17.5％) had a history of NMIBC.Stage was Ta and T1 in 37(58.7％) and 26 (41.3％),respectively.Grade 1,Grade 2 and Grade 3 were the primary grades in 44(69.8％),12(19.0％)and 7(11.1％),respectively.Low risk,intermediate risk and high risk were present in 13 (20.6％),19 (30.2％) and 31 (49.2％),respectively.The tumor recurrence,progression and adverse reactions after Intravesical Instillation in both groups were followed up and recorded.No significant differences were found between the two groups.Results A total of 118 patients were followed up.Mean follow-up time was (33.7 ± 5.4) months.25.5％ (14/55) in the N-CWS group vs.42.8％ (27/63) in the epirubicin group had recurrence after 5 years (x2 =3.922,P =0.048).The five-year RFS was higher in the N-CWS group than in the epirubicin group (74.2％ vs.56.5％,P =0.044).No significant difference was found in the progression rate between the two groups(5.5％ vs.7.9％,P =0.867).The incidences of adverse events in the two groups were 16.4％ (9/55) and 19.0％ (12/63),respectively.The N-CWS group had significantly fewer cases with urinary frequency and dysuria than the epirubicin group.No significant differences were found in other side effects.Conclusions Intravesical instillation of N-CWS after NMIBC TURBT was found to be a promising procedure to prevent recurrence and prolong the recurrence-free survival with less side effects.

Generic drugs account for more than 95% of the chemicals market in China, and their quality is directly related to the efficacy and safety of the people. The bioequivalence evaluation with pharmacokinetic parameters as the end point is the main content of the consistency evaluation of the quality and efficacy of generic drugs. Gut microbiota is considered to have an important influence on pharmacokinetics. This article reviewed the influence of gut microbiota on pharmacokinetics and analyzed its potential significance in the evaluation of the consistency of quality and efficacy of generic drugs.

[Abstract] Objective: To develop a new type of CD7 chimeric antigen receptor modified T cell (CD7-CAR-T) for the treatment of CD7 positive acute myeloid leukemia (AML), and to observe its killing effect on CD7 positive AML cells. Methods: The CD7-CAR lentiviral vector was constructed based on the CD7 Nanobody sequence and costimulatory domain sequence of CD28 and 4-1BB. The lentiviral particles were packaged and used to co-transfect human T cells with protein expression blocker (PEBL), so as to prepare CD7- CAR-T cells. Real time cellular analysis (RTCA) was used to monitor the cytotoxicity of CD7-CAR-T cells on CD7 overexpressed 293T cells. Flow cytometry assay was used to detect the effect of CD7-CAR-T cells on proliferation and cytokine secretion of AML cells with high, medium and low CD7 expressions (KG-1, HEL and Kasumi-1 cells, respectively). Results: CD7-CAR-T cell was successfully constructed and its surface expression of CD7 was successfully blocked. Compared with T cells, CD7-CAR-T cells could significantly inhibit the proliferation of CD7-293T cells and promote the release of TNF, Granzyme B and INF-γ; in addition, CD7-CAR-T cells also significantly promoted the apoptosis (t=147.1, P<0.01; t=23.57, P<0.01) and cytokine release (P<0.05 or P<0.01) in CD7 positive KG-1 and HEL cells, but had little effect on Kasumi-1 cells that only expressed minimal CD7 antigen (t=0.7058, P>0.05). Conclusion: CD7-CAR-T cells can specifically kill CD7-positive AML cells in vitro.