Objective:To explore the impact of recent changes in domestic policies and regulations on the development and appli-cation of generic drugs. Methods:Through the collation of the recent regulatory documents, the policy changes for generic drugs were analyzed, and the corresponding development proposals were provided. Results and Conclusion:According to the possible impact of current policy changes on generic drug development, the relative solutions are proposed with the aim to provide certain reference for ge-neric pharmaceutical R & D institutions.

Objective To investigate the clinical efficacy of photodynamic therapy with red and blue light in the treatment of facial acne. Methods Ninety-two cases of facial acne in dermatology outpatient hospital were randomly divided into the test group and the control group, with 46 cases in each group. Patients in the test group received the photodynamic therapy, and patients in the control group received red plus blue light treatment for eight weeks, respectively. Results Before treatment, patients in the test group and the control group had no significant differences in acne, papules, pustules, nodules, cysts and gags score. After 8-week treatment, the comedones, papules, pustules, nodules cyst number, gags score of patients in the test group were significantly less than or lower than those of patients in the control group (P < 0.05, respectively). The healing rate was 84.78% in the test group, which was higher than that of 65.22%in the control group of (P<0.05). The total efficiency was 97.83%in the test group and 93.48% in the control group, with no significant difference. The adverse reaction rate was 10.87% in the test group and was 23.91% in the control group, with no significant difference. Conclusion The effect of photodynamic therapy for facial acne is better than red plus blue light treatment ,with a less incidence of adverse reactions.

Objective To evaluate the ultrasound guidance method in central venous catheterization (CVC) via the axillary vein.Methods Totally 1369 CVC patients in our center from November 2010 to October 2012 were enrolled in this study.They were randomly divided into two groups based on their different procedures:ultrasound group (n =687):the central veins were assessed using ultrasound,and catheters were placed via axillary vein with ultrasound guidance ; and control group (n =682):CVC was performed using the anatomical landmark method.The operation time,one-attempt success rate,complications,and malposition rate were compared between these two groups.Results The ultrasound group had significantly shorter operation duration than the control group [(7.8± 2.2) min vs (8.4 ± 1.7) min,P =0.000],higher one-attempt success rate [(96.0％ (659/687) vs 81.7％ (557/682),P =0.000],and lower complications and malposition rate [0.6％ (4/687) vs3.7％ (25/682),P=0.000; 0.6％ (4/687) vs2.1％ (14/682),P=0.017,respectively].Conclusions Compared with the conventional landmark method via subclavical vein,ultrasound-guided CVC via axillary vein method can effectively increase success rate,decrease operation duration,attempts of puncture,and complication rate,and avoid catheter malposition.Therefore,the ultrasound method can improve the safety and accuracy of the CVC procedure and deserves wider clinical application.

Purpose To explore the immunohistochemical ( IHC) expression of ALK antibodies with different clones in anaplastic lym-phoma kinase ( ALK) gene fusion non-small cell lung cancer ( NSCLC) . Methods ALK expression in 60 NSCLCs were detected by IHC including autostainer (D5F3, Ventana+BenchMark) and manual staining using 4 different antibodies of D5F3 (Ventana), D5F3 (Cell Signaling), 1A4/1H7 (OriGene), 5A4 (Abcam), and all cases were verified with ALK FISH. Their expressions with 4 anti-bodies were compared with those by D5F3 (Ventana+BenchMark). Results 32 ALK gene rearrangement NSCLCs and 28 negative cases were identified by FISH and D5F3 (Ventana+BenchMark). The sensitivity of D5F3 (Ventana), D5F3 (Cell Signaling), 1A4/1H7 (OriGene), 5A4 (Abcam) was 93. 8%, 84. 4%, 93. 8%, 56. 3%, and all the speciticity was 100%. The consistency with D5F3 (Ventana+BenchMark) was 96. 7%, 91. 7%, 96. 7% and 76. 7%, respectively. The validity of immunohistochemical staining in surgical resection specimens was better than in small biopsies. Conclusion Effective routine manual immunohistochemistry with high-affinity antibody clone may provide a more economic and widespread pre-screening technique.

Objective: To determine the potency of QN-2013, a derivative of quinoxaline 1,4-N-oxide, as a hypoxia-selective cytotoxin or a radiosensitizer. Methods: In vitro cytotoxicity and radiosensitization, as well as in vivo antitumor activity were determined by colony formation and tumor growth delay respectively. The changes in the cell cycle, DNA damage and repair of damaged DNA were assayed by FCM and “comet” assay, separately. Results: ICN250 and ICair50 of QN-2013 for HeLa-S3 cells were 0.08 and 1.7 mmol*L－1 respectively, namely, HCR=21. This suggested that QN-2013 was a fairly hypoxic cytotoxin, but inferior to SR-4233. QN-2013 had an evident radiosensitization either in vitro or in vivo. It was noted, however, that the value of in vitro SERs increased exponentially with increasing concentration of the drug, but the in situ antitumor activity seemed to be independent of doses of the drug. The systemic toxicity of QN-2013 was superior to an LD50 of 265　mg*kg－1 compared with 80　mg*kg－1 for SR-4233. In hypoxic condition QN-2013 induced S retension effect and G2M block in HeLa-S3 cells, caused DNA double strand break, and inhibited the repair of radiation-induced DNA damages. All of these reactivenesses might be involved in the action mechanism of QN-2013. Conclusion: QN-2013 is a fair hypoxia-selective cytotoxin, and has shown improved antitumor activity in vivo in combination with radiation. In general, These results suggest that the series of quinoxaline di-N-oxide derivatives hold out bright prospect for the development of novel bioreductive antitumor drugs.

OBJECTIVETo study the diagnostic value of SATB2, together with CK7 and CK20, in colorectal cancer.

METHODSImmunohistochemical study for SATB2, CK7 and CK20 was carried out in 210 cases of colorectal cancer tissue, 100 cases of non-colorectal cancer tissue, 90 cases of lymph node metastases and 50 cases of normal colorectal mucosa.

RESULTSThe sensitivity and specificity of CK20+/CK7- immunophenotype for diagnosis of colorectal adenocarcinoma were 78.1% and 92.0%, respectively. When triple markers were used, the immunophenotype CK20+/CK7-/SATB2+ had a sensitivity of 57.1% and a specificity of 98.0%. When combining the immunophenotype of SATB2+/CK7- or CK20+/CK7-, the sensitivity was 85.7% and specificity was 90.0%.

CONCLUSIONSA panel of immunohistochemical markers SATB2, CK7 and CK20 could increase the specificity for diagnosis of colorectal adenocarcinoma significantly. SATB2 is considered as a useful adjunct in this respect.

Adenocarcinoma ; diagnosis ; metabolism ; Biomarkers, Tumor ; metabolism ; Colorectal Neoplasms ; diagnosis ; metabolism ; Humans ; Immunophenotyping ; Keratin-20 ; metabolism ; Keratin-7 ; metabolism ; Lymphatic Metastasis ; Matrix Attachment Region Binding Proteins ; metabolism ; Sensitivity and Specificity ; Transcription Factors ; metabolism

OBJECTIVE: To assess the value of chromosomal microarray analysis (CMA) for fetuses with choroid plexus cysts (CPC) detected by prenatal ultrasonography. METHODS: Amniotic fluid chromosomal karyotype was analyzed in 104 fetuses with CPC, and copy number variations (CNVs) among the fetuses were detected by using CMA. RESULTS: Ten fetuses (9.62%) were found to have an abnormal karyotype, and 14 additional CNVs were detected in those with a normal karyotype. The fetuses were divided into isolated CPC group (n = 87) and non-isolated CPC group (n = 17) based on the presence of additional ultrasonographic abnormalities. The detection rates for karyotypic abnormalities of the two groups were 4.6% and 35.3%, respectively, whilst those for the CMA were 4.6% and 47.1%, respectively. The detection rates for karyotypic abnormalities and CMA of the non-isolated CPC group were significantly higher than those of the isolated CPC group (P < 0.05). The detection rate for CMA in the non-isolated group was significantly higher than chromosomal karyotype abnormalities (P < 0.05). Among the 8 fetuses with abnormal CMA, 4 had single umbilical artery, 3 had abnormal cardiac structure, and 2 had enhanced intestinal echo. CONCLUSION CPC is closely associated with chromosomal abnormalities. Chromosome karyotype analysis in combination with CMA can effectively detect fetal chromosomal abnormalities and provide a basis for genetic counseling.
Humans ; Female ; Pregnancy ; DNA Copy Number Variations ; Choroid Plexus/diagnostic imaging* ; Microarray Analysis ; Karyotype ; Chromosome Aberrations ; Amniotic Fluid ; Cysts

To explore the automated immunostainer screening anaplastic lymphoma kinase (ALK) gene fusion non-small cell lung cancer (NSCLC) and clinicopathological characteristics of the molecular subtype lung cancers. Methods Five hundred and sixty-six cases of NSCLC were collected over a 16 month period. The test for ALK was performed by Ventana automated immunostainer with anti-ALK D5F3. The histological features, treatment and outcome of patients were assessed. Results Thirty-eight cases (6.7%, 38/566) of NSCLC showed ALK gene fusion. The frequency of ALK gene fusion was higher in male (7.1%, 25/350) than that in female (6.0%, 13/216) patients, but not achieving statistical significance (chi2 = 0.270, P = 0.604). ALK + NSCLC was more significantly more frequent in patients < or = 60 years (9.9%, 28/282) than >60 years (3.5% , 10/284) of age. Histologically, the ALK + NSCLCs were mostly adenocarcinoma (81.6%, 31/38) , among which eighteen cases were solid predominant subtype with mucin production; nine cases were acinar predominant subtype; one case was papillary predominant subtype and three cases were invasive mucinous adenocarcinoma. The ALK + non-adenocarcinoma included three cases of squamous cell carcinoma, three cases of adenosquamous carcinoma and one case of pleomorphic carcinoma. Among the ALK + NSCLC patients, the number of non/light cigarette smokers (86. 8% , 33/38) was more than that of heavy smokers. Twenty-nine cases were stages III and IV; twenty-nine cases showed lymph node metastasis; twenty cases showed metastases mostly to brain and bone; and one case showed EGFR gene mutation coexisting with ALK gene fusion. Twelve of fifteen patients received crizotinib therapy and remained stable. Conclusions NSCLC with ALK gene rearrangement shows distinctive clinical and histological features. Ventana-IHC may he a feasible and valid technique for detection of ALK rearrangement in NSCLC.
Adenocarcinoma ; genetics ; pathology ; Carcinoma, Adenosquamous ; genetics ; pathology ; Carcinoma, Non-Small-Cell Lung ; genetics ; pathology ; Carcinoma, Squamous Cell ; genetics ; pathology ; Female ; Gene Fusion ; Gene Rearrangement ; Humans ; Lung Neoplasms ; genetics ; pathology ; Male ; Middle Aged ; Protein Kinase Inhibitors ; therapeutic use ; Pyrazoles ; therapeutic use ; Pyridines ; therapeutic use ; Receptor Protein-Tyrosine Kinases ; genetics ; Sex Factors

Objective:To investigate the value of pericoronary adipose tissue histogram parameters based on coronary CT angiography (CTA) images for the differentiation of acute coronary syndrome and stable coronary artery disease.Methods:The clinical data and CTA images of 93 patients with coronary CTA examination in Suzhou Kowloon Hospital from 2013 to 2018 were analyzed retrospectively. There were 39 patients with acute coronary syndrome (acute coronary syndrome group) and 54 patients with stable coronary artery disease (stable coronary artery disease group). A region of interest (ROI) was drawn around the stenosis of the coronary arteries, with CT attenuation ranging from-190 to -30 HU to exclude non-adipose tissue. The CT attenuation of ROI excluding non-adipose were measured and histogram analysis was performed. The obtained parameters included the mean value, median value and the 5th, 10th, 45th, 55th, 70th and 95th percentiles. The differences in histogram parameters between the two groups were compared, and then the value of each parameter in differentiating acute coronary syndrome and stable coronary artery disease was evaluated based on receiver operating characteristic (ROC) analysis. The stepwise regression of multivariate logistic regression analysis was used to identify the useful features and establish the final prediction model. The ROC curve of the final model was calculated and its value was analyzed.Results:The mean, median and the 5th, 10th, 45th, 55th,70th and 95th percentile differences between the acute coronary syndrome group and the stable coronary artery disease group were statistically significant (all P<0.05). The ROC curve for the median and the 95th percentile had the same area under curve (AUC) of 0.73. The sensitivity, specificity and AUC of the diagnostic model established by multiple logistic regression were 82.1%, 89.1% and 0.90 respectively. Conclusion:CT attenuation histogram of pericoronary adipose tissue is of high value in differentiating acute coronary syndrome from stable coronary artery disease.

Objective To establish and implement a central venous linemanagement information system based on the hospital information system (HIS). Methods The central venous line information management system was developed by the infusion therapygroup and the information technology department according to the requirement of completed central venous line management and the Chinese intravenous nursing practice standard. Results ① A complete information management system was constructed for central venous line from placement, maintenance and management of complications to drawing tube, and it operated smoothly. ②Totally, 4304 cases of PICC, 14,330 cases of CVC and 123 cases of PORT were collected from January 2016 to December 2017. The information of the maintenance number, catheter retention time, complications can be counted. Conclusions The central venous vein management information management system can realize the whole-process management, and ensure the continuous evaluation, maintenance and tracking of the patient's central venous line, making detailed statistical analysis of catheter- related complications, whichcan provide reliable basis for continuous nursing quality improvement.