ObjectiveTo evaluate the clinical safety of Naoxintong （NXT） capsules after marketing， find out the potential risk factors of the drug as soon as possible， and reveal the incidence， nature， and clinical manifestations of the adverse events （ADE） and adverse reactions （ADR） of NXT capsules， so as to provide a basis for safe use of the drug in clinical practice. MethodA prospective， large-sample， multi-center observational cohort study was conducted to monitor all the 7 345 inpatients and outpatients orally taking NXT in 14 hospitals in China from January to December in 2018， with at least one follow-up. The demographic characteristics， disease type， NXT medication， ADR occurrence， characteristics， and prognosis of the patients were collected. SPSS 23.0 was used for single-factor and multivariate logistic regression to predict the influencing factors of ADR. ResultThe male and female patients accounted for similar proportions. There were 5 081 patients （79.40%） aged ≥60 years and 3 153 patients （49.27%） with body mass index （BMI） exceeding the normal standard. There were 344 （5.38%） patients with a history of allergy to medicines and food， 9 （0.14%） patients with a family history of allergy， and 52 （0.81%） patients with a history of allergic diseases. The ADRs associated with NXT occurred in 22 patients， with the incidence of 0.34%. The clinical manifestations of ADR appeared in 31 cases， involving 10 organs/systems， of which gastrointestinal system damage was the most common （17， 54.84%）. All ADRs were mild or moderate. Most ADRs （19， 86.36%） occurred within 4 weeks after administration. The patients with alleviated NXT-associated ADRs accounted for 81.82%. No indicators related to significant increases in ADR risks were found. ConclusionNXT is well tolerated in the general population. The hospital centralized monitoring for the clinical safety of oral Chinese patent drugs based on HIS data and Web tracking and follow-up system is an essential means for the post-market research on the safety of drugs.

Objective:To identify causative genes for autosomal recessive woolly hair (ARWH) in a family.Methods:Clinical data were collected from two patients and other family members in a Chinese pedigree of Han nationality with ARWH. Peripheral blood samples were obtained from the two patients, their unaffected parents and 100 unrelated healthy individuals, and DNA was extracted from the blood samples. A next-generation skin-targeted sequencing panel was used to detect gene mutations in the patients, and Sanger sequencing was performed to verify the sequencing results. The function of protein encoded by the mutant gene was predicted.Results:Two missense mutations c.530T>G (p.Leu177Arg) and c.736T>A (p.Cys246Ser) were both identified in the LIPH gene of the two patients, which were inherited from their father and mother respectively. Neither of the two mutations was identified in the 100 unrelated healthy controls. Interspecies sequence alignment showed that leucine at amino acid position 177 and cysteine at amino acid position 246 of the protein encoded by the LIPH gene were highly evolutionarily conserved. As SIFT and Polyphen-2 softwares showed, the mutations c.530T>G (p.Leu177Arg) and c.736T>A (p.Cys246Ser) were both predicted to be detrimental variations.Conclusion:Two missense mutations c.530T>G (p.Leu177Arg) and c.736T>A (p.Cys246Ser) in the LIPH gene may contribute to the clinical phenotype of the two patients with ARWH in this family.

Objective To analyse the breast conserving surgery feasibility in patients with advanced breast cancer after neoadjuvant chemotherapy.Methods Sixty patients with advanced breast cancer were collect-ed from June 2010 to June 2011, and were divided into breast conserving surgery after neoadjuvant chemotherapy group and modified radical mastectomy group according to the intention,30 cases in each group.They were given breast conserving surgery after neoadjuvant chemotherapy and modified radical mastectomy respectively,with fol-lowing-up for 3 years.The treatment effect and contrast analysis of two groups of breast cancer CTCs positive of the two groups were compared,two groups of late follow-up of patients with local recurrence and distant metasta-sis rate,overall survival and disease free survival rate were recorded.Results Compared with the modified radi-cal mastectomy group,CTCs detection rate in breast conserving surgery group had no statistical differences(P>0.05).Two groups of patients in clinical complete remission rate,partial remission rate,disease stability factor and local recurrence and distant metastasis rate,overall survival and disease free survival rate had no statistical significances(P>0.05).Conclusion The application of breast conserving surgery after neoadjuvant chemother-apy for patients with advanced breast cancer can achieve similar effect as modified radical mastectomy surgery treatment,and can be used as a effective treatment for advanced breast cancer.

Objective: To investigate the predictive value of an early inflammatory response factor, Rho kinase activity for left ventricle remodeling (LVR) in patients with acute ST-segment elevation myocardial infarction (STEMI).
Methods: A total of 120 acute STEMI patients treated in our hospital from 2010-10 to 2013-06 were studied, all patients were ifrst time received primary percutaneous coronary intervention (PCI) with stent implantation. Rho kinase activity and B-type natriuretic peptide (BNP) were measured before PCI, echocardiography was conducted at 24 hours and 12 months after STEMI respectively to clarify LVR diagnosis. The patients were divided into 2 groups as LVR group, n=97 and Non-LVR group, n=23, the above indexes were compared between 2 groups.
Results: The level of Rho kinase was higher in LVR group than that in Non-LVR group, P<0.001, after adjustment, Rho kinase was the independent predictor for LVR (OR 3.36, 95%CI 2.01–5.78, P<0.001). The ROC of Rho kinase was 0.88 (95%CI 0.82–0.94) and the ROC of BNP was 0.54 (95%CI 0.41–0.70).
Conclusion: High Rho kinase activity could predict LVR in acute STEMI patients with primary PCI and stent implantation.

Twelve healthy volunteers underwent ECG-triggered non-contrast-enhanced magnetic resonance venography(NCE-MRV)of lower extremities on a 1.5T MR scanner.Image quality was assessed quantitatively and qualitatively with a 17-segment model.ECG-triggered (NCE-MRV) was successfully performed in all patients.Mean signal to noise ratio and contrast to noise ratio of lower extremities were 66 ± 23 and 53 ± 22 respectively.Excellent and good image qualities were achieved in 62％ and 31％ of all segments respectively without non-evaluable segment.Thus ECG-triggered NCE-MRV of lower extremities is feasible with reliable image quality.

The examinations of optical coherence tomography (OCT) images were obtained in 136 patients. Lactated Ringer's solution or physiological saline was used randomly as perfusate. Their electrocardiogram and cardiac enzymes were acquired to compare the safety and image quality of two perfusates.The incidence of ventricular arrhythmia and rise of cardiac enzymes were lower in the lactated Ringer's solution group than those in the physiological saline group.Yet the image quality of OCT had no difference.The use of lactated Ringer's solution as perfusate instead of physiological saline in OCT examination may protect the ischemic myocardium and reduce the incidence of complications.

Objective To investigate the value of susceptibility weighted imaging (SWI) in the diagnosis of hemorrhagic diffuse axonal injury (DAI). Methods A retrospective study was conducted on 20 patients with DAI who received MRI examination at day 3 post-injury.MRI sequences included T1WI,T2WI,fluid attenuated inversion recovery ( FLAIR),diffusion weighted imaging (DWI) and SWI.There were 15 patients with the Glasgow Coma Scale (GCS) score≤8,three with GCS score of 9-12 and two with GCS of 13-15.The location and quantity of hemorrhage focus were counted.The area of hemorrhage focus was measured on each MR sequence.Differences of detection rate of hemorrhage focus on each sequence were compared by using X2 test.The correlation between DAI related bleeding area and GCS score was analyzed. Results DAI related hemorrhage focus showed a larger number in superficial cerebrum than that in posterior cranial fossa and in deep cerebrum.The detection rate of hemorrhage focus on SWI was the highest,as compared with other sequences ( P ＜ 0.05 ).Bleeding area and GCS score showed a negative correlation (r =-0.921,P ＜ 0.01 ). Conclusion SWI is very sensitive in detection of the intracerebral hemorrhage focus in the acute period of traumatic DAI.

Xanthogranulomatous cholecystitis (XGC) is benign and chronic, which is rarely seen in clinical practice.The clinical and imaging presentation of XGC is similar to that of chronic cholecystitis, cholecystolithiasis and gallbladder cancer.Summarizing the computed tomography (CT) presentations of XGC is helpful in improving the diagnostic accuracy. According to the result of a retrospective analysis based on the clinical data of 17 patients with XGC, we concluded that rim enhancement sign and hypodense band sign in the arterial phase of contrast enhanced CT, and clear in interface between liver and gallbladder and trimness of internal wall in gallbladder are the CT characteristics of XGC.

Objective To investigate factors influencing islet isolation and purification in dogs and to explore how to obtain massive purified viable islets from canine pancreas.To provide experimental evidence for pancreatic islet transplantation in clinical practice.Methods Islets were isolated from pancreas of 22 dogs by modified automated techniques,followed by purification using continuous density gradients.The purity of islets was determined by dithizone (DTZ) staining,and the function of islets was evaluated by glucose stimulating insulin release test.Results The crude islets yield was ( 155 040 ±310) IEQ/pancreas while the yield was (74 200 ±185) IEQ/pancreas after purification.The average purity was (89.4 ±2.6) ％.The recovery rate was(47.8 ±1.3) ％.Islet viability was(93.0 ± 1.7)％.The modified techniques improved both the yield and the quality in islet isolation and purification.The islets were morphologically intact after purification.Glucose stimulating insulin release test showed that the difference of the secreted insulin concentration had statistical significance ( P ＜0.001 ) between low concentration glucose group and high concentration glucose group.Conclusion It is of great value for clinical research to obtain enough islets through islet isolation and purification in dogs.

Objective To compare the effect of percutaneons coronary interventions (PCI) combined with polydanshinolate on myocardial reperfusion with PCI combined with regular medicine in patients with acute myocardi-al infrarction ,and whether polydanshinolate would decrease no-reflow,improve the myocardial micro-circulation and the ventricular remodeling and clinical end-point events at the sixth month. Methods Random,parallel control and prospective clinical design was used in the current study. Sixty eligible patients for PCI, who were diagnosed as first-time acute myocardial infrarction with ST stage increasing,were recruited in the study with informed consent. All par-ticipants were divided into two groups randomly. Group A was treated with PCI combined with polydanshinolate, group B was treated with PCI combined with regular medicine. The participants were followed up for six months. The resolution of the sum of ST segment elevation (sum STR) ,corrected TIMI frame count (CTFC) and myocardial con-trast echocardiography (MCE) were used to assess myocardial perfusion. Bleeding events, heart function and major adverse cardiac events (MACE) were observed during hospitalization and follow-up visit. Results No significant difference was observed between two groups on the clinical condition and the results of emergency CAG and PCI. Compared to group B,the incidence of TIMI grade 3 was significantly higher in group A (90.0% vs 63.3% ,χ~2 = 4.565, P=0.0326). Sum STR one hour after PCI in group A was siguificanfly higher than that in group B (80.0% vs 50.0%, χ~2=4.689, P=0.0304). CTFC after PCI also differed significantly between the two groups (24.1±8.3 vs 33.4±15.9 respectively,P=0.0062). Localized myocardial blood flow 48 hours after PCI showed no significant difference between the two groups (P>0.05), whereas both increased at the 7th day after PCI (5.85±1.26 vs 2.09±1.85,t=9.2008,P<0.0001 ;3.95±1.35 vs 1.95±1.29,t=5.8666,P<0.0001) ,and there were signifi-cant difference between the two groups (P<0.05). No significant difference of LVEF, LVEDV, LVESV were found between the two groups during the hospitalization and follow-up visit after 6 months (P>0.05). The incidences of cardiovascular events and severe heart failure during hospitalization and follow-up visit in group A were significantly lower than that in group B (P<0.05 ). Conclusions Polydanshinolate addition to PCI could reduce no reflow phe-nomenan in patients of acute myocardial infrarction, improve myocardial reperfusion, and furthermore, decrease cardi-ovascular events and ameliorate prognosis.