This article systematically summarizes the non-clinical safety studies, pharmacological studies and postmarketing safety studies of Xiyanping injection based on literature. These studies include acute toxicity test, long-term toxicity test, reproductive toxicity test, active and passive anaphylaxis test, curative mechanism study, clinical trials of effectiveness, active surveillance, security analysis of passive monitoring data, the real world analysis of hospital information system (HIS) data, literature analysis, etcetera This article also analysis the relationship of the different evidence, summarizes the strategy of the researches, in order to make it to be a reference for making a systemic research program of traditional Chinese medicine injection.
Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; Injections ; Medicine, Chinese Traditional ; methods ; Product Surveillance, Postmarketing

To investigate the protective effects and possible mechanism of Mycelium of Hirsutella hepiali Chen et Shen (MHCS) on metabolic syndromes, free fatty acid and MHCS-treated hepatocytes were used for detecting autophagy-related LC3, p62 and lipid accumulation. Moreover, high fat diet fed mice were used to establish metabolic syndromes model. 50-weeks age mice were randomly divided into: control group, model group and MHCS group. At 80-weeks age, 15 mice were randomly chosen from each group separately for examining oral glucose tolerance, serum insulin, insulin-like growth factor 1 (IGF-1), hepatic LC3, p62, p-NF-kappaB p65, NF-kappaB p65, IL-6 and CXCL-8. Moreover, insulin resistance index (IRI) was calculated. Hepatic pathological changes, including vacuoles, lipids accumulation and fibrosis were observed. Remaining mice were fed with diet separately to 110 weeks-age for statistics of mortality. MHCS promoted autophagy of free fatty acid treated hepatocytes. Mice fed with high fat plus MHCS diet exhibited improved oral glucose tolerance, insulin resistance, hepatic pathology, inflammation, mortality and activated autophagy. The protective effects of MHCS against metabolic syndroms might be through the activation of hepatic autophagy.
Animals ; Autophagy ; Diet, High-Fat ; adverse effects ; Glucose Tolerance Test ; Hepatocytes ; metabolism ; pathology ; Hypocreales ; Insulin ; blood ; Insulin Resistance ; Insulin-Like Growth Factor I ; metabolism ; Interleukin-6 ; metabolism ; Interleukin-8 ; metabolism ; Liver ; metabolism ; pathology ; Male ; Metabolic Syndrome ; etiology ; metabolism ; pathology ; Mice ; Mice, Inbred C57BL ; Microtubule-Associated Proteins ; metabolism ; Mycelium ; physiology ; Random Allocation ; Transcription Factor RelA ; metabolism ; Transcription Factors ; metabolism

Objective To investigate the mechanisms of the inhibitory effects of peripheral electrical stimu- lation(PES)on chronic central pain(CCP)after spinal cord injury(SCI).Methods Twenty-four male Sprague- Dawley rats with CCP following SCI were randomly divided into three groups:a group without stainless steel needles implanted (NSSN group,n=8),a group with a stainless steel needle implanted but no peripheral electrical stimula- tion applied(NPES group,n=8)and a PES group(PES group,n=8).The rats' CCP was evaluated through ob- serving their response to nociceptive stimulation by means of the paw withdrawal pressure threshold(PWPT)and the paw withdrawal latency(PWL).Spontaneous pain behaviors including autophagia and scratching were observed at the same time.PES was applied via stainless steel needles inserted into standard acupoints on the hind limps and the back.The expression of the NMDA receptor 1(NR-1)subunit in the spinal cord horn was measured using immuno- chemical methods.Results Compared with the NSSN and NPES groups,CCP in the PES group was alleviated, PWPT and PWL were dramatically increased(P＜0.01)and the expression of NR-1 was obviously decreased (P＜0.01).Conclusion Peripheral electrical stimulation may alleviate chronic central pain after spinal cord injury in rats.

AIM:To investigate the timing and efficacy of vitrectomy for patients with vitreous hemorrhage(VH) due to proliferative diabetic retinopathy(PDR).METHODS:Retrospective analysis.Patients who presented to our hospital between Feburary 2012 and May 2014 with VH secondary to PDR treated with vitrectomy were included.All patients were divided into three groups according to the duration of VH.A group was less than 1mo for 22 eyes, B group was 1-3mo for 23 eyes, C group was more than 3mo for 25 eyes.All patients underwent intravitreal injection of ranibizumab 1-2wk before vitrectomy, and supplemented or finished panretinal photocoagulation (PRP) intraoperatively or postoperatively.Patients with cataract accepted phacoemulsification and intraocular lens implantation.Eyes filling silicone oil were implanted intraocular lens in the second phase.All patients were followed up 24 to 42mo (mean:28.7mo).We assessed the intraoperative complications such as hemorrhage, iatrogenic retinal hole, and postoperative complications such as vitreous hemorrhage, neovascular glaucoma.Macular edema and best corrected visual acuity were observed at every follow-up.RESULTS:There was no significant difference for other baseline data (P>0.05) but DR stage between three groups (P=0.033).There was significant difference of last follow up visual acuity between three groups (P<0.001).The significant difference can be seen between group A and B (P=0.03).The same outcome showed between Group A and C(P<0.001).There was no significant difference between Group B and C (P>0.05).The percentage of visual acuity was 0.5 and above in the three groups were:41%, 23%, 0 respectively.The patients with visual acuity of less than 0.1 were 5%, 26% and 40% respectively.Silicone oil filling rate of three groups were:9%, 26%, 40% respectively and there was no significantly difference between three groups on postoperative complications (P>0.05).CONCLUSION:Patients with VH due to proliferative diabetic retinopathy undergoing early vitrectomy may get better visual acuity than who accepting delayed vitrectomy.

A new wood-degrading fungus Monodictys asperospera(Cooke & Massee) Ellis with a high level of laccase production was chosen to study.This laccase was purified by ammonium sulfate precipitation,DEAE-cellulose and sephacryl S-300.Purification of about 8.1 fold was achieved with an overall yield of 5.7%.Its molecular weight was estimated to be about 77 kD.The optimum temperature and pH of the lac-case activity were 55?C and 6.0,respectively.Kinetic studies of the laccase showed that the Km and the Vmax for using syringaldazine as substrate was 0.163 mmol/L and 0.194 mmol/(L.min),respectively.The carbo-hydrate content was 18.14%.In addition,it was found that laccase activity was significantly inhibited by Cu2+.

Objective To investigate the prevalence of subclinical hypothyroidism and its relation to serum total cholesterol (TC),triglyceride (TG) levels and non-alcoholic fatty liver.Methods Serum levels of TC,TG, TSH,TT_3 and TT_4 were determined in 1 602 subjects which were divided into groups by sex and age (20-39,40- 59 and≥60 years).Fatty liver was diagnosed by type B ultrasonography.Restults ( 1 ) Prevalence of subclinical hypothyroidism was 6.6% in this population.(2) The mean levels of serum TC and TG in subclinical hypothyroidism group and normal group showed no significant difference ( both P＞0.05 ).(3) On the whole,the prevalences of subclinical hypothyroidism in hypercholesterolemia group and normal cholesterolemia group showed significant difference (P＜0.01 ).(4) In the three age groups of male and few.ale examinees,the prevalences of subclinical hypothyroidism in hypercholesterulemla group and normal cholesterolemia group showed no significant difference ( all P＞0.05 ).In the multiple regression analysis,TSH level was not related with raised TC level.(5) In the three age groups of male,there was no significant difference between the prevalences of subclinical hypothyroidism in hypertriglyceridemla group and normal triglyceridemia group ( all P＞0.05 ).In female,expect for the elderly group (＞60 years old ),the prevalence of subclinical hypothyroidism was higher in hypertriglyceridemia group than that in normal triglyceridemia.However,in the multiple regression analysis, increased TSH level was positively associated with increased serum TG level ( OR = 1.072,P=0.013 and OR = 1.102,P = 0.03 ).(6) The prevalence of subclinical hypothyroidism in non-alcobolic fatty liver group and normal group showed no significant difference ( P＞0.05 ).In the multiple regression analysis,TSH level was not the independent risk factor of non-alcoholic fatty liver (P＞0.05 ).Conclusion Subclinical hypothyroidism is not asseciated with serum TC level but positively associated with serum TG level.Subclinical hypothyroidism does not apparently increase the prevalence of non-alcoholic fatty liver.

Objective To explore a more reasonable and effective therapeutic regimen and evaluate prognostic factors in hepatoblastoma patients after combined therapy.Methods Sixteen patients diagnosed on hepatoblastoma between Jan.2000 and Nov.2007 were reviewed and followed-up.Resection with chemotherapy was taken among 16 cases.Chemotherapy included pre-operation and post-operation.Five cases were cured by transcatheter arterial chemombolization(TACE).Six cases were cured by single chemotherapy(both TACE and single chemotherapy were taken in 2 cases).Five cases weren't cured by pre-operation chemotherapy.Nine cases were subjected to curative resection,3 cases to alleviative resection,2 cases with single chemotherapy,1 case with single TACE,and 1 case refused operation and left hospital.Their mean survival duration was 13.5 months(3-98 months).SPSS 13.0 software was used to analyze the data.Results The total survival rate of cases as stage Ⅳ as lower than cases as stage Ⅰ,Ⅱand Ⅲ.Both alpha-fetoprotein(AFP)100 000 ?g/L cases had worse survival rate.The prognosis of mixed type was better than fetal type,embryonal type and anaplasia type.The survival rate of cases with standard chemotherapy was higher than cases with unstandard chemotherapy.And the surgical resection cases had better survival chance than non-surgical resection cases.The survival rate of surgical residual cases was worse than non-surgical residual cases.Conclusions Chemotherapy can improve the total survival rate and long-term survival rate of hepatoblastoma patients.TACE is a safe and effective choice for hepatoblastoma patients.We need to be alert and make the diagnosis as early as possibe,and treat it early and properly.

Tanreqing injection is suitable for early pneumonia, acute bronchitis, acute exacerbations of chronic, and upper respiratory tract infection which are classified with phlegm-heat obstructing lung syndrome of traditional Chinese medicine. To understand the clinical adaptation syndromes and medication characteristics of the post-market Tanreqing injection, the research team of the paper monitored the patients who are used with Tanreqing injection from September 2012 to October 2013 in four leader hospitals based on the method--prospective, multi-center, large sample, registration-type hospital centralized monitoring,and analyzes the general information, diagnostic information and medication characteristics of patients, in order to produce evidence for clinical practice and medication decisions and to establish the foundation of rational drug use.
Adolescent ; Adult ; Aged ; Aged, 80 and over ; Child ; Child, Preschool ; Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; therapeutic use ; Female ; Humans ; Infant ; Infant, Newborn ; Male ; Medicine, Chinese Traditional ; Middle Aged ; Prospective Studies ; Respiratory Tract Infections ; Young Adult

We investigated the development of an injectable, biodegradable hydrogel composite of poly(trimethylene carbonate)-F127-poly(trimethylene carbonate)(PTMC11-F127-PTMC11 )loaded with bone morphogenetic protein-2 (BMP-2) derived peptide P24 for ectopic bone formation in vivo and evaluated its release kinetics in vitro. Then we evaluated P24 peptide release kinetics from different concentration of PTMC11-F127-PTMC11 hydrogel in vitro using bicinchoninic acid (BCA)assay. P24/ PTMC11-F127-PTMC11 hydrogel was implanted into each rat's erector muscle of spine and ectopic bone formation of the implanted gel in vivo was detected by hematoxylin and eosin stain (HE). PTMC11-F127-PTMC11 hydrogel with concentration more than 20 percent showed sustained slow release for one month after the initial burst release. Bone trabeculae surround the P24/ PTMC11-F127-PTMC11 hydrogel was shown at the end of six weeks by hematoxylin and eosin stain. These results indicated that encapsulated bone morphogenetic protein (BMP-2) derived peptide P24 remained viable in vivo, thus suggesting the potential of PTMC11-F127-PT- MC11 composite hydrogels as part of a novel strategy for localized delivery of bioactive molecules.
Animals ; Biocompatible Materials ; chemistry ; Bone Morphogenetic Proteins ; pharmacology ; Bone and Bones ; drug effects ; Dioxanes ; chemistry ; Drug Delivery Systems ; Hydrogels ; chemistry ; Osteogenesis ; drug effects ; Peptides ; Prostheses and Implants ; Rats

Adult ; Antigens, CD20 ; metabolism ; Antineoplastic Combined Chemotherapy Protocols ; therapeutic use ; CD3 Complex ; metabolism ; Cyclophosphamide ; therapeutic use ; Diagnosis, Differential ; Doxorubicin ; therapeutic use ; Epstein-Barr Virus Infections ; drug therapy ; metabolism ; pathology ; Follow-Up Studies ; Herpesvirus 4, Human ; Hodgkin Disease ; Humans ; Lymphoma, Large B-Cell, Diffuse ; drug therapy ; metabolism ; pathology ; virology ; Male ; Prednisone ; therapeutic use ; RNA, Viral ; metabolism ; Vincristine ; therapeutic use ; Young Adult