The effective quality control in clinical practices is an effective guarantee for the authenticity and scientificity of the findings. The post-marketing reevaluation for traditional Chinese medicines (TCM) focuses on the efficacy, adverse reaction, combined medication and effective dose of drugs in the market by expanded clinical trials, and requires a larger sample size and a wider range of patients. Therefore, this increases the difficulty of quality control in clinical practices. With the experience in quality control in clinical practices for the post-marketing reevaluation for Kangbingdu oral for cold, researchers in this study reviewed the study purpose, project, scheme design and clinical practice process from an overall point of view, analyzed the study characteristics of the post-marketing reevaluation for TCMs and the quality control risks, designed the quality control contents with quality impacting factors, defined key review contents and summarized the precautions in clinical practices, with the aim to improve the efficiency of quality control of clinical practices. This study can provide reference to clinical units and quality control-related personnel in the post-marketing reevaluation for TCMs.
Drugs, Chinese Herbal ; adverse effects ; economics ; therapeutic use ; Humans ; Medicine, Chinese Traditional ; Product Surveillance, Postmarketing ; methods ; Quality Control ; Randomized Controlled Trials as Topic ; Respiratory Tract Infections ; drug therapy

Diagnosis, Differential ; Endophthalmitis ; diagnosis ; diagnostic imaging ; etiology ; pathology ; Humans ; Infant, Newborn ; Male ; Meningoencephalitis ; complications ; diagnosis ; diagnostic imaging ; pathology ; Suppuration ; Tomography, X-Ray Computed

OBJECTIVETo observe the efficacy of Xingnaojing Injection (XI) in treatment of sepsis-associated encephalopathy (SAE).

METHODSTotally 65 SAE patients were retrospectively analyzed at EICU from September 2010 to September 2013. They were assigned to the control group (32 cases) and the treatment group (33 cases) according to whether they received XI. Patients in the control group received anti-infection and symptomatic support, while those in the treatment group were intravenously injected with XI at 20 mL per day for additional 7-10 days. The fever clearance time, Glasgow coma scale (GCS), C-reactive protein (CRP), neuron-specific enolase (NSE), and improvement of electroen-cephalogram (EEG) were observed in the two groups.

RESULTSCompared with the control group, the fever clearance time was shortened, CRP levels decreased, GCS score and efficacy of EEG was alleviated in the treatment group after treatment with statistical difference (P < 0.05). No adverse reaction occurred during medication.

CONCLUSIONX1 was safe and effective in treatment of SAE.

C-Reactive Protein ; metabolism ; Drugs, Chinese Herbal ; administration & dosage ; therapeutic use ; Humans ; Injections ; Phosphopyruvate Hydratase ; metabolism ; Sepsis-Associated Encephalopathy ; drug therapy ; Treatment Outcome

Objective To observe the effects of intrathecal injection(IT)of agonist and antagonist of cannabinoid receptor 1 on pain threshold in rat model of sciatic nerve ligation(SNL)induced neuropathic pain,and investigate the role and mechanism of CB1 in neuropathic pain. Methods Male Sprague-Dawley rats were randomly divided into 4 groups:sham group( intrathecal normal saline,IT DMSO),SNL group(SNL+IT 30μL DMSO),AM841 group(SNL+IT 5μg AM841,dissolved in 30μL of DMSO)and AM281 group(SNL+IT 5μg AM281,dissolved in 30μL of DMSO). IT was given 3 days before surgery. Sham group only had sciatic nerve exposure but without ligation. SNL model in the other three groups were established by right sciatic nerve ligation. The thermal and mechanical thresholds were assessed by paw withdrawal latency(PWL)to radiant heat and von Frey filaments at 1,3,5,7,10 and 14 days as well as behavior after SNL. Spinal expressions of CB1 were assessed by West-ern blotting. Results Compared with the sham group,symptoms of rats in SNL group,such as heat hyperalgesia,mechanical allodynia and poste-rior paws prone to close together,were gradually appeared in the observation time points,with lower spinal proteins expression of CB1(P<0.05). AM841 group exhibited increased proteins expression of CB1 and inhibited SNL-induced heat hyperalgesia and mechanical allodynia(P<0.05). AM281 group further decreased expression of CB1 and amplified the pain abnormality(P<0.05). Conclusion Spinal CB1 participates in the regulation of neuropathic pain,and exogenous cannabinoid CB1 agonists can alleviate the SNL-induced neuropathic pain.

Objective To investigate the relationship among carotid atherosclerosis,plasma homocysteine and D-dimer level in patients with acute cerebral infarction.Methods Two hundred and eightyseven cases of patients with acute cerebral infarction treated in Pudong Hospital,Shanghai from January 2011 to March 2012 were enrolled into the observation group and 287 cases of healthy people not suffering from cerebral infarction or other patients had nothing to do with cerebrovascular disease were selected into the control group.The serum levels of plasma homocysteine were determined by fluorescence polarization immunoassay (FPIA) and D-dimer level by double antibody clip method.At the same time,neck vascular artery ultrasound were performed by MycoCardR Reader Ⅱ.The relationship of carotid atherosclerosis with plasma homocysteine and D-dimer were compared between these two groups.Results There were significant differences on total cholesterol ((4.25 ± 0.92) mmol/L vs (4.98 ± 0.88) mmol/L,t =3.244,P ＜ 0.05),triacylglycerol ((1.48 ±0.82) mmol/L vs (1.78 ± 1.09) mmol/L,t =3.564,P ＜ 0.05),low density lipoprotein ((2.52-0.76) mmol/L vs (2.92 ± 0.73) mmol/L,t =2.987,P ＜ 0.05),high-density lipoprotein ((1.38 ± 0.26) mmol/L vs (1.06± 0.29) mmol/L,t =3.964,P ＜ 0.05),systolic pressure ((130.28 ± 14.78) mm Hg vs (152.98 ± 20.45) mm Hg,t =3.264,P ＜ 0.05),diastolic pressure ((78.45 ± 16.02) mm Hg vs (93.81 ± 16.88) mm Hg,t =2.785,P ＜0.05) and common carotid artery IMT(left:(0.86 ±0.41)mm vs (1.18 ±0.25)mm,t =2.164,P ＜0.05;right:(0.87 ± 0.39)mm vs (1.12 ± 0.29)mm,t =2.254,P ＜ 0.05) between observation group and control group.Homocysteine concentration and the D-dimer level of patients with carotid atherosclerosis were significant higher than that without carotid atherosclerosis (homocysteine concentration:(12.89 ± 6.56) μnol/L vs (3.17 ± 0.12) μnol/L,t =2.324,P ＜ 0.05 ; D-dimer level:(1.53 ± 0.59) mg/L vs (0.33 ± 0.23) mg/L,t =2.753,P ＜ 0.05).Conclusion The plasma homocysteine concentration and the D-dimer levels are correlated with carotid atherosclerosis in patients with acute cerebral infarction.

10.3969/j.issn.1000-3606.2013.06.014

Objective: To explore the effect of buzhong yiqi decoction(BZYQD) with various concentrations at different time points on gastrin(GAS) gene expression level in spleen-qi deficiency rats.Methods: The spleen-qi deficiency rats were randomly divided into the model control group and the low,medium and high dosage of BZYQD groups.Reverse transcriptase polymerase chain reaction was used to observe the effect of BZYQD on the GAS mRNA of gastric antrum in rats treated at different time points(7,14,21d).Results: As compared with that in model control group,the GAS gene expression level were significantly higher both in the medium and high dosage groups(P

Objective To observe the clinical effects after implantation of an aspherical intraocular lens Acrysof IQ.Design Prospective,randomized concurrent-controlled study.Participants 64 patients(64 eyes)with bilateral senile cataracts.Methods Pa- tients were operated with phacoemulsification and IOL implantation.They were divided randomly into 2 groups according to the table of random number:one group with Aerysof IQ(aspherical IOL)implantation and the other with Acrysof SN60AT(spherical IOL).Thor- ough ophthalmic examinations,including visual acuity,slit lamp examinations,fundoseopy,wavefront aberrometry,contrast sensitivity, were performed 1 week,1 month and 3 months after surgery.Main Outcome Measures Visual acuity,the best corrected visual acuity, spherical aberration(C 12),the root mean square of the total higher-order aberration(RMSh),and contrast sensitivity at 4 kinds of light backgrounds.Results At 1 postoperative month,RMSh(0.30?0.68?m)and C12(0.07,?0.04?m)in aspherical IOL group were signifi- cantly lower than those of the spherical IOL group(0.49?0.14?m,0.36?0.06?m)(P=0.00)with a 6.0 mm aperture.At 3 postoperative months the RMSh(0.30?0.07?m)and C12(0.06?0.06?m)in aspherical IOL group were significantly lower than those of the spherical IOL group(0.47?0.14?m,0.34?0.06?m)(P=0.00)with a 6.0 mm aperture.The asphefieal IOL(Acrysof IQ)provided statistically sig- nificant better contrast sensitivity at all spatial frequencies under mesopic conditions(3 cd/m~2)with and without glare(P

Objective:To study the isolation, culture and identification of the TMJ cells and to observe the biological characteristics of cultured fibrochondrocytes. Methods:The TMJ discs were dissected from two 1 month goats under sterile conditions and were digested with collagenase. The cells were collected. Morphological changes and attachment efficiency were constantly observed under phase-contrast microscope. Immunohistochemical staining for type I collagen as well as toluidine blue staining were performed. Ultrastructures of the TMJ cells were observed under transmission electron microscope. Results: Most of the primary fibrochondrocytes presented a short spindle-shape while the rest showed polygon-shape. On the 7th day, the perliferating fibrochondrocytes started to contact each other to form a monolayer covering the bottom of the incubation disc. Immunohistochemical staining of type I and toluidine blue staining exhibited positive results. The fibrochondrocytes cytoplasms were rich in mictochondria and endoplasm reticulum. Conclusion: The fibrochondrcytes isolated from one-month-old goat TMJ disc have good proliferation ability in vitro and cells from passage 1 to 3 might be used as seed cells for TMJ disc tissue engineering.