Objective To analyze the clinical performance of hepatitis C virus antibody detection by bi-direetional lateral flow method and evaluate whether the bi-directional lateral flow method is suitable for clinical use.Methods Four hurdred and nineteen samples were collected and tested anti-HCV antibodies with hi-directional lateral flow and CMIA kits.These samples contain:107 patients with confirmed hepatitis C virus infection,162 patients with other diseases than hepatitis C virus infection and 150 healthy controls.Two positive reference materials for ELISA were tested at the same time.The testing results were analyzed with statistical methods.Results Compared with RIBA,the sensitivity and specificity of bi- directional lateral flow method were 98.1% and 99.7% respectively,the agreement rate with CMIA was 99.0%.The reproducibility percentage of the+/-20% at the cutoff concentration were 97% and 99% respectively.No crossing reaction with hepatitis A/B/D/E virus infection and HIV-1/2 positive individuals were found in the tests.Conclusion The hi-directional lateral flow method for HCV detection shows good clinical performance and is suitable for clinical use.

Objective To evaluate the role of TCD examination in diagnosis of the early cerebrovascular diseases in aged diabetic patients.Methods 179 cases of aged type Ⅱ diabetic patients were divided into three groups(PDR,BDR and NDB)according to their retinopathy.TCD and retina examination were performed in all patients and the data be analysed. Results (1)The systolic peak flow velocity(Vp) of MCA、ACA、ICA and BA were significant increased in diabetic pa- tients than in normal control group(P

International clinical trials register is one of the global measures to realize transparency in clinical trials and also one of a powerful measure to improve the quality of clinical trials. Many scholars studying the quality of TCM clinical trials find that they are poor in quality and lack transparency. Furthermore, they find that TCM clinical trial registry has many problems. We must base on the successful experiences of WHO and international clinical trial registry to establish technical specifications for registry of traditional Chinese medicine clinical study of their own. Then, it can effectively improve the overall level of TCM clinical studies. We have suggested some concrete and feasible measures to establish technical specifications for registry of traditional Chinese medicine clinical study of their own based on the problems of TCM clinical trial registry.
Biomedical Research ; Humans ; Medicine, Chinese Traditional ; standards ; Registries

In recent 10 years, clinical trials of Chinese medicine and pharmacy (cMP) at clinicalTrials.gov.(USA) are gradually increasing. In order to analyze features of CMP clinical register, ClinicalTrials.gov register database were comprehensively retrieved in this study. Included clinical trials were input one item after another using EXCEL. A final of 348 CMP clinical trials were included. Results showed that China occupied the first place in CMP clinical register, followed by USA. CMP clinical trials, sponsored mainly by colleges/universities and hospitals, mostly covered interventional studies on evaluating safety/effectiveness of CMP. The proportions of studies, sponsored by mainland China and companies, recruitment trials and multi-center clinical trials in interventional trials were increasing. The proportions of studies sponsored by Hong Kong and Taiwan, research completed trials, unclear research status, phase III clinical trials, and published research trials in interventional trials were decreasing. Published ratios of CMP clinical trials were quite low. There were more missing types and higher proportions in trial register information.
Biomedical Research ; China ; Clinical Trials as Topic ; Databases, Factual ; Humans ; Medicine, Chinese Traditional ; United States

Objective To investigate the effects of rigid gas permeable contact lens (RGPCL) wearing 3 years on ocular surface in keratoconus.Design Retrospective case series.Participants 73 patients with keratoconus.Methods From July 2001 to July 2004,73 patients (142 eyes) wearing RGPCL for more than 3 years were collected in Peking University Optometry & Ophthalmology Center.Be- fore and at 1 year,2 years and 3 years of RGPCL wearing,density and morphologic changes of corneal endothelium were examined with non-contact specular microscope.Eye axial length,central and peripheral thickness of cornea were measured with A-scan pachymeter. All eyes were examined with slit-lamp microscope periodically.Main Outcome Measures Corneal endothelial density and morphology, corneal thickness,eye axial length,ocular surface changes.Results Before and at 1 year,2 years and 3 years of RGPCL wearing,aver- age corneal endothelial density was 2901.92?445.20,2862.78?497.13,2854.71?526.80,3015.61?421.22 (cells/mm~2)without significant difference statistically (F=1.571,P=0.20).Morphologic changes were not significant during 3 years.Eye axial length was 25.15?1.50, 24.93?1.36,24.78?1.25,25.39?1.31 (mm) without significant difference statistically (F=2.218,P=0.10).Corneal central thickness was 489.09?59.64,484.02?60.80,496.61?59.74,487.44?54.25(?m)without significant difference statistically (F=0.991,P=0.40).Peripheral thickness changes were also not significant statistically during 3 years.69 eyes with mild conjunctival congestion,12 eyes with corneal fluorescence stain and 6 eyes with corneal epithelial rough were found with slit-lamp microscope during follow-up.Conclusions For the patients with keratoconus,long term of RGPCL wear will not lead to significant ocular changes or severe ocular complications.

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 the danger of lead exposure in newborns who accepted the blood stored in blood bank for blood change treatment.Methods The lead level of blood was examined before and after blood change treatment for 37 neonates with hyperbilirubinemia who accepted 53 cases blood stored in blood bank during Jun.to Dec.2006.The level of blood lead was measured by graphite stove atom absorb spectrum method.Results The average lead level of 53 cases blood stored in blood bank was 101.02 ?g/L,which had attained the level of lead poisoning.There were 15 cases(28.5%) whose blood lead levels was very high(≥100 ?g/L),3 cases whose blood lead level ≥200 ?g/L.After blood change treatment,the percentage of the blood lead level ≥100 ?g/L rose from 2.9% to 19.0%.The average level of blood lead after blood change treatment was higher than before(P

Objective To observe the clinical efficacy of balance acupuncture predominantly by puncturing Jiaji points (EX-B2) from C4 to T1and from T12 to L1in treating hemiplegic balance disturbance after cerebral stroke. Method A total of 180 hemiplegia patients were randomized into 3 groups, 60 cases in balance acupuncture group, 60 cases in ordinary acupuncture group, and 60 cases in basic control group. After 1-month treatment and 3 months after the treatment, the motor function (Fugl-Meyer Assessment, FMA), balance function (Berg Balance Scale, BBS; Timed Up and Go Test, TUGT), and activities of daily living (ADL) (Barthel Index, BI) were observed.Result After 1-month treatment and 3 months after the treatment, limb function, balance ability and ADL were significantly different from those before the treatment in balance acupuncture group (P<0.01); after 1-month treatment, limb function in balance acupuncture group was significantly different from that in basic control group (P<0.05), and the differences were more statistically significant in comparing the rest indexes between the two groups (P<0.01); there were significant differences between ordinary acupuncture group and basic control group (P<0.05). Three months after the treatment, there was a significant difference in comparing balance function between balance acupuncture group and basic control group (P<0.05), and the differences were more statistically significant in comparing the rest indexes between the two groups (P<0.01), there was no significant difference in comparing balance function between ordinary acupuncture group and basic control group (P>0.05).Conclusion In combination with basic treatment, balance acupuncture works better than ordinary acupuncture and basic control in improving limb function, ADL and balance function of hemiplegia patients.

ObjectiveThe procedure of peroral endoscopic myotomy (POEM) was practiced in porcine esophagus-stomach model and the efficacy and safety of POEM for patients with achalasia were evaluated.MethodsThe ex-vivo esophagus-stomach was obtained and the pylorus was closed by hemostatic forceps.The entrance of the esophagus was fixed to foamed plastics.To perform POEM,a submucosal tunnel was created,after which the circular muscle layer was dissected and the mucosal entry was finally closed with clips.After successful animal experiment,we performed POEM on 4 patients with achalasia.Results POEM was completed in 5 porcine training models,in which 2 procedures were successful without any complication,2 were complicated with perforation in muscularis propria layer and 1 with rupture in mucosal layer.POEM was successfully performed in 4 patients with achalasia,with a mean operation time of 110min.The mean length of the submucosal tunnel was 10.5cm ( ranging 8-11 cm) and the mean length of myotomy of circular muscle layer was 7 cm (ranging 5-8 cm).The resting pressure of lower esophageal sphincter (LES) decreased from 52.4 mm Hg before POEM to 19.9 mm Hg.Massive bleeding occurred at the gastroesophageal junction in the first case and perforation occurred in mucosal layer during endoscopic hemostasis.All patients were followed up for 1-4 months,and the symptom of dysphasia was relieved significantly.ConclusionThe ex-vivo esophagus-stomach model can be used as training model for procedure of POEM,enabling endoscopists with enough experience for its use in patients.POEM is an effective therapy for achalasia,while the long-term efficacy and managements for complications are still to be elucidated.

Objective To establish a HRM assay to screen for KRAS mutations in clinical colorectal cancer patients.Methods The sensitivity of HRM was analyzed by detecting somatic mutations in exon 2,notably codons 12 and 13 of the KRAS gene in the serial plasmid mixture samples which were mixed using the different proportions mutation plasmid and wide type plasmid of KRAS.HRM analysis was performed for KRAS on DNA insolated from a panel of 60 colorectal cancer samples derived from fresh tissues.The results were compared with the direct sequencing data.Results After the PCR amplification,the mutation results could be available by performing HRM analysis in the same tube on a real time PCR machine with HRM capability.HRM detection could identify KRAS mutation in a proportion of 10% of mutation plasmid DNA.All 60 samples identified the KRAS mutation by HRM and sequencing.17 samples were positive(28.3%) by HRM for KRAS exon 2 mutations,and 15 samples were confirmed the presence of codon 12 or 13 mutations(25.0%) and the other 2 samples were wild type by sequencing.The 60 samples detected by HRM were given 100% sensitivity with 96% specificity.Conclusions HRM is a sensitive intube methodology to screen for mutations in clinical samples.HRM will enable high-throughput screening to gene mutations to allow appropriate therapeutic choices for patients and accelerate research aimed at identifying novel mutations in human cancer.