Clinical trials are important means to push forward the development of human health. Every new drug needs to under-take clinical trials eventually to determine the efficacy and safety. In the paper, through our clinical trial experiences and extensive lit-erature retrieval, some problems of the communication management in clinical trials were analyzed and relevant countermeasures were suggested to improve the communication management in clinical trials in order to help the development of clinical trials.

Objective To investigate the value of the expressions of estrogen receptor(ER)and progesterone receptor(PR)in the cast-off cells from the fluid of latex ductal lavage in the diagnosis and treatment of breast diseases.Methods A total of 58 female out-patients were examined by fiberoptic ductoscopy(FDS).All patients were divided into 6 groups by the complaints,physical examination,ultrasound and FDS:normal group(10 persons without symptoms and abnormalities in any examination),galactostasis group(n=19),latex fill up group(n=11),intraductal papilloma group(n=2),mammary ductal ectasia group(n=7)and contralateral examination after mastectomy for breast cancer group(n=9).A total of 168 ducts were successfully examined by FDS,and the expressions of ER and PR in the cast-off cells were detected among all of the samples.Results The positive rates of ER and PR expression in the cast-off cells from the fluid of latex ductal lavage in benign breast disease groups were much higher than those in normal group(P

Objective To investigate the influences of sodium salicylate on the auditory brainstem response (ABR)and expression of EphA4mRNA in rat inferior colliculus and its effects on salicylate ototoxicity.Methods A total of 30 healthy SPF rats were randomly divided into five groups:the control group (without any treatment),S7 (i.m.injection of sodium salicylate,175mg/kg,twice daily for 7 days),S14(the same method as S7,twice daily for 14 days),S14+R14(the same method as S14,twice daily for 14 days and recovered for 14 days),and S14+R28(the same method as S14,twice daily for 14 days and recovered for 28 days).After the ABR assessment,rats were sacri-ficed after deep anesthesia and the inferior colliculus tissues were dissected.Real-time PCR was used to detect the expression of EphA4mRNA.Results Compared with the control group,ABR thresholds in the S7 group and S14 group were increased significantly (P<0.05),while there was no significant difference between the control group and the S14+R28 group (P>0.05).The inferior colliculus EphA4mRNA expression level of S7 group was signifi-cantly decreased than the control group (P<0.05).The EphA4mRNA expression level of S7 group was significant-ly decreased than the control group (P<0.05),while there was no significantly difference between the control group and the S14+R28 group (P>0.05).Conclusion Long term injection of sodium salicylate can cause changes in the inferior colliculus of EphA4mRNA which are related closely with synaptic plasticity.It may lead the alteration of the inferior colliculus synaptic plasticity,which is associated with the changes of the hearing failure and the tinni-tus behavior.This indicates that EphA4 which is considered as a related protein in the inferior colliculus may play an important role in the pathology of tinnitus.

ObjectiveTo analyze and summarize the feasibility and characteristics of the posterior spinal canal reduction and fixation in treating mid-upper thoracic spine facture.MethodsA retrospective study was made on 17 patients with mid-upper thoracic spine facture to record the complication, compare the functions of the patients with complete and incomplete spinal cord injuries before and after surgery and examine the iatrogenic injury in patients without spinal cord injuries.ResultsNo complication happened after surgery.Incomplete injury was found in six patients, whose ASIA scales were found to be increased for 1-3 levels during the follow-up.While the complete injury was found in eight patients,whose ASIA scale remained unchanged during the follow-up.The sensory scores of both the incomplete injury group and complete injury group were processed with variance analysis and the results showed a significant difference between pre-operation and post-operation (F = 476.47, P = 0.000).The mean value between complete injury group and incomplete group was with high statistical difference (F = 31.46, P =0.000).The variance analysis of the motor scores showed a significant difference between before and after operation (F=46.75, P =0.000) and the mean value between complete and incomplete injury groups was with statistical difference (F = 158.59, P = 0.000).There were three patients with normal spinal cord function, with no decrease of ASIA scale or no change of the sensory and motor scores.ConclusionsFor patients with mid-upper thoracic spine fracture, posterior spinal surgery is conducive to the recovery of spinal function, for it can safely and effectively avoid worsening the thoracic and other combined injuries and release spinal pressure including the pressure in front part of the spinal cannal.

Objective To investigate whether CD4~+CD25~(high)regulatory T cells(tregs)were increased in the tumor tissue and peripheral blood of prostate cancer patients.Methods The prevalence of CD4~+CD25~(high)regulatory T cells inside the prostate tumor was detected compared with benign tissue from the same prostate.Furthermore,the frequency of CD4~+CD25~(high)regulatory T cells in peripheral blood was detected in prostate cancer patients compared with normal donors.Results Moreover,CD4~+CD25~(high)regulatory T cells from blood and supernatants from cultured prostate tumor tissue samples exhibited immunosuppressive function in vitro.CD4~+CD25~(high)T normal peripheral blood cells were found for the ratio was(0.5?0.1)%.Lower than the proportion of T cells in peripheral blood of patients with CD4~+CD25~(high)was(2.3?0.7)%,P

AIM:To study the effect of transient receptor potential channel 1 ( TRPC1) on the survival of hip-pocampal neurons in mice.METHODS:TRPC1 knockout mice and the control mice (6 months old) were used in this study.Immunofluorescence staining of neuron-specific marker NeuN, Nissl staining and TUNEL staining were performed to measure the changes of the neurons in hippocampal CA1, CA3 and dentate gyrus (DG).Western blot analysis was used to detect the levels of pro-apoptotic protein C/EBP homologous protein ( CHOP) and cleaved caspase-3.RESULTS:Immuno-fluorescence staining and Nissl staining showed that the number of neuronal cells was significantly decreased in hippocampal CA1, CA3 and DG of TRPC1 knockout mice compared with the control mice.TUNEL staining showed that the apoptosis neuronal cell number of the above areas in TRPC1 knockout mice was significantly increased compared with the control mice.The results of Western blot revealed that the levels of CHOP and cleaved caspase-3 were significantly increased in the hippocampus of TRPC1 knockout mice relative to the control mice.CONCLUSION:The depletion of TRPC1 induces neu-ronal loss through a mechanism of TRPC1-mediated apoptosis.

Adult ; Bone Marrow Transplantation ; Fractures, Ununited ; therapy ; Humans ; Male ; Transplantation, Autologous

In order to select high quality and suitable Bupleuri Radix varieties in Qingchuan, and establish a new comprehensive method to evaluation the quality of Bupleuri Radix, 12 characters of 14 samples were evaluated by DTOPSIS and grey related degree. The results showed that varieties No. 8 and No. 10 had high quality. DTOPSIS and grey related degree gave the uniformity result, and the biggest difference of value of Ci in DTOPSIS method was 46. 33% , but the biggest difference of the weighting correlation number( r (i)) in grey related degree was only 13.10%. The DTOPSIS combined with grey related degree can evaluate the quality of Bupleuri Radix comprehensively and objectively.
Bupleurum ; chemistry ; China ; Drugs, Chinese Herbal ; chemistry ; supply & distribution ; Quality Control ; Statistics as Topic ; methods

Objective To determine the agreement of interobserver and intraobserver in diagnosing early glaucoma by optic disc morphology,and to explore the efficacy of established methods for evaluating glaucomatous optic discs.Design Prospective study. Participants Clinicians and evaluating methods for glaucomatous optic discs.Methods 120 digital fundus photographs were enrolled including early glaucoma eyes(67 cases)and non-glaucoma eyes but with glaucomatous appearance(53 cases),which were collected in Tongren Hospital.Thirteen ophthalmologists as observers were divided into three groups:GroupⅠ(5 clinicians)were trained with stan- dardized methods for evaluating glaucomatous optic disc damage recently.GroupⅡ(4 clinicians)were ophthalmologists majoring in glaucoma.GroupⅢwere ophthalmologists not specializing in glaucoma.In general groupⅡandⅢ,none had been trained with the es- tablished criteria.Observers evaluated the photos 3 times,with an interval time of 3 days.Kappa statistics were used to evaluate agree- ment between the intraobserver and interobserver.Main Outcome Measures Interobserver and intraobserver agreement,kappa value. Results In GroupⅠ,4 clinicians were in almost perfect agreement,1 clinician was in substantial agreement,kappa value ranging from 0.779(90.0%)to 0.966(98.3%).In GroupⅡ,almost perfect agreement occurred in 2 clinicians,substantial in 1 clinician and moderate in 1 clinician,kappa value ranging from 0.506(82.5%)to 0.866(93.3%).In GroupⅢ,the agreements in 4 clinicians were substantial, moderate,fair,and slight,respectively,kappa value ranging from 0.094(54.2%)to 0.778(89.2%).In term of interobserver agreement for glaucoma diagnosis,kappa values in GroupⅠranged from 0.768 to 0.983,in GroupⅡ0.354-0.834,in GroupⅢ0.335-0.737,respec- tively.Conclusions Intraobserver and interobserver agreement rates in early glaucoma diagnosis are substantially improved through training on optic disc morphologic evaluation methods.Establishing the diagnosis criteria for glaucomatous optic disc damage can raise the correct rate of diagnosis.

OBJECTIVETo summarize the clinical experience for the reconstruction of upper lip defects in different degrees.

METHODSDifferent treatment methods were selected to reconstruct the upper lip defects according to the subunit, size or location of defects on the upper lip. The therapeutic results were analyzed and compared.

RESULTSFrom Jan. 1998 to Apr. 2012, 243 cases with upper lip defects were treated, including 85 cases of traumatic defects, 110 cases of defects secondary to lip cleft and 48 cases of defects after tumor resection. 48 cases were treated with direct closure, 69 cases with cross-lip flaps, 5 Cases with orbicularis oris muscle flaps, 53 cases with unilateral labial flaps, 42 cases with bilateral labial flaps, 22 cases with lower lip flaps, and 1 case with forehead flap, 1 case with forearm flap and 2 with nasolabial fold flaps. The patients were followed up for 3-18 months with satisfactory results.

CONCLUSIONSSatisfactory results could be achieved for upper lip defects with appropriate treatment methods according to the defects degree and characters.

Cleft Lip ; surgery ; Cosmetic Techniques ; Dermatologic Surgical Procedures ; methods ; Humans ; Lip ; injuries ; surgery ; Mouth Mucosa ; Surgical Flaps ; Treatment Outcome