Bias in undoubled blind design in the clinical trial of Chinese herb affects the evaluation of efficacy and safety. With two examples, the paper recommended a "segregation" technique to minimize the bias in investigators during undoubled blind trial. The results showed that this method combined other strict means can achieve the conclusions the same as a double blind trial.

Objective: To explore the operating procedure for designing the randomized scheme of multi-center clinical trial. Methods: SAS randomized program was written in accordance with the randomized parameters and stipulated randomized rules of centers, cases and blocks. The design of the SAS randomized program adopts the same seed in multi-hierarchical factors, and the principles of succession and repeatability of the randomized code. Results: This program can produce randomized numbers and complete the design and permutation of randomized codes in a standard and convenient way.

Objective To investigate the relationship between the expression of trannsient receptor potential vanilloid 1 (TRPV1) and the severity of airway remodeling in elderly patients with chronic obstructive pulmonary disease(COPD).Methods According to airflow obstruction severity,totally 100 cases of elderly patients with COPD were divided into chronic obstructive pulmonary disease Global Initiative(gold) grade 1 in 23 cases,24 cases of grade GOLD2,GOLD3 27 cases,GOLD4 26 cases,respectively.The TRPV1 concentrations in induced sputum supernatant and serum from each level of elderly patients with COPD as well as in 50 cases of healthy old people were analyzed.Results TRPV1 concentrations in serum and induced sputum in the COPD group was significantly increased compared with the healthy elderly group[(9.94±2.91)μg/L vs.(3.68±0.46)μg/L,(3.29± 1.32)μg/L vs.(0.70 ± 0.30)μg/L] (P ＜ 0.01).The serum and induced sputum TRPV1 concentrations in the mutual pairwise comparison between the elderly COPD patients with all levels had statistical difference (P ＜ 0.01).Conclusion The expression of TRPV1 protein become increased with the severity of airway remodeling in elderly patients with chronic obstructive pulmonary disease.

Objective To investigate the impact of overweight and obesity on left atrial (LA) function in healthy subjects with excess body weight.Methods Conventional echocardiography and tissue Doppler imaging were performed in 30 obese subjects (BMI≥28 kg/m2),30 overweight subjects (BMI,24to 28 kg/m2) and 30 age-matched normal subjects (BMI＜24kg/m2).Strain (S),peak systolic strain rate (SSR),peak early diastolic strain rate (ESR) and peak late diastolic strain rate (ASR) values were used to evaluating LA function.Results Compared with controls,mean S,SSR and ESR were decreased in obese subjects,while mean SSR,ESR and ASR were decreased in overweight subjects.Compared with overweight subjects,mean ESR was decreased in obese subjects.Conclusions An impaired LA function is found in overweight and obese subjects who has no other clinically appreciable cause of heart disease by using strain and SR imaging.

0.05).No adverse reactions were found during the clinical trial. Conclusion Yinhua Jiedu Granule is effective and safe in treating wind-heat syndrome of upper respiratory infection and influenza.

Intravenous preparations take more risk than oral preparation and externally applied agent.In phaseⅠtoler- ance trial of intravenous preparations of TCM on human subjects,minimum dose and maximum dose should be decided in light of data derived from preclinical pharmacodynamic and toxicological experiments,combined with practical situation in clinic.Dose-ascending coefficient of the should be reasonable.During the application of intravenous preparations of TCM in tolerance trial,clinical monitoring must be done to ensure the safety of subjects.Overall and integrated observa- tional indices should be designed on the basis of the features of preparation types,administration methods,the nature of medicine,etc.,so as to provide full-scale data for safe dose range,concentration of the preparation,dripping veloci- ty and possible adverse reactions,etc.

OBJECTIVETo explore the relationship between the needling sensation of catgut embedding therapy and the depth of embedded catgut so as to improve the safety of the needle insertion and catgut implantation of the therapy.

METHODSTwenty healthy adults were selected. Under the ultrasound, the structure of the cervical Jiaji (EX-B 2) was observed. In the ultrasound guidance, the catgut was embedded. The two-dimensional imaging method was adopted to observe the anatomic structure and the procedure of needle insertion at the cervical Jiaji (EX-B 2). The high-frequency ultrasound was used to collect the images at Jiaji (EX-B 2) of C5 and determine the depths from the skin surface to the different layers of the point. Additionally, the visual analogue scale (VAS) was adopted to score the needling sensations when the needle inserted at different layers. The persistent sensation duration in the local area was followed continuously.

RESULTSUnder the ultrasound, the anatomic structure and tissue layers of cervical Jiaji (EX-B 2) were displayed clearly. The difference was significant in the average depth from the skin surface to the subcutaneous tissue, trapezius, splenius capitis, semispinalis capitis, semipinalis cervicis, multifidus and vertebral arch between the males and females (all P<0. 01). During the needle insertion, the sensations were apparently different when the implantation went to different layers. The qi arrival presented when the catgut was embedded to the trapezius, splenius capitis, semispinalis capitis, semipinalis cervicis and multifidus. But the distending pain was the most significant when in the myofascial. Commonly, the embedded catgut 2. 5 cm in length may be implanted deeply to the multifidus and the local needling sensation lasted averagely for (72. 0 ± 10. 2) h. Conclusion Under the ultrasound guidance, the depth of embedded catgut is clearly displayed at cervical Jiaji (EX-B 2). The needle insertion and the implanted material are visible, and the relationship between qi arrival and the layer of needle insertion is determined. The accuracy and safety of minimally invasive catgut embedding therapy is improved in the treatment of cervical spondylosis.

Acupuncture Points ; Acupuncture Therapy ; Adult ; Aged ; Catgut ; utilization ; Female ; Humans ; Male ; Middle Aged ; Neck Muscles ; anatomy & histology ; diagnostic imaging ; Qi ; Sensation ; Spondylosis ; diagnostic imaging ; therapy ; Ultrasonography

OBJECTIVETo explore the relationship between the therapeutic effect of minimally invasive embedding therapy and the implanted depth for cervical spondylosis.

METHODSNinety patients of cervical spondylosis of nerve root type were randomized into a shallow-layer embedding group (subcutaneous layer), a middle-layer embedding group (semispinalis capitis muscle layer) and a deep-layer embedding group (multifidus muscle layer), 30 cases in each one. Jiaji (EX-B 2) of C5 and C6 on the affected side and Dazhui (GV 14) were selected. Under the guide of ultrasound, the catgut was implanted to the corresponding tissue layers. The treatment was given once a week, continuously for 3 weeks in the three groups. The symptoms and physical signs were observed before and after treatment. The pain rating index (PRI), visual analogue scale (VAS) and present pain index (PPI) were assessed. The neck disability index (NDI) was compared.

RESULTSThe score of symptoms and function after treatment was increased apparently in the deep-layer embedding group (P < 0.05), which was increased more apparently as compared with those in the shallow-layer embedding group and the middle-layer embedding group (both P < 0.05). PRI, VAS and PPI after treatment were all reduced apparently as compared with those before treatment in the deep-layer embedding group and the middle-layer embedding group (all P < 0.05), which were reduced more remarkably than the shallow-layer embedding group (all P < 0.05). After treatment, the scores of NDI in the deep-layer embedding group and the middle-layer embedding group, were reduced apparently as compared with those before treatment (both P < 0.05), and that in the deep-layer embedding group was reduced more remarkably as compared with the shallow-layer embedding group and the middle-layer embedding group after treatment (both P < 0.05).

CONCLUSIONIn the acupoint embedding treatment of cervical spondylosis of nerve root type, the efficacy is different apparently in terms of the implantation depth. The deep-layer implantation, meaning to the multifidus muscle layer is more conductive to the treatment of cervical spondylosis.

Acupuncture Points ; Acupuncture Therapy ; Adult ; Aged ; Catgut ; Female ; Humans ; Male ; Middle Aged ; Pain Measurement ; Spondylosis ; diagnostic imaging ; therapy ; Treatment Outcome ; Ultrasonography

Objective:To evaluate facial soft tissue 3-deminsion changes of skeletal Class Ⅲmalocclu-sion patients after orthognathic surgery using structure light scanning technique .Methods:Eight patients [3 males and 5 females, aged ( 27.08 ±4.42 ) years ] with Class Ⅲ dentoskeletal relationship who underwent a bimaxillary orthognathic surgical procedure involving advancement of the maxilla by Le FortⅠosteotomy and mandibular setback by bilateral sagittal split ramus osteotomy (BSSO) and genioplasty to correct deformity were included .3D facial images were obtained by structure light scanner for all the patients 2 weeks preoperatively and 6 months postoperatively .The facial soft tissue changes were evalua-ted in 3-dimension.The linear distances and angulation changes for facial soft tissue landmarks were ana-lyzed.The soft tissue volumetric changes were assessed too .Results: There were significant differences in the sagittal and vertical changes of soft tissue landmarks .The greatest amount of soft tissue change was close to lips.There were more volumetric changes in the chin than in the maxilla , and fewer in the forehead .Conclusion: After biomaxillary surgery , there were significant facial soft tissue differences mainly in the sagittal and vertical dimension for skeletal Class Ⅲ patients .The structure light 3 D scan-ning technique can be accurately used to estimate the soft tissue changes in patients who undergo orthog-nathic surgery .

Objective To assess left ventricular synchronicity in patients with metabolic syndrome(MS)by tissue Doppler imaging.Methods Twenty-two patients with MS and left ventricular hypertrophy(LVH)(MS-LVH group),69 patients with MS and non-LVH(MS-NLVH group)and 33 healthy subjects(control group) were included.Left ventricular(LV)systolic and diastolic synchronicity were determined by measuring the maximal difference in time to peak myocardial systolic contraction(Ts-diff)and time to peak myocardial early diastolic relaxation(Te-diff),and the standard deviation of time to peak myocardial systolic contraction(Ts-SD)and early diastolic relaxation(Te-SD)with 6 basal and 6 middle LV segments.Results Compared with control group,patients with MS in MS-NLVH and MS-LVH group showed significantly prolonged Ts-diff,Ts-SD,Te-diff and Te-SD.Furthermore,Te-diff and Te-SD were much more prolonged in MS-LVH group than in MS-NLVH group.Conclusions Patients with MS have impaired L V systolic and diastolic synchronicity.LVH impacts the LV diastolic synchronicity much more obviously than systolic synchronicity in the patients with MS and LVH.