In the recent 2 decades,the clinical medical mode has been changed greatly.The experience-based medical mode is gradually replaced by evidence-based mode,ie,evidence-based medicine.Large scale clinical trials provide robust evidence for clinical practice and quality control is critical for the success of one trial.We discuss six facets on this subject,including protocol design,staff training,manual formulating,organization,data management and monitoring.The objective of quality control is to ensure the study conducted according to the protocol,the results are reliable and protect the human rights of participants.

OBJECTIVE:To study the pharmacokinetics of domestic zaleplon tablets in Chinese healthy volun?teers.METHODS:20male healthy subjects received a single oral dose of15mg zaleplon tablets.The plasma concentrations of zaleplon were determined by an improved HPLC method.RESULTS&CONCLUSION:The main pharmacokinetic parameters of zaleplon were as follow:C max was55.90?16.20ng/ml,T max was1.05?0.32h,Ke was0.74?0.18h -1 ,T 1/2Ke was1.00?0.29h,AUC 0～8 was123.70?25.64ng?h/ml,AUC 0～∞ was125.20?25.80ng?h/ml.The results are compara?ble to those reported in foreign literature.

OBJECTIVETo explore the optimal intervention time of acupuncture and moxibustion in the treatment of peripheral facial paralysis.

METHODSTwo hundred and four cases of peripheral facial paralysis were collected in clinic for retrospective analysis. According to the time between the disease onset and the intervention of acupuncture and moxibustion, 3 groups (groups A, B and C) were divided. In group A, the treatment was given in 1 to 3 days after onset; in group B, the treatment was given in 4 to 7 days after onset; in group C the treatment was given in 8 to 10 days after onset. The treatment with acupuncture and moxibustion was applied according to the regular stages of disease in the three groups. At the acute stage, the less points and shallow puncture therapy combined with distal acupoints at the limbs were adopted on the affected side. At the stable stage, the more points and shallow puncture therapy were used on the affected side. At the recovery stage, the deep puncture or penetrating punctures was applied on the affected side. The curative effects was given once every day and the treatment of 10 days made one session. The curative effects were analyzed statistically at the end of three sessions of treatments separately.

RESULTSAt the end of the 1st session of treatment, the total effective rate was 58.8% (40/68) in group A, 69.7% (53/76) in group B and 46.6% (28/60) in group C. At the end of the 2nd session of treatment, the total effective rate was 85.3% (58/68), 90.8% (69/76) and 71.6% (43/60) in group A, B and C separately. At the end of 3rd session of treatment, the total effective rates were 89.7% (61/68), 97.4% (74/76) and 83.3% (50/60) in the three groups separately. The differences were significant statistically at the same session of treatment among three groups (all P<0.05), in which, the results in group B was the best, followed by group A and C in sequence.

CONCLUSIONthe best intervention time of acupuncture and moxibustion is in 4 to 7 days after onset of facial paralysis.

Acupuncture Therapy ; Adolescent ; Adult ; Aged ; Child ; Child, Preschool ; Combined Modality Therapy ; Facial Paralysis ; therapy ; Female ; Humans ; Male ; Middle Aged ; Moxibustion ; Retrospective Studies ; Treatment Outcome ; Young Adult

Acupuncture Therapy ; Female ; Humans ; Middle Aged ; Syringomyelia ; therapy

Climate Change ; Health ; Humans ; Risk Adjustment

Adolescent ; Diagnosis, Differential ; Diverticulum, Stomach ; complications ; diagnosis ; pathology ; Gastrointestinal Hemorrhage ; diagnosis ; etiology ; pathology ; Gastroscopy ; Humans ; Male

Adult ; Decompression, Surgical ; Drugs, Chinese Herbal ; therapeutic use ; Femur Head Necrosis ; etiology ; therapy ; Humans ; Integrative Medicine ; Male ; Phytotherapy ; Young Adult

OBJECTIVETo compare the difference in the efficacy on cervical type of cervical spondylosis (CS) between the combined treatment of sword-like needle and chiropractic spinal manipulation (the combined therapy) and the simple chiropractic spinal manipulation.

METHODSOne hundred and thirty-eight cases of cervical type of CS were randomized into a combined therapy group (76 cases) and a simple chiropractic spinal manipulation group (62 cases). In the combined therapy group, the sword-like needle therapy was applied at Fengchi (GB 20), Tianzhu (BL 10) and Jiaji (EX-B 2) C3-C5. The chiropractic spinal manipulation was used in combination. In the chiropractic spinal manipulation group, the simple chiropractic spinal manipulation was adopted. The treatment was given once every other day in the two groups, 10 days made one session. One session of treatment was required. Visual analog scale (VAS) score was observed before and after treatment in the two groups and the efficacies were compared between the two groups.

RESULTSVAS score after treatment was reduced obviously as compared with that before treatment in the patients of the two groups (both P < 0.01) and VAS score after treatment in the combined therapy group was lower than that in the simple chiropractic spinal manipulation group (1.50 +/- 0.58 vs 1.87+/-1.05, P < 0.01). In the combined therapy group, 48 cases were cured, 20 cases remarkably effective, 8 cases improved and 0 case failed. In the chiropractic spinal manipulation group, 30 cases were cured, 16 cases remarkably effective, 15 cases improved and 1 case failed. The overall efficacy in the combined therapy group was better than that in the chiropractic spinal manipulation (P < 0.05).

CONCLUSIONThe sword-like needle therapy combined with chiropractic spinal manipulation relieve effectively pain in cervical type of CS and the efficacy is superior to the simple chiropractic spinal manipulation.

Acupuncture Therapy ; Adult ; Aged ; Combined Modality Therapy ; Female ; Humans ; Male ; Manipulation, Chiropractic ; Manipulation, Spinal ; Middle Aged ; Spondylosis ; therapy

Objective To evaluate the value of computer-aided detection (CAD) system for pulmonary nodule detection using digital chest radiography in lung cancer screening. Methods One hundred consecutive digital chest radiographs from 6280 outpatients for lung cancer screening were independently reviewed by a thoracic radiologist and a computer-aided pulmonary nodule detection system.The radiographs were also reviewed by two experienced thoracic radiologists and the true nodules confirmed by two radiologists with reference to the CT images were marked and stored as a gold standard in the CAD system. The sensitivity and false positive of the radiologist and the CAD system for the detection of nodules on digital chest radiographs were compared. Results Ninety-five and 304 nodules were identified by radiologist and the CAD system, respectively. Of 134 nodules marked as true nodules by experienced radiologists, 82 (61.2%) and 105 (78. 4% ) nodules were identified by the radiologist and the CAD,respectively. The radiologist missed 35 true nodules which were only detected by CAD. The CAD system missed 10 true nodules which were only detected by radiologist. One hundred and twelve (83.6%) nodules were identified by radiologist with the CAD system. One hundred and ninety-nine nodules identified by CAD were false-positive with a rate of 2. 0 ( 199/100 ) per case. Conclusion Combining review of digital radiographs by radiologist with CAD system can improve the detection of pulmonary nodules in lung cancer screening.