Objective:To explore the principles and elements of ethical review of clinical trials regarding medical apparatus and instruments.Methods:This paper introduced Beijing Anzhen Hospital's requirements on considerations for the vulnerable,acquisition of informed consent,the researchers' qualification and experiment design,during ethical review of clinical trials regarding medical apparatus and instruments.Results:Institution review board of Beijing Anzhen Hospital designed principles and standard operating procedures for ethical review of clinical trials regarding medical apparatus and instruments.Conclusion:Ethical review of clinical trials regarding medical apparatus and instruments now is more scientifically standardized,and has become an important approach for the protection of subjects' rights and interests.

Objective To report our clinical experience on laparoscopic common bile duct exploration and primary suture.Methods From March 1992 to December 2006,669 cases of laparoscopic common bile duct exploration and primary suture were carried out in our hospital.Cholangioscopic lithotomy,electrohydraulic lithotripsy,biliary dilation,bile duct drainage,or biliary stenting were performed on the patients.Results The surgeries were completed successfully in 643 of the 669 cases(96.1%).Biliary leakage was observed in 17(2.5%) cases after the operations,and was cured by nasobiliary and intra-abdominal drainage.2(0.3%) patients developed mild stenosis of the bile duct without showing any symptoms.4(0.5%) had residual stones and were cured by a second laparoscopic surgery.The fine duct fell off in 2 cases(0.3%),and was re-fixed by a re-operation.581 of the cases achieved a 6- to 48-month follow-up(mean,25.6 months),during the period,no patient developed biliary leak,and stenosis or hemorrhage of the common bile duct.Conclusion Laparoscopic common bile duct exploration and primary suture is safe and effective.

After the development of different medical social media in China was summarized , the advantages and trend of social media in medical field of China were analyzed , the challenges facing medical social media were pointed out and their countermeasures were proposed .

Objective To investigate the effects of different doses of 1 ,25(OH)2D3 on rat Thy‐1 nephritis mesangial cell ap‐optosis .Methods 120 clean SD rats were divided into the blank control group(group A) and the experimental group .The experi‐mental group was re‐divided into the nephritis group(group B) ,0 .25μg 1 ,25(OH)2D3 intervention group(group C) and 0 .50μg 1 , 25(OH)2D3 group(group D) ,30 cases in each group .The group C and D were performed the medication intervention after success‐fully constructing the model .6 rats were randomly killed in each group on 1 ,3 ,7 ,14 ,21 d after intervention .The renal tissues were taken for determining the renal pathological injury classification after hematoxylin and eosin staining and PAS staining .The expres‐sion of Caspase‐3 in the renal tissues was detected by the immunohistochemistry method ,and the glomerular cell apoptosis was de‐tected by TUNEL .Results The immunohistochemistry results showed that compared with the group A ,the Caspase‐3 expression in the group B was increased (P<0 .05);compared with the group B ,the Caspase‐3 expression in the group C and D was increased , but there was no statistical differences between them (P> 0 .05);the Caspase‐3 expression in the group D was highest ,but the difference was not statistically significant compared with the group C .The TUNEL results showed that compared with the group A ,the apoptotic glomerular cells in the group B were increase obviously (P<0 .05) ,which was gradually enhanced over time ;com‐pared with the group B ,the apoptotic glomerular cells in the group C and D were increased significantly (P<0 .05) ,reaching a peak on 3 d ,then decreasing gradually on 7 ,14 d and tending to be normal on 21 d(P<0 .05);the comparison between the group C and D showed that the apoptotic cells in the group D were increased significantly ,but the difference between these two group ,was not statistically significant(P>0 .05) .Conclusion 1 ,25(OH)2D3 has the effect for inducing glomerular mesangial cell apoptosis in rat , which participates in the regulation of Caspase‐3 ,induces glomerular mesangial cell apoptosis ,promotes the recovery of nephritis and could delay the progression of renal disease .

Objective To explore the feature of electrical physiology and the key aspect of diagnosis in early stage of spinal muscular atrophy in infants.Method The back clinical data of the musle change of electrical physiology within 25 cases were analyzed.Results The children were ill in 1 year old,with the symptom that four limbs present symmetry and paralysing slowly,low limbs being more serious than upper limbs,the close and the distant of the four limbs.The levels of creatine kinase(CK) and lactate dehydrogenase(LDH) in serum were normal and the case unconcentrated was not seen rarely.The show of electromyogram(EMG) was that three limbs presenting wide-range losing nerve electric potential in peace state,when straingently the deadline was long and the motor unit potential(MUP) was high,when strain highly the eletric potential was decreased;the speed of nerve conduction was common.Muscle inspection was typical nervine myatrophy.Conclusion The clinical feature,the changes of muscle electrical physiology and the muscle inspection are valuable for diagnosis so as to afford reliable evidence for further gene diagnosis.J Appl Clin Pediatr,2006,21(3):167

OBJECTIVE:To discuss the effect of performance management in medication consultation service in hospital,and to improve the service quality in medication consultation center. METHODS:The performance management mode of medication consultation center was implemented in our hospital through formulating consultation pharmacist performance evaluation content and accounting rules from four dimensions of business skills,cultural literacy,work attitude,workload,conducting daily evaluation and check,developing training,setting development plan,etc. The effects of the mode were evaluated. RESULTS:In performance evaluation,business skills,cultural literacy,work attitude and workload took up 20,15,15 and 50 points,respectively;they were subdivided into 16 specific items and extra point items. After the implementation of above performance management,average weekly clients increased from 104 persons to 247 persons (increasing by 138%);the proportion of patient medication education mainly provided by clinical pharmacists increased from 18.30% to 46.34%(increasing by 153%);the complex and professional problems of medication consultation such as drug interaction rose from 0.96% to 5.28%;the problem of drug usage and dosage in-creased from 6.73% to 23.17%. The performance management mode not only improved the service consciousness and the enthusi-asm of consultation pharmacists,but also improved the level of pharmaceutical care. CONCLUSIONS:Reasonable and effective performance management mode can promote the service quality and ability of medication consultation center,and play more impor-tant role in hospital pharmaceutical care.

Objective To observe the effect of endoscopic esophagus-jejunum covered stent bypass on the treatment of type 2 diabetes mellitus (T2DM), and analyze the mechanism thereof. Methods Five obese Beagle dog models of T2DM underwent endoscopic esophagus-jejunum covered stent bypass to serve as operation group, and five normal Beagle dogs as control group receive endoscopy and exploratory laparotomy. The T2DM indices of both groups, including fast plasma glucose (FPG) level, fast insulin (FINS) level, intravenous glucose tolerance test-2h plasma glucose (IVGTT-2h PG) and IVGTT-2h FINS, were determined regularly before operation and 4, 8 and 12 weeks after operation. The insulin resistance index (HOMA-IR) and the function of islet β-cell (HOMA-β) were calculated with Homeostasis Model Assessment. The levels of gastric inhibitory polypeptide (GIP) and glucagon-like peptide-1(GLP-1) were also determined. Results Four weeks after operation, FPG, FINS, IVGTT-2h PG, and IVGTT-2h FINS all decreased significantly in operation group (P<0.01), and all these indices reached the levels of control group 12 weeks after operation (P>0.05). The HOMA-IR index declined distinctly and HOMA-β index ascended obviously in operation group 4 weeks after operation (P<0.01), and then recovered to the normal level 12 weeks after operation (P>0.05). The level of GIP lowered significantly (P<0.01), while of GLP-1 was elevated (P<0.05) 4 weeks after operation, and then returned to the normal levels 8 weeks after operation (P>0.05). Conclusion T2DM may be treated with esophagus-jejunum covered stent bypass effectively and safely, and the mechanism thereof might be related to the changes in gastrointestinal hormones.

Objective To observe the effect of endoscopic esophagus-jejunum covered stent bypass on the treatment of type 2 diabetes mellitus (T2DM), and analyze the mechanism thereof. Methods Five obese Beagle dog models of T2DM underwent endoscopic esophagus-jejunum covered stent bypass to serve as operation group, and five normal Beagle dogs as control group receive endoscopy and exploratory laparotomy. The T2DM indices of both groups, including fast plasma glucose (FPG) level, fast insulin (FINS) level, intravenous glucose tolerance test-2h plasma glucose (IVGTT-2h PG) and IVGTT-2h FINS, were determined regularly before operation and 4, 8 and 12 weeks after operation. The insulin resistance index (HOMA-IR) and the function of islet β-cell (HOMA-β) were calculated with Homeostasis Model Assessment. The levels of gastric inhibitory polypeptide (GIP) and glucagon-like peptide-1(GLP-1) were also determined. Results Four weeks after operation, FPG, FINS, IVGTT-2h PG, and IVGTT-2h FINS all decreased significantly in operation group (P<0.01), and all these indices reached the levels of control group 12 weeks after operation (P>0.05). The HOMA-IR index declined distinctly and HOMA-β index ascended obviously in operation group 4 weeks after operation (P<0.01), and then recovered to the normal level 12 weeks after operation (P>0.05). The level of GIP lowered significantly (P<0.01), while of GLP-1 was elevated (P<0.05) 4 weeks after operation, and then returned to the normal levels 8 weeks after operation (P>0.05). Conclusion T2DM may be treated with esophagus-jejunum covered stent bypass effectively and safely, and the mechanism thereof might be related to the changes in gastrointestinal hormones.

OBJECTIVE: Using the method of lactate dehydrogenase (LDH) assay, to observe the activities of rat cerebral microvascular endothelial cells (CMECs) intervened by Tongluo Jiunao Injection (TLJNI), a traditional Chinese compound drug removing toxin to dredge brain collaterals, and then further study the effects of different kinds of conditioned mediums (CMECs-CM) of cerebral microvascular endothelial cells on ischemia and ischemia/reperfusion cerebral cortex cells, and to probe into the drug pharmacological mechanisms of CMECs in modulating the neurons. METHODS: Three kinds of CMECs (normal, ischemic and ischemic/reperfusional) were all treated by TLJNI previously, and then the three pairs of CMECs-CM without serum were collected respectively for LDH assay. Rat cerebral cortex neurons were also primarily cultured and then divided into similar three groups (normal, ischemic and ischemic/reperfusional). The neuron responses caused by CMECs-CM at different concentrations were observed by using LDH transudation rate assay. RESULTS: The LDH release values of ischemic and ischemic/reperfusional CMECs with TLJNI treatment were obviously reduced (P<0.01) compared with the same kinds of CMECs untreated. For ischemic neurons, both conditioned medium of ischemic CMECs (Is-CM) and conditioned medium of ischemic CMECs with drug treatment (IsT-CM) in high concentration of 100% increased the LDH transudation rate (P<0.01), while in low concentration of 10%, IsT-CM reduced the transudation rate (P<0.05). For ischemia/reperfusion neurons, all kinds of CMECs-CM reduced the transudation rate respectively (P<0.05 or P<0.01). As far as each group concentration was concerned, 10% or 50% showed relatively stronger effects, and both conditioned medium of normal CMECs (N-CM) group and conditioned medium of ischemic/reperfusional CMECs (Rp-CM) group had statistical significance (P<0.05 or P<0.01). For normal neurons, all kinds of CMECs-CM increased the transudation rate respectively (P<0.05 or P<0.01). As far as each group concentration was concerned, only conditioned medium of normal CMECs (N-CM) had statistical significance (P<0.05 or P<0.01). CONCLUSION: The study shows that TLJNI is capable of preventing the damage of CMECs from both ischemia and ischemia/reperfusion states. Chinese drug can restrain the brain ischemia and ischemia/reperfusion damage by the media that CMECs modulate the neurons, demonstrating the pharmacological mechanisms of TLJNI. This work also indicates that there exist some active substances against ischemia/reperfusion injury secreted from CMECs-CM with TLJNI treatment.

Objective By analysing the clinical features of Indigo Naturalis-associated ischemic lesion of colon mucosa to improve the precautionary and therapeutic level of the disease.Methods Thirteen patients diagnosed as Indigo Naturalis-associated ischemic lesion of colon mucosa in Peking University Third Hospital from 2005 to 2010 were reviewed.The endoscopic and clinical features were analysed.Results The 13 patients with an average age of(60.6±14.1)years old were prescribed Chinese traditional medicine containing Indigo Naturalis for psoriasis or idiopathic thrombocytopenic purpura(ITP).The ratio of males to females was 1:1.6.The typical manifestations were abdominal pain and bloody stool with watering diarrhea before bloody stool in 61.5%patients.Endoscopic and pathological characteristics were coincident with ischemic lesion and more like a chronic index.Vasodilatic medicine was effective and the average hemostatic time was(1.7±0.8)days.The prognosis was well and no recurrence was found during 3 months follow-up.Conclusions Patients having psoriasis or ITP treated with Chinese traditional medicine containing Indigo Naturalis have an inclination to colon mucosa lesions, even ischemic lesion. Careful assessment and observation before prescribing arc necessary in these patients.