This paper introduced the medical device classification in China and USA. Through the comparison between the two systems, several problems in Chinese classification system were exposed. To the end, some suggestions were proposed referred to the classification system of USA.
China ; Device Approval ; standards ; Equipment and Supplies ; classification ; United States

Traditionally it has been widely accepted that our genes together with adult lifestyle factors determine our risk of developing noncommunicable diseases such as type 2 diabetes mellitus ,cardiovascular disease and obesity in lat-er life.Currently, there is substantial evidence that the early life environment plays a key role in determining our suscepti -ble to such diseases in later life .As an increased focus on the understanding of central insulin resistance , central nerve sys-tem plays an extremely important role in regulating the peripheral glucose homeostasis .Substantial studies have indicated that it may be regulated by epigenetic mechanisms .Epigenetics can be defined as the study of heritable changes in gene ex-pression that do not involve alterations in the DNA sequence .Epigenetic processes play a central role in regulating tissue specific gene expression and hence alterations in these processes can induce long -term changes in gene expression and me-tabolism which persist throughout the lifecourse .This review will focus on the epigenetic machanisms of central neuroregula-tion between early life environment and glucose metabolism in adulthood .

For the preparation of implementing IEC 60601-1 Ed. 3.1 in advance, this paper analyzes the main difference between IEC 60601-1 Ed. 3.1 and GB 9706.1-2007, and discusses the possible influence to medical device designing and testing.
Equipment Design ; standards ; Equipment and Supplies ; standards

Objective To study the effects of green tea extract on the decrease of serum lipids and body mass index in middle-aged person.Methods A total of 248 middle-aged person with mild hypercholesterolemia were randomly divided into 2 groups and assigned to receive tablets containing green tea extract or placebo for 20 weeks.The serum lipids and body mass index were measured.Results The levels of serum total cholesterol and lower-density lipoprotein,and the body mass index were significantly decreased with the treatment of green tea extract(all P

BACKGROUND: Ribavirin is easily diluted by lacrimal fluid and has low bioavailability. In situ ophthalmic gel changes from liquid drug to gel phase upon exposure to physiological conditions, resulting in an increase in the precorneal residence time of drugs. OBJECTIVE: To prepare ribavirin in situ ophthalmic gel and valuate its theological feature. DESIGN, TIME AND SETTING: In vitro controlled observation, performed at the Engineering Research Center of Modem Chinese Medicine Discovery and Preparation Technique, Ministry of Education, Tianjin University of Traditional Chinese Medicine between September and October 2006. MATERIALS: Sodium alginate, Carbopol, and ribavirin. METHODS: Sodium alginate (1% and 2%) and Carbopol (0.3%, 0.6%, and 2%) were combined at different proportions to prepare in sire ophthalmic gel, then in which ribavirin was added. MAIN OUTCOME MEASURES: Viscosity determinations of prepared different concentrations of formulations were determined using a cone and plate viscometer. RESULTS: Ribavirin in situ ophthalmic gel prepared with 1% sodium alginate and 0.6% Carbopol had the largest viscosity. The viscosity change was not influenced by the addition of ribavirin. The in situ ophthalmic gel prepared with sodium alginate and Carbopol changed to the gel phase upon exposure to lacrimal fluid. CONCLUSION: 1% sodium alginate and 0.6% Carbopol produced the best rheological feature and could prolonge the precorneal residence time of drug than that of conventional ophthalmic solution.

Objective To study curative efficacy of compound tanshin injection and acupuncture and moxibustion in treatment of peripheral nerve injury its effects on nerve function.Methods 110 patients of peripheral nerve injury whoreceived therapy from April 2014 to September 2014 in our hospital were selected as research objects,according to the treatment were divided into observation group and control group,observation group using curative efficacy of compound tanshin injection,the control group using compound tanshin injection and low frequency dc therapy.Observe clinical efficacy of the two groups after treatment,compared two groups before and after treatment can motor nerve and sensory nerve nerve conduction velocity,and to evaluate the basic function after treatment.Results After treatment,the observation group total effectiveness 94.5％,obviously higher than the control group total effectiveness 81.8％,significant difference(P< 0.05); Observation group after treatment of nerve function was 80.0％,significantly higher than the control group was 60.0％,significant difference(P<0.05); And after the treatment of motor nerve and sensory nerve conduction velocity observation group were significantly higher than the control group,significant difference(P<0.05).Conclusion Curative of compound tanshin injection and acupuncture and moxibustion in treatment of peripheral nerve injury,can significantly improve patients with nerve function,improve the effect of treatment,and no side effect,is worth popularizing in clinic.

Objective To analyze humanized nursing and postoperative function of early stage training under arthroscopic rotator cuff injury minimally invasive surgery in patients with application value. Methods A total of 104 routine under arthroscopy of minimally invasive surgery in patients with rotator cuff injury by double-blind controls (usual care) and observation group (phase humanized nursing and early function training). With preoperative and postoperative week 5, 10, 15 weeks, 20 weeks of observation point in time, compared two groups of Constant Murley shoulder joint assessment of the indicators (pain, muscle strength, joint mobility, daily life) score, compared two groups of Hamilton Anxiety Scale (HAMA), Hamilton Depression Scale (HAMD) score. Results Preoperative, two groups of patients with pain, muscle strength, (range of motion, ROM), comparison between daily life score group were no significant differences (P> 0.05). Observation group of 10, 15, 20 weeks postoperatively pain scores were (4.32±0.17), (2.20±0.39), (1.01±0.24) points, which were higher than (4.61±0.21), (3.36±0.38), (1.76±0.14) points of the control group, and there were significant differences (t=7.74, 15.36, 19.47, P<0.01). All the observation time point strength postoperative observation group were (11.53±1.40)-(22.01± 0.31)points, which werehigher than (9.16 ± 1.06)- (17.14 ± 1.01) points of control group, and there were significant differences (t=8.97- 33.24,P<0.01). Each time point ROM postoperative observation group were (74.96±4.39)-(150.01±2.34) points which were higher than (69.01±2.63)-(120.15±2.36)points of control group, and there were significant differences(t=8.38-64.79,P<0.01). The observation group of 10 -20 weeks daily life score were (13.05±1.21)-(17.10±0.75) points higher than (10.65±1.31)-(13.42±1.04) points of control group, and there were significant differences(t=9.70- 20.70,P <0.01). HAMA and HAMD score after the intervention of observation group were (10.25±1.60), (12.02±1.84) points which were lower than (12.01 ± 2.78), (14.95 ± 2.11) points of the control group, and there were significant differences (t=3.25, 6.19, P< 0.01). Conclusions Humanized nursing and functional training for early stage in patients with rotator cuff injury under the arthroscope minimally invasive surgery; has the following functions: improve patients'psychological status, the positive application of treatment and rehabilitation; pain relief, and functional training smoothly; the early functional training to increase muscle strength and joint motion and improve everyday life.

Objective To compare laparoscopic hepatectomy to open surgery in recurrent hepatolithiasis.Methods From Jan 2014 to Feb 2016,106 cases of recurrent hepatolithiasis eligible for hepatectomy were prospectively randomized into laparoscopic group (53cases) and open group (53 cases).The perioperative variables,postoperative morbidity and outcomes were analyzed and compared between the 2 groups.Results The statistical results show that the laparoscopic group and open group had similar intraoperative rate of blood loss ＞400 ml,wound infection,abdominal infection,Grade B bile leakage,score of Clavien classification system,stone clearance rate and hospitalization cost (P ＞ 0.05).The laparoscopy group had longer operation time (P ＜ 0.05),and shorter postoperative hospital stay (P ＜0.05).Binary logistic analysis showed that decreased preoperative platelet count,longer operation time,and hepatectomy in difficult places are risk factors for intraoperative blood loss ＞ 400 ml (OR ＞ 1,P ＜0.05);type of past biliary tract operation,positive bile culture during surgery and residual stones are risk factors for grade B bile leakage (OR ＞ 1,P ＜ 0.05).Conclusions Laparoscopic hepatectomy for recurrent hepatolithiasis is safe and feasible.

Objective To explore the pathologic factors influencing the long-term survival of patients with relapsing and/or metastatic colorectal cancer (CRC) after radical operation for founding a basis for the clinical treatment protocols.MethodsThe clinical data were collected of 132 patients who were with relapsing and/or metastatic colorectal cancer (CRC) after radical resection,hospitalized from the beginning of 2002 to the end of 2007,and had integrated hospitalization and follow-up data.The relationship between the clinic pathologic factors and long-term survival was retrospectively analyzed.ResultsUnivariate analysis showed that the survival rate was higher in the patients with single recurrence and/or metastasis than in those with multiple recurrences and/or metastases,in the patients with relapsing and/or metastatic rectal cancer than in those with relapsing and/or metastatic colon cancer,and in patients received secondary operation than in those received non-operative treatment.Cox multivariable regression model analysis showed that the treatment modality for recurrence and/or metastasis,the number of recurrence and/or metastasis sites,the invasive depth of primary tumor,and lymph node metastasis were correlated with the long-term survival of patients.Among them,the treatment modality was the most important factor influencing the prognosis.ConclusionsThe recurrence and/or metastasis rate is higher in the patients with rectal cancer than in those with colon cancer,but the prognosis of the former is better than that of the latter.Secondary operation,which is helpful for the long-term survival,is suggested for the patients with relapsing and/or metastatic CRC.

Objective To investigate the influence of preoperative diabetes mellitus (DM) on postoperative morbidity of pancreatoduodenectomy for pancreatic ductal adenocarcinoma.Methods The clinical data of 302 pancreatic ductal adenocarcinoma patients who underwent pancreatoduodenectomy from January 1,2005 to August 31,2012 were retrospectively analyzed.Results 113 patients (37.4％)had preoperative DM among the total 302 patients.The percentage of the major complication including pancreatic fistulas,delayed gastric emptying,infections,acute kidney injury and mortality accounted for 19.9％,12.9％,25.9％,36.0％,3.2％ and 3.5％ respectively.In the DM group,firm pancreatic texture was more common than that in non-DM group (x2 =15.175,P ＜ 0.01).While pancreatic fistula in the DM group developed less frequently(x2 =7.811,P =0.005) than that in non-DM group.Delayed gastric emptying,infections,acute kidney injury,hemorrhage,pulmonary,cardiovascular and neurologic complications,as well as length of stay in hospital and mortality were in similar frequency in the two groups (P ＞ 0.05).Binary Logistic regression analysis showed DM(OR =0.358,P =0.035) and firm pancreatic texture(OR =0.395,P =0.032) were protective factors against pancreatic fistula while preoperative jaundice(OR =3.819,P =0.010) and intraoperative blood transfusion (OR =1.268,P =0.001) were predisposing factors for pancreatic fistula.Conclusions With good control of perioperative glucose level,DM does not increase operation risk in pancreatoduodenectomy for pancreatic ductal adenocarcinoma.