Objective:To suggest approaches for the establishment of Chinese standards for defining rare disea-ses and advance corresponding Chinese legislation. Methods:By comparing the standards for defining rare diseases in Europe, the United States, and other countries and studying key influencing factors of standards, this paper proposes suggestions for the establishment of proper Chinese standards for defining rare. Results and Conclusion:Social and e-conomic development levels, medical development levels and social security levels influence the establishment of standards. It is recommended that the national conditions should be taken into consideration and the number of pa-tients, severity of the diseases and economic indicators of orphan drugs be used to define rare diseases in China.

Objective: To provide policy recommendations for improving price negotiation system of patented drugs in China. Methods: This paper comparatively analyzes the commonalities and characteristics between Korea’ and Germany’s price negotiation models for patented drugs from three aspects of their goals, procedures and effects. Results:The key objective of both Korea’ and Germany’s price negotiation systems for patented drugs is to efficiently improve the utilization of national health insurance services, and responsibilities are properly assigned among differ-ent institutions to ensure the equity and efficiency of negotiations. However, due to the differences in national cir-cumstances, there is a big difference in the selection of technical assessment criteria. Conclusion: This paper sug-gests China to strengthen the convergence between price negotiations for patented drugs and medical insurance reim-bursement policy, to establish a technical assessment system with the innovation extent for patented drugs as its core, and to develop scientific and rational negotiation procedures and division of responsibilities as well.

Objective:This paper intends to provide reference for consummation of biosimilar registration poli-cies in China. Methods:This paper evaluates the performance of Japanese registration regulation policies on biosimi-lars by analyzing the procedure and reviewing the features of biosimilars. Results and Conclusions:According to the findings of the present investigation, the availability and affordability of biosimilars have been improved, and the bio-medicine industry has achieved great development. On the other hand, it's recommended that the guideline for the de-velopment and evaluation of biosimilars should be amended on the principle of appropriate simplification, which means to simplify the research and development procedure and exempt partial application dossier. Besides, the regis-tration procedures should be adopted continuously to ensure the stability of biosimilars' R&D and registration.

Bone morphogenetic proteins (BMPs) play a pivotal role in the formation,induction and repair of the bone; BMPs have been confirmed to induce bone formation.Transforming growth factor-beta,insulin-like growth factor-Ⅰ and basic fibroblast growth factor also contribute to bone formation; combination of the factors with BMPs can promote the healing of fracture and non-union,which may have a bright future in orthopedics.

Purpose:To investigate the local factors that influenced cervical lymphatic metastasis and prognosis of the floor of mouth carcinoma.Methods:A retrospective study was undertaken of 65 patients with squamous cell carcinoma of floor of mouth, who were treated between 1983 and 1998. Local factors including the tumor location, the tumor size, local invasion and pathological differentiation were investigated for the correlation with cervical lymphatic metastasis and prognosis of the disease.Results:Cervical lymphatic metastasis was 46.2% (30/65) for these 65 patients, and 96.6% of the involved lymph nodes were located in level Ⅰ(submandibular region) of the neck. Of these 65 patients, cervical lymphatic metastasis was 62.2% and 40.0% for 45 anterior and 20 posterior floor of mouth carcinoma, respectively ( P = 0 .096).Cervical metastasis was 59.5% and 21.7% for tumor size greater than or less than 3 cm, respectively ( P = 0.003).Cervical metastasis was 46.8% and 44.4% for tumors invading the tongue or not, respectively.Cervical metastasis was 60 0% and 42 0% for tumors invading the gum or not, respectively.Cervical metastasis was 76.5% for the poorly differentiated and was 42.1% for the moderately and well differentiated squamous cell carcinoma ( P = 0.018). The overall 5 years survival was 46.4% for the 65 patients. The 5 years survival was 61.4% for these without cervical metastasis and 28.9% for these with cervical metastasis ( P = 0.0013).Conclusions:The local factors such as the tumor size greater than 3 cm, tumor invasion to the tongue and the gum, and the poorly differentiated squamous cell carcinoma of floor of mouth increased the incidence of cervical metastasis, and therefore adversely influenced the prognosis.

OBJECTIVE:To establish a pharmacy online to offline (O2O) platform service quality evaluation model,and to provide reference for platform operators to improve the service quality. METHODS:Using SERVQUAL scale,combining the situa-tion of pharmacy O2O platform development in China,the reliability,safety and aspects of O2O platform were analyzed to sum up primary evaluation index of pharmacy O2O platform service quality. Based on this,the expert interviews questionnaire was de-signed. According to the questionnaire results,indicators were modified and empowered to construct the pharmacy O2O platform service quality evaluation model;the reliability and validity of model were validated. RESULTS & CONCLUSIONS:According to the connotations of each dimension analysis in the SERVQUAL scale and expert interview results of pharmacy O2O platform ser-vice quality,pharmacy O2O platform service quality evaluation model is constructed,including five indicators as“reliability”“se-curity”,and 18 secondary indexes as the“number of platform pharmacy”“pharmacy qualification show”“pharmacy type”. The re-sults of model index reliability and validity verification show that model construction is reasonable and can provide reference for platform operators improving service quality. Follow-up research should give full consideration to the Chinese consumer behavior habits,personal preferences and other factors to build more suitable pharmacy O2O platform service quality evaluation model in China.

Objective To investigate the clinical efficacy of ziprasidone in the treatment of first-episode schizophrenia.Methodsfrom January 2014 to June 2016to receive the treatment of patients with first-episode schizophrenia in 156 cases as the research object in the psychiatric hospital, which were randomly divided into two groups, the control group were given risperidone treatment, the observation group was treated with ziprasidone treatment, compared two groups of clinical curative effect of the treatment of patients after.ResultsThe patients in the observation group the total effective rate was 97.4%, the control group total effective rate was 89.7%;group after treatment in patients with negative symptoms score were significantly lower than the control group, with statistical significance between the two groups (P<0.05).ConclusionThe application of ziprasidone in the treatment of first-episode schizophrenia has achieved good clinical efficacy, the total effective rate of treatment is higher, and the negative symptoms are effectively controlled.

Cardiovascular Diseases ; Cell Proliferation ; Humans ; MicroRNAs ; Muscle, Smooth, Vascular

Objective To explore the efficacy and adverse effects of nimotuzumab combined with chemotherapy and radiotherapy in the treatment of locally advanced cervical cancer.Methods Sixty patients with stage Ⅲ cervical cancer by the histopathologic diagnosis were collected,and they were randomly divided into two groups using the random number table method.The control group (n =30)using intensity-modulated radiotherapy,intracavitary afterloading therapy and periodic chemotherapy,the observation group (n =30)in addition to the intensity-modulated radiotherapy,intracavitary afterloading therapy and periodic chemotherapy, the nimotuzumab (200 mg)was given to the patients before weekly radiotherapy.All patients were received 6 to 7 times of treatment.Results The curative effects of all the patients were evaluated after radiotherapy 3 months.In the observation group,there were 20 cases of CR,5 cases of PR,4 cases of SD,1 case of PD,the total effective rate (CR +PR)was 83.3%.In the control group,there were 1 8 cases of CR,3 cases of PR,6 cases of SD,3 cases of PD,the total effective rate was 70.0%.The difference was statistically significant (χ2 =8.356,P <0.05).The main adverse reactions in the observation group and control group included slight radioactive proctitis (1 6.7% vs 1 3.3%),radioactive cystitis (1 0.0% vs 1 0.0%),nausea and vomiting (50.0% vs 46.7%),reduction of white blood cells (40.0% vs 43.3%),with no significant differences (χ2 =3.357,P =0.71 9;χ2 =2.71 7,P =0.925;χ2 =5.882,P =0.623;χ2 =4.728,P =0.687).There were no skin rashes and allergic reactions.Conclusion Nimotuzumab can enhance the locally stage cervical cancer patients′sensitivity on radiotherapy,which can increase the efficacy and doesn′t increase adverse
reaction obviously.

Objective To discuss the feasibility, safety and validity of the use of ViabahnTM self-expanding covered stent in endovascular repair of peripheral traumatic pseudoaneurysm (TPA). Methods During the period from June 2012 to April 2014, a total of 8 patients with peripheral TPA were admitted to the Department of Vascular and Endovascular Surgery of Shanghai Changzheng Hospital . The clinical data were retrospective analyzed. The lesions were located at the common carotid artery (n=4), vertebral artery (n=1), subclavian artery (n=1) and superficial femoral artery (n=2). On the basis of acute and chronic TPA classification and different therapeutic principles, endovascular repair with ViabahnTM self-expanding covered stent was employed in 8 patients. Intraoperative angiographic findings, the size and number of the implanted stent, and the immediate angiographic results after stent implantation were recorded. All the patients were followed up to evaluate the improvement of the symptoms, the effectiveness of the repair of TPA cavity, and the occurrence of endoleak or restenosis. Results Successful implantation of ViabahnTM self-expanding covered stent was accomplished in all 8 patients, with a technical success rate of 100%. Angiography performed immediately after stent implantation showed that complete repair of TPA cavity was obtained in all patients, the distal segment of the parent artery was patent, and no endoleak was observed. The sizes of the stent used in the patients were 8×50 mm (n=2) and 9×50 mm (n=2) in common carotid artery, 6×50 mm (n=1) in vertebral artery, 11×100 mm (n=1) in subclavian artery, and 8×100 mm (n=2) in superficial femoral artery. The patients were followed up for 6-30 months (mean of 14.3 months), and the clinical symptoms disappeared in all patients. CT angiography indicated that there was no endoleak or restenosis. Conclusion Based on the different therapeutic principles, the use of ViabahnTM self-expanding covered stent in endovascular repair of peripheral TPA is technically simple and micro-invasive, and clinically feasible with reliable effect and safety. Therefore, this technique can be employed as a first-line therapy option for peripheral TPA.