The orphan drug management system can significantly improve the quality of care and that of life of patients suffering from rare diseases, and accelerate the progress of medicinal science. With experiences of practicing the orphan drug management system in developed countries and regions,including certification of orphan drugs, supports for developing orphan drugs, market protection and clinic application management. Based on such studies, the authors discussed the feasibility and methodology of establishing an orphan drug management system in China, along with the significance of such a system.

OBJECTIVE:To establish a method for the determination of serum indapamide concentration.METHOD:10healthy male volunteers were assigned to receive7.5mg indapamide capsule on empty stomach with time-concentration de?termined by HPLC,and the pharmacokinetics parameters were accounted.RESULTS:C max was(0.212?0.167)mg/L,t max was(2.14?0.59)h,t 1/2 was(19.69?0.75)h,AUC 0～72 was(3.636?0.503)(mg?L)/h and AUC 0～∝ was(3.937?0.518)(mg?L)/h.CONCLUSION:The established method can be used for the clinical analysis on the use of indapamide and its pharmacokinetics study.

Over the years,the sociological and medical researchers have worked together on smoking cessation intervention model and conducted extensive programs to improve the confidence of smokers,to overcome the withdrawal symptoms and other difficulties in quitting,and to improve the success rate of smoking cessation.This paper reviews the major intervention models of smoking cessation and their implementation in recent years,including psychological intervention,behavior intervention,drug intervention and combined intervention;and also some intervention methods including acupuncture therapy,nicotine vaccine and others.The systematic implementation of smoking cessation model facilitates the success of smoking cessation.

Nausea and vomiting are among the most common complications after surgery. Postoperative nausea and vomiting(PONV) may cause wound dehiscence, pulmonary aspiration, dehydration, and electrolyte disturbances. Despite the new classes of antiemetics and research published, PONV remains high incidence still. This article covers the different pharmacologic strategies taken introduced with multimodal approach by using antiemetic drugs for prevention and treatment of PONV.

Matrix metalloproteinase-8 (MMP-8) is a collagen which belongs to matrix metalloproteinase.Its function is that degrades collagen and be involved in inflammation.In breast cancer,the level of expression of MMP-8 is related to the invasion and metastasis of breast cancer as well as the clinical and pathological stage of breast cancer,but it is unclear on the molecular mechanism of MMP-8 in the malignant tumor.The research of expression in breast cancer prognosis of breast cancer will provide a reliable assessment of molecular marker.

Objective To investigate the expression of matrix metalloproteinase-8 (MMP-8) in human breast cancers and its relationship with the clinicopathological parameters,evaluate the relevance of MMP-8 levels to metastases in breast cancer.Methods Human specimens were obtained from 50 patients with invasive ductal carcinomas,and 20 normal breast glands were enrolled.Intact clinical parameters were aviliable for all patients.The protein expression of MMP-8 was determined by immunohistocbemistry technology SP.Results The rate of MMP-8 positive breast cancer was significantly higher than that in normal breast glands [68 ％ (34/50) vs 15 ％ (3/20),P ＜ 0.05].The expression of MMP-8 showed a negative correlation with breast cancer staging.The expression of MMP-8 in stage Ⅰ was higher than that in stage Ⅱ and Ⅲ/Ⅳ[94 ％ (15/16),57 ％ (13/23),55 ％ (6/11),P ＜ 0.05].Lymph node negative patients had a higher MMP-8 expression than patients with lymph node metastases [84 ％ (21/25) vs 50 ％ (13/25),P ＜ 0.05].Conclusion MMP-8 expression is associated with human breast cancer metastases and might be involved in inhibiting metastases.

Ductal carcinoma in situ belongs to the early stage of breast cancer.The treatment of ductal carcinoma in situ is similar with that of the breast cancer.Because of the low mortality rate in patients with ductal carcinoma in situ,there was an excessive treatment in the treatment of ductal carcinoma in situ.So the key to the treatment of ductal carcinoma in situ was to improve the quality of life.The present study shows that the effect of conserving surgery with radiotherapy is same with mastectomy's in the treatment of breast ductal carcinoma in situ.Sentinel lymph node biopsy can also be used to evaluate the patient's axillary status.For patients with ductal carcinoma in situ with breast conserving surgery,radiotherapy and endocrine therapy can reduce the recurrence rate of ipsilateral breast cancer.Radiotherapy and endocrine therapy have also become the standard treatment for ductal carcinoma in situ.

Objective To observe the therapeutic efficacy and security of hyperthermia combined with chem-otherapy for advanced gastric carcinoma.Methods The clinical data of 126 patients with advanced gastric cancer were retrospectively analyzed.According to the different treatment methods,they were divided into simple chemotherapy group(A group,63 cases)and chemotherapy combined with hyperthermia group (B group,63 cases).A group received chemotherapy through vein,the patients received docetaxel 75mg/m2 on day 1,tegafur 80mg/m2 on day 1 -14 and cisplatin 75mg/m2 on day 2 -4 of 21 -day courses.B group received hyperthermia together with chemothera-py.Hyperthermia was maintained at 40 -42℃ for 90min.The efficacy and toxicity -side -effect after the patients received two courses were evaluated.Results In A group,the rate of complete remission(CR)was 0 case,partial remission(PR)in 28 cases,stable disease(SD)in 27 cases,progressive disease(PD)in 8 cases,and the overall response rate(CR +PR)was 44.4%,while those in B group were 3 cases,36 cases,21 cases,3 cases and 61.9%, respectively.There was significant difference between the two groups(χ2 =4.589,P =0.032).The improvement rate of life quality of B group(58.7%)was better than A group(33.3%),there was statistically significant difference between the two groups(χ2 =9.232,P =0.002).The rates of Ⅲ°+Ⅳ°abnormal liver and kidney function,myelo-suppression and gastrointestinal tract in A group were 19.0%,23.8% and 25.4%,those in B group were 15.9%, 20.6% and 30.2%,there were no statistically significant differences between the two groups (P =0.815,P =0.830, P =0.426).Conclusion Hyperthermia combined with chemotherapy is efficient and safe for advanced gastric carci-noma,and it is worthy of furthermore study and observation in clinic.

Objective To evaluate and analyze the CT imaging of preoperative SOX regimen neoadjuvant chemotherapy in the treatment of advanced gastric cancer.Methods A total of 33 patients with advanced gastric cancer treated in our hospital from January 2010 to February 2015 were enrolled for the study and given tegafur gimeracil oteracil potassium capsule plus oxaliplatin for injection as preoperative adjuvant chemotherapy.And all the patients were given surgery after 3 cycles of SOX regimen chemotherapy, and surgical resection of the tumor was taken as the final pathology gold standard.The CT imaging data of the patients before and after the chemotherapy was counted and then analyzed and compared with the pathological data to clarify the value of CT imaging in the evaluation of SOX regimen neoadjuvant chemotherapy for advanced gastric cancer.Results The effective rate was 33.33% and the ineffective rate was 66.67% in the preoperative SOX regimen neoadjuvant chemotherapy for advanced gastric cancer through clear surgical pathology.The correlation between tumor volume reduction and pathological grading was the strongest(r=0.581, P<0.001).By ROC analysis, the best area value(AUC) of the tumor volume reduction rate was 0.834.When the tumor volume reduction rate with 36.94% was taken as the effective threshold for SOX regimen neoadjuvant chemotherapy, the sensitivity and specificity of the evaluation were the best with 74.62% and 83.01% respectively.Conclusion sCT volume measurement can be used as a reliable clinical data to evaluate the efficacy of preoperative SOX regimen neoadjuvant chemotherapy in the treatment of advanced gastric cancer and have certain guiding significance in the late treatment of patients with advanced gastric cancer.

Objective To establish a method for content determination of hyodeoxycholic acid in Qingkailing Injection. Methods An UltimateXB-C18 column (5 ?m, 250 mm?4.6 mm) was used with a mobile phase of acetonitril-water-phosphoric acid (35∶65∶0.1). The flow rate was 1 mL/min. The temperature of the column was 40 ℃. The detection wavelength was 192 nm. Results There was a good linear relationship between the concentration of hyodeoxycholic acid and absorption area value in range of 0.201 35～1.006 75 mg/mL, r=0.999 6. The average recovery was 98.25% with RSD=1.26%. Conclusion This method was accurate, credible and repeatable which can be used to control the quality of Qingkailing Injection.