OBJECTIVE:To introduce positive response to the security and effectiveness issues on OTC cough and cold medicines for children in New Zealand in order to provide reference for drug risk-benefit evaluation and putting forward reasonable management measures in China. METHODS:The concept of OTC cough and cold medicines for children were introduced firstly. Then the evaluation and countermeasures of OTC cough and cold medicines for children in New Zealand were also introduced. RESULTS & CONCLUSIONS:It has significance for the evaluation of drugs for sale that are review and evaluation,study and countermea-sures and dynamic tracking for OTC cough and cold medicines for children in New Zealand and the realistic attitude of New Zealand Drug and Medical Instruments Security Bureau.

OBJECTIVE:Study on the efficiency of azithromycin sustained-release vaginal suppository in inhibiting ureaplasma urealyticum(Uu)in vitro.METHODS:The method of microdilution was used to determine the minimal inhibitory concentration(MIC)for Uu that azithromycin sustained-release vaginal suppository campared with azithromycin dried suspension. RESULTS:The MIC for Uu that both azithromycin sustained-release vaginal suppository and azithromycin dried suspension is lower than 0.125?g?mL~(-1).CONCLUSION:Azithromycin sustained release vaginal suppository has significant inhibitive effects on Uu under the experiment condition.

OBJECTIVE:To optimize the formulation of azithromycin sustained-release vaginal suppository(ASVS).METHODS:The ASVS was prepared using S-40 as suppository base,HPMC as sustained-release material and glycerine as humectant.The formulation of ASVS was optimized by orthogonal design with accumulated release percentage and hardness as indexes and the amount of 8% HPMC and glycerol as factors;meanwhile,a verification test and the fitting of in vitro drug release model were performed.RESULTS:The optimized formulation ASVS was as follows:azithromycin 6 g,8% HPMC 23.52 g,glycerol 29.40 g,ethanol absolute 3 g,ethylparaben 0.59 g,and S-40 294 g.Three batches of suppositories prepared under the optimized formulation reached a mean content of 99.5%,with hardness up to the standard,showing good reproducibility and homogenicity in drug release in vitro.The accumulative release rates of all samples were greater than 98% at 180 min,and the release dynamics in vitro were in line with Higuchi equations.CONCLUSION:The optimized ASVS is feasible in formulation,stable and reproducible in preparation technology and up to the standard for sustained-release preparation.

OBJECTIVETo investigate the effects of all-trans retinoic acid (atRA) on the function of bone morphogenetic protein receptor 2 (BMPR2) expression in embryonic palate.

METHODSCleft palate mice model was established by atRA. On gestation day (GD) 15 and GD 17, the pregnant mice were killed to obtain the embryos from the uteri. The embryonic palates were stained with hematoxylin-eosin, and the remaining sections were used for the immunohistochemistry of BMPR2 detection. Reverse transcription-polymerase chain reaction was performed to detect the expression levels of Bmpr2 mRNA.

RESULTSIn the atRA-treated group, short extensions and failure to fuse with each other were observed. The positive expression of BMPR2 was detected in developing palatal process from GD 15 to GD 17 in the control group. Compared with those of the control group, BMPR2 protein and Bmpr2 mRNA decreased in the atRA-treated group (P<0.05).

CONCLUSIONThe treatment of pregnant mice with retinoic acid produces small palatal shelves in their fetuses and down-regulates BMPR2 expressions.

Animals ; Bone Morphogenetic Protein 2 ; Cleft Palate ; Disease Models, Animal ; Down-Regulation ; Female ; Mice ; Pregnancy ; RNA, Messenger ; Tretinoin

Objective To assess the efficacy and safety of combining rociverine tablets with Suoquan cap-sules in the treatment of female patients with overactive bladder(OAB).Methods 152 female patients with OAB were randomly divided into three groups.Patients in rociverine group were administered rociverine tablets 10mg three times a day for 4 weeks.Patients in Suoquan capsule group were administered Suoquan capsules 1.8g three times a day for 4 weeks.Patients in combination group were administered rociverine tablets 10mg and Suoquan capsule 1.8g three times a day for 4 weeks.Each group of patients had to complete 3d voiding diary before and after treatment to record daily frequency of micturition,urgency,urgency incontinence,nocturia and avoiding volumes,OABSS score and drug side effects were also observed.All the data were analyzed to assess the efficacy and safety of treatment.Results There were significant differences in daily frequency of micturition,urgency,urgency incontinence,nocturia,avoiding volumes and OABSS score of patients in each group before and after treatment(all P <0.01 ).Moreover,compared with combination group,rociverine and Suoquan capsule group all had significant differences(F =41.765,53.834, 25.304,37.867,214.791,73.486,all P <0.01 ).There was no significant differences between rociverine and Suoquan capsule group(all P >0.05).The incidence rates of adverse events of rociverine and combination group were 7.8% and 22.6%,respectively,there was significant difference between the two groups(χ2 =4.372,P =0.032). Conclusion Combining rociverine tablets with Suoquan capsules in the treatment of female patients with OAB was effective and safe.

Objective To study the efficacy and safety of rociverine combined with tamsulosin in treatment of overactive bladder after transurethral resection of prostate (TURP).Methods 93 cases of overactive bladder patients who received TURP were collected.They were given rociverine tablets 10 mg 3 times a day and tamsulosin 0.2 mg once a day for 7 to 10 days.The efficacy and safety of treatment were assessed by changes before and after treatment in subjective indicators of overactive bladder syndrome score(OABSS),the international prostate symptom score(IPSS) and quality of life score(QOL) and objective indicators including daily frequency of micturition,urgency,urgency incontinence,nocturia,voiding volumes,combining with the adverse drug reaction incidence.Results The average treating time for the 93 cases was (5 ± 3) days.The average score of OABSS reduced 8.12(P ＜0.01,and each score≤ 4).The average score of IPSS reduced 16.69(P ＜0.01).The average score of QOL reduced 2.18 (P ＜ 0.01).There was statistical difference in objective indicators of patients between before and after treatment(P ＜ O.05).The adverse drug reaction incidence was 2.1％ (2 cases with thirsty symptom).Conclusion Rociverine tablets combined with tamsulosin in treatment of patients with overactive bladder after TURP are effective and safe.

Objective To evaluate the concept of artery first and total mesopancreatic excision in radical resection of pancreatic head carcinoma through both anterior and posterior approaches.Method The anterior approach was to identify the superior mesenteric artery (SMA) and the posterior approach to confirm the possibility of negative margin at the origin of SMA,on the posterio-lateral vascular wall of superior mesenteric vein (SMV) and the supposed posterior of the mesopancreas.The resection scope were with the celiac trunk and common hepatic artery as the upper boarder,the SMA as the left boarder,the inferior mesenteric vein (IMA) level as the lower boarder,to achieve a complete mesopancreatic excision,namely the en bloc resection of all the involved nerve,the lymph tissue and vascular tissue along the right side of the axial composed by SMA and celiac trunk.Results Of the 15 patients,11 had radical Whipple procedure,among which 2 had a combining SMV resection and reconstruction.1 case suffered from delayed gastric emptying and 2 cases from bile leakage.There was no mortality.The postoperative pathology reported carcinoma in all 11 cases,with duodenum and low bile duct involved in 4 cases,with the duodenum involved in 6 cases,no surrounding tissue involvement was identified in 1 case.Nerve involvement was found in 7 (7/11),vascular involvement in 10 (10/11),and lymphnode metastasis was (2.5 ± 3.8/12.9 ± 4.9).Conclusions The radical resection of pancreatic head carcinoma using the concept of artery first and the total mesopancreatic excision is helpful for an early evaluation of the possibility of radical resection and guarantees negative margins.

Aim To construct and express anti-CD20Fab-LDP,generate anti-CD20Fab-LDM and identify its biological activity.Methods PCR and overlapping PCR were used to construct anti-CD20Fab-LDP.DNA sequence was analyzed by the Terminus of Dideoxy Nucleotide.The product was purified by affinity chromatography and analyzed by Western blot and its antigen-binding activity was examined by FACS.Specific killing activity in vitro of anti-CD20Fab-LDM was analyzed by MTT.Results The data of DNA sequence showed that anti-CD20Fab-LDP was correct.The fusion protein was recovered in high yield(up to 4 mg·L~(-1))after proteinG purification.The fusion protein could bind to Raji cells(CD20+),and similar affinity data were obtained with anti-CD20Fab.Anti-CD20Fab-LDP showed potent cytotoxicity to Raji cells with IC_(50) values of 0.9×10~(-10) mol·L~(-1).Conclusions Anti-CD20Fab-LDP with high level expression was successfully obtained and could bind to Raji cells cells.Anti-CD20Fab-LDM showed specific killing activity to Raji cells in vitro.

Objective:To investigate the distribution of aldose reductase (AR) C-106T genetic polymorphism in Chinese Han population and its association with the risk for essential hypertension (EH).Methods:The AR C-106T polymorphism was genotyped in 148 Chinese EH patients and 137controls by polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP).The genotype distribution between groups was contrasted by x2- test and the degree of genetic association was evaluated by 95％ confidence interval (CI).Results:Frequency of the variant AR C-106T allele was 13.9％ (95％ CI:11.2％-16.6％) in the controls,which was significantly lower than that in the Japanese (18.4％ in 712 individuals,P=0.0063),the Australians (37.9％ in 240 individuals,P＜0.0001) and the Brazilians (34.7％ in 62individuals,P＜ 0.0001).The frequency ofAR C-106T allele was 11.7％ (95％ CI:7.9％-15.5％)in the EH patients.No significant difference in the allele frequency was observed between the EH patients and the controls (P=0.147).Conclusion:There is obvious racial difference in the distribution of AR C-106T polymorphism.The polymorphism is not associated with the risk for EH.

Objective:To study the technical and essential steps in laparoscopic selective devascularization with paraesophageal veins-preservation.Methods:To retrospectively analyze the clinical data of 13 cirrhotic patients who underwent laparoscopic selective pericardial devascularization for portal hypertension at the Department of Hepatobiliary and Pancreatic Surgery, Zhejiang Provincial People's Hospital from January 2019 to March 2020. There were 9 males and 4 females with age ranging from 41 to 83 years (median 51 years). The operative time, intraoperative blood loss, postoperative complications and follow-up data were analyzed.Results:All the 13 patients completed theoperation, no patient stopped the operation or transferred to laparotomy. The operation time was (170±32) min.The intraoperative bleeding was (160±30) ml. The postoperative hospital stay was (6.1±1.1) days. There were no complications, including pancreatic leakage and intra-abdominal infection. On follow-up which ranged from 1 to 15 months, one patient developed portal vein thrombosis, no upper gastrointestinal rebleeding.Conclusions:Preservation of esophageal veins in laparoscopic selective devascularization is an accurate surgery which requires close teamwork and rich experience in laparoscopic surgery. The preservation of the main trunk of the gastric coronary vein and integrity of the esophageal veins are the keys to the surgery which is safe and feasible.