BACKGROUND: The phakic intraocular lens implantation has advantages of reversibility and accommodative capability, which is a promising refractive operation. Posterior chamber phakic intraocular lens implantation is a developing method for the correction of extreme myopia. OBJECTIVE: To evaluate the efficacy, safety and stability of posterior chamber phakic intraocular lens implantation for the correction of extreme myopia. METHODS: This study included 18 eyes of 11 patients whose received posterior chamber phakic intraocular lens implantation at Shierming Eye Hospital from March 2006 to January 2009, including 4 males (7 eyes) and 7 females (11 eyes). All patients were followed-up 3-6 months, mean 5.3 months. The refraction, intraocular pressure, contrast sensitivity, glare sensitivity, endothelial cell morphometry, as well as lens opacities were observed. RESULTS AND CONCLUSION: After operation, naked visions of the 18 eyes were better than or equal to preoperative corrective vision, and the astigmatism was relieved obviously. The naked contrast sensitivity and glare sensitivity was better than that before the operation. The anterior chamber depth, intraocular pressure and corneal endothelium counting before and after the operation had no significant difference. No serious complication was detected during the follow-up. The vision decent at night and dazzling sensation occurred in 2 cases. Shot-term observation shows that implanting intraocular lens in posterior chamber to correct high myopia is safe, stable and predictable. This operation is a promising method for correcting high myopia.

In the process of promoting the implementation and transformation of the Q3D guideline of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in China, the risk assessment of elemental impurities in naturally sourced excipients often faces challenges such as multiple types of elemental impurities and insufficient detection methods. In this paper, an inductively coupled plasma mass spectrometry (ICP-MS) method for screening 12 elemental impurities in titanium dioxide was established using the optimized acid extraction pre-treatment method. The accuracy and repeatability of the method were good. The recoveries of cadmium, lead, mercury, cobalt, nickel, lithium, barium, molybdenum, copper, chromium and iron were 83.6%−101.6%, the recovery of antimony was 54.1%, and the RSD was 1.1%−10.2% (n=6). The evaluation results of elemental impurities showed that the risk of cadmium, mercury, cobalt, nickel, lithium, barium, molybdenum, copper, chromium and antimony was low, while the risk of lead was high, and it is recommended that a lead salt test be added to the pharmacopoeia standard for this product. Based on the statistical data, the differences in the control levels of elemental impurities and whiteness of 29 batches of titanium dioxide samples from 10 domestic and foreign manufacturers were compared and analyzed. The Pearson correlation coefficient method was used to analyze the correlation between residual elemental impurities and whiteness, and a heat map was used to visualize the results. The results showed that whiteness was significantly negatively correlated with the amount of residual barium and the sum of residual elemental impurities. It is suggested that the manufactures should include whiteness as an internally controlled indicator to further improve the quality of titanium dioxide used as a pharmaceutical excipient.

Objective: To determine the impurities in pharmaceutical adjuvant sodium bisulfite. Methods: An IC method was used with a Dionex IonPac AS17-C RFIC analytical column. ECD was used as the detector by gradient elution and the temperature of column was 30℃. Results:Sulfate radical was detected out in all samples. Conclusion:The method is simple and fast with high sensi-tivity, which is suitable for the determination of related substances in sodium bisulfite.

Duplicate submission of research papers have many negative effects on authors,hospitals,readers,and journals.Reasons for duplicate submission were analyzed.Through strengthening the propaganda and using information management system,duplicate submission of research papers might be eliminated.

A sensitive colorimetric method for the detection of copper ions (Cu2+) was developed based on the surface modification of silver/platinum nanoclusters (Ag/Pt NCs) and regulation of peroxidase-like activity. It was found that 3-mercaptopropionic acid (MPA) could inhibit the catalytic ability of Ag/Pt NCs; however, it lost the inhibition toward catalytic ability of Ag/Pt NCs after oxidized by oxygen through the catalysis of Cu2+. On the basis of this, a colorimetric method was developed for the detection of Cu2+ through measuring the colorimetric signal variation of the TMB-H2O2 reaction. This method exhibited high sensitivity and selectivity toward Cu2+ over a panel of other metal ions. The linear range was 10-100 nmol/L and the detection limit was 5.0 nmol/L (3σ). The above method was also applied to detect real water samples and spiked samples, and the results demonstrated that this method was simple with low cost.

Objective To assess the value of diffusion weighted imaging (DWI) in monitoring therapy effect of neoadjuvant chemotherapy (NAC) in patients with locally advanced breast cancer.Methods The prospective study included 26 lesions in 24 patients with LABC undergoing NAC.MRI was conducted before chemotherapy,after the first cycle of chemotherapyand after all cycles,including conventional MRI and DWI.All patients were confirmed by pre-treatment fine needle aspiration biopsy (FNAB),and postoperative histopathological prout.All lesions were divided into two groups of pathological complete response (pCR) and non-pCR.We evaluated ADC value and its changes in pathological complete response difference between the groups and complete remission in each testing point.Results Before chemotherapy and after the first cycle of chemotherapy,the ADCmean andADCmin had no statistically significant difference hetween pathologic complete response group and non-complete remission.After the whole chemotherapy,both of them had statistically significant difference;pathological complete response (pCR) and non-pCR early ADCmin value rate were (16.78 ± 22.70) ％ and (12.37 ± 10.09) ％respectively.No statistically significant difference was seen (P =0.53).Preoperative ADCmin value rates were (91.41 ± 45.83) ％ and (29.74 ± 22.96) ％ respectively,which were statistically significant (P =0.00) Conclusion ADC which is measured from DWI can be used to assess early response to NAC in breast cancer lesion,but cannat predict pCR or non-pCR for all cycles of chemotherapy on the first cycle.

Objective: To analyze the compatibility rationality between the raw material and auxiliary material sodium bisulfite in Zhengqin Fengtongning injection.Methods: HPLC was applied to detect the contents of the impurity and the main component in Zhengqing Fengtongning injection, and ion chromatography was applied to determine the content of sodium bisulfite in Zhengqing Fengtongning injection.The changes of impurity, main component and sodium bisulfite among the samples were compared before and after the stress testing (high temperature at 40℃, 60℃ and illumination at 4 500 lx).LC-MS-MS was used to identify the structures of the impurities.Results: The impurity in Zhengqing Fengtongning injection was the combination of the raw material and sodium bisulfite.Conclusion: It is irrational for Zhengqing Fengtongning injection to use sodium bisulfite as the antioxidant.

Objective To improve the diagnostic accuracy of nonpalpable calcified breast lesions by establishing a Logistic multivariate prediction model to assess the probability of benign/malignant breast lesions.The proposed model is based on the clinical and BI-RADS-X-ray imaging features of patients with nonpalpable calcified breast lesions.Methods A total of 147 nonpalpable calcified breast lesions were analyzed retrospectively.Firstly, based on the personal experience,the X-ray imaging data of lesions were analyzed to obtain the BI-RADS categorization, and the ROC curve was plotted by comparison with pathology.Then the univariate and multivariate analysis was performed on the clinical and X-ray imaging features of pathology to select the independent factors related to benign/malignant features.Further,a Logistic regression model was built,the suitable cut-off point was determined, and the ROC curve was obtained.Finally,the comparisons of the diagnostic accuracy of breast lesions were made between the method using the BI-RADS categorization and the method using the Logistic regression model.Results The AUC of the BI-RADS method was 0.867 9.The univariate analysis showed that there exist statistical differences among clinical features of patients(age,location,and quadrant),as well as the BI-RADS-X-ray imaging features (distribution,morphological and gland density).Also,by using the multivariate Logistic regression equation,the statistical differences among age,quadrant and morphological difference can be observed.The AUC using the built Logistic regression model was 0.906 3.Conclusion The diagnostic accuracy of breast lesions using the Logistic model is higher than that using the BI-RADS categorization method.Therefore, the proposed model is valuable for obtaining accurate diagnosis of breast lesions.

Objective: To improve the quality standard for Zengguang tablets.Methods: Instead of the microscopic identification, Acorus tatarinowii rhizoma,Lycii Fructus and Polygalae radix were indentified by TLC.The content of schisandrin in Schisandrae Chinensis Fructus was determined by HPLC.The HPLC system consisted of a Hypersil BDS C18(250 mm×4.6 mm,5 μm)column, methanol-water (1∶1) was used as the mobile phase at a flow rate of 1.0 ml·min-1, and the detection wavelength was at 250 nm.The column temperature was 35℃ and the sample size was 10 μl.Results: The microscopic images were with strong specificity.The developed TLC spots were quite clear, and the method of TLC was simple with strong specificity and good reproducibility.The linear range of schisandrin was 21.17-423.40 ng(r=0.999 9).The average recovery was 99.7% and the RSD was 1.4%(n=6).Conclusion: The method for the quality control of Zengguang tablets is comprehensive and perfect.

Objective To determine whether tChoI and ADC and their changes could be applied to predict pathologic response be-fore,during and after NAC of locally advanced breast.To assess the diagnostic performance of each parameter.Methods The tChoI and ADC and their changes in 22 women who underwent MRI before,during and after the NAC were analyzed prospectively.All pa-tients were divided into major histological response group and non-major histological response group by methods of Miller and Payne system according to the final pathologic response.Pre-and post-treatment measurements and changes in tChoI and ADC values in MHR versus NMHR were analyzed using Mann-Whitney U test.ROC curve analysis was performed to assess the diagnostic per-formance of each parameter and also to identify which parameter could be used to predict the pathologic response to NAC and find the optimal cut off value for MHR prediction.Results After NAC,14 patients showed MHR and 8 showed NMHR.After NAC,all the parameters and their changes were significantly different between the MHR and NMHR groups,the change rate of all parameters af-ter NAC can actively diagnosis the MHR according ROC(AUC>0.5).Using 0.913 ×10 -3 mm2/s of ADCmin after NAC as the cut off value,prediction of MHR with sensitivity and specificity was 85.7% and 100%,respectively.Using 81.25% of the change rate of tCho I after NAC as the cut off value,prediction of MHR with sensitivity and specificity was 71.4% and 100%,respectively(AUC=0.881,P =0.008).The △ADCmin 2% and △tChoI2% are better than △ADCmean 2%.Conclusion Application of 3D 1 H-MRS and DWI can predict pathologic response and may provide more detailed and accurate evidence for subsequent treatment.