Visual Inspection with Acetic Acid (VIA) Screening Program: 7 Years Experience in Early Detection of Cervical Cancer and Pre-Cancers in Rural South India

Cervical cancer continues to be a major public health problem in India in the absence of wide spread organised cervical screening programs. Visual inspection of the cervix with acetic acid (VIA) is an effective, inexpensive screening test that can be combined with simple treatment procedures for early cervical lesions, provided by trained health workers. We report 7 years experience in early detection of cervical cancer and pre-cancers using the VIA test in a community-based program in rural Andhra Pradesh, India where there are no existing organised cervical screening programs.

Materials and Methods:

Eligible women aged between 26 and 60 were opportunistically screened by trained health wor kers using the VIA test. Women who tested positive were further evaluated and those with cervical lesions were treated either by cryotherapy in the screening clinic or referred to a higher center.

Results:

A total of 18,869 women were screened by a single round of VIA testing with a positive rate of 10.75%. Biopsy proven high-grade squamous intraepithelials (HSILs) were 90 (0.48%) and low-grade squamous intraepithelials (LSILs) were 43 (0.28%). The overall prevalence of cervical intraepithelial neoplasia (CIN) 2+ lesion rate is 1.05%. A total of 312 (1.65%) cryotherapies were done and 49 women underwent hysterectomy.

Conclusions:

VIA by trained female health workers is a safe, acceptable, and effective test that can save lives from cervical cancer even in remote areas with few resources. These results have important implications for efficient service delivery in cervical screening programs in low-resourced settings.     

复杂随机抽样数据的多重线性回归分析方法及其应用

目的：探讨综合权重在复杂随机抽样数据线性回归分析中的意义和作用。方法基于蒙特卡洛随机模拟思想,采用SAS中REG和SURVEYREG两个不同的多重线性回归分析过程,分别对同一批复杂随机抽样数据（ n＝6756）在不同随机抽样率条件下进行回归建模,对所得结果进行比较。结果在未考虑和考虑观测权重与抽样权重的多重线性回归模型拟合的结果中,自变量的偏回归系数、标准误及P值的大小均有所不同。结论在对基于不同抽样率的复杂随机抽样资料,尤其是分层随机抽样调查资料的回归建模中,采用多重线性回归模型拟合资料时,将调查数据的综合权重纳入统计分析,方能更准确、灵敏地进行回归系数的参数估计和对结果变量的统计预测。     

Case sampling for psychotherapy practice,theory, and policy guidance: Qualities and quantities

Random sampling of cases is usually infeasible for psychotherapy research, so opportunistic and purposive sampling must be used instead. Such sampling does not justify generalizations from sample to population-distribution statistics, but does justify reporting what independent-variable value configurations are associated with what dependent-variable value configurations. This allows only the generalization that these associations occur at least that frequently in the population sampled from, which is enough for suggesting and testing some psychotherapy theories and informing some psychotherapy practice. Although psychotherapy practice is a longitudinal process, formal psychotherapy outcome research is so far most feasible and most widely done in the form of two-phase cross-sectional input-outcome studies. Thus, the analysis of sampling for psychotherapy research here will be in terms of the independent- and dependent-variable value configurations produced in such two-phase studies.     

Diffusion‐weighted MRI of the prostate without susceptibility artifacts: Undersampled multi‐shot turbo‐STEAM with rotated radial trajectories

The aim of this study was to develop and evaluate a clinically feasible approach to diffusion‐weighted (DW) MRI of the prostate without susceptibility‐induced artifacts. The proposed method relies on an undersampled multi‐shot DW turbo‐STEAM sequence with rotated radial trajectories and a multi‐step inverse reconstruction with denoised multi‐shot phase maps. The total acquisition time was below 6 min for a resolution of 1.4 × 1.4 × 3.5 mm³ and six directions at b = 600 s mm^?2. Studies of eight healthy subjects and two patients with prostate cancer were performed at 3 T employing an 18‐channel body‐array coil and elements of the spine coil. The method was compared with conventional DW echo‐planar imaging (EPI) of the prostate. The results confirm that DW STEAM MRI avoids geometric distortions and false image intensities, which were present for both single‐shot EPI (ssEPI) and readout‐segmented EPI, particularly near the intestinal wall of the prostate. Quantitative accuracy of the apparent diffusion coefficient (ADC) was validated with use of a numerical phantom providing ground truth. ADC values in the central prostate gland of healthy subjects were consistent with those measured using ssEPI and with literature data. Preliminary results for patients with prostate cancer revealed a correct anatomical localization of lesions with respect to T₂‐weighted MRI in both mean DW STEAM images and ADC maps. In summary, DW STEAM MRI of the prostate offers clinically relevant advantages for the diagnosis of prostate cancer compared with state‐of‐the‐art EPI‐based approaches. The method warrants extended clinical trials.     

新旧化妆品检验规范的对比及对化妆品审评的影响

目的： 全面解读2019年9月10日国家药品监督管理局发布的《化妆品注册和备案检验工作规范》，为开展化妆品审评提供参考。方法： 从多个方面对比已实施的《化妆品注册和备案检验工作规范》和同步废止的《化妆品行政许可检验规范》，分析二者的不同之处对化妆品审评可能带来的影响，并对今后的工作方向提出预见和建议。结果： 《化妆品注册和备案检验工作规范》取消了现行的由药品监管部门对化妆品注册和备案检验检测机构进行资格认定和指定，允许社会优质资源承担化妆品注册和备案检验工作，并对检验工作流程进行了优化，对检验项目要求进行了调整和规范。结论： 《化妆品注册和备案检验工作规范》的发布和实施，对化妆品注册和备案检验以及化妆品审评工作都提出了新的要求，相关部门应尽快适应。     

诊断试剂应急检验工作机制建设探讨

目的： 通过新型冠状病毒诊断试剂应急检验工作，进一步改进和完善突发公共卫生事件应急检验管理体系建设，为检验检测机构积极开展应急检验工作提供借鉴。方法： 结合新型冠状病毒肺炎疫情中开展应急检验工作实践，梳理开展应急检验工作流程，探讨突发公共卫生事件的应急检验管理策略及措施。结果与结论： 实现应急检验制度化、规范化、程序化，通过合理的应急检验预案制定、应急检验组织架构的建立、应急物资的储备及保障、应急检验人员的培训等方面，构建应急检验管理体系，提高突发公共卫生事件应急检验的能力。建立完善的应急检验管理体系，可以提高应急检验工作效率，协调指导相关工作有序地进行，进一步提高应急检验管理水平。     

美罗培南治疗药物监测的HPLC方法探索及其临床采样流程建立

目的：建立HPLC法测定人血浆中美罗培南的血药浓度，结合其稳定性研究制定临床采样流程，并应用到治疗药物监测个体化给药方案设计。方法：血浆样品经甲醇沉淀蛋白，取上清加水稀释后进样分析；色谱柱为Venusil HILIC（4.6 mm×250 mm，5.0 μm）；流动相为50 mmol·L^-1磷酸二氢钾含0.05%甲酸-乙腈（30：70，V/V）；流速0.8 mL·min^-1；检测波长为299 nm；柱温40℃；分别考察美罗培南全血、溶血样本在不同温度、不同采血管等条件下的稳定性。结果：美罗培南在0.38~71.30 μg·mL^-1范围内线性关系良好（r=0.999 9），定量下限为0.38 μg·mL^-1，低、中、高浓度的萃取回收率在101.87%~107.89%，日内、日间RSD均小于2.81%；以EDTA-K2为最佳的临床采血管，EDTA-K2管和肝素钠管中的美罗培南能在室温（19~22℃）下稳定4 h；溶血样本在2~6℃冰箱存放7 h稳定，但相对于EDTA-K2管和血浆质控，肝素钠管会使美罗培南检出率偏高；血浆样本在室温（19~22℃）、2~6℃冰箱内6 h、-40℃冻存20 d、-40℃反复冻融3次均稳定。结论：建立的TDM临床采样流程充分考虑了临床采样的实际情况并能确保美罗培南药物的稳定性及分析检测结果的准确性，可满足临床血药浓度监测需求。     

2018年广东省药品批发企业及零售连锁企业总部GSP飞行检查缺陷分析

该研究对55家药品批发企业及零售连锁企业总部在GSP飞行检查过程中发现的缺陷项目进行统计,分析存在问题。结果显示企业执行GSP工作较好,但质量管理体系、机构和质量管理职责、人员与培训、设施与设备、校准与验证等环节存在问题依然较为集中,可以采用风险管理的思维加强质量管理工作。