1.Comparison of clinical efficacy of subinguinal microsurgical and single -port laparoscopic high ligation in the treatment of varicocele
Zhiguo YANG ; Guangli JI ; Fachen MIAO ; Qingqin REN ; Bo ZHANG ; Yong MA ; Shiqiao HUANG
Chinese Journal of Primary Medicine and Pharmacy 2017;24(5):763-766
Objective To compare the clinical efficacy of subinguinal microsurgical and single -port laparoscopic high ligation in the treatment of varicocele.Methods 218 patients with varicocele were enrolled in this study.According to the digital table,they were randomly divided into two group.148 cases were treated by subinguinal microscopic varicocelectomy(microscopic group),70 cases were treated by single -port laparoscopic high ligation varicocele(single -port laparoscopic group).Postoperative follow up was 3 -24months.The operative duration,length of hospital stay,hospitalization expense,postoperative complications and semen quality parameters were compared between the two groups.Results There were statistically significant differences in operative duration and hospitalization expense between the two groups(all P <0.05).There was no statistically significant difference in length of hospital stay (P >0.05).In the 218 followed -up patients,the sperm concentration and motility (grade a + b sperm)all significantly improved,which of the microscopic group and single -port laparoscopic group preoperation were (19.1 ± 8.2)×106 /mL,(18.2 ±7.9)×106 /mL and (22.7 ±7.8)%,(21.6 ±8.9)% respectively,which at 3 -6 months after operation were (56.2 ±10.8)×106 /mL,(45.8 ±12.9)×106 /mL and (58.8 ±9.7)%,(44.6 ±10.7)%, there were statistically significant differences compared with preoperation (t =6.227,9.579,all P <0.05 ). Conclusion The surgical methods in the treatment of varicocele can improve the quality of patients,but microscopic group is obviously better than single -port laparoscopic group in improvement of semen quality parameters,safety, patient -based compliance and economy.
2.The clinical significance of plasma PTX3 in patients with secondary hemophagocytic lymphohistiocytosis
Lingling LIU ; Hongxia QIU ; Ji XU ; Limin DUAN ; Tian TIAN ; Jujuan WANG ; Xin GAO ; Guangli YIN ; Jiayu HUANG ; Wanying CHENG
Chinese Journal of Internal Medicine 2020;59(7):528-534
Objective:To investigate the significance of plasma pentraxin 3 (PTX3) in patients with secondary hemophagocytic lymphohistiocytosis (sHLH).Methods:Plasma PTX3 levels were tested by ELISA in 48 newly diagnosed sHLH patients, 18 healthy volunteers and 9 lymphoma controls in the First Affiliated Hospital of Nanjing Medical University from January 2017 to July 2019. Clinical parameters were collected, and the correlations with PTX3 levels were analyzed.Results:PTX3 level in newly diagnosed group was significantly higher than that of healthy control group [16.29(1.17-66.00) vs. 0.76(0.01-7.86) μg/L, P<0.01]. Patients with lymphoma-associated HLH(LHLH) had higher plasma level of PTX3 than Fhose with infection-associated HLH (IHLH) [24.29(3.36-66.00) vs. 9.56(1.17-36.50)μg/L, P<0.05]. Plasma PTX3 levels in 48 sHLH patients were positively correlated with serum ferritin ( P<0.05). Receiver operating characteristic (ROC) curve for plasma PTX3 levels of sHLH and healthy controls produced a cutoff value at 3.9 μg/L, with its 86.7% sensitivity and 94.4% specificity. And ROC analysis showed that PTX3 17.5 μg/L was the critical value for diagnosis of LHLH from non-LHLH group, that the sensitivity and specificity were 63.0% and 76.2% respectively. The 1-year overall survival (OS) rate in patients with PTX3≥17.5 μg/L was significantly lower in those with PTX3<17.5 μg/L (18.5% vs. 75.8%, P<0.01). Conclusion:These results indicate the potential of PTX3 as a biomarker for diagnosis and prognosis in patients with sHLH.
3. General considerations of model-based meta-analysis
Lujin LI ; Junjie DING ; Dongyang LIU ; Xipei WANG ; Chenhui DENG ; Shangmin JI ; Wenjun CHEN ; Guangli MA ; Kun WANG ; Yucheng SHENG ; Ling XU ; Qi PEI ; Yuancheng CHEN ; Rui CHEN ; Jun SHI ; Gailing LI ; Yaning WANG ; Yuzhu WANG ; Haitang XIE ; Tianyan ZHOU ; Yi FANG ; Jing ZHANG ; Zheng JIAO ; Bei HU ; Qingshan ZHENG
Chinese Journal of Clinical Pharmacology and Therapeutics 2020;25(11):1250-1267
With the increasing cost of drug development and clinical trials, it is of great value to make full use of all kinds of data to improve the efficiency of drug development and to provide valid information for medication guidelines. Model-based meta-analysis (MBMA) combines mathematical models with meta-analysis to integrate information from multiple sources (preclinical and clinical data, etc.) and multiple dimensions (targets/mechanisms, pharmacokinetics/pharmacodynamics, diseases/indications, populations, regimens, biomarkers/efficacy/safety, etc.), which not only provides decision-making for all key points of drug development, but also provides effective information for rational drug use and cost-effectiveness analysis. The classical meta-analysis requires high homogeneity of the data, while MBMA can combine and analyze the heterogeneous data of different doses, different time courses, and different populations through modeling, so as to quantify the dose-effect relationship, time-effect relationship, and the relevant impact factors, and thus the efficacy or safety features at the level of dose, time and covariable that have not been involved in previous studies. Although the modeling and simulation methods of MBMA are similar to population pharmacokinetics/pharmacodynamics (Pop PK/PD), compared with Pop PK/PD, the advantage of MBMA is that it can make full use of literature data, which not only improves the strength of evidence, but also can answer the questions that have not been proved or can not be answered by a single study. At present, MBMA has become one of the important methods in the strategy of model-informed drug development (MIDD). This paper will focus on the application value, data analysis plan, data acquisition and processing, data analysis and reporting of MBMA, in order to provide reference for the application of MBMA in drug development and clinical practice.