1.Quality Standard of Mitomycin Nanoparticles for Injection
China Pharmacy 2001;0(07):-
OBJECTIVE: To establish a quality control method for mitomycin nanoparticles(MMC-PBCA-NP) for injection.METHODS: The appearance of nanoparticles was observed by transmission electron microscope(TEM),and its particle size and particle size distribution were measured using Marvin Laser granulometer.The content of MMC in the nanoparticles was determined by HPLC.The related quality test of 3 batches of samples were performed in accordance with the quality standard of injections stated in the appendix of Chinese Pharmacopeia(2005 Edition),and investigate the preliminary stability of the preparation.RESULTS: The preparation was purplish pultaceous cake substance,and the drug-loading nanoparticles were globular in appearance,with the average particle size,the average encapsulation efficiency and the drug loading amount at 100.0 nm,85.8% and 7.0 %,respectively,all in conformity with the standard stated in Chinese Pharmacopoeia.The preliminary stability of the preparation was good.CONCLUSION: The quality standard study on which serves as quality references for its industrialized production.
2.Preparation of Mitomycin for Injection Nanoparticles by Microfluidization and Its Hemolytic Test
Hongling ZHOU ; Jianhai CHEN ; Xiujuan AI ; Xixiao YANG ; Na XI ; Qingfeng JIANG
China Pharmacy 2005;0(13):-
OBJECTIVE: To prepare Mitomycin C for injection-Polybutylcyanoacrylate Nanoparticles (MMC-PBCA-NPs) freeze drying preparation by microfluidization and to investigate its hemolytic feature. METHODS: The crude emulsion of MMC-PBCA-NPs was prepared by emulsion polymerization method, from which MMC-PBCA-NPs solution was prepared by microfluidization method; the encapsulation efficiency (EE) and the drug loading (DD) of the preparation were detected by ultraviolet spectrophotometry. The particle size and appearances of which were observed. A hemolytic test was performed on rabbits to observe the blood reaction of the preparation. RESULTS: The prepared MMC-PBCA-NPs freeze drying preparation was uniformly distributed and in round shape, with EE, DD and mean diameter at (85.1?3.8)%, (7.0?0.2)% and (113.5?3.86)nm, respectively. The hemolytic test was negative. CONCLUSION: It is feasible to prepare MMC-PBCA-NPs by microfluidization method.
3.Risk factor assessment and adverse outcome prediction of placenta accreta in pregnant women after cesarean section complicated with placenta previa: a national multicenter retrospective study
Guiqin BAI ; Weilin CHEN ; Xianghua HUANG ; Shaojie ZHAO ; Shuping ZHAO ; Xiujuan CHEN ; Suwen CHEN ; Hua YANG ; Xia LU ; Guanyuan LIU ; Qionghua CHEN ; Lin′ai ZHANG ; Li JIN
Chinese Journal of Obstetrics and Gynecology 2023;58(1):26-36
Objective:To study the risk factors of adverse pregnancy outcomes for the diagnosis and treatment of pregnancy after cesarean section complicated with placenta previa.Methods:A national multicenter retrospective study was conducted to select a total of 747 pregnant women with the third trimester singleton pregnancy after cesarean section complicated with placenta previa from 12 tertiary hospitals in January 1st to December 31st, 2018. The risk factors of severe adverse outcomes [hysterectomy, intraoperative blood loss ≥1 000 ml, intraoperative diagnosis of placenta accreta spectrum disorders (PAS)] in pregnant women with second pregnancy complicated with placenta previa after cesarean section were investigated by logistic regression analysis. The roles of prenatal ultrasonography and magnetic resonance imaging (MRI) in the prediction of PAS and severe adverse outcomes were observed. According to whether vascular intervention was performed (uterine artery embolization or abdominal aortic balloon occlusion), the pregnant women were divided into the blocked group and the unblocked group, and the maternal and infant perinatal outcomes between the two groups were compared.Results:(1) General information: the hysterectomy rate of 747 pregnant women with second pregnancy complicated with placenta previa after cesarean section was 10.4% (78/747), the intraoperative blood loss ≥1 000 ml in 55.8% (417/747), and PAS was confirmed in 47.5% (355/747). The incidence of uterine rupture was 0.8% (6/747). (2) Analysis of risk factors for severe adverse outcomes: based on binary unconditioned logistic regression univariate and multivariate analysis, the risk factors for hysterectomy were the mode of vascular embolization and intraoperative blood loss. The probability of hysterectomy with uterine artery embolization was 5.319 times higher than that with abdominal aortic balloon occlusion (95% CI: 1.346-21.018). The risk factors of intraoperative blood loss ≥1 000 ml were the number of cesarean section delivery, ultrasonography indicated PAS and suspected PAS, intraoperative PAS and complete placenta previa. The risk factors for intraoperative PAS were uterine scar thickness, ultrasonography indicated PAS and suspected PAS, MRI indicated PAS and suspected PAS, and complete placenta previa. (3) The roles of ultrasonography and MRI in predicting PAS: the sensitivity and specificity of ultrasonography in predicting PAS were 47.5% and 88.4%; the kappa value was 0.279 ( P<0.001), with fair agreement. The sensitivity and specificity of MRI to predict PAS were 79.2% and 97.8%, respectively. The kappa value was 0.702 ( P<0.001), indicating a good agreement. The intraoperative blood loss and hysterectomy rate of pregnant women with PAS indicated by ultrasonography and MRI were significantly higher than those with PAS only by ultrasonography or MRI. (4) Influence of vascular occlusion on pregnancy outcome: there were no significant differences in intraoperative blood loss and incidence of intraoperative bleeding ≥1 000 ml between the blocked group and the unblocked group (all P>0.05). There was no significant difference in intraoperative blood loss between the pregnant women with abdominal aortic balloon occlusion, uterine artery embolization and those without occlusion ( P=0.409). The hysterectomy rate of pregnant women with uterine artery embolization was significantly higher than those with abdominal aortic balloon occlusion [39.3% (22/56) vs 10.0% (5/50), P=0.001]. Conclusions:In the third trimester of pregnancy with placenta previa after cesarean section, MRI examination has better consistency in predicting PAS than ultrasonography examination. Ultrasonography examination combined with MRI examination could effectively predict the hysterectomy rate and intraoperative blood loss. Vascular occlusion could not reduce the amount of intraoperative blood loss. The hysterectomy rate of pregnant women with uterine artery embolization is higher than those with abdominal aortic balloon occlusion.
4.Evaluation of the diagnosis and treatment of cesarean scar pregnancy induced in the second trimester: a national multicenter retrospective study
Guiqin BAI ; Weilin CHEN ; Xianghua HUANG ; Shaojie ZHAO ; Shuping ZHAO ; Xiujuan CHEN ; Suwen CHEN ; Hua YANG ; Xia LU ; Guanyuan LIU ; Qionghua CHEN ; Lin′ai ZHANG ; Li JIN
Chinese Journal of Obstetrics and Gynecology 2021;56(8):545-553
Objective:To study the risk factors of adverse pregnancy outcomes for induced abortion of cesarean scar pregnancy in midtrimester.Methods:A national multicenter retrospective study was conducted. A total of 154 singletons pregnant women with cesarean scar pregnancy during the second trimester induced abortion by various reasons in 12 tertiary A hospitals were selected, their pregnant outcomes were observed and the risk factors of serious adverse outcomes were analyzed with univariate and multivariate logstic regression; the role of ultrasound and MRI in predicting placenta accreta and severe adverse outcomes was evaluated, the effectiveness of uterine artery embolization (UAE) in preventing hemorrhage in pregnant women with and without placenta accreta was compared.Results:Among 154 subjects, the rate of placenta accreta was 42.2% (65/154), the rate of postpartum hemorrhage≥1 000 ml was 39.0% (60/154), the rate of hysterectomy was 14.9% (23/154), the rate of uterine rupture was 0.6% (1/154). The risk factor of postpartum hemorrhage≥1 000 ml and hysterectomy was placenta accreta ( P<0.01). For each increase in the number of parity, the risk of placenta accreta increased 2.385 times (95% CI: 1.046-5.439; P=0.039); and the risk of placenta accreta decreased with increasing ultrasound measurement of scar myometrium thickness ( OR=0.033, 95% CI: 0.001-0.762; P=0.033). The amount of postpartum hemorrhage and hysterectomy rate in the group with placenta accreta diagnosed by ultrasound combined with MRI were not significantly different from those in the group with placenta accreta diagnosed by ultrasound only or MRI only (all P>0.05). For pregnant women with placenta accreta, there were no significant difference in the amount of bleeding and hysterectomy rate between the UAE group [median: 1 300 ml; 34% (16/47)] and the non-embolization group (all P>0.05); in pregnant women without placenta accreta, the amount of bleeding in the UAE group was lower than that in the non-embolization group (median: 100 vs 600 ml; P<0.01), but there was no significant difference in hysterectomy rate [2% (1/56) vs 9% (3/33); P>0.05]. Conclusions:(1) Placenta accreta is the only risk factor of postpartum hemorrhage≥1 000 ml with hysterectomy for induced abortion of cesarean scar pregnancy in midtrimester; multi-parity and ultrasound measurement of scar myometrium thickness are risk factors for placenta accreta. (2) The technique of using ultrasound and MRI in predicting placenta accreta of cesarean scar pregnancy needs to be improved. (3) It is necessary to discuss of UAE in preventing postpartum hemorrhage for induced abortion of cesarean scar pregnancy in midtrimester.
5.Telehealth-based dialysis registration system for the improvement of renal anemia in maintenance hemodialysis:multicenter experiences
Zhaohui NI ; Haijiao JIN ; Gengru JIANG ; Niansong WANG ; Ai PENG ; Zhiyong GUO ; Shoujun BAI ; Rong ZHOU ; Jianrao LU ; Yi WANG ; Ying LI ; Shougang ZHUANG ; Chen YU ; Yueyi DENG ; Huimin JIN ; Xudong XU ; Junli ZHANG ; Junli ZHAO ; Xiuzhi YU ; Xiaoxia WANG ; Liming ZHANG ; Jianying NIU ; Kun LIU ; Xiaorong BAO ; Qin WANG ; Jun MA ; Chun HU ; Xiujuan ZANG ; Qing YU
Chinese Journal of Nephrology 2018;34(11):831-837
Objective To analyze the role of telehealth?based dialysis registration systems in real?time and dynamic reflection of renal anemia in hemodialysis (HD) patients, and discuss the prospect of its application in dialysis registration management. Methods The Red China project was to build up a dialysis registration system based on the WeChat mobile terminal platform. Demographic and baseline laboratory parameters such as age, gender, primary disease, dialysis age, creatinine were recorded in this system. Hemoglobin (Hb) level was monthly recorded. The platform generated Hb statistics report for each HD center monthly, including the detection rate, target rate and the distribution level of Hb, and released it to physicians through the WeChat terminal of mobile phone. After that, physicians could change the treatment of anemia individually on basis of this report. Here the demographic and baseline laboratory parameters, the detection rate, target rate, the average level and the distribution of Hb from June 2015 to October 2017 after the project launched were analyzed. Results From June 2015 to October 2017, 8392 maintenance HD patients from 28 HD centers in Shanghai were enrolled, of whom 5059(60.3%) were male.The average rate age was (60.5 ± 13.7) years old. Baseline average Hb was (108.3±16.0) g/L. Baseline detection rate and target rate were 54.2%and 47.5%, respectively. After 28 months follow?up, the detection rate of Hb increased from 54.2% to 73.6% (P<0.001), the target rate of Hb increased from 47.5% to 56.1% (P<0.001), and the level of average Hb rose from (108.3±16.0) g/L to (110.7±16.0) g/L. The difference between average Hb in two consecutive months was less than 1.3 g/L. Conclusions The telehealth?based dialysis registration system can timely report the anemia situation of HD patients, which may improve the awareness rate of anemia, the degree of attention and the compliance of anemia monitoring, so as to improve the detection rate and target rate of Hb and reduce the fluctuation of Hb, which helps to maintain the HD patients to correct anemia in a timely, stable and long?term way. The telehealth?based dialysis registration system, as an improved mode of dialysis registration is a promising way for long?term management of renal anemia in dialysis patients.