1.Evaluation the efficacy and safety of estradiol and drospirenone tablets in the treatment of menopausal symptoms among postmenopausal Chinese healthy women:a randomized,multi-center,double-blind,placebo-controlled clinical study
Yuanzheng ZHOU ; Lizhou SUN ; Jinfang LIN ; Xin YANG ; Lijia ZHANG ; Jie QIAO ; Zehua WANG ; Yanxue XU ; Zhengai XIONG ; Shouqing LIN
Chinese Journal of Obstetrics and Gynecology 2011;46(5):345-349
Objective To study the efficacy and safety of estradiol and drospirenone tablets (Angeliq)in treatment of menopausal symptoms among postmenopausal Chinese healthy women.Methods Total 244 postmenopausal Chinese healthy women who had moderate to severe hot flushes were randomly assigned for 16 weeks in this randomized multi-center double-blind placebo-controlled study.During the trial.the follow-up visits were conducted at week 4,8,12,16 of treatment and 2 weeks after treatment respectively.Height,weight,vital signs,hot flushes,other relevant menopausal symptoms and vaginal bleeding were observed in each follow-up visit,while the clinical global impression scale Was assessed at 16 weeks as well.Results It showed that hot flushes were reduced significantly more in observation group than that in placebo group ( P<0.01 ), although both treatments were effective. The absolute values of mean severity index of total hot flushes decreased by - 0. 6± 0. 5 in observation group and - 0. 4 ± 0. 4 in placebo group from baseline respectively, which reached significant difference ( P < 0. 05 ). However, the absolute values of mean severity index of moderate to severe hot flushes decreased by - 0. 6± 0. 8 in observation group and -0. 3± 0.6 in placebo group from baseline respectively, which had no significant difference (P > 0. 05 ).After 16 weeks treatment, it also showed that estradiol and drospirenone had significant better efficacy than placebo on moderate to severe sweating, vaginal dryness and clinical global impression scale (P <0. 01 ).During the trial, blood pressure in observation group was stable. The rate of vaginal bleeding in observation group was higher than that in the placebo group, especially during the week 4 to week 8 when 48. 9% (87/178) in observation group and 10. 7% (6/56) in placebo group of patients bled. Although the cumulative amenorrhea rate of observation group was lower than that of placebo group in each cycle (28 days), it increased gradually along with duration of the treatment. The commonest adverse event in observation group was breast tenderness which accounted for 12.0% (22/183 ). The level of serum potassium was in the normal range in observation group mostly. Meanwhile, the other adverse events rate was low. Serious adverse events reported in this trial were assessed as not study drug related or as unlikely study drug related. Conclusion Estradiol and drospirenone tablets which could effectively alleviate menopausal symptoms in postmeuopausal Chinese healthy women is a novel hormone replacement therapy regimen with high safety and efficacy.
2.Preparation of high-drug-loading cantharidin polymer micelle delivery system and its anti-breast cancer activity
Silu LIU ; Yun BAI ; Jianhua WANG ; Keqing ZHANG ; Yanxue SUN ; Kexin ZHANG ; Pengcheng XU
Journal of China Pharmaceutical University 2024;55(3):381-389
Abstract: The aim of this study was to prepare a high drug-carrying capacity micellar drug delivery system (CTD@Sol) of the polymer zebra tetracycline and to preliminarily investigate the feasibility of this drug delivery system for the treatment of breast cancer. Firstly, CTD@Sol was prepared using sol as the carrier material and CTD as the model drug, and its pharmacological properties such as appearance and morphology, particle size, potential and in vitro release were evaluated. The growth inhibitory and apoptotic effects of CTD@Sol on breast cancer (4T1) cells were investigated by MTT assay and Annexin V-FITC/PI double staining assay; the uptake efficiency of 4T1 to this delivery system was investigated by flow cytometry; and the in vivo tissue distribution of the delivery system and the targeting of tumour tissues were investigated by small animal in vivo imaging technique. The results showed that CTD@Sol appeared as a light pale blue creamy white colour, with an average particle size of (159.73 ± 1.96) nm, a PDI of 0.198 ± 0.006, Zeta potential of –(47.60 ± 1.77) mV, an encapsulation rate of (90.29 ± 1.69)% and a drug loading capacity of (45.00 ± 0. 84)%; the in vitro release and haemolysis experiments showed that the drug release rate of CTD@Sol in acidic environment (pH 5.5) was significantly faster than that in neutral environment (pH 7.4), suggesting that the system is acid-sensitive and has good biosafety under endocytosed pH conditions. Cellular uptake, cytotoxicity and apoptosis experiments showed that CTD@Sol was more lethal to 4T1 cells, and the sol-gel polymer micelles as a drug delivery vehicle could significantly improve the cellular uptake efficiency of the drug; in vivo experiments showed that the delivery system had a significant targeting effect on tumour tissues.In conclusion, this study has successfully produced a CTD@Sol drug delivery system with high drug loading capacity (>45%), good pharmacological performance, strong targeting and biosafety, which has the potential to be used in the treatment of breast cancer.
3.Study on the correlation between health education compliance and treatment outcome of chronic obstructive pulmonary disease
Xiaowei CAO ; Hao CHANG ; Bo SUN ; Jun CAO ; Yanxue WANG ; Peng ZHOU ; Shuzheng CUI ; Zhijie XIA
Chinese Journal of Health Management 2017;11(5):446-452
Objective To explore the influence of health education and treatment compliance on COPD patients' outcome.Methods 258 subjects (186 males,72 females,average age 75.2±8.5 years) were enrolled from patients diagnosed with COPD between June 2013 to June 2014 in huashan hospital north compus.Study began in July 2014,health condition assessment and grading、telephone follow-up and education were performed once every half a year together with COPD lectures,the number of patients participated in education sessions,and status of smoking cessation,exercise\home oxygen therapy and medication were recorded as indicators for health education compliance.Clinic/hospital stay and cost,condition change were also recorded.The study ended in December 2015 with final assessments of conditions and classification of patient outcome.Multiple logistic regression was used to analyze factors influencing the COPD patient's outcome;Independent sample t test was applied to compare different compliance in patients with outpatient and hospitalization per-time cost difference.Results Higher reimbursement ratio,the better adherence for health education,no complications and the low grade of disease classification at the beginning of the study were protective factors (OR=10.35,2.147,5.791,4.51,P<0.05);Underweight to normal weight,5 times or more acute attacks during during the study,poor health education compliance were risk factors for disease progression (OR=0.031,0.131,0.010,P< 0.05);Never exercise and never participating in health education management are the risk of illness/death((OR=6.793,P=0.005,95%CI:1.766~26.125) vs.(OR=11.872,P=0.002,95%CI:2.525~55.815));for mild COPD patients,these never participating in health education management had a higher per hospitalization than patients with health education management (6 619 yuan,t=2.681,P=0.010).The outpatient cost of more severe COPD patients who are smoking or quitted smoking in less than 5 years was higher than these quitted smoking more than 5 years (985 yuan,t=-2.225,P=0.028).Conclusions Health education management can help medical staff to provide guidance to patients to quit smoking,encouraging the regular use of home oxygen therapy,doing more exercise,taking prescription of preventive drugs,these will in turn improve patient compliance for disease control and prevention.These efforts can effectively slow disease progression and improve patient outcomes,reduce medical costs,reduce the burden of the family and society.
4.Effects of Mild Moxibustion on Proteins Expression of BDNF/TrkB Signaling Pathway in Hypothalamus of Primary Dysmenorrhea Rats with Cold and Dampness Stagnation Syndrome
Xiangyun MENG ; Fei GAO ; Di WANG ; Yulei LIANG ; Xuan ZHANG ; Yanqiu SUN ; Yanxue XING ; Zhiguo ZHAO ; Xinhua LI
Chinese Journal of Information on Traditional Chinese Medicine 2024;31(3):127-131
Objective To observe the analgesic effects of mild moxibustion on primary dysmenorrhea(PD)rats with cold and dampness stagnation syndrome and its effect on BDNF/TrkB signaling pathway in hypothalamus;To explore its mechanism for the treatment of PD.Methods A total of 32 Wistar non-pregnant female rats were randomly divided into blank group,model group,Western medicine group and mild moxibustion group,with 8 rats in each group.Except for the blank group,the other groups received estradiol benzoate intraperitoneal injection combined with ice bath treatment + oxytocin intraperitoneal injection to establish PD with cold and dampness stagnation syndrome model.The mild moxibustion group received treatment at"Shenque"and"Guanyuan"from the eighth day of modeling for 10 min,and the Western medicine group was given ibuprofen solution intragastically for 4 days.The latency period of rats twisting was observed and the twisting score was calculated,Western blot and PCR were used to detect the expressions of c-fos,BDNF,TrkB protein and mRNA in hypothalamic tissue.Results Compared with the blank group,the model group showed a shortened latency period and an increased twisting score(P<0.01),the expressions of c-fos,BDNF,TrkB protein and mRNA in hypothalamic tissue increased(P<0.01,P<0.05).Compared with the model group,the mild moxibustion group had a longer latency period and lower twisting score(P<0.01),while the expressions of c-fos,BDNF,TrkB protein and mRNA in hypothalamic tissue increased(P<0.01,P<0.05).Conclusion Mild moxibustion may effectively improve the pain state of PD rats with cold and dampness stagnation syndrome.This mechanism may be related to downregulating c-fos expression,inhibiting BDNF/TrkB signaling pathway activation,thereby inhibiting pain signal transmission,regulating pain occurrence and maintenance.