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.Application of nursing quality evaluating indicators in gastrointestinal surgery department
Weixin XIONG ; Jinfang QIAO ; Ling CHENG ; Shuwen WU ; Shouzhen CHENG
Chinese Journal of Practical Nursing 2017;33(30):2351-2354
Objective To evaluate the application of nursing quality indicators in gastrointestinal surgery department. Methods The indicator system was established by use of the Delphi method, applied in nursing quality control in gastrointestinal surgery department, and was used to analyze and improve nursing quality continuously according to the routine data collection. Results After the application of quality indicators for 6 months, the complications′ observation and prevention awareness rate of the patients increased from 75.00% to 92.00%(x2=4.200, P<0.05), and most of the process indicators had improved. Conclusions The nursing quality indicators provide basis for nursing quality management,and provide standards and guidance for clinical works.
3.Effects of mild hypothermia on the expression of high mobility group protein B1 in lung tissues of septic mice
Ying SHENG ; Qifang SHI ; Shuyun WANG ; Guangyao YANG ; Xiangdong QIAO ; Jinfang CAI
Clinical Medicine of China 2020;36(3):233-239
Objective:To investigate the effects of naturally occurring mild hypothermia and artificial mild hypothermia on the expression of high mobility group box 1(HMGB1) in lung tissues of septic mice.Methods:One hundred and twenty BALB/C mice (SPF level) were randomly numbered.Twelve mice with integer multiples of 10 were used as the normal control (NC) group, and the remaining 108 mice were chosen as the septic group.The septic mouse model was established by intra abdominal injection of lipopolysaccharide (LPS) 10 mg/kg.The NC group was given the same dose of normal saline.Anal temperature of the septic mice were measured 1 hour after the model was established successfully, and then were divided into naturally occurring mild hypothermia group and non-mild hypothermia group according to T≤36℃ and T>36℃.In the naturally occurring mild hypothermia group, the mice with T<34℃ were eliminated, and the remaining septic mice were randomly divided into the naturally occurring mild hypothermia(NOMH) observation group and the keep normothermia (KN) group.NOMH group was not given preheating intervention, while KN group was placed in an incubator to maintain the anal temperature between 36.0℃ and 37.5℃.Septic mice in the non-mild hypothermia group were randomly divided into the nonhypothermia (NH) observation group and the artificial mild hypothermia (ATMH) group.The NH group was not treated with hypothermia, while the ATMH group was treated with physical hypothermia, so that the anal temperature of the mice were maintained at 34℃-36℃.Four mice in each group were randomly selected at 6 and 12 hours after modeling, and the concentrations of tumor necrosis factor-α(TNF-α), interleukin-6(IL-6) and HMGB1 in serum were detected by enzyme-linked immunosorbent assay(ELISA). At 12 hours, the survival rate of each group of mice was observed.Then 4 mice of each group were sacrificed and lung tissues were taken.The pathological changes of lung tissues were observed by hematoxylin-eosin (HE) staining, and the expression of HMGB1 in lung tissues was observed by immunohistochemical staining.Real time fluorescence quantitative PCR and Western blot were used to detect the relative expression of HMGB1 at mRNA and protein levels.Results:(1)Twelve hours after modeling, the survival number of NOMH group, ATMH group, KN group and NH group were 36(40), 6(11), 27(40), 4(11), respectively, and there were differences between the four groups (χ 2=32.286, P=0.002). Compared with the other three groups of septic mice, the survival rate was highest in the NOMH group (compared with ATMH group: χ 2=5.222, P=0.022; compared with the KN group: χ 2=6.050, P=0.013; and the NH group: χ 2=11.672, P=0.001), but the differences between the other two groups were not statistically significant (all P>0.05). (2)Compared with the NC group, the concentrations of serum TNF-α, IL-6 and HMGB1 of septic mice in each group were significantly increased at 6 h and 12 h (all P<0.05). Compared with NOMH group, the concentrations of TNF-α, IL-6 and HMGB1 in ATMH group, KN group and NH group were significantly increased at 6 h and 12 h(all P<0.05), and the concentrations of TNF-α, IL-6 and HMGB1 in NH group were the highest at all time points (all P<0.05). The concentrations of TNF-α at 12 h decreased compared with 6 h (all P<0.05), while the concentrations of IL-6 and HMGB1 at 12 h increased compared with 6 h (all P<0.05). (3)HE staining showed that the lung tissue damage were minimal in NOMH group, followed by ATMH group.(4)Immunohistochemical staining showed that the expression of HMGB1 protein was in order of NOMH group, ATMH group, KN group and NH group; (5)The relative expressions of HMGB1 protein in lung tissues of septic mice in NOMH group, ATMH group, KN group, and NH group was 0.280±0.013, 0.320±0.016, 0.340±0.018, and 0.380±0.014, respectively, and the relative expression level of HMGB1 mRNA was 4.86±0.22, 6.02±0.18, 6.26±0.20, and 7.98±0.28, respectively, compared with NC group (HMGB1 protein content was 0.240±0.013, and the relative expression level of HMGB1 mRNA was 2.21±0.12) significantly increased (all P<0.05). Cmpared with NOMH group, the relative expression levels of HMGB1 protein and HMGB1 mRNA in the lung tissues of the ATMH group, KN group and NH group were significantly increased(all P<0.05), with the highest expression level in the NH group(all P<0.05). Conclusion:Mild hypothermia may reduce lung tissue damage by down-regulating the expression of HMGB1 in lung tissues of septic mice, and the improvement of spontaneous mild hypothermia was more significant.
4.Effect of timing of immune checkpoint inhibitor monotherapy and application of hormone on the efficacy and safety of brain metastasis in advanced non-small cell lung cancer: a Meta-analysis
Binbin SHAN ; Jinfang ZHAI ; Hongwei LI ; Xiaoqin AN ; Chang ZHAO ; Qiao HAN ; Yuan LI ; Weihua YANG
Cancer Research and Clinic 2022;34(7):529-536
Objective:To evaluate the efficacy and safety of programmed death 1 (PD-1), programmed death ligand 1 (PD-L1) immune checkpoint inhibitor (ICI) monotherapy for brain metastasis in advanced non-small cell lung cancer (NSCLC), and to explore the timing of immunomonotherapy and the application of hormone on the efficacy of ICI.Methods:By searching literature in CNKI, Wanfang, VIP, PubMed, CBM, Embase, Cochrane Library and Web of Science databases, the advanced NSCLC patients with brain metastasis who received ICI treatment were identified, including patients with symptomatic brain metastasis who had received hormone therapy or brain surgery or radiotherapy. Meta-analysis was performed on the collected data to evaluate the systemic objective response rate (sORR) and intracerebral tumor objective response rate (iORR), the iORR of whether ICI monotherapy was first-line therapy, and the iORR of whether hormone was used were evaluated, and the incidence of adverse reactions was evaluated.Results:Fifteen studies were finally included, with a total of 4 033 patients, including 917 patients with brain metastasis. The iORR of immunomonotherapy was 26% (95% CI 19%-34%) and the sORR was 28% (95% CI 18%-40%). The iORR of first-line immunomonotherapy was 49% (95% CI 39%-58%). The iORR of symptomatic patients with hormone therapy and asymptomatic patients without hormone therapy was 26% (95% CI 20%-33%) and 19% (95% CI 16%-22%), respectively. The overall incidence of grade 3-4 adverse reactions was 14% (95% CI 11%-17%). Conclusions:The efficacy of ICI monotherapy in the first-line treatment of PD-L1-positive NSCLC patients with brain metastasis is better than that in the subsequent line therapy, and the application of hormone does not affect the efficacy of ICI. ICI monotherapy in the treatment of advanced NSCLC patients with brain metastasis is safe.