1.Study on the efficacy and safety of Metformin hydrochloride enteric-coated capsules in patients with type 2 diabetes mellitus
Yiming WU ; Jian ZHANG ; Nan GU ; Qijuan DONG ; Ruiyun LIU ; Hong ZHANG ; Haixia LIU ; Yongcai ZHAO ; Lin CHENG ; Lianshan PU ; Fang BIAN ; Gang HE ; Quanmin LI ; Wei DU ; Zhaoling WANG ; Wei XU ; Liyong ZHONG ; Xiaohui GUO
Chinese Journal of Diabetes 2025;33(3):210-214
Objective To evaluate the efficacy and safety of enteric-coated metformin hydrochloride capsules(Junlida?)in patients with T2DM and poor glycemic control under lifestyle interventions.Methods In this study,419 patients with T2DM were recruited from 15 research centers from July 2020 to March 2022,and randomly divided into observation(Obs)group(n=209)and control group(Con,n=210)using a multicenter,randomized,double-blind,non-inferiority trial design.Patients in the Obs group were treated with enteric-coated Metformin hydrochloride capsules(Junlida?),and patients in the Con group were treated with Metformin hydrochloride tablets(Glucophage?).The optimal effective dose of 2 g/d was achieved within 4 weeks,and the reasonable dose was maintained until the end of treatment.The treatment period was 24 weeks.HbA1c and its compliance rate,FPG,and body weight were compared between the two groups in full analysis set(FAS)and protocol set(PPS).Safety and adverse events(AE)were evaluated in safety set(SS).Results A total of 414 participants were randomized(207 cases in Obs group and 207 cases in Con group).414 cases in FAS population(207 cases in Obs group and 207 cases in Con group),and 328 cases in PPS population(164 cases in Obs group and 164 cases in Con group),and 414 cases in SS population(207 cases in Obs group and 207 cases in Con group).After treatment,HbA1c,FPG and body weight were lower in both groups(P<0.05)in FAS and PPS.HbA1c compliance rate was not significantly different between the two groups in FAS and PPS(P>0.05).The results of non-inferiority test showed that the lower limit was>-0.4%in both FAS(-0.154,95%CI-0.384~0.069)and PPS(-0.139,95%CI-0.390~0.112),and the Obs group reached non-inferiority end point.The achievement rate,compliance rate,safety index and incidence of AE were not significantly different between the two groups(P>0.05).Conclusions Junlida? demonstrated non-inferiority to Glucophage? in glycemic control and can be safely and effectively used in patients with diabetes.
2.Study on the efficacy and safety of Metformin hydrochloride enteric-coated capsules in patients with type 2 diabetes mellitus
Yiming WU ; Jian ZHANG ; Nan GU ; Qijuan DONG ; Ruiyun LIU ; Hong ZHANG ; Haixia LIU ; Yongcai ZHAO ; Lin CHENG ; Lianshan PU ; Fang BIAN ; Gang HE ; Quanmin LI ; Wei DU ; Zhaoling WANG ; Wei XU ; Liyong ZHONG ; Xiaohui GUO
Chinese Journal of Diabetes 2025;33(3):210-214
Objective To evaluate the efficacy and safety of enteric-coated metformin hydrochloride capsules(Junlida?)in patients with T2DM and poor glycemic control under lifestyle interventions.Methods In this study,419 patients with T2DM were recruited from 15 research centers from July 2020 to March 2022,and randomly divided into observation(Obs)group(n=209)and control group(Con,n=210)using a multicenter,randomized,double-blind,non-inferiority trial design.Patients in the Obs group were treated with enteric-coated Metformin hydrochloride capsules(Junlida?),and patients in the Con group were treated with Metformin hydrochloride tablets(Glucophage?).The optimal effective dose of 2 g/d was achieved within 4 weeks,and the reasonable dose was maintained until the end of treatment.The treatment period was 24 weeks.HbA1c and its compliance rate,FPG,and body weight were compared between the two groups in full analysis set(FAS)and protocol set(PPS).Safety and adverse events(AE)were evaluated in safety set(SS).Results A total of 414 participants were randomized(207 cases in Obs group and 207 cases in Con group).414 cases in FAS population(207 cases in Obs group and 207 cases in Con group),and 328 cases in PPS population(164 cases in Obs group and 164 cases in Con group),and 414 cases in SS population(207 cases in Obs group and 207 cases in Con group).After treatment,HbA1c,FPG and body weight were lower in both groups(P<0.05)in FAS and PPS.HbA1c compliance rate was not significantly different between the two groups in FAS and PPS(P>0.05).The results of non-inferiority test showed that the lower limit was>-0.4%in both FAS(-0.154,95%CI-0.384~0.069)and PPS(-0.139,95%CI-0.390~0.112),and the Obs group reached non-inferiority end point.The achievement rate,compliance rate,safety index and incidence of AE were not significantly different between the two groups(P>0.05).Conclusions Junlida? demonstrated non-inferiority to Glucophage? in glycemic control and can be safely and effectively used in patients with diabetes.
3.Real-world research on Panlongqi tablets in the treatment of fractures
Shiyuan FANG ; Jian QIN ; Liyong ZHANG ; Zerong WU ; Tuanmao GUO ; Ting DONG ; Wei XU ; Jiazhao YANG ; Lei CHEN ; Bin LIU
China Pharmacy 2024;35(24):3046-3051
OBJECTIVE To evaluate the effectiveness and safety of Panlongqi tablets in the treatment of fractures based on real-world research.METHODS From September 2021 to September 2023,fracture patients admitted to 33 medical institutions were collected retrospectively.Patients who received conventional treatment were divided into control group(n=3 750),and patients who received combination of Panlongqi tablets on the basis of conventional treatment were divided into observation group(n=3 706).Self-reported indicators of patients were collected through telephone follow-up at 0,4,7 and 14 days after treatment.The improvement values of pain score,swelling score and health utility value,as well as effective rate and adverse drug reactions were compared between 2 groups.The propensity matching score(PSM)method was adopted to perform baseline matching on patient's age,gender,fracture site,fracture severity,surgical type,type of hospital,and other indicators.Statistical analysis was performed on each therapeutic effect indicator.RESULTS After PSM,a total of 6 425 patients were included,of which 3 055 were in the observation group and 3 370 were in the control group.After 14 days of treatment,the observation group showed significant improvement in pain score(4.768 vs.4.353),swelling grading score(2.979 vs.2.391),and life quality utility value(0.430 vs.0.363),as well as effective rate(87.20%vs.75.99%)compared to the control group(P<0.05).The results of subgroup analyses conducted by gender,age,hospital type,and fracture site were consistent with the aforementioned results.In terms of safety,the observation group had no serious adverse reactions,with a total of 29 cases of mild adverse reactions such as dizziness,stomach pain,and allergies,with an incidence rate of 0.78%.CONCLUSIONS Panlongqi tablets combined with conventional treatment are significantly better than conventional treatment in improving pain,swelling,quality of life,and effective rate in patients with fractures,and have good safety.
4.Analysis of mosquito ecology and insecticide resistance monitoring results in Liaocheng City, Shandong Province, 2020-2022
GUO Tingmin ; SUN Qintong ; CHEN Liyong ; WANG Juan ; WANG Xuejun ; MA Qing ; SUN Yunfeng ; LIU Qinghua ; HUAN Lijun
China Tropical Medicine 2023;23(12):1283-
Objective To analyze the composition, population density, seasonal trends, and insecticide resistance monitoring results of vector mosquitoes in Liaocheng City from 2020 to 2022, providing a reference basis for further mosquito control measures. Methods According to the "Implementation Plan for National Vector Biomonitoring", adult mosquito monitoring was carried out using mosquito traps and double-layer stacked nets at two national level monitoring points in Dong’e and Chiping. The Bretu Index method was used for monitoring throughout the city, and the immersion method was used for monitoring mosquito insecticide resistance. The monitoring period for adult mosquitoes was from March to November, and for juvenile mosquitoes was from May to October. Results From 2020 to 2022, a total of 816 mosquito traps were deployed, capturing 4 717 adult mosquitoes with an average density of 5.78 mosquitoes per trap-night. Among them, 4 232 were Culex pipiens pallens, accounting for 89.72% of the total mosquito population, followed by 15 were Anopheles sinensis, accounting for 0.32%; 10 Aedes albopictus, accounting for 0.21%; 460 other mosquito species, accounting for 9.75%. Mosquito density was higher in rural areas compared to urban areas, with the highest density found in livestock sheds, followed by parks, hospitals, farms, and residential areas. Adult mosquito was first observed in May, with the peak activity occurring from June to August. The double-layer net method captures only Aedes albopictus, with an average net trapping index of 2.99 mosquitoes/(net·h), and their activity was concentrated from June to September. The average Brayton Index (BI) from May to October was 15.95, with a peak occurring in July and gradually decreasing after August. Insecticide resistance monitoring found that Culex pipiens pallens in Liaocheng City exhibited low resistance to permethrin, deltamethrin, dithion, and beta cypermethrin, with beta cypermethrin having the highest resistance. Conclusion The dominant mosquito species in Liaocheng City is Culex pipiens pallens, followed by Aedes albopictus. The peak activity of adult and juvenile mosquitoes is concentrated between July and September, showing a distinct seasonal trend of growth and decline, posing a risk of dengue fever outbreaks. Culex pipiens pallens exhibits resistance to some insecticides, and timely measures should be taken to prevent the outbreak of mosquito-borne infectious diseases.
5.Comparison of invasive and non-invasive blood pressure in perioperative elderly hypertensive patients with atherosclerosis of the extremities
Wenjun LIU ; Hong LI ; Liyong GUO ; Liyun ZHAO ; Jun MA
Chinese Journal of Geriatrics 2023;42(5):552-556
Objective:To compare the correlation and differences between invasive blood pressure(IBP)and noninvasive blood pressure(NBP)monitoring at three different levels of systolic blood pressure(SBP), diastolic blood pressure(DBP)and mean arterial pressure(MAP)in elderly hypertensive patients with atherosclerosis of the extremities during perioperative anesthesia.Methods:156 elderly patients were prospectively admitted to the Department of Vascular Surgery, Beijing Anzhen Hospital, Capital Medical University, for peripheral vascular stenosis interventions between December 2018 and December 2021.Their IBP and NBP were measured simultaneously during the perioperative anesthesia period.Then the correlation and consistency between IBP and NBP were analyzed via the Pearson correlation coefficient, Bland-Altman plots, and the receiver operating characteristic curve(ROC curve).Results:A total of 156 elderly patients were enrolled, including 108 men(69.2%)and 48 women(30.8%), with a mean age of 72.2±7.6.Pearson correlation analysis revealed that there was a significant positive correlation between IBP and NBP.The correlation coefficient was 0.993 for invasive systolic blood pressure(ISBP)and non-invasive systolic blood pressure(NSBP), 0.808 for invasive diastolic blood pressure(IDBP)and non-invasive diastolic blood pressure(NDBP), and 0.853 for invasive mean arterial pressure(IMAP)and non-invasive mean arterial pressure(NMAP)( P<0.001 for all). Bland-Altman analysis showed that the mean deviation of ISBP and NSBP was(20.3±6.5)mmHg(95% CI: 19.18-21.38)(1 mmHg=0.133 kPa), the mean deviation of IDBP and NDBP was(3.8±9.7)mmHg(95% CI: 2.13-5.41), and the mean deviation of IMAP and NMAP was(12.7±11.0)mmHg(95% CI: 10.83-14.55). The correlation coefficient of ISBP-NSBP deviation with ISBP was 0.856, the correlation coefficient of IDBP-NDBP deviation with IDBP was 0.206, and the correlation coefficient of IMAP-NMAP deviation with IMAP was 0.583( P<0.05 for all). When ISBP≥137 mmHg, the sensitivity of an ISBP-NSBP deviation ≥20 mmHg was 96.3%, the specificity was 96.4%, and the area under the ROC curve was 0.970(95% CI: 0.934-1.000). When ISBP≥158 mmHg, the sensitivity and specificity of a predicted ISBP-NSBP deviation≥25 mmHg were 97.4% and 78.8%, respectively, and the area under the ROC curve was 0.876(95% CI: 0.820-0.933); When ISBP≥208 mmHg, the sensitivity and specificity of a predicted ISBP-NSBP deviation≥30 mmHg were 100% and 98.5%, respectively, and the area under the ROC curve was 0.985(95% CI: 0.964-1.000). Conclusions:There is a good agreement between IBP and NBP in elderly hypertensive patients with peripheral atherosclerosis during perioperative anesthesia.The magnitude of the deviation between the two is significantly and positively correlated with the level of blood pressure, suggesting that we should appropriately choose the method of blood pressure measurement in the perioperative period to correctly evaluate the blood pressure of these elderly patients.
6.Clinical characteristics and outcomes of preoperactive short-acting octreotide treatment in patients with thyrotropin-secreting pituitary adenomas
Jian XU ; Zheng LI ; Ying GUO ; Dan LIANG ; Liyong ZHONG
Chinese Journal of Internal Medicine 2021;60(4):345-349
Objective:To explore the clinical characteristics of patients with pituitary thyrotropin-secreting adenoma and evaluate the effect of preoperative short-acting octreotide treatment on hyperthyroidism.Methods:A retrospective analysis was performed in 40 patients with pituitary thyrotropin adenoma diagnosed in Beijing Tiantan Hospital from January 2008 to January 2018. The general data, laboratory examinations and imaging findings were reviewed and analyzed. The clinical effect of preoperative octreotide on hyperthyroidism was evaluated.Results:The age of onset year of the 40 patients (male: female = 24∶16) was (30.5±5.1) years. Among them, 35 patients (87.5%) were with macroadenoma. The most common symptoms were thyroid hypermetabolism syndrome, followed by headache, dizziness, visual field damage and hypogonadism. The thyroid function of 30 patients (75%) recovered to normal within 3-5 days after the octreotide treatment. The total effective rate of the octreotide was 90.0%. The level of free thyroxine (FT 4) before treatment in patients with more than 10 times of effective cumulative dose was significantly higher than that in patients with less than 10 doses. Conclusions:Thyroid hypermetabolism syndrome and pituitary occupying effect are the most common clinical manifestations of thyrotropin-secreting adenoma. Preoperative octreotide treatment can effectively control hyperthyroidism. The level of FT 4 is a crucial factor affecting the efficacy of octreotide.
7. Consensus on emergency surgery and infection prevention and control for severe trauma patients with 2019 novel coronavirus pneumonia
Yang LI ; Zhanfei LI ; Qingxiang MAO ; Ding LIU ; Letian ZHANG ; Fan YANG ; Yu XIE ; Siru ZHOU ; Huayu ZHANG ; Shanmu AI ; Hao TANG ; Qiu ZHONG ; Qingshan GUO ; Yaoli WANG ; Weiguo ZHANG ; Liyong CHEN ; Xiangjun BAI ; Lianyang ZHANG
Chinese Journal of Trauma 2020;36(2):1-7
A novel coronavirus pneumonia (NCP) epidemic has occurred in Wuhan, Hubei Province since December 2019, caused by a novel coronavirus (2019-nCoV) never been seen previously in human. China has imposed the strictest quarantine and closed management measures in history to control the spreading of the disease. However, severe trauma can still occur in the NCP patients. In order to standardize the emergency treatment and the infection prevention and control of severe trauma patients with hidden infection, suspected or confirmed infection of 2019-nCoV, Trauma Surgery Branch of Chinese Medical Doctors' Association organized this expert consensus. The consensus illustrated the classification of the NCP patients, severe trauma patients in need of emergency surgery, emergency surgery type, hierarchical protection for medical personnel and treatment places. Meanwhile, the consensus standardized the screening, injury severity evaluation, emergency surgical treatment strategy and postoperative management strategy of severe trauma patients during the epidemic period of NCP, providing a basis for the clinical treatment of such kind of patients.
8. Summary of nursing disable and mental retarded children with dental treatment under dental general anesthesia
Yuxia GUO ; Xin XUE ; Jiyin LI ; Ping HE ; Liyong JIA
Chinese Journal of Practical Nursing 2019;35(32):2534-2536
Objective:
This is a retrospective study of nursing 99 disable and mental retarded children with dental treatment under dental general anesthesia (DGA). This study may show a reference to nursing this kind of patients.
Methods:
We choose the patients in our hospital from July 2017 to July 2018. And start the special nursing for disable and mental retarded children with dental treatment under dental general anesthesia.
Results:
99 cases of children with disabilities can successfully complete all oral treatment. Among them, children with social disorders account for the majority of the visiting population; among disabled children, the incidence of caries, pulpitis and periapical periodontitis was increased.
Conclusions
Our nursing work should be done individually for this kind of children, improve the children obedience and can ensure the treatment smoothly and successfully, reduce the pain through the treatment and improve the recovery. It will give a theoretical and practical reference of nursing this kind of children for dental treatment.
9.Efficacy and safety of domestic exenatide injection in treating type 2 diabetes: A multicenter, randomized, controlled, and non-inferiority trial
Qing TIAN ; Tianpei HONG ; Lixin GUO ; Quanmin LI ; Liyong ZHONG ; Jinkui YANG ; Jing YANG ; Yongyi GAO ; Wenhua XIAO ; Jin YANG
Chinese Journal of Endocrinology and Metabolism 2017;33(4):301-306
Objective To investigate the efficacy and safety of domestic exenatide injection versus imported exenatide injection in type 2 diabetic patients with inadequate glycemic control on monotherapy or combination therapy of metformin and insulin secretagogues. Methods A multicenter, randomized, parallel-controlled, and non-inferiority trial was carried out. A total of 240 subjects were randomized at a 1:1 ratio to add domestic exenatide injection (trial group) or imported exenatide injection (control group) on the background therapies. The primary endpoint of efficacy was HbA1C change from baseline to week 16. The secondary endpoints of efficacy were the proportion of HbA1C<7.0%, and the changes in fasting plasma glucose (FPG), 2 h plasma glucose after standard meal (2hPG), 7-point self monitoring of blood glucose (7P-SMBG), and body weight from baseline to week 16. Results Among subjects of per-protocol sets, adjusted mean HbA1C reduction was -1.07% in the trial group versus -1.06% in the control group after 16 weeks of treatment. The lower boundary of the two-sided 95% confidence intervals of the mean HbA1C reduction difference between the trial and control groups was -0.29%, which was more than -0.35%, suggesting that the predefined statistical criterion for non-inferiority was achieved. The proportions of subjects achieving HbA1C<7.0% at the end of the 16-week treatment were 56.19% and 54.08% in the trial and control groups, respectively (P>0.05). The changes in FPG, 2hPG, 7P-SMBG and body weight from baseline to week 16 were comparable between the two groups (all P>0.05). Moreover, the incidences of hypoglycemia and adverse events were similar between the two groups (both P>0.05). Conclusion In type 2 diabetic patients inadequately controlled by monotherapy or combination therapy of metformin and insulin secretagogues, the efficacy of cotreatment with domestic exenatide injection is not inferior to that of imported product ones, with a similar safety profile.
10.Comparison of Efficacy and Safety of Docetaxel Combined with Carboplatin and Paclitaxel and Cisplatin in the Treatment of Advanced Ovarian Cancer
Yuanqiang HU ; Yongbo ZHANG ; Hua WANG ; Liyong ZHOU ; Gang XIONG ; Zekui CHEN ; Nian GUO ; Yue QIN
China Pharmacy 2016;27(24):3353-3355,3356
OBJECTIVE:To compare the efficacy,safety,vascular endothelial growth factor(VEGF)and matrix metallopro-teinase-2 (MMP-2) of docetaxel combined with carboplatin and paclitaxel combined with cisplatin (DDP) in the treatment of ad-vanced ovarian cancer. METHODS:120 patients with advanced ovarian cancer were randomly divided into docetaxel combined with carboplatin group(60 cases)and paclitaxel combined with DDP group(60 cases). Docetaxel combined with carboplatin group received 70 mg/m2 Docetaxel injection,intravenous infusion of 1 h,d1;50 mg/m2 carboplatin injection,intravenous infusion of 1 h,d2. Paclitaxel combined with DDP group received 135 mg/m2 Paclitaxel injection,intravenous infusion of 24 h,d1;30 mg/m2 DDP for injection,intravenous infusion,d3;60 mg/m2 Paclitaxel injection (a maximum of 2.0 m2) by intraperitoneal infusion,d8. 3-week was regarded as 1 treatment course,and it lasted 6 courses. Clinical efficacy,VEGF,MMP-2,progression-free survival, overall survival before and after treatment,mortality rate within 2 years of treatment and the incidence of adverse reactions in 2 groups were compared. RESULTS:There were no significant differences in the objective response rate,disease control rate,mortal-ity rate,incidence of adverse reactions between 2 groups(P>0.05). The progression-free survival in docetaxel combined with car-boplatin group was significantly longer than paclitaxel combined with DDP group,the difference was statistically significant (P<0.05). Before treatment,there were no significant differences in VEGF and MMP-2 level between 2 groups(P>0.05). After treat-ment,VEGF and MMP-2 level in 2 groups were significantly lower than before,and VEGF at different time points and MMP-2 level after 4 weeks,8 weeks and 12 weeks of treatment in docetaxel combined with carboplatin group were lower than paclitaxel combined with DDP group,the differences were statistically significant(P<0.05). CONCLUSIONS:Docetaxel combined with car-boplatin and paclitaxel combined with DDP shows similar efficacy and safety in the treatment of advanced ovarian cancer,but docetaxel carboplatin combined with is superior to paclitaxel combined with DDP in reducing VEGF and MMP-2 and improving pro-gression-free survival.

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