1.Phase Ⅲ, multicenter, randomized comparative study of LY01005 and Zoladex ? for patients with premenopausal breast cancer
Xiying SHAO ; Qingyuan ZHANG ; Zhaofeng NIU ; Man LI ; Jingfen WANG ; Zhanhong CHEN ; Ruizhen LUO ; Guangdong QIAO ; Jianguo WANG ; Liyuan QIAN ; Ronghua YANG ; Zhendong CHEN ; Jian WANG ; Yumin YAO ; Jianghua OU ; Tao SUN ; Qiao CHENG ; Yongsheng WANG ; Jian HUANG ; Hongying ZHAO ; Wuyun SU ; Zhong OUYANG ; Yu DING ; Lilin CHEN ; Sumei YANG ; Mengsheng CUI ; Aimin ZANG ; Enxiang ZHOU ; Peizhi FAN ; Jing ZHANG ; Qiang LIU ; Yuee TENG ; Hui LI ; Jianyun NIE ; Jin YANG ; Xiaojia WANG ; Zefei JIANG
Chinese Journal of Oncology 2025;47(4):340-348
Background:To compare the efficacy and safety of monthly administrations of gonadotropin releasing hormone (GnRH) agonists LY01005 and Zoladex ? in Chinese patients with premenopausal breast cancer. Methods:From October 2020 to November 2021, 188 premenopausal breast cancer patients were enrolled in 34 hospitals and randomized 1:1 to receive either LY01005 or Zoladex ? every 28 days for a total of three injections. All patients concomitantly received oral tamoxifen (TAM). The primary efficacy endpoint was cumulative probability of maintaining menopausal level [oestradiol (E2) ≤30 pg/ml] from day 29 to day 85. The second efficacy endpoint included changes in E2, luteinizing hormone (LH), and follicle-stimulating hormone (FSH) compared with the baseline. Pharmacokinetics (PK), pharmacodynamics (PD), and safety were analyzed. The study also evaluated the pharmacokinetic and pharmacodynamic characteristics of LY01005. Results:A total of 188 patients were randomised and 187 patients received either LY01005 or Zoladex ?. Cumulative probabilities of maintaining menopausal level (E2≤30 pg/ml) from day 29 to day 85 were 93.1% for LY01005 and 86.3% for Zoladex ?. The between-group difference was 6.8% (95% CI: -2.3%, 15.9%) and primary efficacy in the LY01005 group was not inferior to that in the Zoladex ? group. Changes in E2, LH, and FSH levels compared with the baseline were equivalent between the two groups (E2: 89.34% to 90.23% vs. 82.11% to 85.02%; LH: 88.89% to 95.52% vs. 89.70% to 97.02%; FSH: 75.36% to 80.85% vs.73.07% to 80.24%, respectively). After three consecutive doses of LY01005, the LH and FSH levels of the subjects showed a transient increase after the first dose, reached a peak on the second day and then started to decrease. The LH and FSH reached a lower level and remained at or below that level until the 85th day. Both treatments were well-tolerated. Conclusion:LY01005 is as effective as Zoladex ? in suppressing E2 to menopausal levels in Chinese patients with premenopausal breast cancer, with a similar safety profile.
2.Phase Ⅲ, multicenter, randomized comparative study of LY01005 and Zoladex ? for patients with premenopausal breast cancer
Xiying SHAO ; Qingyuan ZHANG ; Zhaofeng NIU ; Man LI ; Jingfen WANG ; Zhanhong CHEN ; Ruizhen LUO ; Guangdong QIAO ; Jianguo WANG ; Liyuan QIAN ; Ronghua YANG ; Zhendong CHEN ; Jian WANG ; Yumin YAO ; Jianghua OU ; Tao SUN ; Qiao CHENG ; Yongsheng WANG ; Jian HUANG ; Hongying ZHAO ; Wuyun SU ; Zhong OUYANG ; Yu DING ; Lilin CHEN ; Sumei YANG ; Mengsheng CUI ; Aimin ZANG ; Enxiang ZHOU ; Peizhi FAN ; Jing ZHANG ; Qiang LIU ; Yuee TENG ; Hui LI ; Jianyun NIE ; Jin YANG ; Xiaojia WANG ; Zefei JIANG
Chinese Journal of Oncology 2025;47(4):340-348
Background:To compare the efficacy and safety of monthly administrations of gonadotropin releasing hormone (GnRH) agonists LY01005 and Zoladex ? in Chinese patients with premenopausal breast cancer. Methods:From October 2020 to November 2021, 188 premenopausal breast cancer patients were enrolled in 34 hospitals and randomized 1:1 to receive either LY01005 or Zoladex ? every 28 days for a total of three injections. All patients concomitantly received oral tamoxifen (TAM). The primary efficacy endpoint was cumulative probability of maintaining menopausal level [oestradiol (E2) ≤30 pg/ml] from day 29 to day 85. The second efficacy endpoint included changes in E2, luteinizing hormone (LH), and follicle-stimulating hormone (FSH) compared with the baseline. Pharmacokinetics (PK), pharmacodynamics (PD), and safety were analyzed. The study also evaluated the pharmacokinetic and pharmacodynamic characteristics of LY01005. Results:A total of 188 patients were randomised and 187 patients received either LY01005 or Zoladex ?. Cumulative probabilities of maintaining menopausal level (E2≤30 pg/ml) from day 29 to day 85 were 93.1% for LY01005 and 86.3% for Zoladex ?. The between-group difference was 6.8% (95% CI: -2.3%, 15.9%) and primary efficacy in the LY01005 group was not inferior to that in the Zoladex ? group. Changes in E2, LH, and FSH levels compared with the baseline were equivalent between the two groups (E2: 89.34% to 90.23% vs. 82.11% to 85.02%; LH: 88.89% to 95.52% vs. 89.70% to 97.02%; FSH: 75.36% to 80.85% vs.73.07% to 80.24%, respectively). After three consecutive doses of LY01005, the LH and FSH levels of the subjects showed a transient increase after the first dose, reached a peak on the second day and then started to decrease. The LH and FSH reached a lower level and remained at or below that level until the 85th day. Both treatments were well-tolerated. Conclusion:LY01005 is as effective as Zoladex ? in suppressing E2 to menopausal levels in Chinese patients with premenopausal breast cancer, with a similar safety profile.
3.Multivariate analysis of the clinical outcome of 16 458 natural artificial insemination cycles with donor sperm
Qingjian ZHANG ; Ge SONG ; Xiaoying ZHONG ; Ronghua JIANG ; Xiaoling LIU ; Weiwei ZHENG ; Xiaoli ZHU ; Minru LI ; Zehu ZHAN ; Xiaolin CAI ; Qiao CHEN
Chinese Journal of Reproduction and Contraception 2020;40(8):620-628
Objective:To analyze the effects of various factors on the clinical outcome of artificial insemination with donor sperm (AID) under natural cycles.Methods:A total of 16 458 natural cycles with donor sperm were analyzed from January 2011 to December 2018 in Reproductive Center of Guangdong Province Family Planning Science and Technology Research Institute. The relationship between the clinical outcome and the factors such as the women's character, donor sperm quality and cycle related factors with χ 2 and multiple factor generalized estimating equation. Results:Many factors such as women's age ≤ 30 years ( OR=1.865, P<0.001), the woman's age from 31 to 35 years ( OR=1.215, P<0.001), duration of infertility≤5 ( OR=1.139, P=0.007), day 3 luteining hormone (LH) level>8.10 IU/L ( OR=1.309, P=0.022), day 3 estrogen level≤77.10 pmol/L ( OR=1.301, P=0.012), day 3 estrogen level from 77.11 pmol/L to 293.60 pmol/L ( OR=1.099, P=0.044), one dominant follicle per cycle ( OR=1.473, P=0.038), cervical mucus score ≥10 ( OR=1.256, P=0.026), A type endometrium ( OR=1.114, P=0.005), urinary LH strong positive ( OR=1.171, P=0.002), sperm activity ratio more than 54% after thawing ( OR=1.142, P=0.002), progressively motile sperm number ≥ 35×10 6 after thawing ( OR=1.217, P=0.001) and double inseminations per cycle ( OR=1.376, P=0.001) significantly affected the pregnancy rates of AID women under natural cycles. Conclusion:Many factors such as the woman's age, duration of infertility, day 3 LH level, day 3 estrogen level, dominant follicle number per cycle, cervical mucus score, endometrial type, sperm activity ratio after thawing, progressively motile sperm number and insemination times per cycle can affect the women’s pregnancy rate under AID natural cycles.
4.Multivariate analysis of the clinical outcome of 16 458 natural artificial insemination cycles with donor sperm
Qingjian ZHANG ; Ge SONG ; Xiaoying ZHONG ; Ronghua JIANG ; Xiaoling LIU ; Weiwei ZHENG ; Xiaoli ZHU ; Minru LI ; Zehu ZHAN ; Xiaolin CAI ; Qiao CHEN
Chinese Journal of Reproduction and Contraception 2020;40(8):620-628
Objective:To analyze the effects of various factors on the clinical outcome of artificial insemination with donor sperm (AID) under natural cycles.Methods:A total of 16 458 natural cycles with donor sperm were analyzed from January 2011 to December 2018 in Reproductive Center of Guangdong Province Family Planning Science and Technology Research Institute. The relationship between the clinical outcome and the factors such as the women's character, donor sperm quality and cycle related factors with χ 2 and multiple factor generalized estimating equation. Results:Many factors such as women's age ≤ 30 years ( OR=1.865, P<0.001), the woman's age from 31 to 35 years ( OR=1.215, P<0.001), duration of infertility≤5 ( OR=1.139, P=0.007), day 3 luteining hormone (LH) level>8.10 IU/L ( OR=1.309, P=0.022), day 3 estrogen level≤77.10 pmol/L ( OR=1.301, P=0.012), day 3 estrogen level from 77.11 pmol/L to 293.60 pmol/L ( OR=1.099, P=0.044), one dominant follicle per cycle ( OR=1.473, P=0.038), cervical mucus score ≥10 ( OR=1.256, P=0.026), A type endometrium ( OR=1.114, P=0.005), urinary LH strong positive ( OR=1.171, P=0.002), sperm activity ratio more than 54% after thawing ( OR=1.142, P=0.002), progressively motile sperm number ≥ 35×10 6 after thawing ( OR=1.217, P=0.001) and double inseminations per cycle ( OR=1.376, P=0.001) significantly affected the pregnancy rates of AID women under natural cycles. Conclusion:Many factors such as the woman's age, duration of infertility, day 3 LH level, day 3 estrogen level, dominant follicle number per cycle, cervical mucus score, endometrial type, sperm activity ratio after thawing, progressively motile sperm number and insemination times per cycle can affect the women’s pregnancy rate under AID natural cycles.
5. Extirpation of primary malignancies in the pterygopalatine and infratemporal fossa via modified maxillary swing approach
Li XIE ; Wenxiao HUANG ; Junqi WANG ; Jie CHEN ; Hailin ZHANG ; Pingqing TAN ; Ronghua BAO ; Jinyun LI ; Waisheng ZHONG ; Haolei TAN ; Pengxin HUANG
Chinese Journal of Stomatology 2019;54(3):194-197
Five patients with primary malignancies in the pterygopalatine fossa (PPF) and infra temporal fossa (ITF) were enrolled in this retrospective study between January 2012 and January 2018. After malignancies proven by biopsy and evaluation with CT and MRI scan, all patients received modified maxillary swing (MMS) approach for extirpation of malignant tumors in the PPF and ITF under general anesthesia. En bloc resection with wide surgical margins was successfully performed in all cases. Negative margins were observed in 4 cases and positive margins were found in one patient with adenoid cystic carcinoma who received postoperative radiotherapy. The most common complication was facial numbness. During the follow-up period (range 12 to 57 months), one patient suffered from recurrence while others did not. The advantages of MMS include wide surgical field, full exposure and easy manipulation. The MMS approach is expected to become an standard method for monobloc resection of malignancies in the PPF and ITF.
6.Clinical characteristics and antibiotic susceptibility features of different types of invasive infections caused by group B Streptococcus: a multicenter prospective study
Xinzhu LIN ; Yao ZHU ; Yayin LIN ; Dengli LIU ; Liping XU ; Ronghua ZHONG ; Zhifang LIU ; Dongmei CHEN ; Zhongling HUANG ; Hong YANG ; Wenying QIU ; Chao CHEN
Chinese Journal of Perinatal Medicine 2019;22(8):597-603
Objective To study the clinical manifestations and antibiotic sensitivity features of early-and late-onset invasive infections caused by group B Streptococcus (GBS). Methods A total of 96 infants with invasive GBS infections were enrolled prospectively from seven tertiary hospitals of GBS Infection Research Cooperative Group in southwest Fujian, such as Xiamen Maternal and Child Care Hospital, etc., from January 2016 to June 2018. According to the onset time of infection after birth, they were divided into early-onset GBS disease (GBS-EOD) group (<7 d, n=67) and the late-onset GBS disease (GBS-LOD) group (7-89 d, n=29). Clinical manifestations, disease spectrum, complications and outcomes of the two groups were compared. Drug sensitivity test was carried out using disk diffusion test. Chi-square or Fisher's exact test, two independent sample t-test or Mann-Whitney U tests were used for statistical analysis. Results (1) The average ages at onset in GBS-EOD and GBS-LOD groups were (15.8±6.7) h (0.5-142.0 h) and (25.0±8.1) d (9-89 d), respectively. The incidence of tachypnea, pallor, fever and convulsion were noted in 68.7% (46/67) vs 44.8% (13/29), 52.2% (35/67) vs 17.2% (5/29), 23.9% (16/67) vs 65.5% (19/29) and 7.5% (5/67) vs 48.3% (14/29) of GBS-EOD and GBS-LOD groups with χ2 values of 6.282, 10.199, 15.146 and 21.237 (all P<0.05). The main clinical manifestations of GBS-EOD were tachypnea and pallor, while most of the patients in the GBS-LOD group developed fever and convulsions. (2) The incidence of pneumonia, sepsis, meningitis, sepsis complicated by septic joints, pneumonia complicated by sepsis, sepsis complicated by meningitis and pneumonia complicated by sepsis and meningitis were noted in 43.3% (29/67) vs 20.7% (6/29), 9.0% (6/67) vs 17.2% (5/29), 0.0% (0/67) vs 3.4% (1/29), 0.0% (0/67) vs 6.9% (2/29), 31.3% (21/67) vs 13.8% (4/29), 6.0% (4/67) vs 31.0% (9/29) and 10.4% (7/67) vs 6.9% (2/29) of GBS-EOD and GBS-LOD groups. There was a statistically significant difference in the disease spectrum between the two groups (Fisher's exact test, all P<0.001). Compared with the GBS-LOD group, the GBS-EOD group had a higher incidence of pneumonia [85.1% (57/67) vs 41.4% (12/29), χ2=19.116, P<0.001] and a lower incidence of meningitis [16.4% (11/67) vs 41.4% (12/29), χ2=6.922, P=0.009]. Complications such as acute respiratory distress syndrome (ARDS), pulmonary hemorrhage, shock and persistent pulmonary hypertension of the newborn (PPHN) occurred much more in the GBS-EOD group than the GBS-LOD group [28.4% (19/67) vs 6.9% (2/29), 13.4% (9/67) vs 0.0% (0/29), 11.9% (8/67) vs 10.3% (3/29), 4.5% (3/67) vs 0.0% (0/29), χ2=13.683, P<0.001]. (3) Among the 96 patients, 23 (24.0%) had meningitis and 73 (76.0%) developed pneumonia and sepsis. Meningitis resulted in a higher fatality rate [17.4% (4/23) vs 4.1% (3/73), χ2=4.564, P=0.035] and longer average hospital stay [(37.2±12.6) vs (14.1±5.3) d, t=7.831, P<0.001] than pneumonia and sepsis. Seven out of the 19 meningitis survivors developed intracranial complications. (4) The overall fatality rate in this study was 7.3% (7/96) and no significant difference was found between GBS-EOD and GBS-LOD group [7.5% (5/67) vs 6.9% (2/29), χ2=0.010, P=0.982]. Among the 67 GBS-EOD infants, 58 (86.6%) occurred within 24 h and five of them died, but no death was reported in the other nine cases occurred after 24 h. (5) Totally 96 strains of GBS were isolated with 100% sensitivity to penicillin, ampicillin, cefazolin and meropenem, and 97% to vancomycin. Around 79.3%-91.0% of GBS isolates were resistant to clindamycin and erythromycin. Conclusions Clinial features vary greatly in GBS-LOD and GBS-EOD cases. Infants with meningitis have poor prognosis. The drug resistance rate of GBS to erythromycin and clindamycin are relatively high.
7.Influence of network intervention on lifestyle and behaviors habit of middle -aged patients with hypertension
Xiuhua LI ; Meisheng RUAN ; Ping ZHONG ; Chunhua LIU ; Hualong HU ; Ronghua DAN
Chinese Journal of Primary Medicine and Pharmacy 2016;23(9):1315-1320
Objective To explore the influence of network intervention on lifestyle and behaviors habit of the middle -aged patients with hypertension.Methods All 300 middle -aged patients with hypertension were randomly assigned into the study group and the control group.Each group had 150 cases.All patients in the both two groups were given hypotensive drugs according to treatment specification of hypertension.The patients in the study group received a network intervention for 2 years,while the patients in the control group received an outpatient service follow-up.The difference of lifestyle and behaviors habit of the patients in the two groups were observed and compared. Results There were no significant differences with all items of the lifestyle and behaviors habit of the patients between the two groups before intervention(P >0.05 ).In the 12th end of month after intervention,there were no significant differences between the two groups with the items of smoking control,working and resting regularly,hobby and psychological balance(P >0.05),but other items in the study group were significantly better than those in the control group(Z =-3.062,-2.509,-2.239,-2.056,-2.126,-2.045,-2.023,all P <0.05).In the 24th end of month after intervention,all items in the study group were significantly better than those in the control group (Z =-4.078,-3.792,-2.080,-2.098,-1.985,-2.478,-2.173,-2.478,-3.290,-2.514,-2.730,all P <0.05 ).Conclusion The network intervention can significantly improve lifestyle and behaviors habit of the middle -aged patients with hypertension.Its effect is much better than that of outpatient service follow -up.
8.Flexible sensors and their application in healthcare
Xuesi ZHOU ; Ronghua ZHONG ; Tianhui WANG
Military Medical Sciences 2015;(11):876-880
The traditional approach to accessing healthcare information restricts the further development of healthcare services,thus unable to meet the growing needs of individual healthcare.The flexible sensor technology has emerged along with the development of new materials,machinery and manufacturing technology.As a result,textiles,accessories,human skin and even internal body organs can be integrated with various sensors.The popularization of flexible sensors provides new methods for monitoring health,improving therapeutics,investigating disease status and building the human-machine in-terface.Through a systematic investigation of literature,this paper reviews the applications of flexible sensors in health-care,discusses the key technologies,and introduces the common materials and manufacturing technology.
9.Clinicopathologic features and differential diagnoses of non-involuting congenital hemangioma in children.
Wenping YANG ; E-mail: YWP07912000@163.COM. ; Hongyan XU ; Songtao ZENG ; Ronghua FU ; Hua ZENG ; Meijun TAN ; Yan WU ; Feng XIONG ; Hui HUANG ; Meihui ZHONG ; Shouhua ZHANG ; Junlin ZHOU
Chinese Journal of Pathology 2015;44(7):495-498
OBJECTIVETo investigate the clinicopathologic features and differential diagnoses of non-involuting congenital hemangioma (NICH) in children.
METHODSThe clinical, morphologic and immunophenotypic characteristics of 22 cases of NICH were retrospectively analyzed.
RESULTSThe mean patients' age at diagnosis was 4.2 years, with a male to female ratio of 1.75:1. The tumors were located in the head and face (5 cases), neck (3 cases), body (6 cases), upper limbs (5 cases), and lower limbs (3 cases). Histologically, the tumor was dominated by rather large lobules of small vessels that were mostly rounded, curved, small and thin-walled, and were lined by endothelial cells surrounded by one or more layers of pericytes. The center of the lobules was occupied by one or more thin or thick walled vessels, which were surrounded by fibrous and fatty tissue, which contained abnormal arterial and venous structures. At the edge of the lobules there were lymphatic vessels. Immunohsitochemical study showed that tumor cells in NICH were positive for CD34 (22/22), CD31 (22/22), SMA (22/22), vimentin (22/22) and Glut1 (0/22). D2-40 expression was located at the edge of the capillary lobules.
CONCLUSIONSNICH is a benign lesion. Clinically and pathologically, it needs to be differentiated from rapidly involuting congenital hemangioma, infantile hemangiomas, tufted angioma, vascular malformation, and others.
Biomarkers, Tumor ; Child, Preschool ; Diagnosis, Differential ; Female ; Hemangioma, Capillary ; congenital ; diagnosis ; Humans ; Male ; Retrospective Studies
10.Application of improved submental island flap in hypopharyngeal cancer reserved laryngeal function surgery.
Pingqing TAN ; Jie CHEN ; Wenxiao HUANG ; Ronghua BAO ; Jinyun LI ; Junqi WANG ; Li XIE ; Waisheng ZHONG ; Hailin ZHANG
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2015;29(15):1342-1345
OBJECTIVE:
This study aimd to evaluate the application and clinical effect of improved submental island flap in hypopharyngeal cancer reserved laryngeal function surgery.
METHOD:
A retrospective review of clinical data was performed on 38 patients of hypopharyngeal cancer reserved laryngeal function using sumental island flaps, by the way of improving in design of vascular pedicle, reconstructive mode of laryngeal and hypopharyngeal function and closing of wound of neck following hypopharyngeal cancer resection. Meanwhile, the effect and prognosis was comprehensively assessed on patients with hypopharyngeal cancer reserved laryngeal function using improved submental island flaps.
RESULT:
The submental flaps kept alive in all 38 cases. During the follow-up period, 18 cases were dead, and of them, 7 cases died of the second primary carcinoma, included 4 cases of esophagus cancer, 1 case of cancer of soft palate, 2 cases of nasopharyngeal carcinoma; and 5 cases died of cervical or parapharyngeal lymph nodes recurrence; 2 cases died of hepatic metastasis; and 4 cases died of pulmonary metastasis. The overall 5-years survival rate was 52.6%.
CONCLUSION
Improved submental island flap repairing postoperative defect of hypopharyngeal cancer reserved laryngeal function has many advantages including higher success rate, more security, easy and simple to operate as well as good clinical effects, and is worth to widespread using.
Humans
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Hypopharyngeal Neoplasms
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surgery
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Hypopharynx
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surgery
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Larynx
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Neck
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surgery
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Neoplasm Recurrence, Local
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Prognosis
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Reconstructive Surgical Procedures
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Retrospective Studies
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Surgical Flaps
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Survival Rate

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