1.Clinical analysis of 76 cases of erlotinib-induced skin rash in the treatment of non-small cell lung cancer
Tumor 2010;(4):338-342
Objective:To evaluate the relationship between erlotinib-induced skin rash and clinical outcome and explore the effective way to prevent skin rash. Methods:The data from 76 non-small cell lung cancer(NSCLC) patients who experienced erlotinib-induced skin rash from Dec 2005 to Sep 2008 were collected. All the patients were confirmed with NSCLC by pathological and cytological examination and received erlotinib 150 mg/d till they had progressive disease or intolerable adverse reaction. The severity of skin rash was recorded and graded according to National Cancer Institute-Common Toxicity Criteria (NCI-CTC). The therapeutic outcome of skin rash was observed. Results:The skin rash develops as early as 3 days after commencement of erlotinib therapy, with median onset at 8 days. Twenty-seven (35.5%) patients experienced grade 1 skin rash, 44 patients (57.9%) had grade 2 and 5 cases (6.6%) had grade 3 skin rash. A statistically significant correlation was observed between skin rash and erlotinib therapy. The disease-controlling rate was 63.0% for grade 1 skin rash patients including 5 cases with partial remission and 12 cases with stable disease and 91.8% for grade 2/3 skin rash patients including 32 cases with partial remission and 13 cases with stable disease (P<0.05). The median time to progression(TTP) and median overall survival(OS) were prolonged in patients experienced grade 2/3 skin rash compared with those in patients with grade 1 skin rash (TTP: 5.1 months vs 9.7 months, P<0.01; OS: 10.0 months vs 14.6 months, P<0.01). The skin rash was alleviated in 60 out of 76 patients (78.9%). Conclusion:Skin rash is a potent surrogate marker of favorable outcome in patients who received erlotinib treatment. It was tolerable to most patients. Appropriate therapy may be useful in decreasing the severity of skin rash.
2.Different prognosis in patients of peritoneal dialysis with high peritoneal solute transport
Xiaoling ZHOU ; Qingfeng HAN ; Yue WANG ; Linghua SUN ; Jiandong NIE
Chinese Journal of General Practitioners 2011;10(6):427-430
To investigate association between prognosis of patients of peritoneal dialysis with their initial high peritoneal solute transport and complications. Two hundred and two patients with end-stage renal disease who began peritoneal dialysis during September 1,2006 to September 1, 2008 at Peking University Third Hospital, Beijing were recruited in the study. They were undergone peritoneal equilibration test within six weeks after initiating peritoneal dialysis, and their types of peritoneal solute transport, complications,nutrition status and outcomes were all recorded until August 31,2010. Their survival rate was estimated by Kaplan-Meier method. Compare to those with other types of solute transport, patients with high peritoneal solute transport showed higher proportion of complications ( P < 0. 05 ) during dialysis, but less ultrafiltration function ( P < 0. 05 ), worse nutrition status ( P < 0. 05 ) and lower cumulative survival rate ( P < 0. 01 ).Among patients with high peritoneal solute transport, cumulative survival rate in those with complication was lower than those without it ( P = 0. 031 ). Prognosis of patients with high peritoneal solute transport possibly varies with their complications in dialysis.
3.Correlational study between Idiopathic pneumothorax and thoracic deformity in the youth
Qiugen HU ; Jiang QIAN ; Zhaogan ZHOU ; Jiali ZHANG ; Linghua HE
Chinese Journal of Primary Medicine and Pharmacy 2010;17(10):1311-1312,后插2
Objective To test the possibility that the thoracic defomity is a risk factor of the diopathic pneumothorax in youth by making a statistical analysis of the thoracic sagittal diameter and transverse diameter ratio in patients and normal people. To study the correlation between this ratio and age of the patients. Methods 107 cases of idiopathic pneumothorax were taken as subjects and other 105 cases in' the same period with normal pneumothorax were used as the control group. T-test,correlation study and scottered spot maps were made based on the ratio of vertical and horizontal diameters,the mean and the age. Results The mean thorax aspect ration( MTAR) of the patients with spontaneous pneumothorax was 0.38, and MTAR in normal people was 0.44, indicating a statistical significance ( P < 0.01) of the difference of MTAR between the two groups. The age of the patients' first onset age and the ratio of vertical and horizontal diameter was positively correlated. Conclusion Thoracic deformity of idiopathic pneumothorax had a higher incidence in young people,and there was a positive correlation between of the age of their first onset and the ratio of vertical and horizontal tracks.
4.Biomechanical study on bone marrow-derived mesenchymal stem cells promoting tendon-bone healing following anterior cruciate ligament reconstruction
Weifeng ZHOU ; Songlin TONG ; Jianjie XU ; Rongfu CHEN ; Linghua XU ; Xianlun PANG
Chinese Journal of Trauma 2013;29(7):667-670
Objective To observe the effect of bone marrow-derived mesenchymal stem cells (bMSCs) on graft healing within a bone tunnel after anterior cruciate ligament (ACL) reconstruction in rabbits.Methods The study involved 24 New Zealand white rabbits undergone ACL reconstruction with an autologous ipsilateral gastrocnemius tendon graft.Both hindlimbs were included.In one hindlimb,graft coated with fibrin glue compound by bMSCs was employed (bMSCs group).Whereas in the contralateral hindlimb,graft coated with fibrin glue without cells was employed (control group).At postoperative 2,4,6 and 8 weeks,specimens were harvested to have a biomechanical test of tensile strength and stiffness of tendon-bone interface.Results Tensile strength and stiffness of tendon-bone interface in both experiment and control groups presented a rising trend with the prolong of repair time.In contrast,significantly higher tensile strength and stiffness of tendon-bone interface were observed in experiment group since the 6 weeks (P < 0.05).Conclusion bMSCs transplantation significantly enhances the early tensile strength and stiffness at tendon-bone interface after ACL reconstruction in rabbits and improves the graft healing within a bone tunnel.
5.Effect of health management of progressive resistance training on the self-efficacy and bone mineral density improvement in patients with osteoporosis
Linghua ZHOU ; Jianping JIANG ; Wei ZHUANG
Chinese Journal of Health Management 2023;17(6):449-454
Objective:To explore the effect of health management of progressive resistance training on self-efficacy and bone mineral density (BMD) improvement in osteoporosis patients.Methods:It was a cross-sectional study. Clinical data of 156 patients with primary osteoporosis treated in Jiangnan Hospital Affiliated to Zhejiang University of Traditional Chinese Medicine from September 2019 to March 2022 were analyzed retrospectively. A simple random sampling method was implied, and 78 patients were set as control group, they were treated with conventional osteoporosis drugs and routine health education and peer education. And the other 78 patients were set as observation group, and progressive resistance training was added to the health management program in these patients on the basis of the intervention of the control group. Combined with the 6-month follow-up records of the two groups, the changes of self-efficacy level and the improvement of BMDin the two groups before and after the intervention were analyzed and compared. The above indexes were statistically analyzed with χ2 test or t test. Results:The compliance of diet, psychology, exercise and medication in the observation group was 97.4%, 97.4%, 98.7% and 97.4%, respectively, which were all higher than those in the control group (89.7%, 87.2%, 88.5% and 87.2%). The self-efficacy score before and after intervention in the observation group was 110.09±11.73 and 217.05±8.12, the anxiety score was 46.44±3.17 and 31.92±3.28, the depression score was 51.60±3.42 and 33.32±2.98, the osteoporosis knowledge score was 14.99±2.14 and 24.40±1.28, respectively; and those were 110.81±12.53 and 185.36±12.29, 46.92±2.18 and 36.53±3.54, 51.56±3.93 and 39.02±2.65, 14.76±2.93 and 20.11±1.84 respectively in the control group; and there was no statistically significant difference in above-mentioned indexes between the two groups before the intervention (all P>0.05); but after 6 months of intervention, the above-mentioned scores of the observation group were all significantly superior than those in the control group (all P<0.05). The BMD of lumbar spine L 1-4, femoral trochanter and hip in the observation group before intervention was 0.869±0.127, 0.608±0.110 and 0.740±0.138, respectively, and after the intervention, it was 0.915±0.107, 0.654±0.108 and 0.785±0.134, respectively; the BMD of lumbar spine L 1-4, femoral trochanter and hip in the control group was 0.833±0.126, 0.607±0.114 and 0.738±0.135, respectively before intervention, and it was 0.869±0.114, 0.643±0.114 and 0.748±0.124, respectively after intervention. After intervention, the lumbar L 1-4 bone density in the observation group was higher than that in the control group, the difference was statistically significant ( P<0.05). There was no significant difference in all the BMD before intervention and the BMD of the femoral trochanter and the hip after intervention between the two groups (all P>0.05). Conclusion:The health management of progressive resistance training combined with drug therapy can effectively improve the BMD in patients with osteoporosis.
6.Efficacy and safety of LY01005 versus goserelin implant in Chinese patients with prostate cancer: A multicenter, randomized, open-label, phase III, non-inferiority trial.
Chengyuan GU ; Zengjun WANG ; Tianxin LIN ; Zhiyu LIU ; Weiqing HAN ; Xuhui ZHANG ; Chao LIANG ; Hao LIU ; Yang YU ; Zhenzhou XU ; Shuang LIU ; Jingen WANG ; Linghua JIA ; Xin YAO ; Wenfeng LIAO ; Cheng FU ; Zhaohui TAN ; Guohua HE ; Guoxi ZHU ; Rui FAN ; Wenzeng YANG ; Xin CHEN ; Zhizhong LIU ; Liqiang ZHONG ; Benkang SHI ; Degang DING ; Shubo CHEN ; Junli WEI ; Xudong YAO ; Ming CHEN ; Zhanpeng LU ; Qun XIE ; Zhiquan HU ; Yinhuai WANG ; Hongqian GUO ; Tiwu FAN ; Zhaozhao LIANG ; Peng CHEN ; Wei WANG ; Tao XU ; Chunsheng LI ; Jinchun XING ; Hong LIAO ; Dalin HE ; Zhibin WU ; Jiandi YU ; Zhongwen FENG ; Mengxiang YANG ; Qifeng DOU ; Quan ZENG ; Yuanwei LI ; Xin GOU ; Guangchen ZHOU ; Xiaofeng WANG ; Rujian ZHU ; Zhonghua ZHANG ; Bo ZHANG ; Wanlong TAN ; Xueling QU ; Hongliang SUN ; Tianyi GAN ; Dingwei YE
Chinese Medical Journal 2023;136(10):1207-1215
BACKGROUND:
LY01005 (Goserelin acetate sustained-release microsphere injection) is a modified gonadotropin-releasing hormone (GnRH) agonist injected monthly. This phase III trial study aimed to evaluated the efficacy and safety of LY01005 in Chinese patients with prostate cancer.
METHODS:
We conducted a randomized controlled, open-label, non-inferiority trial across 49 sites in China. This study included 290 patients with prostate cancer who received either LY01005 or goserelin implants every 28 days for three injections. The primary efficacy endpoints were the percentage of patients with testosterone suppression ≤50 ng/dL at day 29 and the cumulative probability of testosterone ≤50 ng/dL from day 29 to 85. Non-inferiority was prespecified at a margin of -10%. Secondary endpoints included significant castration (≤20 ng/dL), testosterone surge within 72 h following repeated dosing, and changes in luteinizing hormone, follicle-stimulating hormone, and prostate specific antigen levels.
RESULTS:
On day 29, in the LY01005 and goserelin implant groups, testosterone concentrations fell below medical-castration levels in 99.3% (142/143) and 100% (140/140) of patients, respectively, with a difference of -0.7% (95% confidence interval [CI], -3.9% to 2.0%) between the two groups. The cumulative probabilities of maintaining castration from days 29 to 85 were 99.3% and 97.8%, respectively, with a between-group difference of 1.5% (95% CI, -1.3% to 4.4%). Both results met the criterion for non-inferiority. Secondary endpoints were similar between groups. Both treatments were well-tolerated. LY01005 was associated with fewer injection-site reactions than the goserelin implant (0% vs . 1.4% [2/145]).
CONCLUSION:
LY01005 is as effective as goserelin implants in reducing testosterone to castration levels, with a similar safety profile.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT04563936.
Humans
;
Male
;
Antineoplastic Agents, Hormonal/therapeutic use*
;
East Asian People
;
Gonadotropin-Releasing Hormone/agonists*
;
Goserelin/therapeutic use*
;
Prostate-Specific Antigen
;
Prostatic Neoplasms/drug therapy*
;
Testosterone