1.The preliminary report of the device and clinical application of continu ous and constant pressure skin expansion perfusion apparatus(CCPSEPA)
Zhongwen HE ; Biao WANG ; Jiang LI
Chinese Journal of Medical Aesthetics and Cosmetology 2001;7(2):69-71
Objective To search for a simple and rapid skin expansion. Methods CCPSEPA-A kind of mutual feedback type continuous normal saline perfusion system was assembled with the use of conventional transfusi on apparatus, sphygmomanometer, three-way stopcocks, plasma bag etc.14 cases ( 17 expanders) were carried out with such a device, controlled by patients themselves. Results The volume of expanders was 50~300 ml and the duration of expansion was 7~14 days. All the cases proved a wonderful effect that the expansion was finished by only one or two times of water filling of storage water bag, and without any complications.Conclusion CCPSEPA is a new skin expansion apparatus of new type and practical ,simple and low price .The general goal of safe,simple, rapid and useful was realized basically by the device,and worth popularizing.
2.Clinical effectiveness of low cut and five dissector thyroidectomy to treat hyperthyroidism
Jinghua YANG ; Zhongwen LI ; Jiayou ZHANG ; Yongqiang WU ; Guoyong HE
Chinese Journal of Primary Medicine and Pharmacy 2005;0(02):-
Objective To study the clinical effectiveness of low cut and five dissector thyroidectomy to treat hyperthyroidism.Methods 337 cases of hyperthyroidism were randomly divided into study group(low cut and five dissector technique,223 cases) and control group(traditional technique,114 cases) according to the ratio of two:operating time,bleeding,complications,recur were compared between these two groups.Results The operating time of the study group and control group were(66.33?25.11)min and(121.27?42.35)min(t=12.75,P0.05).The rate of recurrence was marked(P
3.Effect of laparoscopic complete peritoneal hernia repair on respiratory function and motilin in elderly patients with inguinal hernia
Feng WANG ; Junhua XIE ; Zhongwen HE
Chinese Journal of Postgraduates of Medicine 2023;46(12):1112-1116
Objective:To investigate the effects of laparoscopic total extraperitoneal hernia repair (TEP) on respiratory function and motilin (MOL) in elderly patients with inguinal hernia.Methods:One hundred and twenty elderly patients with inguinal hernia admitted in Chongqing Fengdu People′s Hospital from January 2020 to December 2021 were divided into two groups according to the method of operation, 60 patients who performed laparoscopic preperitoneal hernia repair (TAPP) was enrolled in control group, and 60 patients who performed TEP was enrolled in the study group. The operation index, visual analogue scale (VAS) scores at different time, respiratory function index and gastrin (GAS), MOL levels and postoperative complications were compared between the two groups.Results:Compared with the control group, the operation time in the study group was longer, the recovery time was shorter and the VAS scores were lower on the 1st, 3rd and 7th day after operation: (66.36 ± 10.05) min vs. (53.69 ± 8.59) min, (4.09 ± 0.59) d vs. (5.15 ± 1.06) d, (4.49 ± 1.26) scores vs. (5.46 ± 1.48) scores, (3.65 ± 0.58) scores vs. (4.52 ± 0.95) scores, (2.42 ± 0.41) scores vs. (3.54 ± 0.48) scores, there were statistical differences ( P<0.05). The levels of end-expiratory carbon dioxide pressure (P ETCO 2) and airway pressure (Paw) in the study group at 10, 30 and 90 min postoperatively were higher than those in the control group: (40.66 ± 4.52)mmHg(1 mmHg = 0.133 kPa) vs. (37.48 ± 5.26) mmHg, (19.88 ± 1.63) cmH 2O (1 cmH 2O = 0.098 kPa) vs. (16.59 ± 2.15) cmH 2O; (44.65 ± 4.18) mmHg vs. (41.58 ± 4.58) mmHg, (20.49 ± 1.65) cmH 2O vs. (16.95 ± 2.84) cmH 2O; (50.16 ± 3.54) mmHg vs. (45.59 ± 4.65)mmHg, (21.69 ± 1.78) cmH 2O vs. (17.49 ± 2.15) cmH 2O, there were statistical differences ( P<0.05). The levels of MOL and GAS in the study group at 3 d postoperatively were higher than those in the control group: (396.54 ± 13.58) ng/L vs. (332.52 ± 16.95) ng/L, (118.95 ± 8.95) ng/L vs. (102.58 ± 10.65) ng/L, there were statistical differences ( P<0.05). There was no significant difference in the incidence of complications between the two groups ( P>0.05). Conclusions:Both TEP and TAPP have certain therapeutic effects on the inguinal hernia, but TEP has shorter postoperative recovery time, less pain, less impact on gastrointestinal function, but it will have a certain impact on respiratory function.
4.A Non-inferiority Randomized Controlled Trial of Topical Bisaitong (鼻塞通) in Treatment of Moderate to Severe Allergic Rhinitis
Jintao PANG ; Feiting FAN ; Jingmin XIAO ; Bing HE ; Lei WU ; Yisheng XU ; Fuping XU ; Zhongwen WANG ; Yuanbin CHEN
Journal of Traditional Chinese Medicine 2023;64(19):1995-2002
ObjectiveTo evaluate the efficacy and safety of topical Bisaitong (鼻塞通) in treating moderate-to-severe allergic rhinitis (AR). MethodsA randomized, positive-controlled, non-inferiority clinical trial design was adopted. Totally, 108 cases of moderate-to-severe AR were randomly divided into Bisaitong group and mometasone furoate group,with 54 cases in each group. The Bisaitong group was treated with Bisaitong smeared at the nasal cavity twice a day, and the mometasone furoate group received inhalation of mometasone furoate nasal spray 100 μg in each nostril, once a day. Both groups were treated for 4 weeks and followed up after additional 4 weeks. Both groups were compared on the rhinoconjunctivitis quality of life questionnaire (RQLQ), rhinoconjunctivitis total symptom score (RTSS), visual analogue score (VAS) of sneezing, runny nose, nasal itching, nasal congestion degree, days of AR episodes at enrollment, after 2- and 4-week, and at follow-up. The peripheral blood eosinophil (EOS) count and percentage (EOS%), serum eosinophil cationic protein (ECP), serum dust mite, dermatophagoides farinae, and cockroach allergen-specific IgE (sIgE) levels were compared between groups at enrollment and after 4-week treatment. Drug overuse rate was calculated, and the safety was evaluated. The analysis of all efficacy outcomes was based on both full analysis set (FAS) and per-protocol set (PPS). ResultsThe lower limit of the 95% confidence interval for the differences in RQLQ scores were greater than -0.6 measured after 2- and 4-week treatment and at follow-up compared to that measured at the enrollment in both groups, indicating of the Bisaitong group being non-inferior to the mometasone furoate group. There was no statistically significant difference between groups on RTSS score, VAS scores of sneezing, runny nose, nasal itching, nasal congestion degree and days of episodes at all timepoints (P>0.05), but each outcome changed significantly over time in both groups (P<0.01). The differences between groups in EOS count, EOS%, ECP levels, serum dust mite, dermatophagoides farinae, cockroach sIgE levels, and drug overuse rate were not statistically significant at enrollment and after 4-week treatment (P>0.05). Adverse events occurred in eight cases (15.10%) in the Bisaitong group and five cases (9.30%) in the mometasone furoate group, showing no significant difference between groups (P>0.05). ConclusionTopical Bisaitong is non-inferior to mometasone furoate nasal spray in the treatment of moderate to severe AR in terms of clinical symptom relief,reduction in the episodes, improvement of quality of life, and sound safety.
5.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