1.Fingerprint of Ciwujia Injection and its application in quality control
Jiandi LIU ; Qionglin LIANG ; Guoan LUO ; Yiming WANG
Chinese Traditional Patent Medicine 1992;0(01):-
AIM: An effective and convenient method was established for HPLC fingerprints of Ciwujia Injection (Radix et Rhizoma seucaulis acanthopanacis senticost) which provided an approach for quality control in production. METHODS: Komasil-C_(18) column, phase A: 0.2% formic acid, phase B: 35% Acetonitrile, eluted with a gradient program and detected at 270 nm. The fingerprints of extraction from crude herbs, intermediate and finished product were compared. RESULTS: The fingerprint method for Ciwujia Injection was established. The similarity of 10 batches of Ciwujia Injection was not lower than 0.977. Obvious difference was carried on among the extraction from crude herbs, intermediate and finished product. CONCLUSION: This validated method is available for quality evaluation and quality control in Ciwujia Injection's production.
2.Clinical effects of ganglioside on delayed encephalopathy after acute carbon monoxide poisoning
Zhirong ZHAO ; Jiandi ZHANG ; Aiping WU ; Rong WANG ; Zhi LI
Clinical Medicine of China 2012;28(8):864-866
Objective To observe the clinical effects of hyperbaric oxygen combined large dose ganglioside on delayed encephalopathy after acute carbon monoxide poisoning(DEACMP).Methods A totol of 72 patients of DEACMP were randomly divided into the observation group(37)and the control group(35).The patients of control group were given the routine treatment with hyperbaric oxygen.In the treatment group patients were given large doses of gangliosides 100 mg,1 times a day,for a period of 20 to 30 days additionally to the routine treatment of hyperbaric oxygen.All patients were examined before and after treatment in EEG examination (EEG),mini-mental state examination(MMSE).Results The abnormal rate of EEG was 37.83%(14/37) in the control group,which was significantly lower than that of 65.71%(23/35) in the treatment group((x2 =5.60,P < 0.05).In the treatment group,the MMSE was(15.45±2.93) and(23.70±2.13) before and after treatment,respectively; in the control group,the MMSE was(14.88±2.84) and(20.33±2.09) before and after treatment.The MMSE was significantly impoved after treatment in both group(t =3.18 and 2.91,Ps <0.05).Furthermore,the MMSE impoved more significantly in the treatment group compared to the control group (t =6.28,P < 0.05).The effective rate of treatment group was 86.48%(32/37),which was significantly higher than that of 51.43%(20/35) in the control group(x2 =7.72,P < 0.01).Conclusion Application of large dose ganglioside treatment had significant clinical effects in delayed encephalopathy after acute car-bon monoxide poisoning,which is better than the effect of routine hyperbaric oxygen treatment.
3.Effect of frequency of transcatheter arterial chemoembolization on preventing tumor recurrence after radical resection for hepatocel-lular carcinoma
Yuelin ZHANG ; Junhui SUN ; Chunhui NIE ; Liming CHEN ; Lixia CAI ; Jiandi HE ; Lixia ZHANG ; Weilin WANG ; Shusen ZHENG
Chinese Journal of Clinical Oncology 2013;(16):975-978
Objective:To compare the effect of the frequency of transcatheter arterial chemoembolization (TACE) on preventing tumor recurrence after hepatectomy. Methods:A total of 45 post-operative patients who had received prophylactic TACE once or thrice were retrospectively examined between January 2008 and June 2009. Of the 45 patients, 23 underwent TACE once, and the others un-derwent it thrice. TACE was administered to all patients via the hepatic artery one to two months after operation and was repeated every two to four months with patients who underwent TACE three times. All cases were followed up for 36 to 40 months after surgery. The rates of cumulative recurrence between the two groups were compared. Results:In the group that underwent TACE once, the 1-, 2-and 3-year cumulative recurrence rates were 30.43%, 47.83%, and 47.83%, respectively. In the group that underwent TACE thrice, the 1-, 2-and 3-year cumulative recurrence rates were 4.55%, 27.27%, and 36.36%, respectively. Statistical analysis showed that the relapse rate within one year was lower in the group that underwent TACE thrice than in the group that underwent TACE only once (P=0.022). How-ever, no significant difference in the cumulative recurrence rate was found between the two groups in two and three years (P=0.086, 0.225). Conclusion:Hepatocellular carcinoma patients who undergo preventive TACE three times after hepatectomy exhibit reduced re-currence rates during the peak time of tumor recurrence and extended disease-free survival intervals.
4.Nursing care of patients with cardiogenic shock combined with acute respiratory distress syndrome treated by extracorporeal membrane oxygenation and transferred outer-hospital in long distance
Weizhong WANG ; Hongli MA ; Zhijuan WANG ; Yaoying ZHOU ; Jiandi YU ; Chunyan WU
Chinese Journal of Practical Nursing 2020;36(10):774-777
Objective:To summarize the nursing experience in 2 patients with cardiogenic shock combined with acute respiratory distress syndrome(ARDS) treated by extracorporeal membrane oxygenation (ECMO) and transferred outer-hospital in long distance.Methods:There were many risk factors in this transport: high parameters of ECMO included V-A mode, 100% oxygen, and a flow of oxygen from 6 L/min to 10 L/min. High ventilator parameters included oxygen concentration of 100% and positive end-expiratory pressure of 15-17 cmH 2O(1 cmH 2O=0.098 kPa). Transport distance was up to 196 km. And the transport time was up to 2 h 36 min. In this regard, we carried out adequate preparations before transport and professional cares during transport. The main points were as follows: setted up a professional transport team; prepared adequate power and oxygen supply; reduced the number of interruption of ECMO and ventilator support during transport; provided the reasonable remedial actions when ECMO and ventilator support were interrupted. Results:Two patients arrived at the destination safely.Conclusions:Adequate preparations before transport and professional cares during transport could effectively avoid and respond to the occurrence of adverse events, and it is feasible and safe to patients supported by ECMO for long distance outer-hospital transport.
5.Expression and its clinical significance of serum insulin-like growth factors in patients with clear cell carcinoma of kidney
Yi HE ; Hua WANG ; Renye DING ; Jiandi LIU ; Linfeng LU ; Yanqin GU ; Zhenhua JIANG ; Zengfu YU ; Yansong HOU ; Hao CHEN ; Lingfeng WU
Chinese Journal of Geriatrics 2011;30(3):223-225
Objective To observe the expressions of serum insulin-like growth factor (IGF)- Ⅰ ,Ⅱ and IGF binding protein (IGFBP) 3, 5 and to explore the clinical significances in patients with clear cell carcinoma of kidney. Methods Enzyme-linked immunosorbent assay (ELISA) methods were adopted to examine serum expressions of IGF-Ⅰ , Ⅱ and IGFBP 3, 5 in 40 cases with clear cell carcinoma of kidney (renal carcinoma group) and 16 cases with hydronephrosis (control group) from May 2007 to December 2009. Results IGF- Ⅰ , Ⅱ and IGFBP 3,5 in renal carcinoma showed higher expressions before operation (985. 7 μg/L, 1154.0 μg/L,46.6 μg/L and 9.6 μg/L, respectively)than after operation (431.4 μg/L, 632.6 μg/L, 26.7 μg/L, and 6.7 μg/L, respectively, all P<0. 05 ~0.01). There were no significant differences in those indexes between pre- and post- operation in control group (P> 0. 05). Conclusions There are high expressions of serum IGF-Ⅰ , Ⅱ and IGFBP 3, 5 in renal carcinoma patients, and IGF- Ⅱ has clinical significance in diagnosis.
6.Short-term efficacy of pemetrexed combined with cisplatin in the treatment of malignant pleural effusion and its effect on serum carbohydrate antigen 199 level and circulating tumor cells
Jiandi WANG ; Jie CHEN ; Mingjie HU
Chinese Journal of Primary Medicine and Pharmacy 2021;28(6):849-854
Objective:To investigate the short-term efficacy of pemetrexed combined with cisplatin in the treatment of malignant pleural effusion and its effect on serum carbohydrate antigen 199 level and circulating tumor cells.Methods:Sixty patients with advanced lung cancer complicated by malignant pleural effusion who received treatment in Healthcare Group of Cixi Third People's Hospital, China from January 2017 to January 2020 were included in this study. They were randomly assigned to receive intrapleural injection of cisplatin (cisplatin alone group, n = 30) or intrapleural injection of cisplatin combined with intravenous injection of pemetrexed (cisplatin + pemetrexed group, n = 30) after thoracic drainage. Before and 1 month after treatment, pleural effusion was measured to evaluate clinical efficacy and improvement in quality of life. Serum carcinoembryonic antigen level, serum carbohydrate antigen 199 level and circulating tumor cells were determined. Adverse reactions during the treatment were recorded. Results:Total effective rate and the rate of improvement in quality of life in the cisplatin + pemetrexed group were 66.67% (20/30) and 70.00% (21/30), respectively, which were significantly higher than those in the cisplatin alone group [40.00% (12/30) and 43.33% (13/30), χ2 = 4.286, 4.344, both P < 0.05]. After treatment, serum carcinoembryonic antigen and serum carbohydrate antigen 199 levels in each group were significantly decreased compared with before treatment (both P < 0.05). Serum carcinoembryonic antigen and serum carbohydrate antigen 199 level in the cisplatin + pemetrexed group were (22.26 ± 5.13) ng/mL and (20.12 ± 4.35) U/mL, respectively, which were significantly lower than those in the cisplatin alone group [(31.64 ± 6.46) ng/mL, (28.07 ± 5.61) U/mL, t = 6.228, 3.134, both P < 0.05). In the cisplatin alone group, there was no significant difference in the proportion of circulating tumor cells before and after treatment ( P > 0.05). In the cisplatin + pemetrexed group, the proportion of circulating tumor cells after treatment was significantly lower than that before treatment ( χ2 = 4.286, P < 0.05). After treatment, there was no significant difference in the proportion of circulating tumor cells between the two groups ( P > 0.05). During the treatment, there were no significant differences in the incidences of rash, nausea and vomiting, leukopenia, and anemia between the two groups (all P > 0.05). Conclusion:Pemetrexed combined with cisplatin in the treatment of malignant pleural effusion exhibits better short-term efficacy than cisplatin alone. The combined therapy is more conducive to relieving clinical symptoms and improving the quality of life with higher safety than monotherapy.
7.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