1.Preparation of a co-amorphous form of bexarotene-PVP-K30 and evaluation in rats
Shu-yue REN ; Ling-tai JIAO ; Hao-ying YU ; Jing-rong WANG ; Jun-ke SONG ; Ting-ting LÜ ; Yang LÜ ; Shi-ying YANG ; Lan SUN ; Guan-hua DU
Acta Pharmaceutica Sinica 2020;55(5):1015-1021
		                        		
		                        			
		                        			 Bexarotene is a synthetic analogue of retinoic acid and exerts protective effects on the nervous system. However, low bioavailability and poor solubility of the crystal type I form severely limits the application of bexarotene in the clinic. A co-amorphous sample of bexarotene-PVP-K30 was prepared and the structure was characterized by X-ray diffraction and infrared spectroscopy. To determine the pharmacokinetics and tissue distribution of bexarotene, an LC-MS method was established to profile and quantify bexarotene in plasma and tissues of SD rats. 
		                        		
		                        	
2.Efficacy of Rituximab for Patients with Chronic Lymphocytic Leukemia.
Heng LI ; Wen Jie XIONG ; Hui Min LIU ; Shu Hua YI ; Rui LÜ ; Ting Yu WANG ; Zhen YU ; Lu Gui QIU ; Zeng Jun LI
Acta Academiae Medicinae Sinicae 2017;39(6):800-805
		                        		
		                        			
		                        			Objective To evaluate the efficacy of rituximab in treating chronic lymphocytic leukemia (CLL). Methods The clinical data of CLL patients receiving fludarabine,cyclophosphamide±rituximab (with or without rituximab) regimen or cyclophosphamide,vincristine,and prednisone±doxorubicin±rituximab regimen in our hospital from March 2000 to February 2015 were analyzed retrospectively. Therapeutic efficacies and survivals of patients treated with different regimens were evaluated and compared. Results The complete response (CR) rate and the overall response rate (ORR) in 72 patients (43.6%) treated with rituximab were significantly higher than those treated without rituximab (38.9% vs. 21.5%,P=0.015;83.3% vs. 60.2%,P=0.001). The median PFS and OS for patients treated with rituximab were 53.0 (27.0-79.0) months and 112.0 (81.1-142.9) months,and the median PFS and OS for patients treated without rituximab were 28.0 (18.3-37.7) months and 89.0(72.0-106.0),but the results were not statistically significant (P=0.094,P=0.109). According to the cytogenetic features,patients were further divided into high-risk subgroup (with chromosome 17p deletion or 11q deletion) and non-high-risk subgroup. And in the high-risk subgroup,the ORR of patients treated with rituximab was 86.4%,which was significantly higher than that in patients treated without rituximab (53.3%)(P=0.012);in the non-high-risk subgroup,the PFS was marginally prolonged in patients treated with rituximab,but the difference was not statistically significant(P=0.050). Conclusions Compared with traditional chemotherapy,the chemoimmunotherapies with rituximab result in higher CR rate and ORR in CLL patients. In patients without 17p deletion or 11q deletion,the use of rituximab can marginally prolong PFS.
		                        		
		                        		
		                        		
		                        	
3.Multi-center clinical trial of FLAMIGEL (hydrogel dressing) for the treatment of residual burn wound.
Hui-zhong YANG ; Wen-kui WANG ; Li-li YUAN ; Shun-bin WANG ; Gao-xing LUO ; Jun WU ; Xi-hua NIU ; Bing-wei SUN ; Guang-gang DU ; Hai-hui LI ; Shun CHEN ; Zhao-hong CHEN ; Cheng-de XIA ; Shu-ren LI ; Tao LÜ ; Hui SUN ; Xi CHEN ; Xiao-long HE ; Bing ZHANG ; Jing-ning HUAN
Chinese Journal of Burns 2013;29(2):177-180
OBJECTIVETo evaluate the effect of FLAMIGEL (hydrogel dressing) on the repair of residual burn wound.
METHODSSixty burn patients with residual wounds hospitalized in 6 burn units from November 2011 to May 2012 were enrolled in the multi-center, randomized, and self-control clinical trial. Two residual wounds of each patient were divided into groups T (treated with FLAMIGEL) and C (treated with iodophor gauze) according to the random number table. On post treatment day (PTD) 7 and 14, wound healing rate was calculated, with the number of completely healed wound counted. The degree of pain patient felt during dressing change was evaluated using the visual analogue scale (VAS). The mean numbers of wounds with score equal to zero, more than zero and less than or equal to 3, more than 3 and less than or equal to 6, more than 6 and less than or equal to 10 were recorded respectively. Wound secretion or exudate samples were collected for bacterial culture, and the side effect was observed. Data were processed with repeated measure analysis of variance, t test, chi-square test, and nonparametric rank sum test.
RESULTSWound healing rate of groups T, C on PTD 7 was respectively (67 ± 24)%, (45 ± 25)%, and it was respectively (92 ± 16)%, (72 ± 23)% on PTD 14. There was statistically significant difference in wound healing rate on PTD 7, 14 between group T and group C (F = 32.388, P < 0.01). Ten wounds in group T and four wounds in group C were healed completely on PTD 7, with no significant difference between them (χ(2) = 0, P > 0.05). Forty-two wounds in group T and seven wounds in group C healed completely on PTD 14, with statistically significant difference between them (χ(2) = 42.254, P < 0.01). Patients in group T felt mild pain during dressing change for 37 wounds, with VAS score higher than zero and lower than or equal to 3. Evident pain was observed in patients of group C during dressing change for 43 wounds, and it scored higher than 3 and less than or equal to 6 by VAS evaluation. There was statistically significant difference in mean number of wounds with different grade of VAS score between group T and group C (Z = -4.638, P < 0.01). Staphylococcus aureus, Pseudomonas aeruginosa, Klebsiella pneumoniae, E. coli, Baumanii, and Staphylococcus epidermidis were all detected in both groups, but there was no statistical difference between group T and group C (χ(2) = 0.051, P > 0.05). No side effect was observed in either of the two groups during the whole trial.
CONCLUSIONSFLAMIGEL can accelerate the healing of residual burn wounds and obviously relieve painful sensation during dressing change.
Adolescent ; Adult ; Aged ; Bandages ; Burns ; therapy ; Female ; Humans ; Hydrogels ; Male ; Middle Aged ; Young Adult
4.Retrospective analysis of clinical and epidemiological characteristics of hand-foot-and-mouth disease deceased cases in Zhejiang Province.
Jian CAI ; Jun-Fen LIN ; Hua-Kun LÜ ; Zi-Ping MIAO ; Shu-Wen QIN ; Yan-Li CAO ; Zhi-Ping CHEN
Chinese Journal of Pediatrics 2013;51(4):265-269
OBJECTIVETo understand the clinical and epidemiological characteristics of hand-foot-and-mouth disease (HFMD) deceased cases.
METHODInformation of demographics, diagnosis and treatment, clinical symptoms and signs, laboratory test results, and epidemiological contact history of 72 HFMD cases who died between May 2008 and September 2011, in Zhejiang Province, were collected and analyzed.
RESULTThe average age of the 72 cases was 1.8 years, 45 were males, accounting for 62.5%, 63 (87.5%) of the cases were scattered children. Eighteen counties reported 2 or more deaths, accounting for 46.1% (18/39) among the counties where the deaths were reported. The deaths occurred mainly in April to August, the peak occurred in May and June. Fever (98.4%, 63/64) and rash (95.1%, 58/61) were the most common symptoms, but the rash was not obvious at the first diagnosis. Fever occurred before the rash (79.0%, 49/62), persisted for 4 days in average. Vomiting (71.9%, 46/64), dyspnea (65.6%, 42/64), cyanosis (53.1%, 34/64) and impaired consciousness (51.6%, 33/64) were often seen among the cases; 53.1% (34/64) cases went to see the doctor on the first day, but 82.5%(52/63)cases were misdiagnosed. Time to diagnosis of HFMD was in average 3 days. About 3 to 4 days after the onset, the disease deteriorated sharply, deaths occurred within 1 day after admission in 78.9%(45/57)of the deceased cases; 85.0% (34/40) cases had high white blood cells level, mainly neutrophils increased, the ratio of neutrophil was more than 70% in 55.6% (15/27) of cases. Enterovirus 71 (EV71) infection was found in 93.3% (56/60) cases, the deceased cases often died of pulmonary hemorrhage (42.9%, 21/49) and encephalitis (34.7%, 17/49). The sanitary conditions of the cases' family were poor (65.5%, 36/55), but 73.3% (33/45) cases had no exposure history.
CONCLUSIONThe HFMD deceased cases were mostly younger aged boys, scattered children, nonlocal-residents, and had poor sanitation. They were often infected with EV71, had high fever but had no typical rash, no clear exposure history, they had increased leukocyte, and were often misdiagnosed. Three or 4 days after onset, the disease deteriorated abruptly, most cases died within 1 week after onset. To decrease the HFMD mortality, early detection of severe cases should be stressed, and relative measures should be taken. The guardian should be aware of having good sanitary situation and healthy habits.
Animals ; Child, Preschool ; China ; epidemiology ; Disease Outbreaks ; Enterovirus A, Human ; isolation & purification ; Feces ; virology ; Female ; Fever ; etiology ; pathology ; Hand, Foot and Mouth Disease ; epidemiology ; mortality ; pathology ; Humans ; Infant ; Male ; Retrospective Studies ; Sex Distribution
5.Treatment of acromion base fractures with double plates internal fixation.
Guo-Qiang LÜ ; Jun-Kun ZHU ; Shu-Hua LAN ; Quan-Zhou WU ; Rong-Zong ZHENG ; Chong-Wu ZHENG
China Journal of Orthopaedics and Traumatology 2013;26(9):779-783
OBJECTIVETo study clinical effects of double plates fixation for the treatment of acromion base fracutres.
METHODSFrom January 2010 to May 2012, 7 patients with acromion base fractures were treated with double plates ORIF surgical treatment. There were 5 males and 2 females, with an average age of 36.3 years old (ranged, 24 to 62 years old). All fractures were acuted and closed injuries. The duration from injury to surgery was 4.6 days (ranged, 2 to 10 days). Hardegger functional criterion, Visual Analogue Scale (VAS) and complications of the patients were documented analysis.
RESULTSAll the patients were followed up,and the duration ranged from 4 to 13 months (averaged 8.9 months). The healing duration of fractures ranged from 8 to 14 weeks without any infection, shoulder instability, subacromial impingement syndrome, nonunion and failure of internal fixation. At the latest follow-up, the VAS ranged from 0 to 5. According to Hardegger criterion, 2 patients got an excellent result, 4 good and 1 poor.
CONCLUSIONDouble plates ORIF plays a positive role in the treatment of acromion base fractures, which reduces complications and maximally restore the function of shoulder.
Acromion ; injuries ; surgery ; Adult ; Bone Plates ; Female ; Fracture Fixation, Internal ; methods ; Fractures, Bone ; surgery ; Humans ; Male ; Middle Aged ; Visual Analog Scale
6.Surgical treatment of acetabular type C1 acetabular fracture by posteroproximal-posteroanterior sequential reduction and internal fixation.
Shu-Hua LAN ; Jun-Kun ZHU ; Shu-Ming HUANG ; Ji-Fei YE ; Quan-Zhou WU ; Fang YE ; Guo-Qiang LÜ
China Journal of Orthopaedics and Traumatology 2013;26(6):516-520
OBJECTIVETo investigate the operative reduction techniques and clinical results of surgical treatment of type C1 (AO/ASIF) acetabular fracture by posteroproximal-posteroanterior sequential reduction and internal fixation.
METHODSFrom August 2004 to January 2012, 13 patients with type C1 (AO/ASIF) acetabular fracture were treated by posteroproximal-posteroanterior sequential reduction and internal fixation. Of them, 8 cases were male and 5 cases were female with an average age of 42 years years old (ranged, 18 to 64). Pelvis 3-dimentional CT reconstruction were used to confirmed the classification of fracture, and the operation were performed during from 5 to 20 days with an average of 9.5 days. Operation time, blood loss, complications and reduction were recorded and evaluated. The function of hip joint were accessed at the final follow-up.
RESULTSThe operation time ranged from 190 to 290 min with an average of 240 min. The mean blood loss was 1 800 ml (ranged, 1 300 to 3 000 ml). One case had superficial infection and healed after 3 weeks. According to Matta reduction criteria, 8 cases obtained anatomical reduction, 4 cases got satisfied results and 1 cases got unsatisfied results. Eleven cases were followed up with an average of (24.0 +/- 8.0) months, and 2 cases were lost to follow-up. According to revised Mede d'Aubingne and Postel evaluation system, 7 cases got excellent results, 2 good, 1 moderate and 1 poor.
CONCLUSIONPosteroproximal-posteroanterior sequential reduction and internal fixation for the treatment of type C1 (AO/ASIF) acetabular fracture can achieve satisfied surgical proces and operation quality.
Acetabulum ; diagnostic imaging ; injuries ; surgery ; Adolescent ; Adult ; Female ; Fracture Fixation, Internal ; Hip Fractures ; diagnostic imaging ; surgery ; Hip Joint ; diagnostic imaging ; surgery ; Humans ; Male ; Middle Aged ; Radiography ; Treatment Outcome ; Young Adult
7.Change in cholesterol absorption and synthesis markers in patients with coronary heart disease after combination therapy with simvastatin plus ezetimibe.
Tao ZHANG ; Wen-feng WU ; Yang LIU ; Qi-hui WANG ; Lü-ya WANG ; Shu-hua MI
Chinese Medical Journal 2013;126(9):1618-1623
BACKGROUNDStatins and ezetimibe have been reported to change the balance of cholesterol metabolism, but few studies have been performed on Chinese patients. The aim of this study was to evaluate changes in cholesterol metabolism markers in patients with coronary heart disease.
METHODSForty-five patients with coronary heart disease were treated with 20 mg/d of simvastatin for four weeks. Subjects were then divided into two different therapy groups according to whether they reached the target values for total cholesterol and low density lipoprotein cholesterol level. Patients who reached the target values remained on simvastatin and those who did not reach the target values took a combination of simvastatin plus 10 mg/d ezetimibe until the 12th week. The concentrations of cholesterol synthesis markers (lathosterol and desmosterol) and absorption markers (campesterol and sitosterol) were measured on the 1st, 4th, and 12th week of the study by gas chromatography.
RESULTSAfter treatment with simvastatin for four weeks, the levels of total cholesterol and low density lipoprotein cholesterol decreased significantly compared to levels measured during the 1st week (P < 0.05). On the 12th week the levels of total cholesterol and low density lipoprotein cholesterol had decreased significantly (P < 0.001) compared to levels during the 4th week. By the 12th week the levels of campesterol and sitosterol in the combination group had decreased significantly (P < 0.05) compared with levels measured during the 4th week.
CONCLUSIONSCoronary heart disease patients with high cholesterol synthesis at baseline might gain a greater benefit from simvastatin treatment. Combination therapy with simvastatin plus ezetimibe in patients with low cholesterol synthesis at baseline might increase the success rate of lipid-lowering through decreasing the absorption of cholesterol.
Adult ; Aged ; Azetidines ; administration & dosage ; Cholesterol ; metabolism ; Cholesterol, LDL ; blood ; Coronary Disease ; drug therapy ; metabolism ; Drug Therapy, Combination ; Ezetimibe ; Female ; Humans ; Male ; Middle Aged ; Simvastatin ; administration & dosage
8.Clinical variability in onset of influenza A (H7N9) infection.
Shu-Ying WANG ; Shu-Hua REN ; Mei-Xian HUANG ; Dao-Jun YU ; Qiang SHEN ; Hong-Feng ZHAO ; Qiao-Hong LÜ ; Shen-Xian QIAN
Chinese Medical Journal 2013;126(21):4194-4196
		                        		
		                        		
		                        		
		                        			Adult
		                        			;
		                        		
		                        			Aged
		                        			;
		                        		
		                        			Brugada Syndrome
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		                        			diagnosis
		                        			;
		                        		
		                        			virology
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		                        			Humans
		                        			;
		                        		
		                        			Influenza A Virus, H7N9 Subtype
		                        			;
		                        		
		                        			pathogenicity
		                        			;
		                        		
		                        			Influenza, Human
		                        			;
		                        		
		                        			diagnosis
		                        			;
		                        		
		                        			virology
		                        			;
		                        		
		                        			Male
		                        			;
		                        		
		                        			Middle Aged
		                        			
		                        		
		                        	
9.Clinical observation of icotinib hydrochloride for patients with advanced non-small cell lung cancer.
Xi LI ; Xin-jie YANG ; Yi-fen SUN ; Na QIN ; Jia-lin LÜ ; Yu-hua WU ; Hui ZHANG ; Quan ZHANG ; Shu-cai ZHANG
Chinese Journal of Oncology 2012;34(8):627-631
OBJECTIVETo explore the efficacy and side effects of icotinib hydrochloride in the treatment of patients with advanced non-small cell lung cancer (NSCLC).
METHODSThe efficacy and side effects of icotinib hydrochloride in treatment of 59 cases with stage IV NSCIC and followed-up from March 2009 to January 2012 were retrospectively analyzed.
RESULTSTwenty seven patients (45.8%) showed partial response (PR), 17 patients (28.8%) achieved SD, and 15 (25.4%) had progressive disease. The objective response rate (ORR) was 45.8% (27/59), and disease control rate (DCR) was 74.6% (44/59). Among the 23 patients with EGFR mutation, ORR was 73.9% (17/23), and DCR was 95.7% (22/23). Thirty six patients (61.0%) achieved remission of symptoms to varying degrees. The main symptoms relieved were cough, asthmatic suffocating, pain and hoarseness. The major adverse events were mild skin rash (35.6%) and diarrhea (15.3%). Others were dry skin, nausea and stomach problems. The efficacy of icotinib hydrochloride were related to the ECOG performance status, smoking history, EGFR mutation and rash significantly (P < 0.05).
CONCLUSIONSMonotherapy with icotinib hydrochloride is effective and tolerable for patients with advanced NSCLC, especially with EGFR mutation.
Adult ; Aged ; Aged, 80 and over ; Antineoplastic Agents ; adverse effects ; therapeutic use ; Carcinoma, Non-Small-Cell Lung ; drug therapy ; genetics ; pathology ; Crown Ethers ; adverse effects ; therapeutic use ; Diarrhea ; chemically induced ; Disease Progression ; Exanthema ; chemically induced ; Exons ; Female ; Follow-Up Studies ; Humans ; Lung Neoplasms ; drug therapy ; genetics ; pathology ; Male ; Middle Aged ; Mutation ; Neoplasm Staging ; Quinazolines ; adverse effects ; therapeutic use ; Receptor, Epidermal Growth Factor ; genetics ; Remission Induction ; Retrospective Studies ; Survival Rate
10.Comparison of the short-term outcomes of surgical treatment for non-small cell lung cancer via video assisted thoracoscopic surgery and open thoracotomy.
Ju-wei MU ; Bai-hua ZHANG ; Ning LI ; Fang LÜ ; You-sheng MAO ; Qi XUE ; Shu-geng GAO ; Jun ZHAO ; Da-li WANG ; Zhi-shan LI ; Yu-shun GAO ; Liang-ze ZHANG ; Jin-feng HUANG ; Kang SHAO ; Fei-yue FENG ; Liang ZHAO ; Jian LI ; Gui-yu CHENG ; Ke-lin SUN ; Jie HE
Chinese Journal of Oncology 2012;34(4):301-305
OBJECTIVETo compare the short-term outcomes of surgical treatment for non-small cell lung cancer (NSCLC) by video-assisted thoracoscopic surgery (VATS) and open thoracotomy (OT).
METHODSData of 737 consecutive NSCLC patients who underwent surgical treatment for non-small cell lung cancer by video-assisted thoracoscopic surgery and 630 patients who underwent pulmonary resection via open thoracotomy (as controls) in Cancer Institute & Hospital, Chinese Academy of Medical Sciences between January 2009 and August 2011 were retrospectively reviewed. The risk factors after lobectomy were also analyzed.
RESULTSIn the 506 NSCLC patients who received VATS lobectomy, postoperative complications occurred in 13 patients (2.6%) and one patient died of acute respiratory distress syndrome (0.2%). In the 521 patients who received open thoracotomy (OT) lobectomy, postoperative complications occurred in 21 patients (4.0%) and one patient died of pulmonary infection (0.2%). There was no significant difference in the morbidity rate (P > 0.05) and mortality rate (P > 0.05) between the VATS group and OT group. In the 190 patients who received VATS wedge resections, postoperative complications occurred in 3 patients (1.6%). One hundred and nine patients received OT wedge resections. Postoperative complications occurred in 4 patients (3.7%). There were no significant differences for morbidity rate (P = 0.262) between these two groups, and there was no perioperative death in these two groups. Univariate and multivariate analyses demonstrated that age (OR = 1.047, 95%CI: 1.004 - 1.091), history of smoking (OR = 6.374, 95%CI: 2.588 - 15.695) and operation time (OR = 1.418, 95%CI: 1.075 - 1.871) were independent risk factors of postoperative complications.
CONCLUSIONSTo compare with the NSCLC patients who should undergo lobectomy or wedge resection via open thoracotomy, a similar short-term outcome can be achieved via VATS approach.
Age Factors ; Carcinoma, Non-Small-Cell Lung ; mortality ; pathology ; surgery ; Female ; Humans ; Length of Stay ; Lung Neoplasms ; mortality ; pathology ; surgery ; Lymphatic Metastasis ; Male ; Middle Aged ; Operative Time ; Pneumonectomy ; adverse effects ; classification ; methods ; Postoperative Complications ; etiology ; Respiratory Distress Syndrome, Adult ; etiology ; Retrospective Studies ; Smoking ; Thoracic Surgery, Video-Assisted ; adverse effects ; Thoracotomy ; adverse effects ; methods
            
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