1.Efficacy and safety of mitoxantrone hydrochloride liposome injection in treatment of peripheral T-cell lymphomas: a multicenter, non-interventional, ambispective cohort, real-world study (MOMENT)
Huiqiang HUANG ; Zhiming LI ; Lihong LIU ; Liang HUANG ; Jie JIN ; Hongyan TONG ; Hui ZHOU ; Zengjun LI ; Zhenqian HUANG ; Wenbin QIAN ; Kaiyang DING ; Quande LIN ; Ming HOU ; Yunhong HUANG ; Jingbo WANG ; Pengcheng HE ; Xiuhua SUN ; Xiaobo WANG ; Zunmin ZHU ; Yao LIU ; Jinhai REN ; Huijing WU ; Liling ZHANG ; Hao ZHANG ; Liangquan GENG ; Jian GE ; Ou BAI ; Liping SU ; Guangxun GAO ; Xin LI ; Yanli YANG ; Yijian CHEN ; Aichun LIU ; Xin WANG ; Yi WANG ; Liqun ZOU ; Xiaobing HUANG ; Dongping HUANG ; Shujuan WEN ; Donglu ZHAO ; Jun MA
Journal of Leukemia & Lymphoma 2023;32(8):457-464
Objective:To evaluate the efficacy and safety of mitoxantrone hydrochloride liposome injection in the treatment of peripheral T-cell lymphoma (PTCL) in a real-world setting.Methods:This was a real-world ambispective cohort study (MOMENT study) (Chinese clinical trial registry number: ChiCTR2200062067). Clinical data were collected from 198 patients who received mitoxantrone hydrochloride liposome injection as monotherapy or combination therapy at 37 hospitals from January 2022 to January 2023, including 166 patients in the retrospective cohort and 32 patients in the prospective cohort; 10 patients in the treatment-na?ve group and 188 patients in the relapsed/refractory group. Clinical characteristics, efficacy and adverse events were summarized, and the overall survival (OS) and progression-free survival (PFS) were analyzed.Results:All 198 patients were treated with mitoxantrone hydrochloride liposome injection for a median of 3 cycles (range 1-7 cycles); 28 cases were treated with mitoxantrone hydrochloride liposome injection as monotherapy, and 170 cases were treated with the combination regimen. Among 188 relapsed/refractory patients, 45 cases (23.9%) were in complete remission (CR), 82 cases (43.6%) were in partial remission (PR), and 28 cases (14.9%) were in disease stabilization (SD), and 33 cases (17.6%) were in disease progression (PD), with an objective remission rate (ORR) of 67.6% (127/188). Among 10 treatment-na?ve patients, 4 cases (40.0%) were in CR, 5 cases (50.0%) were in PR, and 1 case (10.0%) was in PD, with an ORR of 90.0% (9/10). The median follow-up time was 2.9 months (95% CI 2.4-3.7 months), and the median PFS and OS of patients in relapsed/refractory and treatment-na?ve groups were not reached. In relapsed/refractory patients, the difference in ORR between patients with different number of treatment lines of mitoxantrone hydrochloride liposome injection [ORR of the second-line, the third-line and ≥the forth-line treatment was 74.4% (67/90), 73.9% (34/46) and 50.0% (26/52)] was statistically significant ( P = 0.008). Of the 198 PTCL patients, 182 cases (91.9%) experienced at least 1 time of treatment-related adverse events, and the incidence rate of ≥grade 3 adverse events was 66.7% (132/198), which was mainly characterized by hematologic adverse events. The ≥ grade 3 hematologic adverse events mainly included decreased lymphocyte count, decreased neutrophil count, decreased white blood cell count, and anemia; non-hematologic adverse events were mostly grade 1-2, mainly including pigmentation disorders and upper respiratory tract infection. Conclusions:The use of mitoxantrone hydrochloride liposome injection-containing regimen in the treatment of PTCL has definite efficacy and is well tolerated, and it is a new therapeutic option for PTCL patients.
2.Efficacy and Safety of Pulse Magnetic Therapy System in Insomnia Disorder: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
Jiwu LIAO ; Sisi WANG ; Borong ZHOU ; Wei LIANG ; Ping MA ; Min LIN ; Weisen LIN ; Congrui LI ; Xiaotao ZHANG ; Hongyao LI ; Yin CUI ; Jiajia HU ; Yuanyi QIN ; Yanhua DENG ; Aibing FU ; Tianhua ZHU ; Shanlian ZHANG ; Yunhong QU ; Lu XING ; Wumei LI ; Fei FENG ; Xinping YAO ; Guimei ZHANG ; Jiyang PAN
Psychiatry Investigation 2023;20(6):559-566
Objective:
This study’s objective is to assess the efficacy and safety of Pulsed Magnetic Therapy System (PMTS) in improving insomnia disorder.
Methods:
Participants with insomnia disorder were randomly assigned to receive either PMTS or sham treatment for four weeks (n= 153; PMTS: 76, sham: 77). Primary outcomes are the Insomnia Severity Index (ISI) scores at week 0 (baseline), 1, 2, 3, 4 (treatment), and 5 (follow-up). Secondary outcomes are the Pittsburgh Sleep Quality Index at baseline and week 4, and weekly sleep diary-derived values for sleep latency, sleep efficiency, real sleep time, waking after sleep onset, and sleep duration.
Results:
The ISI scores of the PMTS group and the sham group were 7.13±0.50, 11.07±0.51 at week 4, respectively. There was a significant group×time interaction for ISI (F3.214, 485.271=24.25, p<0.001, ηp 2=0.138). Only the PMTS group experienced continuous improvement throughout the study; in contrast, the sham group only experienced a modest improvement after the first week of therapy. At the end of the treatment and one week after it, the response of the PMTS group were 69.7% (95% confidence interval [CI]: 58.6%–79.0%), 75.0% (95% CI: 64.1%–83.4%), respectively, which were higher than the response of the sham group (p<0.001). For each of the secondary outcomes, similar group×time interactions were discovered. The effects of the treatment persisted for at least a week.
Conclusion
PMTS is safe and effective in improving insomnia disorders.
3.Prevalence and risk factors of diabetic retinopathy in Tibet
Dan ZHANG ; Suyuan WANG ; Mingxia LI ; Xuanyu YAO ; Zengmei SUN ; Chenghui ZHANG ; Shuyao SUN ; Yunhong WU
Chinese Journal of Primary Medicine and Pharmacy 2022;29(6):835-840
Objective:To investigate the prevalence and risk factors of diabetic retinopathy (DR) in patients in Tibet.Methods:A total of 239 patients with DR who received treatment in Department of Endocrinology and Metabolism, Hospital of Chengdu Office of People's Government of Tibet Autonomous Region from December 2017 to December 2018 were included in this study. They were divided into Han nationality and Zang nationality groups according to ethnicity. The condition of DR was evaluated with nonmydriatic ocular fundus photography according to the staging criteria of the severity of retinopathy.Results:The prevalence of DR in Tibet was 18.0%. The prevalence of DR in Tibetan and Han patients with diabetes was 17.5% and 19.2%, respectively. There was no significant difference in the prevalence of DR between Tibetan and Han patients with diabetes ( χ2 = 0.10, P = 0.754). Logistic regression analysis revealed that the risk factors of developing DR in Tibet included diabetes duration ( OR = 1.14, 95% CI: 1.05-1.24, P < 0.05), insulin therapy ( OR = 2.74, 95% CI: 1.09-6.89, P < 0.05), fasting plasma glucose ( OR = 1.37, 95% CI: 1.07-1.75, P < 0.05) and hypertension ( OR = 1.98, 95% CI: 1.02-3.86, P < 0.05). Diabetes duration and fasting plasma glucose are independent risk factors of DR. However, although elevated glycated hemoglobin levels were high in Tibet, they could not be used to predict the risk for developing DR ( OR = 1.01, 95% CI: 0.82-1.25, P > 0.05). Conclusion:Hyperglycemia is an important risk factor of developing DR in Tibet. However, elevated glycated hemoglobin levels cannot be used to predict the risk of developing DR in Tibet. Findings from this study fill the gap in the research on DR prevalence and ethic difference of DR prevalence, providing scientific evidence for prevention and treatment of DR in high-altitude areas.
4.Clinical efficacy of free flap in repairing Gustilo ⅢB and ⅢC fractures of tibia and fibula combined with soft tissue defects
Yongjun RUI ; Yongwei WU ; Jun LIU ; Yunhong MA ; Fengfeng LI ; Yao LU ; Tong YANG ; Ming ZHOU ; Yongqiang KANG ; Jun GU
Chinese Journal of Trauma 2018;34(10):881-885
Objective To investigate the clinical efficacy of free flap transplantation in repairing the Gustilo type ⅢB and ⅢC fractures of tibia and fibula combined with soft tissue defects.Methods A retrospective case series study was conducted on the clinical data of 46 patients who had Gustilo type ⅢB and ⅢC fractures of tibia and fibula with soft tissue defects admitted from June 2013 to January 2017.There were 34 males and 12 females,aged 1-67 years (mean,39 years).The wound defect areas ranged from 6 cm × 20 cm to 7 cm × 38 cm.According to the Gustilo fracture classification,there were 31 cases of type ⅢB and 15 cases of type ⅢC.According to the AO fracture typing,there were five cases of type A,23 type B,and 18 type C.All patients were repaired with free flap transplantation,among which 40 patients were treated with anterolateral thigh flap and six with latissimus dorsi flap.The areas of anterolateral thigh flap ranged from 6 cm × 13 cm to 14 cm ×32 cm,and those of the latissimus dorsi flap from 6 cm × 22 cm to 7 cm × 40 cm.Efficacy was evaluated by flap survival rate,complications,fracture healing time,lower limb function scoring system (LEFS),and skin flap function.Results All limbs were salvaged successfully.One case of total flap necrosis and eight cases of postoperative crisis occurred.After active exploration and treatment,three cases were seen distal local necrosis,and the total survival rate was 91%.Infection at the donor site was found in two cases.The complication incidence rate was 4%.All patients were followed up for 7-42 months,with an average of 19 months.The fracture healing time averaged 43.5 weeks,and the LEFS score averaged 54 points.According to the seven indexes of flap function,the results were excellent in 1 1 cases,good in 29 cases,fair in four cases,and poor in two cases,with an excellent and good rate of 87%.Conclusion Free flap transplantation can achieve satisfactory efficacy in treating Gustilo type ⅢB and ⅢC of tibia and fibula combined with soft tissue defects,with high limb salvage rate and good function recovery.
5.Early internal fixation combined with perforator flap for treatment of forearm open fractures with soft tissue defects of Gustilo types Ⅲ B & Ⅲ C
Yongjun RUI ; Yongwei WU ; Jun LIU ; Fengfeng LI ; Yunhong MA ; Yao LU ; Yongqiang KANG ; Ming ZHOU ; Tong YANG ; Fang LIN
Chinese Journal of Orthopaedic Trauma 2018;20(8):648-653
Objective To investigate the clinical therapy of early internal fixation combined with perforator flap for forearm open fractures of Gustilo types Ⅲ B & Ⅲ C.Methods A retrospective study was conducted of the 45 patients with forearm open fracture of Gustilo type ⅢB or Ⅲ C who had been treated from July 2012 to October 2016 at Department of Traumatic Orthopaedics,The Ninth People's Hospital of Wuxi.They were 26 men and 19 women,aged from 20 to 61 years (average,41 years).Twenty cases were Gustilo type ⅢB and 25 Gustilo type ⅢC.By AO classification,8 cases were type A,21 ones type B,and 16 ones type C.The wound size ranged from 4 cm × 3 cm to 36 cm × 8 cm.Thirty-three patients were treated by primary internal fixation plus secondary transfer with a perforator flap,12 ones by secondary internal fixation plus transfer with a perforator flap.The period from injury to secondary flap transfer ranged from 5 to 20 days (average,12 days).In this series,36 anterolateral thigh perforator flaps,5 latissimus dorsal muscular flaps and 4 lateral arm flaps were transferred.Results All the 45 free flaps survived with no deep infection or osteomyelitis.Partial necrosis happened at the distal ends of 2 latissimus dorsal muscular flaps which were cured by skin graft.Postoperative circulatory crisis happened after transfer of an anterolateral thigh perforator flap which survived with 5 cm skin necrosis at the distal end after successful surgical exploration.Superficial wound infection happened in 12 patients with no deep or bone infection.All the patients were followed up for 12 to 36 months (average,18.5 months).All the flaps were soft in texture,with varying degrees of pigmentation.The sensory recovery was S2 in 8 flaps,S3 in 29 flaps,and S4 in 8 flaps.Obvious scar hyperplasis was observed at the donor site in 5 cases while no obvious scar hyperplasis was observed in the other 40 ones.All the fractures got united after 4 to 14 months (average,8.6 months).Nonunion happened in 2 patients who were treated with autologous iliac graft 8 months after operation.By Anderson criteria,the curative efficacy was assessed as excellent in 15 cases,as good in 21,as fair in 7 and as poor in 2,yielding an excellent to good rate of 80.0%.Conclusion Early internal fixation combined with perforator flap transfe is an effective strategy for treatment of forearm open fractures with soft tissue defects of Gustilo types Ⅲ B &Ⅲ C,due to its advantages of shortened treatment period,possibility for early rehabilitation,decreased complications and satisfactory functional recovery.
6.Efficacy and safety of endoscopic retrograde cholangiopancreatography for children with pancreaticobiliary diseases
Xiwei DING ; Yuling YAO ; Han WU ; Erhua WANG ; Qibin HE ; Yunhong LI ; Jun CAO ; Lei WANG ; Xiaoping ZOU
Chinese Journal of Digestive Endoscopy 2017;34(2):99-103
Objective To assess the safety and efficacy of endoscopic retrograde cholangiopancreatography (ERCP) for children with pancreaticobiliary diseases. Methods Data of children under 14 years old who have underwent ERCP in Nanjing Drum Tower Hospital between September 2007 and August 2016 were reviewed for completion, complications and therapeutic methods. Results A total of 41 children underwent 68 ERCP, including 6(8. 8%) diagnostic and 62(91. 2%) therapeutic procedures. All procedures were performed under deep sedation. Cannulation failed in only 1 child with anomalous junction of pancreaticobiliary duct. The procedure success rate was 98. 5%( 67/68 ) . There were 8 adverse events, including 7 mild post?ERCP pancreatitis and 1 fever. Incidence of adverse event was 11. 8%( 8/68) . There was no such severe adverse event as bleeding, perforation, death, or other anesthesia related adverse event. Thirty?two children ( 78. 0%) had follow?up, ranging from 2 month to 6 years. Children followed lived well with no long?term adverse event. Conclusion ERCP is an effective and safe procedure for the diagnosis and treatment of pancreaticobiliary diseases in children.
7.Effects of glucose supplementation on the activity of myocardial AMP-activated protein kinase in rats induced by exercise
Haiyan YU ; Weiyu GU ; Zhiqiang WANG ; Zhengli YAO ; Jia ZHAO ; Rui ZHU ; Yunhong WANG
Acta Laboratorium Animalis Scientia Sinica 2017;25(4):444-449
Objective To investigate the effect of glucose supplement on AMPK activation in myocardium of exercised rats by measuring the myocardial AMPK activation and glycogen content after acute exercise training.Methods Rats were subjected to an acute endurance exercise and glucose supplement in varying doses and time points before and after exercise.The dynamic changes of myocardial AMPK activities was measured with Western blotting, changes of myocardial glycogen content were measured with Anthrone method.Results AMPK activation in myocardium of exercised rat was increased significantly throughout the exercise, and remained at a higher level 1 hour after acute exercise.However the level of AMPK activity was not significantly increased in exercised rat with glucose supplement.Glycogen content was not significantly changed after exercise.Rats subjected to lower dose glucose supplement did not show significant changes in glycogen content neither.But glycogen content was significantly increased in rats at 24 hours after exercise, subjected to higher dose of glucose supplement.Conclusions 1) Acute exercise induces a significant increase in AMPK activation in myocardium of exercised rats.Glucose supplement significantly inhibites the activation of AMPK induced by acute exercise.(2) Higher dose glucose supplement significantly increases glycogen content in the rat myocardium 24 h after exercise.
8.Diagnostic value of intraductal ultrasonography and brush cytology on differentiating malignant and benign biliary stricture
Ruhua ZHENG ; Lei WANG ; Yuling YAO ; Yunhong LI ; Jun CAO ; Xiaoping ZOU
Chinese Journal of Digestive Endoscopy 2017;34(11):787-790
Objective To investigate the diagnostic value of intraductal ultrasonography ( IDUS ) with or without brush cytology on distinguishing malignant from benign biliary stricture. Methods The data of patients with biliary stricture, who underwent endoscopic retrograde cholangiography( ERC) and IDUS in Drum Tower Hospital from September 2007 to October 2015 were retrospectively analyzed. Features of IDUS images and results of brush cytology were compared with postoperative histological results to evaluate the diagnostic yield of IDUS and brush cytology on differential diagnosis of malignant biliary stricture. Results A total of 230 patients with biliary stricture underwent ERC and IDUS, and 206 patients meanwhile received brush cytology, including 84 cases of malignant biliary stricture. Of the 230 patients, 87 cases underwent surgery, and 75 revealed malignant results, including 65 cases of cholangiocarcinoma, 8 cases of pancreatic adenocarcinoma, and 2 cases of periampullary adenocarcinoma. Using postoperative pathologic results as the gold standard, 72 malignant and 9 benign biliary strictures were correctly diagnosed by IDUS. The sensitivity, specificity, positive predictive value, and negative predictive value of IDUS for diagnosis of malignant biliary stricture was 96. 0%, 75. 0%, 96. 0%, and 75. 0%, respectively. Sixty-five patients underwent IDUS with brush cytology during ERC before surgery, and 56 out of 65 showed malignant results. Thirty-one malignant and 9 benign biliary stricture were correctly diagnosed by brush cytology. The sensitivity, specificity, positive predict value, and negative predict value of brush cytology for diagnosis of malignant biliary stricture was 55. 4%, 100%, 100%, and 26. 5%, respectively. If brush cytology combined with IDUS to diagnose malignant biliary stricture, the sensitivity rose up to 94. 6%, while the specificity went down to 77. 8%, and the positive and negative predictive value was 96. 4% and 70. 0%, respectively. Conclusion IDUS exhibited excellent sensitivity and specificity, while brush cytology revealed perfect specificity and positive predictive value on diagnosis of malignant biliary stricture. If IDUS combined with brush cytology, the sensitivity and negative predictive value could rise significantly, while the specificity and positive predictive value mildly went down, which suggested that IDUS remained a certain degree of over judgment and false positive rate.
9. Second-stage wound reconstruction for Gustilo type ⅢB、ⅢC open fractures with skin and soft tissue defects on the upper extremities
Yongqiang KANG ; Yongwei WU ; Jun LIU ; Yunhong MA ; Yao LU ; Tong YANG ; Yongjun RUI
Chinese Journal of Plastic Surgery 2017;33(5):345-349
Objective:
To investigate the clinical therapy for Gustilo type Ⅲ B、ⅢC open fractures with skin and soft tissue defects on the upper extremities.
Methods:
From July 2014 to July 2016, 19 patients with Gustilo type Ⅲ open fractures (type ⅢB 12 cases , type ⅢC 7 cases) and soft-tissue defects in upper extremity were admitted, including 14 males and 5 females , aged 22 to 59 years (average 42 ). All the cases were treated by staged treatment. In the first stage, early debridement, nerves, vessels and tendons repairment, fixation of the fractures, VSD for the wound were performed. One patient underwent amputation 5 days after first operation. All the other 18 patients received flap transplantion, including 10 anterolateral thigh perforator flaps, 3 latissimus dorsal muscular flaps and 5 free lateral arm flaps.
Results:
8 patients were followed up for an average duration of 14.5 months(ranged from 7 to 23 months). Partial necrosis happened at the distal end of one anterolateral thigh perforator flap and healed with skin-grafting.1 flap encountered vascular complication which survived with 5cm-in-width skin necrosis at the distal end of the flap after successful surgical exploration. 1 case had superficial infection at wound. The wounds at donor sites were primarily healed except for 1 case with skin graft necrosis and superficial infection. All the other flaps survived completely. The patients received 2-6 operations each. The average hospital stay was 34 days (12-71 days). All Skin flap texture was soft and had varying degrees of pigmentation. The flap sensory recovery was S2 in 4 cases, S3 in 9 cases, S4 in 5 cases. 1 case had obvious scar hyperplasia.
Conclusions
Staged surgical treatment in Gustilo type Ⅲ open fractures with soft-tissue defects in upper extremity provide a high survival rate of flaps and satisfactory results. The treatment is well tolerate by patients.
10.Modified endoscopic resection of duodenal major papillary adenoma
Jun CAO ; Yunhong LI ; Yuling YAO ; Qibin HE ; Han WU ; Xiaoping ZOU
Chinese Journal of Digestive Endoscopy 2015;32(11):734-738
Objective To assess feasibility and advantages of the improved endoscopic resection of duodenal major papillary.Methods A total of 56 cases were collected in Drum Tower Hospital from October 2007 to December 2012, which were diagnosed as duodenal major papillary adenoma or carcinoma in situ, where tumor didn't extend to the biliary or pancreatic duct by the endoscopic ultrasonography, intraductal ultrasonography or histology of biopsy specimens.The diameters of these adenoma ranged from 0.3 cm to 5.0 cm.Twenty-four lesions were resected by routine endoscopic method and 32 lesions were removed by modified endoscopic method.All patients underwent ERCP and biliary and/or pancreatic stents were placed.Results En bloc resection rate was significantly higher in modified group(87.5% ,28/32) than that in routine group (60.9%, 14/23, P < 0.05).There were no significant differences in complete resection rates (93.8% ,30/32 VS 87.0%, 20/23;P >0.05), or in the amount and difficulty of pancreaticobiliary stenting(P > 0.05)between modified group and routine group.Short-term complication occurrence in modified group was lower than that of the routine group(15.6% ,5/32 VS 41.6%, 10/24, P < 0.05), but long-term complication occurrence showed no significant difference.There was no significant difference in recurrence rate between two groups[7.1% (2/28) VS 15.0% (3/20) ,P >0.05].Conclusion Endoscopic resection of duodenal major papillary adenoma with a modified method shows more therapeutic effect.

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