1.Expert consensus on dispensing management of intravenous infusion drugs for clinical trials in PIVAS
Xingchen YANG ; Wenhuan FU ; Donghui LAO ; Jing ZHAO ; Jianzhong ZHANG ; Group PHARMACY ; Committee HOSPITAL ; Association Pharmaceutical SHANGHAI
China Pharmacy 2025;36(1):1-6
OBJECTIVE To further standardize the dispensing management standard of intravenous infusion drugs for clinical trials in pharmacy intravenous admixture services (PIVAS), and provide reference for medical institutions to provide high-quality pharmaceutical services. METHODS Initiated by PIVAS Group, Hospital Pharmacy Professional Committee, Shanghai Pharmaceutical Association, jointly led by Longhua Hospital, Shanghai University of Traditional Chinese Medicine and Shanghai Geriatric Medical Center, a writing group was established by PIVAS experts from multiple medical institutions to discuss the basic requirements and dispensing process of intravenous infusion drugs for clinical trials in PIVAS. The experts from the leading unit sorted out, summarized, analyzed, fed back and revised the opinions, and finally reached Expert Consensus on Dispensing Management of Intravenous Infusion Drugs for Clinical Trials in PIVAS. RESULTS & CONCLUSIONS The main contents of this consensus include information management, operation process, fund management and document management of intravenous infusion drugs for clinical trials in PIVAS. This consensus establishes a more standardized model for dispensing management of intravenous infusion drugs for clinical trials in PIVAS, by standardizing clinical trail drug management operational procedures, accurately recording and preserving drug-related information, with the aim of achieving standardized and meticulous management of PIVAS’s receipt of clinical trial drugs.
2.Antibiotic-loaded bone cement enhances ability of tibial cortex transverse transport for treating infected wounds
Junpeng LIU ; Xingchen YAO ; Hui ZHAO ; Ziyu XU ; Yue WU ; Fuchun PEI ; Lin ZHANG ; Xinru DU
Chinese Journal of Tissue Engineering Research 2024;28(29):4599-4604
BACKGROUND:Diabetic foot patients with wound infections constitute a large patient population,and there is currently no satisfactory treatment approach. OBJECTIVE:To investigate the clinical efficacy of a modified tibial cortex transverse transport combined with antibiotic-loaded bone cement for treating refractory diabetic foot ulcers. METHODS:A total of 46 diabetic foot ulcers patients,27 males and 19 females,with an average age of 64.37 years,were selected from Beijing Chaoyang Hospital,Capital Medical University and Beijing Chaoyang Integrative Medicine Rescue and First Aid Hospital from January 2020 to January 2023.All of them underwent the modified tibial cortex transverse transport combined with antibiotic-loaded bone cement treatment.Ankle-brachial index,WIFi(Wound/Ischemia/Foot infection)classification,pain visual analog scale score,and ulcer area were recorded before and 3 months after surgery. RESULTS AND CONCLUSION:(1)The mean ulcer healing time for the 46 patients was(58.07±24.82)days.At 3 months postoperatively,there were significant improvements in ankle-brachial index,pain visual analog scale score,ulcer area,and WIFi classification in 46 patients,as compared to the preoperative values,with statistically significant differences(P<0.05).Two patients experienced pin-tract infections,without infection or ulcer recurrence during the follow-up period.(2)These findings indicate that the modified tibial cortex transverse transport combined with antibiotic-loaded bone cement effectively alleviates patients'pain,improves lower limb circulation,controls infections,and promotes ulcer healing.
3.Micro-osteotomy bone transport combined with vacuum sealing drainage for the treatment of diabetic foot:A retrospective cohort study of 128 patients from two centers
Junpeng LIU ; Xinru DU ; Xingchen YAO ; Ziyu XU ; Fuchun PEI ; Lin ZHANG ; Hui ZHAO
The Journal of Practical Medicine 2024;40(18):2590-2596
Objective To assess the effectiveness of enhanced tibial transverse transport(TTT)in con-junction with vacuum-assisted closure(VAC)therapy for managing recalcitrant diabetic foot ulcers.Methods A retrospective analysis was conducted on data from diabetic foot patients with Wagner grade≥2 who were treated at Beijing Chaoyang Hospital and Beijing Chaoyang Hospital of Integrated Traditional Chinese and Western Medicine between July 2020 and December 2022.The patients were categorized into three groups based on their treatment regimen:VSD treatment(VSD group),modified TTT treatment(TTT group),and combined application of TTT and VSD(combined group).A one-year follow-up was performed to assess general data,ulcer area before and three months after surgery,ankle brachial index,visual analog pain score,as well as adverse events within one year post-surgery among the three groups.Results The VSD group consisted of 43 patients,while the TTT group consisted of 43 patients,and the combined group consisted of 42 patients.There were no statistically significant differences in baseline characteristics among the three groups(P>0.05).Patients in the VSD group had longer ulcer healing time,higher pain scores,lower ankle brachial index(P<0.05),larger ulcer area(P=0.029),and higher one-year ulcer recurrence rate compared to those in the TTT group.On the other hand,patients in the combined group had shorter ulcer healing time compared to those in the TTT group(P=0.046).However,there were no significant differences observed between these two groups regarding ulcer area(P=0.362),pain scores(P=0.932),ankle brachial index(P=0.671),and one-year ulcer recurrence rate(P=0.710).Conclusions The efficacy of modified TTT surpasses that of VSD in promoting ulcer healing,alleviating pain,and enhancing lower limb circulation.Furthermore,the combination of VSD with modified TTT demonstrates a potential to further expedite wound healing time.
4.Research progress on the regulatory effect of macrophage extracellular traps on cardiovascular diseases
Xingchen LI ; Qianqian WU ; Kexin ZHAO ; Runsen WANG ; Xiaoping WANG
Journal of Xinxiang Medical College 2024;41(7):614-618
Macrophage extracellular traps(METs)are extracellular fibrous web-like structures produced by macrophages.METs play a crucial role in the development and progression of various cardiovascular diseases(CVDs),including atherosclerosis and myocardial infarction.This article summarizes the mechanism of METs in CVDs,future research directions and the possibility of using METs as potential therapeutic targets for clinical diseases.
5.Analysis of the real situation of medication in the population with gout achieving T2T indicators: a multicentre real-world study
Weiqin GAO ; Xuezhong GONG ; Yuanyuan ZHANG ; Xingchen DU ; Ping JIANG ; Fengyuan GUAN ; Ying LU ; Xiao SU ; Hongze JIANG ; Hongbin LI ; Yongfei FANG ; Hengli ZHAO ; Jiangyun PENG ; Mingli GAO ; Li SU ; Fang HE ; Qingwen TAO ; Chunrong HU ; Peng LI ; Zeguang LI ; Yuelan ZHU ; Ying GU ; Ming ZHANG ; Rongsheng WANG ; Ting JIANG ; Xiaolin YANG ; Qi ZHU ; Quan JIANG ; Jianyong ZHANG ; Xiaolei FAN ; Yu XUE ; Dongyi HE
Chinese Journal of Rheumatology 2023;27(6):361-367
Objective:To explore the therapeutic characteristics of population with gout achieving treat-to-target (T2T) indicators through real-world research and evaluate their safety.Methods:A total of 3 287 patients diagnosed with gout by rheumatologists in 21 first-class tertiary hospitals in 10 provinces, municipalities, and autonomous regions in China from January 2015 to December 2021 were included in this polycentric cross-sectional study. The database included patients′ general information, disease characteristics, and clinical application of traditional Chinese and Western medicine treatment measures. SPSS and Excel software were used for data analysis. Frequency analysis, cluster analysis, and factor analysis were used to summarize the characteristics and rules of treatment measures for patients with gout who achieved the target after treatment. The occurrence of adverse events (AE) was recorded during treatment.Results:After treatment, 691 visits (7%) achieved the serum urate (SUA) target, and the most frequent use of urate-lowering therapy (ULT) was febuxostat, followed by benzbromarone. The most common treatment options were following: GroupⅠ: traditional Chinese medicine (TCM) decoction-TCM external treatment-physical exercise-proprietary Chinese medicine; GroupⅡ: ferulic acid-nonsteroidal anti-inflammatory drugs (NSAIDs); Group Ⅲ: allopurinol-sodium bicarbonate-benzbromarone; Group Ⅳ: glucocorticoid-colchicine; Group Ⅴ: febuxostat. A total of 5 898 visits (60%) chieved manifestations of joint pain VAS scores target, and the most frequently used drug to control joint symptoms was NSAIDs. The frequency of use of drugs to control joint symptoms were 2 118 times (usage rate reached 35.9%), while the frequency of ULT were 2 504 times (usage rate reached 42.5%), which was higher than the joint symptom control drug. The most common treatment options were following: Group Ⅰ: proprietary Chinese medicine-TCM decoction-TCM external treatment-physical exercise; Group Ⅱ: NSAIDs-colchicine hormones; Group Ⅲ: allopurinol, Group Ⅳ: benzbromarone; Group Ⅴ: febuxostat. A total of 59 adverse events occurred during treatment.Conclusion:The proportions of gout patients who reach target serum urate level & good control of joint symptoms are both very low, and ULT and anti-inflammatory prescription patterns are very different from international guidelines, so it is necessary to strengthen the standardized management of gout patients. At the same time, life intervention measures account for a certain proportion of the treatment plans for the T2T population, and further exploration is needed.
6.Wear Simulation on Tibiofemoral Joint Surface of Rotating Hinge Knee Prosthesis
Ji ZHANG ; Kunxi LIU ; Xingchen ZHOU ; Jiawei TANG ; Xiaoyu ZHU ; Feng ZHAO ; Yubo FAN
Journal of Medical Biomechanics 2022;37(4):E591-E596
Objective To study the wear condition of rotating hinge knee prosthesis (RHKP) during horizontal walking gait, and provide technical references for wear prediction and clinical application of this kind of prosthesis. Methods A finite element wear model of RHKP was established based on the standard ISO 14243, and the simulation results including the wear distribution and mass wear rate of tibiofemoral joint surface were compared with the results from in vitro experiments on the same type of prosthesis. Results The mass wear rate of the polyethylene insert was 26.01 mg/MC (million cycle)from finite element analysis (FEA) and (30.06±1.21) mg/MC from in vitro experiments, and the mass wear rate of the upper surface of polyethene insert from FEA was about 3.3 times that of the lower surface. The wear area obtained by FEA was basically consistent with that obtained by in vitro wear measurement. The main wear area was symmetrically distributed in the middle and back of the upper surface. Conclusions The mass wear rate of RHKP, as a semi-restrictive prosthesis, is obviously higher than that of primary total knee joint prosthesis. More attention should be paid to wear test and evaluation of RHKP.
7.Application value of different polypropylene meshes in inguinal hernia repair of adults
Shaochun LI ; Yan GU ; Xingchen HU ; Shaojie LI ; Zhao CAI ; Lei HUANG ; Yunxiao MENG ; Jianxiong TANG
Chinese Journal of Digestive Surgery 2020;19(7):767-772
Objective:To compare the application value of different polypropylene mesh in inguinal hernia repair of adults.Methods:The prospective cohort study was conducted. The clinical data of 120 adult patients with inguinal hernia who were admitted to two medical centers (60 in Huadong Hospital affiliated to Fudan University and 60 in Shanghai Ninth People′s Hospital affiliated to Shanghai Jiaotong University from March 2012 to Match 2014 were collected. Patients were randomly divided into study group and control group using the random number table. Patients in the study group underwent repair of inguinal hernia using the SMP95958X mesh, and patients in the control group underwent repair of inguinal hernia using the modified Kugel mesh. All patients underwent preperitoneal repair by senior hernia surgery specialists. Observation indicators: (1) postoperative pain; (2) complications and follow-up. Patients were followed up at postoperative 3 months and 6 months using outpatient examination to detect the short-term complications by physical or color doppler ultrasonography examination, and at postoperative 5 years using telephone interview or outpatient examination to detect long-term complications including infection, foreign body sensation and recurrence of hernia. The follow-up was up to March 2019. Measurement data with normal distribution were represented as Mean± SD, and comparison between groups was analyzed using the t test. Measurement data with skewed distribution were represented as M (range), comparison between groups was analyzed using the nonparametric rank sum test. Count data were described as absolute numbers or percentages, and comparison between groups was analyzed using the chi-square, continuous correction chi-square test or Fisher exact probability. Comparison of ranked data were analyzed using the nonparametric rank sum test. Results:A total of 118 patients with inguinal hernia were selected for eligibility, including 116 males and 2 females, aged (64±12)years, with a range from 29 to 84 years. Of the 118 patients, 59 were in the study group and 59 were in the control group, respectively. (1) Postoperative pain: of the 59 patients in the control group, 34 took painkiller and 1 case lost the data of taking painkiller at postoperative 2 days. Of the 59 patients in the study group, 29 cases took painkiller. There was no significant difference in taking painkiller between the two groups ( χ2=1.055, P>0.05). The pain score at postoperative 2 days and 3 months were 3.26(range, 0.70-6.90) and 0.87(range, 0.00-4.10) of the control group, respectively, and 3.03(range, 0.00-8.80) and 0.83(range, 0.00-3.10) of the study group, respectively, showing no significant difference between the two groups ( Z=0.782, 0.729, P>0.05). (2) Complications and follow-up: the incidence of postoperative complications at perioperative period (within postoperative 2 days) was 1.7%(1/59) and 1.7%(1/59) in the control group and study group, respectively, showing no significant difference between the two groups ( P>0.05). Both of 59 patients in the control group and study group were followed up for 6 months after operation, respectively. The incidence of postoperative complications at 3 months and 6 months after operation was 1.7%(1/59) and 1.7%(1/59) in the control group, respectively, and 5.1%(3/59) and 5.1%(3/59) in the study group, showing no significant difference between the two groups ( P>0.05). Fifty-five patients of the control group and 52 patients of the study group were followed up for 5 years after operation, respectively. There was 1 case of infection in the control group, with the incidence of postoperative long-term ( within 5 years after operation) complication of 1.8%(1/55), and there were 2 cases of infection and 1 case of foreign body sensation in the study group with the incidence of postoperative long-term (within 5 years after operation) complication of 5.8%(3/52), showing no significant difference between the two group ( P>0.05). There was no recurrence of hernia in either group. Conclusion:Both of the SMP95958X mesh and the modified Kugel mesh can be used in preperitoneal repair of inguinal hernia, showing no significant difference in the efficacy between them.
8.Wear Simulation of Tibiofemoral Joint Surface of Total Knee Prosthesis with High Conformity
Wenyu DING ; Shuqin MA ; Xingchen ZHOU ; Yujing YANG ; Yan SUN ; Feng ZHAO ; Yubo FAN
Journal of Medical Biomechanics 2018;33(3):E193-E199
Objective To investigate the effect of the tibiofemoral joint surface with high conformity on total knee prosthesis motion and insert wear. Methods A type of knee prosthesis with a high coronal conformity was designed and manufactured, and its insert wear was studied by in vitro wear testing combined with finite element simulation. ResultsThe mass wear rates calculated by the in vitro wear testing and finite element simulation were (14.29±3.19) mg/MC and 14.67 mg/MC (MC, million cycle), respectively. After five MCs, the areas of the insert wear obtained by both the methods were basically consistent, and severe wear was found to occur in the middle part of the insert. ConclusionsThe result of the finite element simulation coincided with that of the in vitro testing. The wear rate of the tibiofemoral joint surface of the total knee prosthesis with a high coronal conformity was relatively low. The research outcomes have practical significance for the evaluation and clinical application of the total knee prosthesis with a high conformity.
9.Clinical efficacy of mesh repair via inguinal approach in acute femoral hernia
Zhao CAI ; Lei HUANG ; Shaojie LI ; Xingchen HU ; Jianxiong TANG
Chinese Journal of Digestive Surgery 2018;17(11):1111-1115
Objective To investigate the clinical efficacy of mesh repair via inguinal approach in acute femoral hernia.Methods The retrospective cohort study was conducted.The clinical data of 48 patients with acute femoral hernia who were admitted to Huadong Hospital Affiliated to Fudan University between January 2007 and December 2016 were collected.Of 48 patients,29 undergoing hernia repair with polypropylene mesh and 19 undergoing hernia repair with suture were allocated into the study group and control group respectively.All the patients underwent hernia repair via inguinal approach.Observation indicators:(1) surgical and postoperative situations;(2) follow-up and survival situations.Follow-up was performed by outpatient examination and telephone interview to detect complications,hernia recurrence,survival situations at 1-,3-month and 1 year postoperatively for 1 year up to December 2017.Measurement data with normal distribution were represent as x±s and comparison between groups was done by the t test.Comparison of count data was analyzed using the chi-square test or Fisher exact probability.Results (1) Surgical and postoperative situations:patients in the 2 groups underwent successful incarcerated or strangulated acute femoral hernia repair.There were 3 and 4 patients receiving small bowel resection in the study group and control group respectively,with no statistically significant difference between groups (x2=1.50,P>0.05).The operation time was respectively (82±16)minutes and (96± 13)minutes in the study group and control group,with statistically significant difference between groups (t =-2.94,P<0.05).There was no femoral vascular injury in the 2 groups.The time of drainage-tube removal and duration of postoperative hospital stay were respectively (4.5 ± 1.6) days and (9±4) days in the study group and (3.9± 1.3)days and (10±4)days in the control group,with no statistically significant difference between groups (t =1.36,-0.33,P>0.05).(2) Follow-up and survival situations:all the 48 patients were followed up for one year.No mesh infection was found in the study group.[ncisional infection was detected in 4 and 2 patients of the study group and control group respectively,with no statistically significant difference between groups (x2 =0.11,P> 0.05).Patients with incisional infection were cured after incision open drainage.Two and 2 patients had postoperative chronic pain in the study group and control group respectively,with no statistically significant difference between groups (x2 =0o 20,P>0.05).The 4 patients had mild intermittent pain,without special treatment.There were no seroma occurred in the 2 groups.Hernia recurrence was occurred in 0 aud 5 patients of the study group and control group respectively,with statistically significant difference between groups (x2 =8.52,P<0.05).There were 2 and 1 patient dead in the study group and control group respectively,with no statistically significant difference between groups (P > 0.05).Conclusions Hernia repair with Polypropylene mesh via inguinal approach in acute femoral hernia is safe and feasible.Compared to suture repair,it can not only shorten operation time and reduce hernia recurrence,but also had no mesh infection and cannot iucrease postoperative complications.
10.Laparoscopic and hybrid technique for the repair of incisional hernia : a report of 70 cases
Ge CHEN ; Yunxiao MENG ; Shaojie LI ; Xingchen HU ; Lei HUANG ; Zhao CAI ; Jianxiong TANG
Chinese Journal of General Surgery 2017;32(12):997-999
Objective To analyze the clinical value of laparoscopic and hybrid technique for the repair of incisional hernia.Methods The clinical data of 70 cases of incisional hernia undergoing laparoscopic and hybrid repair from Jan 2014 to Dec 2015 in Huadong Hospital were analyzed retrospectively.Results All cases were operated on successfully and recovered.The operation time was (60 ± 27) min for laparoscopic and (120 ± 32) min for hybrid repair.The length of incision was (6 ± 4) cm for laparoscopic repair and (8 ± 6) cm for hybrid.Postoperative complications included seroma in 1 case in laparoscopic group,incisional fat liquefation in 1 case in hybrid group.All were cured with conservative treatment.Hospital stay was (8 ± 5) days in hybrid group and (14 ± 16) days in hybrid group.No recurrence was observed during 6-30 months of follow-up.Conclusion Both laparoscopic and hybrid technique for incisional hernia repair are safe and effective.

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