1.Detection method of bipolar HF leakage current in HF surgical equipment
An-Ni ZENG ; Qiu-Nan DU ; Jian-Xun HOU
Chinese Medical Equipment Journal 2024;45(4):88-92
Bipolar HF leakage current testing was carried out for two pieces of HF surgical equipment respectively by using a combination of different equipment and different connection methods according to the test method in GB 9706.202-2021 Medical electrical equipment-Part 2-2:Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories.It's pointed out relatively accurate measurements could be obtained when the HF analyzer was accessed to the circuit only as a test resistor and/or ammeter.References were provided for bipolar HF leakage current detection in HF surgical equipment.[Chinese Medical Equipment Journal,2024,45(4):88-92]
2. The protective effect of L-Shikonin on LPS/D-GalN-induced acute liver injury in mice via inhibiting NF-κB inflammatory signaling pathway
Jin-Qiu HOU ; Meng-Ge DU ; Dong-Mei QIN ; Nan ZOU ; Jin-Qi YUAN ; Wei ZHANG
Chinese Pharmacological Bulletin 2023;39(1):130-138
Aim To investigate the anti-inflammatory effect of L-Shikonin ( SK ) on lipopolysaccharide ( LPS)-induced RAW 264. 7 macrophages in vitro and its protective effect on LPS/D-GalN-induced acute liver injury. Methods The mouse model of acute liver in¬jury was established in vivo experiments by LPS/D- GalN. The survival rate of the mice and the changes of liver and spleen indices in each group were examined. The levels of AST, ALT and AKP in serum and NO, superoxide dismutase ( SOD ) and malondialdehyde (MDA) in liver tissue homogenate were measured, and the histopathological sections of the liver of each group were observed by H&E staining. M I T colorimet- ric assay was used for cell viability in vitro experi¬ments, Griess method for the detection of NO content, RT-PCR assay and Western blot assay for examining the effect of levulinic acid on the expression levels of mRNA and related pathway proteins of pro-inflammato¬ry factors in LPS-induced RAW264. 7 cells. Results The results of in vivo experiments showed that L-SK significantly improved the liver and spleen indices, de¬creased AST, ALT and AKP levels in serum, de¬creased NO and MDA in liver homogenate, and in¬creased SOD activity in mice with acute liver injury. The results of in vitro experiments showed that L-SK significantly inhibited the mRNA expression of INOS, COX2, I FN-(3 and pro-inflammatory factors 1L-6, TNF-a and IL-10 in LPS-induced RAW264. 7 cells, and significantly inhibited the protein expression of IN¬OS, COX2 and the NF-kB signaling pathway. Conclu¬sions L-SK has good anti-inflammatory effects in LPS-induced inflammation in RAW 264. 7 cells in vitro. Il inhibits the protein expression of phosphorylated P65 and IKKaαβ in the NF-kB signaling pathway, thereby suppressing the anti-inflammatory effects in vitro and L- Shikonin has protective effects against acute liver injury in mice.
3.Development of the Scientific, Transparent and Applicable Rankings (STAR) tool for clinical practice guidelines.
Nan YANG ; Hui LIU ; Wei ZHAO ; Yang PAN ; Xiangzheng LYU ; Xiuyuan HAO ; Xiaoqing LIU ; Wen'an QI ; Tong CHEN ; Xiaoqin WANG ; Boheng ZHANG ; Weishe ZHANG ; Qiu LI ; Dong XU ; Xinghua GAO ; Yinghui JIN ; Feng SUN ; Wenbo MENG ; Guobao LI ; Qijun WU ; Ze CHEN ; Xu WANG ; Janne ESTILL ; Susan L NORRIS ; Liang DU ; Yaolong CHEN ; Junmin WEI
Chinese Medical Journal 2023;136(12):1430-1438
BACKGROUND:
This study aimed to develop a comprehensive instrument for evaluating and ranking clinical practice guidelines, named Scientific, Transparent and Applicable Rankings tool (STAR), and test its reliability, validity, and usability.
METHODS:
This study set up a multidisciplinary working group including guideline methodologists, statisticians, journal editors, clinicians, and other experts. Scoping review, Delphi methods, and hierarchical analysis were used to develop the STAR tool. We evaluated the instrument's intrinsic and interrater reliability, content and criterion validity, and usability.
RESULTS:
STAR contained 39 items grouped into 11 domains. The mean intrinsic reliability of the domains, indicated by Cronbach's α coefficient, was 0.588 (95% confidence interval [CI]: 0.414, 0.762). Interrater reliability as assessed with Cohen's kappa coefficient was 0.774 (95% CI: 0.740, 0.807) for methodological evaluators and 0.618 (95% CI: 0.587, 0.648) for clinical evaluators. The overall content validity index was 0.905. Pearson's r correlation for criterion validity was 0.885 (95% CI: 0.804, 0.932). The mean usability score of the items was 4.6 and the median time spent to evaluate each guideline was 20 min.
CONCLUSION
The instrument performed well in terms of reliability, validity, and efficiency, and can be used for comprehensively evaluating and ranking guidelines.
Reproducibility of Results
;
Surveys and Questionnaires
;
Practice Guidelines as Topic
;
Humans
4.Evaluation of the residual risk of HIV transmission through blood transfusion after nucleic acid testing in blood centers in China
Yanhong WAN ; Zhijun ZHEN ; Ying LI ; Yanqin HE ; Feng YAN ; Dongmin ZHANG ; Shouguang XU ; Nan WU ; Kejin LI ; Youhua SHEN ; Lin BAO ; Xiaoli CAO ; Xia DU ; Jianling ZHONG ; Weiping FENG ; Peng WANG ; Ying LI ; Dong GUO ; Yang LIU ; Li LI ; Xinyan FAN ; Junbing ZHOU ; Xiaotong SUN ; Lijun ZHOU ; Liping NENG ; Bing JU ; Fang WANG ; Yan QIU
Chinese Journal of Experimental and Clinical Virology 2023;37(4):361-366
Objective:To evaluate the residual risk (RR) of transfusion transmitted HIV (TT-HIV) after the implementation of nucleic acid amplification test (NAT) in blood screening test among blood centers in China.Methods:The data of blood donors and HIV infection markers from 2017 to 2020 were collected from 28 blood centers via the Platform of Comparison of blood establishments Practice in Chinese Mainland. The new infection rate/window period mathematical model was used for two types of blood screening strategies, namely, two rounds ELISA plus individual NAT take turn with pooling NAT (2ELISA+ ID-NAT/MP-NAT) and two ELISA plus one round pooling NAT (2ELISA+ MP-NAT), and the RR of HIV infection was estimated also based on first donors (FDs) and repeated donors (RDs) in different blood donation years. T-test analyses were conducted for comparing TT HIV RR among FDs and RDs in different blood donation years with two blood screening strategies, and the variation trend of RR in HIV test was observed.Results:From 2017 to 2020, the RR of FDs in 2ELISA+ ID-NAT/MP-NAT blood screening strategy was 2.869/10 6 person-year, 3.795/10 6 persons-year, 3.879/10 6 person-year, and 2.890/10 6 person-year respectively. The RR of RDs was 1.797/10 6 person-year, 1.502/10 6 person-year, 1.857/10 6 person-year, and 1.483/10 6 person-year respectively. Significant difference exists between RR of FDs and RDs, with F=9.898 and p<0.05. In 2ELISA+ MP-NAT strategy, the RR of FDs was 3.508/10 6 person-year, 1.868/10 6 person-year, 2.204/10 6 person-year, and 1.765/10 6 person-year respectively. The RR of RDs was 0.948/10 6 person-year, 0.926/10 6 person-year, 0.748/10 6 person-year, and 0.682/10 6 person-year respectively. Statistical difference existed between RR of FDs and RDs, with F=17.126 and P<0.05. There was no significant difference between the RR of FDs in these two strategies with F=3.493 and P>0.05, while there was a difference between the RR of RDs in these two strategies with F=24.516 and P<0.05, and a difference between the RR of total donors (TDs) in these two strategies F=20.216 and P<0.05. Conclusions:The RR of TT HIV significantly decreased after the introduction of NAT into blood test among blood centers in China. There were some differences in the RR of HIV testing among different blood screening strategies. There could be significant differences in the RR of HIV testing among different groups of blood donors. Compared with FDs, RDs is the low risk group for HIV.
5.Analysis of red blood cells supply before and after the outbreak of COVID-19 from 2018 to 2021 in 18 domestic blood centers
Dongyan ZHAO ; Hongwei MA ; Dingjie TANG ; Xiaorong FENG ; Hao TIAN ; Mengzhuo LUO ; Nan WU ; Yan LIN ; Xia DU ; Qi FU ; Junlei HUANG ; Changchun LU ; Xiaoli CAO ; Yi YANG ; Lin WANG ; Ying LI ; Hai QI ; Dongtai WANG ; Yan QIU
Chinese Journal of Blood Transfusion 2023;36(10):892-898
【Objective】 To compare the supply data of red blood cells(RBCs) from 18 blood centers in China before and after the outbreak of COVID-19 during 2018 to 2021. 【Methods】 Eight indicators related to RBCs supply from 18 blood centers in China during 2018-2021 were collected retrospectively, including the storage of total amount of qualified RBCs (referred to as the total amount of storage), the distribution of total amount of RBCs (referred to as the total amount of distribution), the distribution amount of RBCs per 1 000 population (referred to as the amount of distribution per 1 000 population), the distribution amount of RBCs from 400 mL original blood per 1 000 population [referred to as the amount of distribution per 1 000 population (400 mL)], the average daily distribution amount of RBCs (referred to as the average daily distribution amount), the average daily storage amount of RBCs (referred to as the average daily storage amount), the average storage days of RBCs when distribute (referred to as the RBC storage days), and the expired amount of RBCs (referred to as the expired amount). Based on the outbreak time of COVID-19, the data of 2018 and 2019 were the pre-pandemic group, and the data of 2020 and 2021 were the post-pandemic group. 【Results】 Data on RBCs supply in 18 blood centers from 2018 to 2021(comparison of the pre-pandemic group and the post-pandemic group): the amount of distribution per 1 000 population (median 14.68 U>13.92 U) decreased, the amount of distribution per 1 000 population (400 mL) (median 10.16 U>9.21 U) decreased, and the difference was statistically significant (P<0.05); data comparison between 2019 and 2020:the total amount of distribution (median 117 770.38 U>99 084.08 U) decreased, the amount of distribution per 1 000 population (median 15.04 U>12.19 U) decreased, the amount of distribution per 1000 population (400 mL) (median 10.11 U>8.94 U), the average daily distribution amount(322.66 U>270.73 U) decreased and RBC storage days (median 10.50 d<11.45 d) increased, the difference has statistical significance (P<0.05); data comparison between 2020 and 2021:the total amount of storage (median 101 920.25 U<120 328.63 U), the total amount of distribution (median 99 084.08 U<118 428.62 U), the amount of distribution per 1 000 population (median 12.19 U<15.00 U), the amount of distribution per 1 000 population (400 mL) (median 8.94 U<9.46 U), the average daily distribution amount (270.73 U>324.46 U), the average daily inventory (median 3 222.00 U<4 328.00 U) increased, the expired amount (median 1.50 U>0.00 U) decreased, the difference has statistical significance (P<0.05). The results of ANOVA showed that there were significant differences on the data related to RBCs supply (except expired amount) in different blood centers (P<0.05). The ratio of average daily stock to average daily distribution in the post-outbreak group (median 12.36 d) was higher than that in the pre-outbreak group (median 10.92 d), the difference has statistical significance (P<0.05), with significant difference among different blood centers (P <0.05). 【Conclusion】 The COVID-19 pandemic has a significant impact on RBCs supply in different blood centers. In the second year of the pandemic, the supply capability had recovered to some extent, and there were differences in RBCs supply in different blood centers.
6.Epidemiological characteristics of hepatitis A in Guangxi in 2010—2020
Jia-gui CHEN ; Qiu-yun DENG ; Ren-cong YANG ; Jin-fa DU ; Yu-yan MA ; Ming GAN ; Ying HUANG ; Jing LIU ; Sha LI ; Jia-nan WEI ; Shi-yi CHEN ; Ai-hu DONG
Journal of Public Health and Preventive Medicine 2022;33(6):47-50
Objective To analyze the epidemiological characteristics of hepatitis A in Guangxi from 2010 to 2020, and to provide a scientific basis for formulating effective prevention and control strategies. Methods Descriptive epidemiological method was used to analyze the incidence data of hepatitis A in Guangxi from 2010 to 2020. Results From 2010 to 2020, a total of 8,742 cases of hepatitis A were reported in Guangxi, with an average annual incidence rate of 1.66 /100,000. There were 5 298 male cases (60.60%), and 3,444 female cases (39.40%). The incidence rate decreased from 2.73/100 000 in 2010 to 1.38/100 000 in 2020. The onset seasonality was strong in 2010, but there was no obvious seasonality in other years. A total of 5 891 cases (67.39%) were aged from 25 to 64 years. Farmers accounted for 59.79% of the cases. A total of 7 hepatitis A outbreaks were reported during 2010-2020, including 273 cases,accounting for 3.12% of the total cases.The incidence rates of hepatitis A in Hezhou (3.97/100 000), Wuzhou (2.98/100 000), Hechi (2.44/100 000), Guigang (2.00/100 000) and Beihai (1.79/100 000) were relatively higher than other places. Conclusion The number of reported hepatitis A cases in Guangxi has been declining year by year, and the prevention and control measures of hepatitis A vaccine prevention are effective. The surveillance of hepatitis A should be strengthened, and prevention and control strategies should be formulated for high-risk areas and key populations.
7.An innovative exploration of endoscopic nipple-sparing mastectomy combined with immediate pre-pectoral implant-based breast reconstruction with TiLoop Bra via single axillary incision for breast cancer patients
Xiangquan QIN ; Tiantian WANG ; Yanyan XIE ; Faqing LIANG ; Yu FENG ; Jiao ZHOU ; Yixuan HUANG ; Juan LI ; Mengxue QIU ; Songbo ZHANG ; Nan WEN ; Yuting ZHOU ; Huanzuo YANG ; Qing LV ; Zhenggui DU
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2021;28(09):1029-1036
Objective To explore the surgical technique and preliminary results of endoscopic nipple-sparing mastectomy (E-NSM) and immediate pre-pectoral implant-based breast reconstruction (BR) with titanium-coated polypropylene mesh (TiLoop Bra) via single axillary incision for breast cancer patients. Methods The clinical data of 9 consecutive female patients who underwent E-NSM and immediate pre-pectoral implant-based BR with TiLoop Bra from March to May 2021 were retrospectively analyzed. The mean age of patients was 40.6 (22-60) years. The operation time, early complications were collected, and the patients' social and mental health, breast satisfaction and chest function before and after the operation were assessed with the BREAST-Q questionnaire. Results All the patients had unicentric tumor with a mean diameter of 2.4 (0.6-4.7) cm. The mean distance from the tumor to the nipple was 2.5 (2-4) cm. There were 2 patients with tumor stage 0 and 7 patients with stageⅠ. The mean operation time was 161.1 (125-201) min, the mean blood loss was 41.1 mL and the hospital stay time was 1.5 d. There were 5 patients in the day-care unit. All the patients were successfully followed up with a median follow-up time of 1 (1-2) month. One (11.1%) patient with depigmentation of the nipple-areola complex caused by mild ischemia. None of the patients had incision complications, subcutaneous emphysema, hematoma, infection, nipple-areola or skin flaps necrosis, implant loss. During the follow-up period, no local/regional recurrence or distant metastasis was found. Chest well-being was decreased in the first month after the surgery compared with preoperative status, and the difference was statistically significant (P=0.001). There was no statistical difference in the breast satisfaction or psychosocial function scores between pre- and post-operation (P>0.05). Conclusion E-NSM and immediate pre-pectoral implant-based BR with TiLoop Bra via single axillary incision has minimal trauma, rapid postoperative recovery, short operation time, few early complications and good early cosmetic effect, and the short-term result is satisfactory.
8.Bendamustine treatment of Chinese patients with relapsed indolent non-Hodgkin lymphoma: a multicenter, open-label, single-arm, phase 3 study.
Yuan-Kai SHI ; Xiao-Nan HONG ; Jian-Liang YANG ; Wei XU ; Hui-Qiang HUANG ; Xiu-Bin XIAO ; Jun ZHU ; Dao-Bin ZHOU ; Xiao-Hong HAN ; Jian-Qiu WU ; Ming-Zhi ZHANG ; Jie JIN ; Xiao-Yan KE ; Wei LI ; De-Pei WU ; Shen-Miao YANG ; Xin DU ; Yong-Qian JIA ; Ai-Chun LIU ; Dai-Hong LIU ; Zhi-Xiang SHEN ; Lian-Sheng ZHANG ; Leonard JAMES ; Edward HELLRIEGEL
Chinese Medical Journal 2021;134(11):1299-1309
BACKGROUND:
Bendamustine was approved in China on May 26th, 2019 by the National Medical Product Administration for the treatment of indolent B-cell non-Hodgkin lymphoma (NHL). The current study was the registration trial and the first reported evaluation of the efficacy, safety, and pharmacokinetics of bendamustine in Chinese adult patients with indolent B-cell NHL following relapse after chemotherapy and rituximab treatment.
METHODS:
This was a prospective, multicenter, open-label, single-arm, phase 3 study (NCT01596621; C18083/3076) with a 2-year follow-up period. Eligible patients received bendamustine hydrochloride 120 mg/m2 infused intravenously on days 1 and 2 of each 21-day treatment cycle for at least six planned cycles (and up to eight cycles). The primary endpoint was the overall response rate (ORR); and secondary endpoints were duration of response (DoR), progression-free survival (PFS), safety, and pharmacokinetics. Patients were classified according to their best overall response after initiation of therapy. Proportions of patients in each response category (complete response [CR], partial response [PR], stable disease, or progressive disease) were summarized along with a two-sided binomial exact 95% confidence intervals (CIs) for the ORR.
RESULTS:
A total of 102 patients were enrolled from 20 centers between August 6th, 2012, and June 18th, 2015. At the time of the primary analysis, the ORR was 73% (95% CI: 63%-81%) per Independent Review Committee (IRC) including 19% CR and 54% PR. With the follow-up period, the median DoR was 16.2 months by IRC and 13.4 months by investigator assessment; the median PFS was 18.6 months and 15.3 months, respectively. The most common non-hematologic adverse events (AEs) were gastrointestinal toxicity, pyrexia, and rash. Grade 3/4 neutropenia was reported in 76% of patients. Serious AEs were reported in 29 patients and five patients died during the study. Pharmacokinetic analysis indicated that the characteristics of bendamustine and its metabolites M3 and M4 were generally consistent with those reported for other ethnicities.
CONCLUSION:
Bendamustine is an active and effective therapy in Chinese patients with relapsed, indolent B-cell NHL, with a comparable risk/benefit relationship to that reported in North American patients.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, No. NCT01596621; https://clinicaltrials.gov/ct2/show/NCT01596621.
Adult
;
Antineoplastic Combined Chemotherapy Protocols
;
Bendamustine Hydrochloride/therapeutic use*
;
China
;
Humans
;
Lymphoma, Non-Hodgkin/drug therapy*
;
Neoplasm Recurrence, Local/drug therapy*
;
Prospective Studies
;
Rituximab/therapeutic use*
9.A brief introduction to the clinical pathway of the endoscopic-assisted immediate implant-based breast reconstruction after nipple sparing mastectomy for breast cancer patients in day surgery center of West China Hospital
Jiao ZHOU ; Faqing LIANG ; Yanyan XIE ; Nan WEN ; Songbo ZHANG ; Yu FENG ; Xinran LIU ; Yixuan HUANG ; Huanzuo YANG ; Mengxue QIU ; Qing LV ; Zhenggui DU
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2021;28(12):1393-1399
The traditional view is that breast reconstruction is not an option for day surgery center. As a result, few hospitals in the world conduct this operation in day surgery center. Endoscopic breast reconstruction with liposuction and robot-assisted breast reconstruction are minimally invasive surgeries for breast cancer patients, but they cannot be carried out in the day surgery center due to long operation time. The novel endoscopic-assisted immediate implant-based breast reconstruction after nipple sparing mastectomy through a single axillary incision for breast cancer patients has been successfully conducted in the day surgery center in our hospital due to short operation time and small trauma. Standardized management of the complete process from the patient selection to follow-up after discharge brings rapid recovery and few complications. At the same time, the development of endoscopic surgery makes the breast almost scarless and improves aesthetic results. Therefore, the mode of endoscopic-assisted reconstruction in the day surgery center of our hospital is expected to be popularized in the whole country.


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