1.Comparison of therapeutic effects of tibial transverse transport microcirculation reconstruction and periosteal distraction in the treatment of early diabetic foot.
Bi-Hui SONG ; Kang-Quan SHOU ; Tong-Zhu BAO ; Hua-Rui YANG ; Ya-Dong TAN
China Journal of Orthopaedics and Traumatology 2025;38(9):910-916
OBJECTIVE:
To compare clinical efficacy of tibial transverse transport (TTT) microcirculation reconstruction and periosteal distraction in treating patients with early diabetic foot(DF).
METHODS:
From June 2021 to June 2024, 60 patients with DF were admitted and divided into bone transport group and stretch group according to different treatment methods. There were 30 patients in bone transport group, including 16 males and 14 females;aged from 48 to 65 years old with an average of (55.59±3.78) years old;the course of disease ranged from 2 to 9 months with an average of(5.95±1.32) months;TTT microcirculation reconstruction surgery was performed. There were 30 patients in distraction group, including 17 males and 13 females;aged from 47 to 67 years old with an average of (55.24±3.81) years old;the course of disease ranged from 2 to 10 months with an average of (5.68±1.54) months;periosteal distraction surgery was performed. The skin temperature of the affected feet, the time of getting out of bed and walking after operation, the time of full weight-bearing, the wound healing time and complications were compared between two groups;the pain was evaluated by visual analogue scale (VAS) before operation and one month after operation respectively;the changes of blood flow velocity of dorsal foot arteries, ankle brachial index(ABI), epidermal growth factor (EGF), and basic fibroblast growth factor (bFGF) before and after operation at 3 months were compared between two groups.
RESULTS:
All patients were followed up for 3 to 4 months with an average of (3.52±0.12) months. There were no statistically significant differences in comparison of foot skin temperature, postoperative walking time, full weight-bearing time and complications between two groups (P>0.05). The wound healing time of bone transport group (61.26±7.31) days was shorter than that of distraction group (70.17±7.15) days, and the difference was statistically significant (P<0.05). Postoperative VAS at 1 month of bone transport group (2.19±0.21) was lower than that of distraction group (2.55±0.20), and the difference was statistically significant (P<0.05). At 3 months after operation, the blood flow velocity of dorsal foot artery, ankle-brachial index, EGF and bFGF in bone transport group were(34.73±4.18) cm·s-1, (0.95±0.13), (716.61±71.13) pg·ml-1 and (175.69±31.28) pg·ml-1, respectively;which were higher than that of distraction group (31.86±3.23) cm·s-1, (0.84±0.11), (677.37±70.21) pg·ml-1, (149.26±30.13) pg·ml-1, and the differences were statistically significant (P<0.05). There was no recurrence of ulcers in situ or at other sites in both groups during follow-up.
CONCLUSION
Compared with periosteal distraction, TTT microcirculation reconstruction surgery has a definite effect in the treatment of early DF. It could effectively reduce pain level, improve blood flow indicators and vascular endothelial function of the foot, and has a relatively high safety.
Humans
;
Male
;
Female
;
Middle Aged
;
Aged
;
Tibia/blood supply*
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Diabetic Foot/physiopathology*
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Microcirculation
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Periosteum/surgery*
;
Plastic Surgery Procedures/methods*
;
Osteogenesis, Distraction
2.Effects of biological amnion membrane coverage combined with corneal bandage lens on chemical burns of ocular surface
Peng-Fei TIAN ; Kun HE ; Shou-Hui ZHU ; Min ZHANG ; Guo-Ning YE ; Bing-Xin PAN
International Eye Science 2023;23(1):167-171
AIM: To investigate the clinical effect and stability of biological amnion membrane coverage combined with corneal bandage lens for patients with chemical burns of ocular surface.METHODS: Retrospective study. The clinical data of 49 cases(49 eyes)of patients with chemical burns of ocular surface treated in our hospital between December 2018 and August 2021 were collected. They were divided into the biological amnion membrane coverage group and the biological amnion membrane coverage combined with corneal bandage lens group according to the surgical method. The loss time of biological amniotic membrane, postoperative pain score, repair rate and time of ocular surface, visual acuity and complications were compared between the two groups.RESULTS: The ocular pain scores of the two groups were 2.208±0.758(the biological amnion membrane coverage group)and 2.063±0.800(the biological amnion membrane coverage combined with corneal bandage lens group)at 1d after surgery, respectively(P>0.05). But at the 3d and 7d after surgery, pain scores were 1.844±0.762 and 1.150±0.582, 1.684±0.820 and 0.750±0.514, respectively(all P<0.05). The loss time of biological amniotic membrane in the biological amnion membrane coverage combined with corneal bandage lens group was 10.75±2.63d, which was longer than that in the biological amnion membrane coverage group(7.60±2.22d; P<0.05). Moreover, it has better ocular surface repair effect than the biological amnion membrane coverage group. At 6mo after operation, visual acuity in the two groups was 0.30(0.10, 0.55)and 0.30(0.20, 0.58), respectively(P>0.05). Additionally, there was no differences in the complications of both groups(P>0.05).CONCLUSION:Biological amnion membrane coverage has effective treatment effects on patients with chemical burns of ocular surface, and it can delay the loss time of biological amniotic membrane, increase repair rate of ocular surface and alleviate postoperative discomfort if combined with corneal bandage lens.
3.HbA1c comparison and diagnostic efficacy analysis of multi center different glycosylated hemoglobin detection systems.
Ping LI ; Ying WU ; Yan XIE ; Feng CHEN ; Shao qiang CHEN ; Yun Hao LI ; Qing Qing LU ; Jing LI ; Yong Wei LI ; Dong Xu PEI ; Ya Jun CHEN ; Hui CHEN ; Yan LI ; Wei WANG ; Hai WANG ; He Tao YU ; Zhu BA ; De CHENG ; Le Ping NING ; Chang Liang LUO ; Xiao Song QIN ; Jin ZHANG ; Ning WU ; Hui Jun XIE ; Jina Hua PAN ; Jian SHUI ; Jian WANG ; Jun Ping YANG ; Xing Hui LIU ; Feng Xia XU ; Lei YANG ; Li Yi HU ; Qun ZHANG ; Biao LI ; Qing Lin LIU ; Man ZHANG ; Shou Jun SHEN ; Min Min JIANG ; Yong WU ; Jin Wei HU ; Shuang Quan LIU ; Da Yong GU ; Xiao Bing XIE
Chinese Journal of Preventive Medicine 2023;57(7):1047-1058
Objective: Compare and analyze the results of the domestic Lanyi AH600 glycated hemoglobin analyzer and other different detection systems to understand the comparability of the detection results of different detectors, and establish the best cut point of Lanyi AH600 determination of haemoglobin A1c (HbA1c) in the diagnosis of diabetes. Methods: Multi center cohort study was adopted. The clinical laboratory departments of 18 medical institutions independently collected test samples from their respective hospitals from March to April 2022, and independently completed comparative analysis of the evaluated instrument (Lanyi AH600) and the reference instrument HbA1c. The reference instruments include four different brands of glycosylated hemoglobin meters, including Arkray, Bio-Rad, DOSOH, and Huizhong. Scatter plot was used to calculate the correlation between the results of different detection systems, and the regression equation was calculated. The consistency analysis between the results of different detection systems was evaluated by Bland Altman method. Consistency judgment principles: (1) When the 95% limits of agreement (95% LoA) of the measurement difference was within 0.4% HbA1c and the measurement score was≥80 points, the comparison consistency was good; (2) When the measurement difference of 95% LoA exceeded 0.4% HbA1c, and the measurement score was≥80 points, the comparison consistency was relatively good; (3) The measurement score was less than 80 points, the comparison consistency was poor. The difference between the results of different detection systems was tested by paired sample T test or Wilcoxon paired sign rank sum test; The best cut-off point of diabetes was analyzed by receiver operating characteristic curve (ROC). Results: The correlation coefficient R2 of results between Lanyi AH600 and the reference instrument in 16 hospitals is≥0.99; The Bland Altman consistency analysis showed that the difference of 95% LoA in Nanjing Maternity and Child Health Care Hospital in Jiangsu Province (reference instrument: Arkray HA8180) was -0.486%-0.325%, and the measurement score was 94.6 points (473/500); The difference of 95% LoA in the Tibetan Traditional Medical Hospital of TAR (reference instrument: Bio-Rad Variant II) was -0.727%-0.612%, and the measurement score was 89.8 points; The difference of 95% LoA in the People's Hospital of Chongqing Liang Jiang New Area (reference instrument: Huizhong MQ-2000PT) was -0.231%-0.461%, and the measurement score was 96.6 points; The difference of 95% LoA in the Taihe Hospital of traditional Chinese Medicine in Anhui Province (reference instrument: Huizhong MQ-2000PT) was -0.469%-0.479%, and the measurement score was 91.9 points. The other 14 hospitals, Lanyi AH600, were compared with 4 reference instrument brands, the difference of 95% LoA was less than 0.4% HbA1c, and the scores were all greater than 95 points. The results of paired sample T test or Wilcoxon paired sign rank sum test showed that there was no statistically significant difference between Lanyi AH600 and the reference instrument Arkray HA8180 (Z=1.665,P=0.096), with no statistical difference. The mean difference between the measured values of the two instruments was 0.004%. The comparison data of Lanyi AH600 and the reference instrument of all other institutions had significant differences (all P<0.001), however, it was necessary to consider whether it was within the clinical acceptable range in combination with the results of the Bland-Altman consistency analysis. The ROC curve of HbA1c detected by Lanyi AH600 in 985 patients with diabetes and 3 423 patients with non-diabetes was analyzed, the area under curve (AUC) was 0.877, the standard error was 0.007, and the 95% confidence interval 95%CI was (0.864, 0.891), which was statistically significant (P<0.001). The maximum value of Youden index was 0.634, and the corresponding HbA1c cut point was 6.235%. The sensitivity and specificity of diabetes diagnosis were 76.2% and 87.2%, respectively. Conclusion: Among the hospitals and instruments currently included in this study, among these four hospitals included Nanjing Maternity and Child Health Care Hospital in Jiangsu Province (reference instrument: Arkray HA8180), Tibetan Traditional Medical Hospital of TAR (reference instrument: Bio-Rad Variant Ⅱ), the People's Hospital of Chongqing Liang Jiang New Area (reference instrument: Huizhong MQ-2000PT), and the Taihe Hospital of traditional Chinese Medicine in Anhui Province (reference instrument: Huizhong MQ-2000PT), the comparison between Lanyi AH600 and the reference instruments showed relatively good consistency, while the other 14 hospitals involved four different brands of reference instruments: Arkray, Bio-Rad, DOSOH, and Huizhong, Lanyi AH600 had good consistency with its comparison. The best cut point of the domestic Lanyi AH600 for detecting HbA1c in the diagnosis of diabetes is 6.235%.
Pregnancy
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Child
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Humans
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Female
;
Glycated Hemoglobin
;
Cohort Studies
;
Diabetes Mellitus/diagnosis*
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Sensitivity and Specificity
;
ROC Curve
4.The investigation of modified double wing flap combined with medial plantar skin graft in the treatment of congenital syndactyly
Jia LI ; Guangnan PEI ; Hui ZHU ; Daolian TENG ; Haijian LI ; Dawei ZHENG ; Fei YIN ; Kuishui SHOU
Chinese Journal of Plastic Surgery 2023;39(3):273-277
Objective:To explore the clinical effect of the modified double wing flap combined with medial plantar skin graft in the treatment of congenital syndactyly.Methods:The data of children with congenital syndactyly treated by modified double wing flap combined with medial plantar skin graft in the Department of Pediatric Orthopaedics of Xuzhou Renci Hospital from January 2019 to February 2022 were retrospectively analyzed. All of them had skin deficiency after separating syndactyly during the operation. The medial plantar was selected as the skin graft donor area. The patients were followed up through WeChat and outpatient review after operations, the contents include the shape of finger web, the shape of finger, the degree of scar contracture in the skin graft area and the medial plantar skin donor area, and the appearance of finger web was evaluated by the modified Withey correction score, and investigate the satisfaction of parents of the children.Results:A total of 10 children were included, including 5 males and 5 females, aged 1 year and 6 months to 4 years, with an average age of 2 years and 10 months. There were 8 cases of middle ring finger syndactyly, 1 case of ring little finger syndactyly, and 1 case of index middle finger syndactyly. After separating syndactyly, the skin defect area is about 1.0 cm×1.5 cm-1.5 cm×3.0 cm, and a medial plantar full-thickness skin graft with the same area is taken. The postoperative follow-up was 6-18 months, with an average of 11.3 months. All the flaps and grafts survived, and the wounds healed in primary stage. The depth, width and slope of the finger web were normal, there was no color difference between the skin graft and the surrounding skin, and the appearance of the finger was beautiful. The scar in the skin graft area and the medial plantar skin donor area was not obvious. The modified Withey correction score was 0-1, with an average of 0.1. The parents were all satisfied.Conclusion:The texture of the medial plantar skin is similar to that of the hand. After the treatment of congenital syndactyly with the modified double wing flap combined with the medial plantar skin graft, the shape of the finger web is normal, the shape of the hand is beautiful, the scar is not obvious, and the medial plantar skin donor area is hidden, which does not affect walking. After the operation, good function and shape can be obtained. It is one of the effective method to treat congenital syndactyly with insufficient skin.
5.The investigation of modified double wing flap combined with medial plantar skin graft in the treatment of congenital syndactyly
Jia LI ; Guangnan PEI ; Hui ZHU ; Daolian TENG ; Haijian LI ; Dawei ZHENG ; Fei YIN ; Kuishui SHOU
Chinese Journal of Plastic Surgery 2023;39(3):273-277
Objective:To explore the clinical effect of the modified double wing flap combined with medial plantar skin graft in the treatment of congenital syndactyly.Methods:The data of children with congenital syndactyly treated by modified double wing flap combined with medial plantar skin graft in the Department of Pediatric Orthopaedics of Xuzhou Renci Hospital from January 2019 to February 2022 were retrospectively analyzed. All of them had skin deficiency after separating syndactyly during the operation. The medial plantar was selected as the skin graft donor area. The patients were followed up through WeChat and outpatient review after operations, the contents include the shape of finger web, the shape of finger, the degree of scar contracture in the skin graft area and the medial plantar skin donor area, and the appearance of finger web was evaluated by the modified Withey correction score, and investigate the satisfaction of parents of the children.Results:A total of 10 children were included, including 5 males and 5 females, aged 1 year and 6 months to 4 years, with an average age of 2 years and 10 months. There were 8 cases of middle ring finger syndactyly, 1 case of ring little finger syndactyly, and 1 case of index middle finger syndactyly. After separating syndactyly, the skin defect area is about 1.0 cm×1.5 cm-1.5 cm×3.0 cm, and a medial plantar full-thickness skin graft with the same area is taken. The postoperative follow-up was 6-18 months, with an average of 11.3 months. All the flaps and grafts survived, and the wounds healed in primary stage. The depth, width and slope of the finger web were normal, there was no color difference between the skin graft and the surrounding skin, and the appearance of the finger was beautiful. The scar in the skin graft area and the medial plantar skin donor area was not obvious. The modified Withey correction score was 0-1, with an average of 0.1. The parents were all satisfied.Conclusion:The texture of the medial plantar skin is similar to that of the hand. After the treatment of congenital syndactyly with the modified double wing flap combined with the medial plantar skin graft, the shape of the finger web is normal, the shape of the hand is beautiful, the scar is not obvious, and the medial plantar skin donor area is hidden, which does not affect walking. After the operation, good function and shape can be obtained. It is one of the effective method to treat congenital syndactyly with insufficient skin.
6.Analysis of the effect of sensation reconstructed free medial plantar artery perforator flap in repair of digit-tip defects
Guangnan PEI ; Jia LI ; Daolian TENG ; Hui ZHU ; Haijian LI ; Dawei ZHENG ; Kuishui SHOU
Chinese Journal of Microsurgery 2022;45(5):534-538
Objective:To retrospectively analyse the clinical effect of sensation reconstructed free medial plantar artery perforator flap in repair of digit-tip defects.Methods:From March 2017 to February 2021, 11 cases with digit-tip defect were repaired by medial plantar artery perforator flap in the Department of Hand Surgery of Xuzhou Renci Hospital. The cutaneous sensory nerves were separated when the flap was harvested, and then the sensory nerves were sutured to the palmar nerves of the digits to reconstruct the sensation of the flap. All wounds had exposure of phalangeal bones, the size of the digit-tip defects was 1.2 cm×1.0 cm-2.5 cm×2.2 cm, the size of the flaps was 1.6 cm×1.5 cm-3.0 cm×2.7 cm. Ten donor sites were directly sutured and 1 was repaired by skin grafting. All patients were included in the postoperative follow-up through outpatient clinic and WeChat reviews to collect relevant information, including texture, sweating, stability, sensation, degree of bloating, blood circulation, usage of the flaps and skin and scars at the donor sites.Results:All flaps survived besides 1 case had venous occlusion occurred 12 hours after the operation, and the venous occlusion was relieved by releasing the dressing and removing some of sutures, and the flap survived smoothly. The wounds in the donor sites healed well. The postoperative follow-up period lasted for 6-18 months, with an average of 10.7 months. The flaps were soft, wear-resistant, and stable. The skin texture was restored with a small amount or normal sweating. One flap had mild bloated, and another flap showed a slightly poor colour of the flap together with a lower temperature. The sensory recovery of the flaps was good, reaching S 3+ or above. The TPD had achieved 6.0-8.5 mm, with an average of 7.1 mm. One patient had concerns in using the affected digit and 3 cases were in protective use of the affected digits. There was no wear and ulcer in the foot donor sites. According to Wang Shuhuan's assessment of flap function and Evaluation Trial Standards of Upper Limb Partial Functional of Hand Surgery of Chinese Medical Association, the patients in this group were scored excellent in 8 cases and good in 3 cases. Conclusion:The application of free medial plantar artery perforator flap in repair of digit-tip wounds can achieve good repairs. The donor site is hidden without effect on walking. It is one of the ideal donor sites for repairing digit-tip wounds.
7.Comparison of chemical components between aerial and underground parts of Coptis chinensis based on UPLC-Q-TOF-MS~E technology.
Tong ZHU ; Dan YANG ; Shan-Shan LIU ; Fei TENG ; Jing-Jing ZHU ; Yong-Xin ZHANG ; Guo-Bing XU ; Shou-Jin LIU ; Zhi-Min WANG ; Liang-Mian CHEN ; Hui-Min GAO
China Journal of Chinese Materia Medica 2022;47(4):980-987
The ultra-performance liquid chromatography-quadrupole time-of-flight mass spectrometry(UPLC-Q-TOF-MS~E) technology was employed to compare the chemical components between the aerial and underground parts of Coptis chinensis samples from different batches. According to the retention time, molecular ion peak, and LC-MS~E fragment information of the reference substances and available literature, we identified a total of 40 components. Thirty-three and 31 compounds were respectively identified in the underground part(taproots) and the aerial part(stems and leaves) of C. chinensis. Among them, 24 compounds, including alkaloids(e.g., berberine and jatrorrhizine) and phenolic acids(e.g., chlorogenic acid, quinic acid, and tanshinol), were common in the two parts. In addition, differential components were also identified, such as magnoline glucoside in the underground part and(±) lariciresionol-4-β-D-glucopyranoside in the aerial part. The analysis of fragmentation pathways based on spectra of reference substances indicated the differences among samples of different batches. Furthermore, we performed the principal component analysis(PCA) for the peak areas of C. chinensis in different batches. The results showed that the underground part and the aerial part were clearly clustered into two groups, indicating that the chemical components contained in the two parts were different. Furthermore, the results of partial least squares discriminant analysis(PLS-DA) identified 31 differential compounds(VIP value>1) between the underground part and the aerial part, mainly including alkaloids, phenolic acids, lignans, and flavonoids. This study proves that C. chinensis possesses great development potential with multiple available compounds in stems and leaves. Moreover, it sheds light on for the development and utilization of non-medicinal organs of C. chinensis and other Chinese medicinal herbs.
Chromatography, High Pressure Liquid/methods*
;
Coptis chinensis
;
Spectrometry, Mass, Electrospray Ionization/methods*
;
Tandem Mass Spectrometry/methods*
;
Technology
8.Relationship between the ideal cardiovascular health behaviors and factors and newonset heart failure.
Chen Rui ZHU ; Ji Hong SHI ; Zhe HUANG ; Xiao Ming WEI ; Hui Ying LI ; Li Ming LIN ; Xin DU ; Yan LIU ; Chun Peng JI ; Shou Ling WU
Chinese Journal of Cardiology 2021;49(9):905-911
Objective: To explore the relationship between the ideal cardiovascular health behaviors and factors and newonset heart failure. Methods: It was a prospective cohort study. People who attended the 2006-2007 physical examination of Kailuan Group Company and with complete data of cardiovascular behaviors and related factors were eligible for this study. A total of 95 167 participants who were free of valvular heart diseases, congenital heart diseases and a prior history of heart failure were included. Basic cardiovascular health score (CHS) of each participant was calculated. Participants were divided into 3 groups according to CHS. Group 1:CHS<8 (n=26 640), Group 2:8≤CHS<10 (n=35 230), Group3:CHS≥10 (n=33 297). The general clinical data and laboratory test results were collected. The outcome was defined as the first occurrence of heart failure at the end of followup(December 31, 2016). Cox regression model was used to determine the association between baseline CHS and the risk of newonset heart failure. Results: After a median followup of 10.3 years, the incidence of newonset heart failure in the group of CHS<8,8≤CHS<10,CHS≥10 were 2.7%(729/26 640), 1.8%(651/35 230) and 1.1%(360/33 297),respectively. After adjustment for age, sex, history of myocardial infarction, history of atrial fibrillation, income, alcohol consumption, education and the use of antihypertensive, cholesterol-lowering, glucose-lowering medications, compared with the group of CHS<8, the Cox regression model showed that HRs of the group of 8≤CHS<10 and CHS≥10 were 0.68 (95%CI 0.61-0.75), 0.49 (95%CI 0.43-0.55), respectively. Cox regression analysis after removing each single cardiovascular behavior or factor showed that the HR value range ability was as follows:systolic blood pressure(HR=0.78,95%CI 0.74-0.82), body mass index(HR=0.78,95%CI 0.74-0.82), fasting blood glucose (HR=0.77,95%CI 0.73-0.81), total cholesterol(HR=0.76,95%CI 0.72-0.80), physical exercise(HR=0.72,95%CI 0.69-0.76), smoking(HR=0.75,95%CI 0.71-0.79) and salt intake(HR=0.73,95%CI 0.69-0.77). Conclusion: CHS is negatively associated with the risk of newonset heart failure, and there is a dose-response relationship between the two indexes.
Blood Pressure
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Cardiovascular Diseases/epidemiology*
;
Health Behavior
;
Heart Failure/epidemiology*
;
Humans
;
Prospective Studies
;
Risk Factors
9.Chimeric bone flap pedicled with superficial palmar branch of radial artery in reconstruction of fingers with composite tissue defect
Hui ZHU ; Dawei ZHENG ; Zhangcan LI ; Yong PAN ; Jichao ZHANG ; Rongjian SHI ; Kuishui SHOU
Chinese Journal of Microsurgery 2021;44(5):487-490
Objective:To investigate the clinical effect of free chimeric bone flap pedicled with superficial palmar branch of radial artery in reconstruction of partial finger with composite tissue defect.Methods:From July, 2018 to January, 2020, 9 cases of compound tissue defect of fingers were reconstructed by free transfer of chimeric bone flap pedicled with superficial palmar branch of radial artery. The wrist transverse striated flap and distal radius bone flap pedicled with superficial palmar branch of radial artery were harvested in operations. The size of flap were 2.0 cm × 4.0 cm -3.0 cm × 6.5 cm, and the length of bone flaps were 1.5-2.5 cm. All patients entered monthly follow-up by clinic visit in 6 months after the surgery, and thereafter by WeChat interviews.Results:All of the 9 chimeric bone flaps survived well. The average healing time of bone flap was 1.7 months, and the average length of reconstructed finger was 2.4(1.8-3.0) cm; The appearance of the affected fingers restored well, the scars of the donor sites were mild, and average of the TPD of the flaps was 6.6(5.3-8.6) mm at 6 months after the surgery. The function of the affected finger was evaluated according to the Trial Standard of the Upper Limb Function Evaluation proposed by the Hand Surgery Society of the Chinese Medical Association: excellent in 7 cases, good in 1 case and medium in 1 case.Conclusion:Free chimeric bone flap pedicled with superficial palmar branch of radial artery can be used in reconstruction of the soft tissue and bone defects of fingers at the same time. It restores the functional length of fingers, improves the function and appearance of fingers, with less damage to the donor site. It is a simple method for reconstruction of finger defects.
10.A multicenter study on the establishment and validation of autoverification rules for coagulation tests
Linlin QU ; Jun WU ; Wei WU ; Beili WANG ; Xiangyi LIU ; Hong JIANG ; Xunbei HUANG ; Dagan YANG ; Yongzhe LI ; Yandan DU ; Wei GUO ; Dehua SUN ; Yuming WANG ; Wei MA ; Mingqing ZHU ; Xian WANG ; Hong SUI ; Weiling SHOU ; Qiang LI ; Lin CHI ; Shuang LI ; Xiaolu LIU ; Zhuo WANG ; Jun CAO ; Chunxi BAO ; Yongquan XIA ; Hui CAO ; Beiying AN ; Fuyu GUO ; Houmei FENG ; Yan YAN ; Guangri HUANG ; Wei XU
Chinese Journal of Laboratory Medicine 2020;43(8):802-811
Objective:To establish autoverification rules for coagulation tests in multicenter cooperative units, in order to reduce workload for manual review of suspected results and shorten turnaround time (TAT) of test reports, while ensure the accuracy of results.Methods:A total of 14 394 blood samples were collected from fourteen hospitals during December 2019 to March 2020. These samples included: Rules Establishment Group 11 230 cases, including 1 182 cases for Delta check rules; Rules Validation Group 3 164 cases, including 487cases for Delta check; Clinical Application Trial Group 77 269 cases. Samples were analyzed for coagulation tests using Sysmex CS series automatic coagulation analyzers, and the clinical information, instrument parameters, test results, clinical diagnosis, medication history of anticoagulant and other relative results such as HCT, TG, TBIL, DBIL were summarized; on the basis of historical data, the 2.5 and 97.5 percentile of all data arranged from low to high were initially accumulated; on the basis of clinical suggestions, critical values and specific drug use as well as relative guidelines, autoverification rules and limits were established.The rules were then input into middleware, in which Stage I/Stage II validation was done. Positive coincidence, negative coincidence, false negative, false positive, autoverification pass rate, passing accuracy (coincidence of autoverification and manual verification) were calculated. Autoverification rules underwent trial application in coagulation results reports.Results:(1) The autoverification algorisms involve 33 rules regarding PT/INR, APTT, FBG, D-dimer, FDP,Delta check, reaction curve and sample abnormalities; (2)Autoverification Establishment Group showed autoverification pass rate was 68.42% (7 684/11 230), the false negative rate was 0%(0/11230), coincidence of autoverification and manual verification was 98.51%(11 063/11 230), in which positive coincidence and negative coincidence were respectively 30.09% (3 379/11 230) and 68.42%(7 684/11 230); Autoverification Validation Group showed autoverification pass rate was 60.37%(1 910/3 164), the false negative rate was 0%(0/11 230), coincidence of autoverification and manual verification was 97.79%(3 094/3 164), in which positive coincidence and negative coincidence were respectively 37.42%(1 184/3 164) and 60.37%(1 910/3 164); (3) Trialed implementation of these autoverification rules on 77 269 coagulation samples showed that the average TAT shortened by 8.5 min-83.1 min.Conclusions:This study established 33 autoverification rules in coagulation tests. Validation showedthese rules could ensure test quality while shortening TAT and lighten manual workload.

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