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1.
Article in Chinese | WPRIM (Western Pacific) | ID: wpr-1009110

ABSTRACT

OBJECTIVE@#To investigate the clinical application of high-frequency color Doppler ultrasound (HFCDU) in detecting perforators in the deep adipose layers for harvesting super-thin anterolateral thigh flap (ALTF).@*METHODS@#Between August 2019 and January 2023, 45 patients (46 sides) with skin and soft tissue defects in the foot and ankle were treated, including 29 males and 16 females, aged from 22 to 62 years, with an average of 46.7 years. The body mass index ranged from 19.6 to 36.2 kg/m 2, with an average of 23.62 kg/m 2. The causes of injury included traffic accident injury in 15 cases, heavy object crush injury in 20 cases, mechanical injury in 8 cases, heat crush injury in 1 case, and chronic infection in 1 case. There were 20 cases on the left side, 24 cases on the right side, and 1 case on both sides. After thorough debridement, the wound size ranged from 5 cm×4 cm to 17 cm×11 cm. All patients underwent free super-thin ALTF transplantation repair. HFCDU was used to detect the location of the perforators piercing the deep and superficial fascia, as well as the direction and branches of the perforators within the deep adipose layers before operation. According to the preoperative HFCDU findings, the dimensions of the super-thin ALTF ranged from 6 cm×4 cm to 18 cm×12 cm. The donor sites of the flaps were directly sutured.@*RESULTS@#A total of 55 perforators were detected by HFCDU before operation, but 1 was not found during operation. During operation, a total of 56 perforators were found, and 2 perforators were not detected by HFCDU. The positive predictive value of HFCDU for identifying perforator vessels was 98.2%, and the sensitivity was 96.4%. Among the 54 perforators accurately located by HFCDU, the orientation of the perforators in the deep adipose layers was confirmed during operation. There were 21 perforators (38.9%) traveled laterally and inferiorly, 12 (22.2%) traveled medially and inferiorly, 14 (25.9%) traveled laterally and superiorly, 5 (9.3%) traveled medially and superiorly, and 2 (3.7%) ran almost vertically to the body surface. Among the 54 perforators accurately located by HFCDU, 35 were identified as type 1 perforators and 12 as type 2 perforators (HFCDU misidentified 7 type 2 perforators as type 1 perforators). The sensitivity of HFCDU in identifying type 1 perforators was 100%, with a positive predictive value of 83.3%. For type 2 perforators, the sensitivity was 63.2%, and the positive predictive value was 100%. The surgeries were successfully completed. The super-thin ALTF had a thickness ranging from 2 to 6 mm, with an average of 3.56 mm. All super-thin ALTF survived, however, 1 flap experienced a venous crisis at 1 day after operation, but it survived after emergency exploration and re-anastomosis of the veins; 1 flap developed venous crisis at 3 days after operation but survived after bleeding with several small incisions; 3 flaps had necrosis at the distal edge of the epidermis, which healed after undergoing dressing changes. All 45 patients were followed up 6-18 months (mean, 13.6 months). Three flaps required secondary defatting procedures, while the rest had the appropriate thickness, and the overall appearance was satisfactory.@*CONCLUSION@#Preoperative application of HFCDU to detect the perforator in the deep adipose layers can improve the success and safety of the procedure by facilitating the harvest of super-thin ALTF.


Subject(s)
Male , Female , Humans , Thigh/surgery , Plastic Surgery Procedures , Prospective Studies , Skin Transplantation , Free Tissue Flaps , Burns , Soft Tissue Injuries/surgery , Ultrasonography, Doppler, Color , Crush Injuries/surgery , Perforator Flap , Treatment Outcome
2.
Preprint in English | medRxiv | ID: ppmedrxiv-22277985

ABSTRACT

BackgroundBoth Coronavirus Disease-2019 (COVID-19) infection and COVID-19 vaccination have been associated with the development of acute myocardial infarction (AMI). This study compared the rates of AMI after COVID-19 infection and among the COVID-19 vaccinated populations in Hong Kong. MethodsThis was a population-based cohort study from Hong Kong, China. Patients with positive real time-polymerase chain reaction (RT-PCR) test for COVID-19 between January 1st, 2020 and June 30th, 2021 were included. The data of the vaccinated and unvaccinated population was obtained from the "Reference Data of Adverse Events in Public Hospitals" published by the local government. The individuals who were vaccinated with COVID-19 vaccination prior the observed period (December 6th, 2021 to January 2nd, 2022) in Hong Kong were also included. The vaccination data of other countries were obtained by searching PubMed using the terms ["COVID-19 vaccine" AND "Myocardial infarction"] from its inception to February 1st, 2022. The main exposures were COVID-19 test positivity or previous COVID-19 vaccination. The primary outcome was the development of AMI within 28 days observed period. ResultsThis study included 11441 COVID-19 patients, of whom 25 suffered from AMI within 28 days of exposure (rate per million: 2185; 95% confidence interval [CI]: 1481-3224). The rates of AMI were much higher than those who were not vaccinated by the COVID-19 vaccine before December 6th, 2021 (rate per million: 162; 95% CI: 147-162) with a rate ratio of 13.5 (95% CI: 9.01-20.2). Meanwhile, the rate of AMI was lower amongst the vaccinated population (rate per million: 47; 95% CI: 41.3-53.5) than COVID-19 infection with a rate ratio of 0.02 (0.01, 0.03). Regarding post-vaccination AMI, COVID-19 infection was associated with a significantly higher rate of AMI than post-COVID-19 vaccination AMI in other countries. ConclusionsCOVID-19 infection was associated with a higher rate of AMI than the vaccinated general population, and those immediately after COVID-19 vaccination.

3.
Chinese Journal of Microsurgery ; (6): 515-520, 2022.
Article in Chinese | WPRIM (Western Pacific) | ID: wpr-958396

ABSTRACT

Objective:To investigate the clinical effect of superthin anterolateral thigh flap(ALTF) with retrograde dissection of perforator in the interface plane between the superficial and deep layer of superficial fascia for reconstruction of soft tissue defect in the foot.Methods:The study involved 24 Side of 23 patients with foot soft tissue defects in Department of Foot and Ankle Surgery in Wuxi Ninth People’s Hospital from August 2019 to July 2021. There were 15 males and 8 females with an average of 42(range, 22-59) years old, including 9 in left foot, 13 in right foot, and 1 in both feet. The size of soft tissue defects was 4 cm×4 cm-11 cm×17 cm. The dimension of the superthin ALTF was 4 cm×5 cm-12 cm×18 cm. CTA and high-frequency CDU were used to locate the perforator in the superficial fascia plane. The perforator was exposed and dissected retrograde in the adiposal layer. The superthin ALTF was harvested to repair the foot wound. The donor site was sutured directly. All patients enter follow-up reviews at outpatient clinic or by WeChat. The appearance of flaps were recorded.Results:The superthin ALTF survived in all patients. Two cases had partial epidermal necrosis at the distal part of the flap. The thickness of the flap averaged approximately 4(range 3-6) mm. During 8-16(mean 12) months of follow-up, all superthin ALTF were soft in texture without ulceration. Two flaps required secondary defatting procedures, others showed satisfactory appearance without bulky deformity. Only linear scars left in donor areas.Conclusion:The technique of harvesting superthin ALTF with retrograde dissection of perforator in the superficial fascia plane for repairing foot wounds is reliable and is able to achieve satisfactory functional and esthetic outcome.

4.
Chinese Journal of Microsurgery ; (6): 377-382, 2022.
Article in Chinese | WPRIM (Western Pacific) | ID: wpr-958379

ABSTRACT

Objective:To investigate the therapeutic effect of Flow-through anterolateral thigh perforator flap (ALTPF) or medial sural artery perforator flap (MSAPF) in repair of Gustilo III C wound of foot.Methods:From July 2015 to June 2021, 8 patients with Gustilo III C wound of foot were treated in the Department of Foot and Ankle Surgery of Wuxi No.9 People’s Hospital. The patients were 7 males and 1 female, aged 25-62 years old, and (45.88±12.96) years old in average. Flow-through ALTPF or Flow-through MSAPF were used to repair the defect according to the size of the wound and the length and diameter of the defect vascular. Among the patients, 6 were repaired with free Flow-through ALTPF, and 2 with free Flow-through MSAPF. The size of flap was 9 cm×5 cm-22 cm×8 cm with (115.00±46.16) cm 2 in average, and the vascular bridging was 6-12 cm in length, with (8.75±2.50) cm in average. All patients received outpatient follow-up. The appearance of the flap, blood supply of affected limb, healing of fracture and dislocation and the recovery of limb function were recorded. Maryland score was used to evaluate functional recovery. Results:The flaps survived uneventfully in all 8 patients, and the wounds in donor site healed primarily. All patients were followed-up for 6-22 months with (12.25±5.39 ) months in average. At the last follow-up, all the flaps had satisfactory contour in soft texture and blood supply without occlusion in the bridging vessels. The fractures and dislocation were healed, and the appearance and function of the foot recovered satisfactorily. The Maryland score showed excellent in 3 patients, good in 4 patients and fair in 1 patient.Conclusion:Flow-through ALTPF or MSAPF can selectively used to reconstruct the Gustilo III C wound of foot in one stage. The functional recovery of the affected limb was satisfactory and the clinical effect was good.

5.
Preprint in English | medRxiv | ID: ppmedrxiv-21267730

ABSTRACT

BackgroundBoth COVID-19 infection and COVID-19 vaccines have been associated with the development of myopericarditis. The objective of this study is to 1) analyze the rates of myopericarditis after COVID-19 infection and COVID-19 vaccination in Hong Kong and 2) compare to the background rates, and 3) compare the rates of myopericarditis after COVID-19 vaccination to those reported in other countries. MethodsThis was a population-based cohort study from Hong Kong, China. Patients with positive RT-PCR test for COVID-19 between 1st January 2020 and 30th June 2021 or individuals who received COVID-19 vaccination until 31st August were included. The main exposures were COVID-19 positivity or COVID-19 vaccination. The primary outcome was myopericarditis. ResultsThis study included 11441 COVID-19 patients from Hong Kong, of whom four suffered from myopericarditis (rate per million: 350; 95% confidence interval [CI]: 140-900). The rate was higher than the pre-COVID-19 background rate in 2020 (rate per million: 61, 95% CI: 55-67) with a rate ratio of 5.73 (95% CI: 2.23-14.73. Compared to background rates, the rate of myopericarditis among vaccinated subjects in Hong Kong was substantially lower (rate per million: 8.6; 95% CI: 6.4-11.6) with a rate ratio of 0.14 (95% CI: 0.10-0.19). The rates of myocarditis after vaccination in Hong Kong are comparable to those vaccinated in the United States, Israel, and the United Kingdom. ConclusionsCOVID-19 infection is associated with a higher rate of myopericarditis whereas COVID-19 vaccination is associated with a lower rate of myopericarditis compared to the background.

6.
Chinese Journal of Microsurgery ; (6): 637-641, 2021.
Article in Chinese | WPRIM (Western Pacific) | ID: wpr-934163

ABSTRACT

Objective:To investigate the clinical effect of free anterolateral thigh flap(ALTF) combined with medial plantar flap(MPF) transfer in repairing forefoot and mid-foot degloving injury.Methods:From May, 2016 to November, 2019, 6 patients with forefoot and mid-foot degloving injuries underwent reconstructions using free ALTF combined with MPF. The study included 4 males and 2 females patients with an average of 43 (range, 35-55) years. The size of soft tissue defects was 15 cm×12 cm-19 cm×14 cm. The dimension of the MPF was 8 cm×5 cm-10 cm× 6 cm, and that of ALTF was 16 cm×7 cm-20 cm×8 cm. The ALTF was used to cover the dorsal and lateral foot, the flap artery was anastomosed to the dorsalis pedis artery. The MPF was used to repair the weight-bearing area of the forefoot, the flap artery was anastomosed to the medial plantar artery in recipient site. All patients entered follow-up by outpatient clinic or Wechat for 9-18(mean, 14) months, and the appearance of flap and limb function were recorded.Results:The MPF and ALTF survived uneventfully in all 6 patients, and the wound in donor and recipient areas healed in one stage. At the last follow-up, the flaps had satisfactory contour, the texture of the flaps was soft, the protective sensation was recovered, and the appearance and function of the foot recovered satisfactorily. The Maryland score of reconstructed foot function was considered excellent (90-100) in 4 cases and good (75-89) in 2 cases. The average Maryland score was 91.2.Conclusion:ALTF combined with MPF generated good effect and satisfactory function in repairing forefoot and mid-foot degloving injury.

7.
Preprint in English | medRxiv | ID: ppmedrxiv-20248645

ABSTRACT

AimsRenin-angiotensin system blockers such as angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) may increase the risk of adverse outcomes in COVID-19. In this study, the relationships between ACEI/ARB use and COVID-19 related mortality were examined. MethodsConsecutive patients diagnosed with COVID-19 by RT-PCR at the Hong Kong Hospital Authority between 1st January and 28th July 2020 were included. ResultsThis study included 2774 patients. The mortality rate of the COVID-19 positive group was 1.5% (n=42). Those who died had a higher median age (82.3[76.5-89.5] vs. 42.9[28.2-59.5] years old; P<0.0001), more likely to have baseline comorbidities of cardiovascular disease, diabetes mellitus, hypertension, and chronic kidney disease (P<0.0001). They were more frequently prescribed ACEI/ARBs at baseline, and steroids, lopinavir/ritonavir, ribavirin and hydroxychloroquine during admission (P<0.0001). They also had a higher white cell count, higher neutrophil count, lower platelet count, prolonged prothrombin time and activated partial thromboplastin time, higher D-dimer, troponin, lactate dehydrogenase, creatinine, alanine transaminase, aspartate transaminase and alkaline phosphatase (P<0.0001). Multivariate Cox regression showed that age, cardiovascular disease, renal disease, diabetes mellitus, the use of ACEIs/ARBs and diuretics, and various laboratory tests remained significant predictors of mortality. ConclusionsWe report that an association between ACEIs/ARBs with COVID-19 related mortality even after adjusting for cardiovascular and other comorbidities, as well as medication use. Patients with greater comorbidity burden and laboratory markers reflecting deranged clotting, renal and liver function, and increased tissue inflammation, and ACEI/ARB use have a higher mortality risk. Key PointsO_LIWe report that an association between ACEIs/ARBs with COVID-19 related mortality even after adjusting for cardiovascular and other comorbidities, as well as medication use. C_LIO_LIPatients with greater comorbidity burden and laboratory markers reflecting deranged clotting, renal and liver function, and increased tissue inflammation, and ACEI/ARB use have a higher mortality risk. C_LI

8.
Preprint in English | medRxiv | ID: ppmedrxiv-20248646

ABSTRACT

BackgroundDiabetes mellitus-related complications adversely affect the quality of life. Better risk-stratified care through mining of sequential complication patterns is needed to enable early detection and prevention. MethodsUnivariable and multivariate logistic regression was used to identify significant variables that can predict mortality. A sequence analysis method termed Prefixspan was applied to identify the most common couple, triple, quadruple, quintuple and sextuple sequential complication patterns in the directed comorbidity pathology network. A knowledge enhanced CPT+ (KCPT+) sequence prediction model is developed to predict the next possible outcome along the progression trajectories of diabetes-related complications. FindingsA total of 14,144 diabetic patients (51% males) were included. Acute myocardial infarction (AMI) without known ischaemic heart disease (IHD) (odds ratio [OR]: 2.8, 95% CI: [2.3, 3.4]), peripheral vascular disease (OR: 2.3, 95% CI: [1.9, 2.8]), dementia (OR: 2.1, 95% CI: [1.8, 2.4]), and IHD with AMI (OR: 2.4, 95% CI: [2.1, 2.6]) are the most important multivariate predictors of mortality. KCPT+ shows high accuracy in predicting mortality (F1 score 0.90, ACU 0.88), osteoporosis (F1 score 0.86, AUC 0.82), ophthalmological complications (F1 score 0.82, AUC 0.82), IHD with AMI (F1 score 0.81, AUC 0.85) and neurological complications (F1 score 0.81, AUC 0.83) with a particular prior complication sequence. InterpretationSequence analysis identifies the most common pattern characteristics of disease-related complications efficiently. The proposed sequence prediction model is accurate and enables clinicians to diagnose the next complication earlier, provide better risk-stratified care, and devise efficient treatment strategies for diabetes mellitus patients.

9.
Preprint in English | medRxiv | ID: ppmedrxiv-20217380

ABSTRACT

BackgroundRecent studies have reported numerous significant predictors for adverse outcomes in COVID-19 disease. However, there have been few simple clinical risk score for prompt risk stratification. The objective is to develop a simple risk score for severe COVID-19 disease using territory-wide healthcare data based on simple clinical and laboratory variables. MethodsConsecutive patients admitted to Hong Kongs public hospitals between 1st January and 22nd August 2020 diagnosed with COVID-19, as confirmed by RT-PCR, were included. The primary outcome was composite intensive care unit admission, need for intubation or death with follow-up until 8th September 2020. ResultsCOVID-19 testing was performed in 237493 patients and 4445 patients (median age 44.8 years old, 95% CI: [28.9, 60.8]); 50% male) were tested positive. Of these, 212 patients (4.8%) met the primary outcome. A risk score including the following components was derived from Cox regression: gender, age, hypertension, stroke, diabetes mellitus, ischemic heart disease/heart failure, respiratory disease, renal disease, increases in neutrophil count, monocyte count, sodium, potassium, urea, alanine transaminase, alkaline phosphatase, high sensitive troponin-I, prothrombin time, activated partial thromboplastin time, D-dimer and C-reactive protein, as well as decreases in lymphocyte count, base excess and bicarbonate levels. The model based on test results taken on the day of admission demonstrated an excellent predictive value. Incorporation of test results on successive time points did not further improve risk prediction. ConclusionsA simple clinical score accurately predicted severe COVID-19 disease, even without including symptoms, blood pressure or oxygen status on presentation, or chest radiograph results.

10.
Preprint in English | medRxiv | ID: ppmedrxiv-20143651

ABSTRACT

BackgroundThe coronavirus disease 2019 (COVID-19) has become a pandemic, placing significant burdens on the healthcare systems. In this study, we tested the hypothesis that a machine learning approach incorporating hidden nonlinear interactions can improve prediction for Intensive care unit (ICU) admission. MethodsConsecutive patients admitted to public hospitals between 1st January and 24th May 2020 in Hong Kong with COVID-19 diagnosed by RT-PCR were included. The primary endpoint was ICU admission. ResultsThis study included 1043 patients (median age 35 (IQR: 32-37; 54% male). Nineteen patients were admitted to ICU (median hospital length of stay (LOS): 30 days, median ICU LOS: 16 days). ICU patients were more likely to be prescribed angiotensin converting enzyme inhibitors/angiotensin receptor blockers, anti-retroviral drugs lopinavir/ritonavir and remdesivir, ribavirin, steroids, interferon-beta and hydroxychloroquine. Significant predictors of ICU admission were older age, male sex, prior coronary artery disease, respiratory diseases, diabetes, hypertension and chronic kidney disease, and activated partial thromboplastin time, red cell count, white cell count, albumin and serum sodium. A tree-based machine learning model identified most informative characteristics and hidden interactions that can predict ICU admission. These were: low red cells with 1) male, 2) older age, 3) low albumin, 4) low sodium or 5) prolonged APTT. A five-fold cross validation confirms superior performance of this model over baseline models including XGBoost, LightGBM, random forests, and multivariate logistic regression. ConclusionsA machine learning model including baseline risk factors and their hidden interactions can accurately predict ICU admission in COVID-19.

11.
Chinese Journal of Microsurgery ; (6): 464-468, 2020.
Article in Chinese | WPRIM (Western Pacific) | ID: wpr-871567

ABSTRACT

Objective:To investigate the clinical effectiveness of peroneal artery perforator flap with anterior tibial artery perforator in repair of the soft tissue defect of dorsum of forefoot and midfoot.Methods:From February, 2015 to July, 2019, peroneal artery perforator flaps with anterior tibial artery perforator were used to repair dorsal foot soft tissue defect in 42 patients. There were 25 males and 17 females, with an averge age of 62(44-73) years. The size of soft tissue defect ranged from 7 cm×4 cm to 18 cm×5 cm. The recipient sites on forefoot and midfoot were repaired by peroneal artery perforator flaps with anterior tibial artery from the anterolateral aspect of shank. The donor sites were resurfaced with full-thickness skin graft. All patients were followed-up at the outpatient clinic or through WeChat for 3-12 months. The appearance of the flaps and limb recovery were recorded.Results:All flaps survived successfully. The donor sites and recipient sites were well healed. At the last follow-up, the texture and aesthetic of flaps were good, and the appearance and function of the foot were satisfactory.Conclusion:The peroneal artery perforator flaps with anterior tibial artery double blood supply and can be designed to repair large and distanced soft tissue defect of forefoot and midfoot.

12.
Article in Chinese | WPRIM (Western Pacific) | ID: wpr-871511

ABSTRACT

Objective:To explore clinical application of the island flap pedicled of the descending branch of perforating branch from lateral anterior malleolus of peroneal artery in repairing the soft tissue defects in midfoot and forefoot.Methods:From January, 2010 to December, 2016, based on the anastomosis between the descending branch from a terminal branch of peroneal artery on the anterior aspect of the lateral malleolus and other branches located around the ankle joint and sinus tarsi, island flap with a pedicle could be harvested more distally and to be used in covering the soft tissue defects in midfoot and forefoot of 5 patients. Sizes of the flap were from 15 cm×12 cm to 8 cm×6 cm. All patients were followed-up in outpatient clinic or through WeChat. The appearance of the flaps and ankle function were recorded simultaneously.Results:All flaps were survived without any secondary surgeries. During the follow-up of 6-15 months, the texture of flaps was good with satisfactory estheticity. Range of motion at the injured ankle was 15° in dorsi flexion and 25° in plantar flexion.Conclusion:The flap with a pedicle of the descending branch of perforating branch from lateral anterior malleolus of peroneal artery is good enough to be used in the reconstruction of soft tissue defects in midfoot and forefoot.

13.
Article in Chinese | WPRIM (Western Pacific) | ID: wpr-871509

ABSTRACT

Objective:To compare the application and results in repairing wounds on shank and medial malleolus by perforator pedicled middle and lower third of posterior tibial flap, saphenous neurovascular flap and posterior tibial artery perforator plus saphenous neurovascular (double blood supply) flap.Methods:Clinical data of 60 patients with wounds on shank and medial malleolus and treated between August, 2015 and December, 2018 were analyzed. Among the patients, 25 were treated with perforator pedicled middle and lower third of posterior tibial flaps, 15 with saphenous neurovascular flaps, and 20 with double blood supply flaps. The data of surgery, survival of the flaps, texture and swelling of the flaps, patient satisfaction and scores set by American Orthopaedic Foot and Ankle Society(AOFAS) were collected. Statistic analysis was carried out to compare observations among the 3 groups.Results:Postoperative followed-up was 6 to 24(average 13.4) months. One flap suffered insufficient blood supply in the group of perforator pedicled middle and lower third of posterior tibial flaps, 2 flaps suffersd necrosis and skin graft was carried out in reverse saphenous nerve neurocutaneous flaps group. In double blood supply flaps group, 2 flaps appeared purple after surgery, and improved after removing the pedicle sutuer, and flaps became swelling and received secondary repair. All AOFAS scores (93.8, 93.3 and 92.8, respectively) and patient satisfaction were high in all 3 groups.Conclusion:All 3 types of flap are able to be used in repairing the soft tissue defect on shank and medial malleolus. The inclusive of saphenous nerve should be determined in intraoperation according to the presence and size of the perforator. If artery perforation is reliable, the use of posterior tibial artery perforator flap in wound repairing will deliver satisfactory outcomes in terms of blood supply and appearance of the flap. For the wider area of wound, a flap with double blood supply is preferred.

14.
Chinese Journal of Microsurgery ; (6): 276-279, 2011.
Article in Chinese | WPRIM (Western Pacific) | ID: wpr-419615

ABSTRACT

ObjectiveTo introduce clinical experience of the modified lateral crural reverse island skin flap with two sets of blood supply system for aged ankle & foot soft tissue defect.MethodsOn the anatomy base that cutaneous artery branches of lateral crural reverse island skin flap and perforating branches of sural neurocutaneous vascular flap were originated from peroneal artery, we designed the modified lateral crural reverse island skin flap located in posterolateral cruris treated for aged ankle & foot soft tissue defect. The modified flap had two sets of blood supply system which were from lateral crural flap and sural neurocutaneous flap.ResultsAll 11 flaps survived. The skin grafting of donor sites healed well. Followed up 3-9 months, six cases were satisfactory. Five cases with extensor defect were regained by tendon transplantation after 3 months of the operations.Conclusion The modified lateral crural reverse island skin flap with two sets of blood supply system is a good method for aged ankle & foot soft tissue defect.

15.
Article in Chinese | WPRIM (Western Pacific) | ID: wpr-683590

ABSTRACT

Intravenous preparations take more risk than oral preparation and externally applied agent.In phaseⅠtoler- ance trial of intravenous preparations of TCM on human subjects,minimum dose and maximum dose should be decided in light of data derived from preclinical pharmacodynamic and toxicological experiments,combined with practical situation in clinic.Dose-ascending coefficient of the should be reasonable.During the application of intravenous preparations of TCM in tolerance trial,clinical monitoring must be done to ensure the safety of subjects.Overall and integrated observa- tional indices should be designed on the basis of the features of preparation types,administration methods,the nature of medicine,etc.,so as to provide full-scale data for safe dose range,concentration of the preparation,dripping veloci- ty and possible adverse reactions,etc.

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