1.Clinical effect of indocyanine green angiography-assisted design and harvest of expanded flaps for scar reconstruction
Yanan HU ; Tingjun XIE ; Yuanbo LIU ; Shan ZHU ; Zengjie YANG ; Jia TIAN ; Cheng GAN ; Hu JIAO ; Shanshan LI ; Zixiang CHEN ; Lu ZHOU ; Bing HAN ; Shengyang JIN ; Yan ZENG ; Miao WANG ; Mengqing ZANG
Chinese Journal of Burns 2025;41(4):341-347
Objective:To investigate the clinical effect of indocyanine green angiography (ICGA)-assisted design and harvest of expanded flaps for scar reconstruction.Methods:This study was a retrospective observational study. From April 2019 to August 2023, 19 patients with scars (8 males, 11 females; aged 3-38 years) treated at the Plastic Surgery Hospital of Peking Union Medical College and Chinese Academy of Medical Sciences met the inclusion criteria. The scars were distributed on the head, face, trunk, and extremities. In stage Ⅰ surgery, skin soft tissue expanders were implanted in suitable areas around the scars for skin soft tissue expansion. In stage Ⅱ surgery, the scar tissue was excised, resulting in wound areas ranging from 100 to 210 cm 2, and expanded flaps were designed. ICGA was used to identify target perforators and their accompanying veins, and the flap design was adjusted to ensure the inclusion of complete arterial and venous axes. The expanded flap with an area of 120 to 240 cm2 was harvested using unilateral back-cut technique and transferred to the recipient site, and the donor site wound was sutured directly. The durations of the arterial and venous phases of ICGA during flap design were recorded. The length-to-width ratios of the back-cut flaps were calculated for different regions. After stage Ⅱ surgery, the blood perfusion and survival of the flap, the wound healing at the donor site, and the occurrence of complications were observed. During follow-up, the appearance, color, and texture of the patient's flap were observed. Results:The arterial phase of ICGA lasted 10-27 (18±5) s, and the venous phase lasted 78-116 (100±10) s. The length-to-width ratios of the back-cut flaps were 1.22±0.32, 1.63±0.12, and 1.15±0.21 for the head and neck, trunk, and limb regions, respectively. After stage Ⅱ surgery, one patient had a large area of insufficient blood perfusion in the flap. By comparing ICGA images before and after flap transfer, the sutures at the oral commissure were loosened, the blood flow of the flap was restored. The blood perfusion of the flaps in other patients was good. All flaps survived completely, with well-healed donor site wounds and no complications. During 0.5-14.0 months of follow-up, all flaps of patients demonstrated excellent appearance, with color and texture matching the surrounding skin.Conclusions:As a means of superficial blood flow visualization, ICGA can not only clearly show the microvascular distribution of the expanded flap before operation, assist in optimizing the design of the flap, but also evaluate the blood perfusion of the flap after operation, reduce the occurrence of complications, and provide a full-process navigation for the harvesting of expanded flaps, thereby improving the safety of flap transfer for scar reconstruction.
2.Clinical effect of indocyanine green angiography-assisted design and harvest of expanded flaps for scar reconstruction
Yanan HU ; Tingjun XIE ; Yuanbo LIU ; Shan ZHU ; Zengjie YANG ; Jia TIAN ; Cheng GAN ; Hu JIAO ; Shanshan LI ; Zixiang CHEN ; Lu ZHOU ; Bing HAN ; Shengyang JIN ; Yan ZENG ; Miao WANG ; Mengqing ZANG
Chinese Journal of Burns 2025;41(4):341-347
Objective:To investigate the clinical effect of indocyanine green angiography (ICGA)-assisted design and harvest of expanded flaps for scar reconstruction.Methods:This study was a retrospective observational study. From April 2019 to August 2023, 19 patients with scars (8 males, 11 females; aged 3-38 years) treated at the Plastic Surgery Hospital of Peking Union Medical College and Chinese Academy of Medical Sciences met the inclusion criteria. The scars were distributed on the head, face, trunk, and extremities. In stage Ⅰ surgery, skin soft tissue expanders were implanted in suitable areas around the scars for skin soft tissue expansion. In stage Ⅱ surgery, the scar tissue was excised, resulting in wound areas ranging from 100 to 210 cm 2, and expanded flaps were designed. ICGA was used to identify target perforators and their accompanying veins, and the flap design was adjusted to ensure the inclusion of complete arterial and venous axes. The expanded flap with an area of 120 to 240 cm2 was harvested using unilateral back-cut technique and transferred to the recipient site, and the donor site wound was sutured directly. The durations of the arterial and venous phases of ICGA during flap design were recorded. The length-to-width ratios of the back-cut flaps were calculated for different regions. After stage Ⅱ surgery, the blood perfusion and survival of the flap, the wound healing at the donor site, and the occurrence of complications were observed. During follow-up, the appearance, color, and texture of the patient's flap were observed. Results:The arterial phase of ICGA lasted 10-27 (18±5) s, and the venous phase lasted 78-116 (100±10) s. The length-to-width ratios of the back-cut flaps were 1.22±0.32, 1.63±0.12, and 1.15±0.21 for the head and neck, trunk, and limb regions, respectively. After stage Ⅱ surgery, one patient had a large area of insufficient blood perfusion in the flap. By comparing ICGA images before and after flap transfer, the sutures at the oral commissure were loosened, the blood flow of the flap was restored. The blood perfusion of the flaps in other patients was good. All flaps survived completely, with well-healed donor site wounds and no complications. During 0.5-14.0 months of follow-up, all flaps of patients demonstrated excellent appearance, with color and texture matching the surrounding skin.Conclusions:As a means of superficial blood flow visualization, ICGA can not only clearly show the microvascular distribution of the expanded flap before operation, assist in optimizing the design of the flap, but also evaluate the blood perfusion of the flap after operation, reduce the occurrence of complications, and provide a full-process navigation for the harvesting of expanded flaps, thereby improving the safety of flap transfer for scar reconstruction.
3. Efficacy and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir combined with ribavirin in Asian adult patients with chronic HCV genotype 1b infection and compensated cirrhosis
Lai WEI ; Guiqiang WANG ; Kopecky-Bromberg SARAH ; Jun CHENG ; Qing XIE ; Maorong WANG ; Min XU ; Zhongping DUAN ; Jinlin HOU ; Mingxiang ZHANG ; Yuexin ZHANG ; Hong TANG ; Wei ZHAO ; Shumei LIN ; Zhansheng JIA ; Junqi NIU ; Zhiliang GAO ; Hong YUAN ; Minghua LIN ; Xinmin ZHOU ; Yan LUO ; Fredrick LINDA ; Mobashery NILOUFAR ; Ye WANG ; Jidong JIA
Chinese Journal of Hepatology 2018;26(5):353-358
Objective:
To evaluate the efficacy and safety of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) 25/150/100 mg once daily and dasabuvir (DSV) 250 mg twice daily combined with ribavirin in adult patients of Mainland China with chronic HCV genotype 1b infection and compensated cirrhosis.
Methods:
An open-label, multicenter, phase 3 clinical trial study was conducted in mainland China, Taiwan, and South Korea. Adult patients with compensated cirrhosis (Metavir score =F4) who were newly diagnosed and treated for hepatitis C virus genotype 1b infection with ombitasvir/paritaprevir/ritonavir and dasabuvir combined with ribavirin for 12 weeks were included. Assessed SVR rate of patients obtained at 12 and 24 weeks after drug withdrawal. Efficacy and safety were evaluated in patients who received at least one time study drugs.
Results:
A total of 63 patients from mainland China were enrolled, 62 of whom (98.4%) had a baseline Child-Pugh score of 5 points. The overall rate of SVR12 and SVR24 in patients was 100% (95% CI: 94.3% to 100.0%). Most of the adverse events that occurred were mild. The incidence of common (≥10%) adverse events and laboratory abnormalities included elevated total bilirubin (36.5%), weakness (19.0%), elevated unconjugated bilirubin (19.0%) and conjugated bilirubin (17.5%), and anemia (14.3%). Three cases (4.8%) of patients experienced Grade ≥ 3 adverse events that were considered by the investigators to be unrelated to the study drug. None patients had adverse events leading to premature drug withdrawal.
Conclusion
Mainland Chinese patients with chronic HCV genotype 1b infection and compensated cirrhosis who were treated with OBV/PTV/r plus DSV combined with RBV for 12 weeks achieved 100 % SVR at 12 and 24 weeks after drug withdrawal. Tolerability and safety were good, and majority of adverse events were mild.
4.Revaluation of post-marketing safety of kanglaite injection
Bin HE ; Yufei YANG ; Peihong LI ; Juan ZHANG ; Yang YANG ; Yonghong TONG ; Qing WEI ; Weiguo WANG ; Qingyuan ZHANG ; Jun BIE ; Wenju CHEN ; Rutian HAO ; Na WANG ; Zhongguo LIU ; Hui YANG ; Shengyang XIE ; Zhongqi YANG ; Xiaojun ZHOU ; Xuejun HONG ; Lin CHEN ; Jun ZHANG
Adverse Drug Reactions Journal 2017;19(3):187-194
To understand the adverse reactions of Kan,glaite injection and its incidenceand explore the factors affecting the safety of Kan,glaite Injection in clinical use.Methods A noninterventional and prospective hospital based monitoring study and nested case-control study were conducted.All hospitalized cancer patients receiving Kan.glaite injections from 28 hospitals in northeast, north, central,east, south, southwest, northwest regions of China from September 2013 to September 2014 were enrolled in this study. The main monitoring contents included the general status of patients, the drug administration (including indications and combined use), medication safety, and so on. Patients developing adverse reactions related to Kan,glaite injection distributed in the case group and patients who did not develop adverse reactions were randomly selected and distributed into the control group with a ratio of l : 3 , and the factors that affect the safe use of Kan,glaite injection were analyzed.Results A total of 5 022 cancer patients were entered into the study, including 2 926 males and 2 096 females with age from 9 t0 95 years and their average age was (60 + 12) years. The top five tumors were lung cancer (1 456 patients,28.99%) ,intestinal cancer (867 patients,17.26% ) , marmuary cancer ( 372 patients, 7.41% ) , gastric cancer ( 346 patients, 6.89%) , and liver cancer (335 cases,6.67%). There were 3 863 patients (76.92% ) with tumor stage III and IV, 348 patients with allergic history (6.93%) ; 2 524 patients were complicated with other diseases (50.26% ) ; 4 687 patients (93.33%) had combined drug therapy.During the monitoring period,751(14.95%) of 5 022 patients developed adverse events and of them, 18 cases met the criteria of causality of adverse reactions, including 7 cases of phlebitis, 3 cases of nausea and vomiting, 3 cases of chills, 2 cases of rash, 1 case of palpitation, 1 case of transammase increase, and l case of fever. The incidence of adverse reactions was 0.36%. Univariate analysis showed that the incidence of adverse reactions in patients with combined diseases was higher than that in patients without combined diseases (X2=5.4723,P=0.019),the incidence of adverse reactions in patients with combined western medication was higher than that in patients with combined westem and Chinese medication (P=0.002).Logistic regression analysis showed that the influencing factors of adverse reactions were coexisting diseases (OR=1. 636, 95%C/:1.100-2.433,P= 0.013)and combined medication (OR=1.475,95%C/:1.108-1.965,P=0.027).Nested case-control study showed that the influencing factors of adverse reactions induced by Kan.glaite injection were radiotherapy (OR= 1.864,95% C/:0.930-3.736,P<0.01)and corubined medication (OR=1.622,95% C/:1.102-2.389,P<0.01) .Conclusions The incidence of adverse reactions of Kan,glaite injection in clinical application is lower and the safety is good. Coexisting diseases, combined medication and radiotherapy are main factors affecting its clinical safety.
5.Revaluation of post-marketing safety of kanglaite injection
Bin HE ; Yufei YANG ; Peihong LI ; Juan ZHANG ; Yang YANG ; Yonghong TONG ; Qing WEI ; Weiguo WANG ; Qingyuan ZHANG ; Jun BIE ; Wenju CHEN ; Rutian HAO ; Na WANG ; Zhongguo LIU ; Hui YANG ; Shengyang XIE ; Zhongqi YANG ; Xiaojun ZHOU ; Xuejun HONG ; Lin CHEN ; Jun ZHANG
Adverse Drug Reactions Journal 2017;19(3):187-194
To understand the adverse reactions of Kan,glaite injection and its incidenceand explore the factors affecting the safety of Kan,glaite Injection in clinical use.Methods A noninterventional and prospective hospital based monitoring study and nested case-control study were conducted.All hospitalized cancer patients receiving Kan.glaite injections from 28 hospitals in northeast, north, central,east, south, southwest, northwest regions of China from September 2013 to September 2014 were enrolled in this study. The main monitoring contents included the general status of patients, the drug administration (including indications and combined use), medication safety, and so on. Patients developing adverse reactions related to Kan,glaite injection distributed in the case group and patients who did not develop adverse reactions were randomly selected and distributed into the control group with a ratio of l : 3 , and the factors that affect the safe use of Kan,glaite injection were analyzed.Results A total of 5 022 cancer patients were entered into the study, including 2 926 males and 2 096 females with age from 9 t0 95 years and their average age was (60 + 12) years. The top five tumors were lung cancer (1 456 patients,28.99%) ,intestinal cancer (867 patients,17.26% ) , marmuary cancer ( 372 patients, 7.41% ) , gastric cancer ( 346 patients, 6.89%) , and liver cancer (335 cases,6.67%). There were 3 863 patients (76.92% ) with tumor stage III and IV, 348 patients with allergic history (6.93%) ; 2 524 patients were complicated with other diseases (50.26% ) ; 4 687 patients (93.33%) had combined drug therapy.During the monitoring period,751(14.95%) of 5 022 patients developed adverse events and of them, 18 cases met the criteria of causality of adverse reactions, including 7 cases of phlebitis, 3 cases of nausea and vomiting, 3 cases of chills, 2 cases of rash, 1 case of palpitation, 1 case of transammase increase, and l case of fever. The incidence of adverse reactions was 0.36%. Univariate analysis showed that the incidence of adverse reactions in patients with combined diseases was higher than that in patients without combined diseases (X2=5.4723,P=0.019),the incidence of adverse reactions in patients with combined western medication was higher than that in patients with combined westem and Chinese medication (P=0.002).Logistic regression analysis showed that the influencing factors of adverse reactions were coexisting diseases (OR=1. 636, 95%C/:1.100-2.433,P= 0.013)and combined medication (OR=1.475,95%C/:1.108-1.965,P=0.027).Nested case-control study showed that the influencing factors of adverse reactions induced by Kan.glaite injection were radiotherapy (OR= 1.864,95% C/:0.930-3.736,P<0.01)and corubined medication (OR=1.622,95% C/:1.102-2.389,P<0.01) .Conclusions The incidence of adverse reactions of Kan,glaite injection in clinical application is lower and the safety is good. Coexisting diseases, combined medication and radiotherapy are main factors affecting its clinical safety.
6.Interventional Investigation on International Indicators for Rational Drug Use
Jianping WANG ; Yunhua JIA ; Shenhong WANG ; Shengyang XIE ; Weiqin WANG
China Pharmacy 2007;0(35):-
OBJECTIVE:To promote clinical rational drug use (RDU). METHODS:2000 prescriptions before intervention (from Jan. to Apr. in 2003) and another 2000 after intervention (from Jan. to Apr. in 2006) were randomly selected for a statistical analysis in accordance with the international RDU indicators of WHO/INRUD. RESULTS:Regarding the prescription indicators,the average number of drugs per prescription was 3.88 kinds before intervention versus 1.97 after intervention; the proportion of patients treated with antibiotics was 38.40% before intervention versus 24.05% after intervention; the proportion of injections was 21.75% before intervention versus 12.75% after intervention. In terms of patient care indicators,the average consultation time was 9.5 minutes and the average dispensing time was 23 seconds,and the percentage of drugs with integral labeling was as high as 100%. CONCLUSION:Most of the RDU indictors in our hospital were satisfactory; however,the average cost per prescription was still on the high side,which calls for further intervention.

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