1.Comparison of effects of different positioning and puncture methods for epidural anesthesia in obese parturients undergoing cesarean section
Gaofeng GUO ; Lidong DOU ; Mingzhu CUI ; Jiaqiang ZHANG ; Xiongfei RONG
Chinese Journal of Anesthesiology 2024;44(12):1470-1475
Objective:To compare the effects of different positioning and puncture methods for epidural anesthesia in obese parturients undergoing cesarean section.Methods:In this prospective, randomized, controlled study, 175 obese parturients, of American Society of Anesthesiologists Physical Status classification Ⅰ or Ⅱ, with a body mass index of > 30 kg/m 2, who underwent elective cesarean section with epidural anesthesia at Henan Provincial People′s Hospital from July 2023 to April 2024, were selected and assigned into 4 groups using a random number table method: palpation positioning + median approach to puncture group (PM group, n=44), body surface marker positioning + paramedian approach to puncture group (BP group, n=43), ultrasound-assisted positioning + paramedian approach to puncture group (UP group, n=45), and ultrasound-assisted positioning + ultrasound-guided in-plane approach to puncture group (UU group, n=43). The procedures were performed by anesthesiology residents skilled in the four different epidural anesthesia positioning and puncture methods. Main observation indicators: success rate of puncture at first attempt and total success rate of puncture. Secondary observation indicators: the number of puncture, changes in puncture interspaces, positioning time, puncture time, anesthesia operation time, postoperative nausea and vomiting, sensory abnormalities at the puncture site, bleeding at the puncture site, maternal satisfaction rates, and occurrence of low back pain at day 7, 1 month, 2 months, and 3 months postoperatively. Results:In this study, 2 cases were excluded from PM group, 2 from BP group, 2 from UP group, and 2 from UU group. The total success rates of puncture were as follows: 95% (40/42) in PM group, 98% (40/41) in BP group, 93% (40/43) in UP group, and 98% (40/41) in UU group. There was no significant difference in the total success rates of puncture among the four groups ( P>0.05). Compared to PM group, the success rate of puncture at first attempt was significantly increased, the rate of changes in puncture interspaces was decreased, the positioning time was shortened, the incidence of nausea and vomiting was decreased, satisfaction rates were increased, and the incidence of low back pain was reduced at 7 days after operation in BP group; the success rate of puncture at first attempt was significantly increased, the number of puncture was reduced, the rate of changes in puncture interspaces was decreased, the positioning time, puncture time and anesthesia operation time were shortened, the satisfaction rates were increased, and the incidence of low back pain was decreased at 7 days after operation in UP group; the rate of changes in puncture interspaces was significantly decreased, and the positioning time was shortened in UU group ( P<0.05). Compared to BP group, the puncture time was significantly shortened in UP group, and the number of puncture was significantly increased, the anesthesia operation time was prolonged, the incidence of nausea and vomiting was increased, and the satisfaction rate was decreased in UU group ( P<0.05). Compared to UP group, the success rate of puncture at first attempt was significantly decreased, the number of puncture was increased, the puncture time and anesthesia operation time were prolonged, the incidence of nausea and vomiting was increased, and the satisfaction rates were decreased in UU group ( P<0.05). Conclusions:Ultrasound-assisted positioning combined with the paramedian approach to puncture can raise the success rate of puncture at first attempt, reduce the development of puncture-related complications, and increase the maternal satisfaction in obese parturients undergoing cesarean section.
2.Comparison of effects of different positioning and puncture methods for epidural anesthesia in obese parturients undergoing cesarean section
Gaofeng GUO ; Lidong DOU ; Mingzhu CUI ; Jiaqiang ZHANG ; Xiongfei RONG
Chinese Journal of Anesthesiology 2024;44(12):1470-1475
Objective:To compare the effects of different positioning and puncture methods for epidural anesthesia in obese parturients undergoing cesarean section.Methods:In this prospective, randomized, controlled study, 175 obese parturients, of American Society of Anesthesiologists Physical Status classification Ⅰ or Ⅱ, with a body mass index of > 30 kg/m 2, who underwent elective cesarean section with epidural anesthesia at Henan Provincial People′s Hospital from July 2023 to April 2024, were selected and assigned into 4 groups using a random number table method: palpation positioning + median approach to puncture group (PM group, n=44), body surface marker positioning + paramedian approach to puncture group (BP group, n=43), ultrasound-assisted positioning + paramedian approach to puncture group (UP group, n=45), and ultrasound-assisted positioning + ultrasound-guided in-plane approach to puncture group (UU group, n=43). The procedures were performed by anesthesiology residents skilled in the four different epidural anesthesia positioning and puncture methods. Main observation indicators: success rate of puncture at first attempt and total success rate of puncture. Secondary observation indicators: the number of puncture, changes in puncture interspaces, positioning time, puncture time, anesthesia operation time, postoperative nausea and vomiting, sensory abnormalities at the puncture site, bleeding at the puncture site, maternal satisfaction rates, and occurrence of low back pain at day 7, 1 month, 2 months, and 3 months postoperatively. Results:In this study, 2 cases were excluded from PM group, 2 from BP group, 2 from UP group, and 2 from UU group. The total success rates of puncture were as follows: 95% (40/42) in PM group, 98% (40/41) in BP group, 93% (40/43) in UP group, and 98% (40/41) in UU group. There was no significant difference in the total success rates of puncture among the four groups ( P>0.05). Compared to PM group, the success rate of puncture at first attempt was significantly increased, the rate of changes in puncture interspaces was decreased, the positioning time was shortened, the incidence of nausea and vomiting was decreased, satisfaction rates were increased, and the incidence of low back pain was reduced at 7 days after operation in BP group; the success rate of puncture at first attempt was significantly increased, the number of puncture was reduced, the rate of changes in puncture interspaces was decreased, the positioning time, puncture time and anesthesia operation time were shortened, the satisfaction rates were increased, and the incidence of low back pain was decreased at 7 days after operation in UP group; the rate of changes in puncture interspaces was significantly decreased, and the positioning time was shortened in UU group ( P<0.05). Compared to BP group, the puncture time was significantly shortened in UP group, and the number of puncture was significantly increased, the anesthesia operation time was prolonged, the incidence of nausea and vomiting was increased, and the satisfaction rate was decreased in UU group ( P<0.05). Compared to UP group, the success rate of puncture at first attempt was significantly decreased, the number of puncture was increased, the puncture time and anesthesia operation time were prolonged, the incidence of nausea and vomiting was increased, and the satisfaction rates were decreased in UU group ( P<0.05). Conclusions:Ultrasound-assisted positioning combined with the paramedian approach to puncture can raise the success rate of puncture at first attempt, reduce the development of puncture-related complications, and increase the maternal satisfaction in obese parturients undergoing cesarean section.
3.Role of gut microbiota in amelioration of postoperative cognitive dysfunction in mice by ketamine: association with subdiaphragmatic vagal nerve
Xiongfei RONG ; Yali YANG ; Guangzhi WANG ; Jibing ZHANG
Chinese Journal of Anesthesiology 2023;43(11):1322-1328
Objective:To evaluate the role of ketamine in postoperative cognitive dysfunction (POCD) and to clarify the association with subdiaphragmatic vagus nerve in mice.Methods:One hundred and forty-four SPF healthy male C57BL/6J mice, aged 18 months, weighing 32-35 g, were divided into 8 groups ( n=18 each) using a random number table method: sham operation group (group C), surgery group (group S), ketamine + surgery group (group SK), ketamine + surgery + subdiaphragmatic vagotomy group (group SK+ SDV), pseudo germ-free mice+ normal saline group (group GM+ V), pseudo germ-free mice that received fecal microbiota transplantation (FMT) from group S mice group (group GM+ S), pseudo germ-free mice that received FMT from group SK mice group (group GM+ SK), and pseudo germ-free mice received subdiaphragmatic vagotomy and FMT from group SK mice group (group GM+ SDV+ SK). Tibial fracture internal fixation was performed under anesthesia with 2.0% isoflurane. Ketamine 50 mg/kg was intraoperatively administered at the beginning of the suture in group SK. The fecal samples were collected at 24 h after surgery to prepare fecal bacteria filtrate in S and SK groups. The dorsal and ventral branches of subdiaphragmatic vagus nerve were cut prior to ketamine administration in SK+ SDV group and prior to FMT in GM+ SDV+ SK group. Broad-spectrum antibiotics dissolved in drinking water were given ad libitum to mice for 14 consecutive days at 2 weeks before FMT or subdiaphragmatic vagotomy and replaced once every 2 days to establish the pseudo germ-free model. Pseudo germ-free mice were gavaged with normal saline or fecal suspension 200 μl obtained from mice for 14 consecutive days at fixed time starting from 14 days after antibiotic intervention in GM+ SK and GM+ SDV+ SK groups. While normal saline was given instead for 14 consecutive days in GM+ V group. The fecal samples were collected after tibial fracture internal fixation or at 24 h after completion of FMT for 16S rRNA gene sequence analysis. The contents of interleukin-6 (IL-6), IL-17, tumor necrosis factor-alpha (TNF-α), IL-4 and IL-10 in the hippocampus were measured by enzyme linked-immuno-sorbent assay at 24 h after surgery or FMT. The spatial memory and learning ability was assessed by the Morris water maze test at 24 h after surgery or FMT. Results:Compared with group Sham, Simpson′s diversity index, Shannon index and Ace index were significantly decreased, the contents of IL-6, IL-17 and TNF-α were increased, contents of IL-4 and IL-10 were decreased, the escape latency in the training and testing phases and swimming distance were prolonged, and the time spent in the target quadrant was shortened in group S ( P<0.05). Compared with group S, Simpson′s diversity index, Shannon index and Ace index were significantly increased, the contents of IL-6, IL-17 and TNF-α were decreased, contents of IL-4 and IL-10 were increased, the escape latency in the training and testing phases and swimming distance were shortened, and the time spent in the target quadrant was prolonged in group SK ( P<0.05). Compared with group SK, Simpson′s diversity index, Shannon index and Ace index were significantly decreased, the contents of IL-6, IL-17 and TNF-α were increased, contents of IL-4 and IL-10 were decreased, the escape latency in the training and testing phases and swimming distance were prolonged, and the time spent in the target quadrant was shortened in group SK+ SDV ( P<0.05). Compared with group GM+ V, the contents of IL-6, IL-17 and TNF-α were significantly increased, contents of IL-4 and IL-10 were decreased, the escape latency in the training and testing phases and swimming distance were prolonged, and the time spent in the target quadrant was shortened in group GM+ S ( P<0.05). Compared with group GM+ S, the contents of IL-6, IL-17 and TNF-α were significantly decreased, contents of IL-4 and IL-10 were increased, the escape latency in the training and testing phases and swimming distance were shortened, and the time spent in the target quadrant was prolonged in group GM+ S ( P<0.05). Compared with group GM+ SK, the contents of IL-6, IL-17 and TNF-α were significantly increased, contents of IL-4 and IL-10 were decreased, the escape latency in the training and testing phases and swimming distance were prolonged, and the time spent in the target quadrant was shortened in group GM+ SDV+ SK ( P<0.05). Conclusions:Ketamine can improve intestinal flora disorders and reduce POCD in mice, and the mechanism may be related to subdiaphragmatic vagal nerve conduction.
4.Darbepoetin alfa injection versus epoetin alfa injection for treating anemia of Chinese hemodialysis patients with chronic kidney failure: A randomized, open-label, parallel-group, non-inferiority Phase III trail
Nan CHEN ; Changying XING ; Jianying NIU ; Bicheng LIU ; Junzhou FU ; Jiuyang ZHAO ; Zhaohui NI ; Mei WANG ; Wenhu LIU ; Jinghong ZHAO ; Ling ZHONG ; Xiongfei WU ; Wenge LI ; Yuqing CHEN ; Wei SHI ; Jianghua CHEN ; Aiping YIN ; Ping FU ; Rong WANG ; Gengru JIANG ; Fanfan HOU ; Guohua DING ; Jing CHEN ; Gang XU ; Yuichiro KONDO ; Yuliang SU ; Changlin MEI
Chronic Diseases and Translational Medicine 2022;08(1):59-70
Background::Erythropoietin is a glycoprotein that mainly regulates erythropoiesis. In patients with chronic renal failure with anemia, darbepoetin alfa can stimulate erythropoiesis, correct anemia, and maintain hemoglobin levels. This study was designed to demonstrate the efficacy and safety of darbepoetin alfa injections as being not inferior to epoetin alfa injections (Recombinant Human Erythropoietin injection, rHuEPO) when maintaining hemoglobin (Hb) levels within the target range (10.0-12.0 g/dL) for the treatment of renal anemia.Methods::Ninety-five patients were enrolled in this study from April 15, 2013 to April 10, 2014 at 25 sites. In this study, patients ( n = 95) aged 18-70 years were randomized into a once per week intravenous darbepoetin alfa group ( n = 56) and a twice or three times per week intravenous epoetin alfa group ( n = 39) for 28 weeks, who had anemia with hemoglobin levels between 6 g/dL and 10 g/dL due to chronic kidney disease (CKD) and were undergoing hemodialysis or hemofiltration with ESA-naive (erythropoiesis stimulating agent-naive). The primary efficacy profile was the mean Hb level (the non-inferiority margin was -1.0 g/dL, week 21-28); the secondary efficacy profiles were the Hb increase rate (week 0-4), the target Hb achievement cumulative rate and time, the change trends of the Hb levels, and the target Hb maintenance ratio. Adverse events (AEs) were observed and compared, and the efficacy and safety were analyzed between the two treatment groups. Additionally, the frequencies of dose adjustments between the darbepoetin alfa and epoetin alfa groups were compared during the treatment period. SAS? software version 9.2 was used to perform all statistical analyses. Descriptive statistics were used for all efficacy, safety, and demographic variable analyses, including for the primary efficacy indicators. Results::The mean Hb level was 11.3 g/dL in the darbepoetin alfa group and 10.7 g/dL in the epoetin alfa group, respectively; the difference of the lower limits of the 95% confidence intervals (CI) between the two groups was 0.1 g/dL (>-1.0 g/dL), and non-inferiority was proven; the Hb levels started to increase in the first four weeks at a similar increase rate; no obvious differences were observed between the groups in the target Hb achievement cumulative rates, and the Hb levels as well as the target Hb level maintenance rate changed over time. The incidence of AEs was 62.5% in the darbepoetin alfa group and 76.9% in the epoetin alfa group. All the adverse events observed in the study were those commonly associated with hemodialysis.Conclusion::Darbepoetin alfa intravenously once per week can effectively increase Hb levels and maintain the target Hb levels well, which makes it not inferior to epoetin alfa intravenously twice or three times per week. Darbepoetin alfa shows an efficacy and safety comparable to epoetin alfa for the treatment of renal anemia.
5.Efficacy and safety of darbepoetin alfa injection replacing epoetin alfa injection for the treatment of renal anemia in Chinese hemodialysis patients: A randomized, open-label, parallel-group, noninferiority phase III trial
Bicheng LIU ; Nan CHEN ; Jinghong ZHAO ; Aiping YIN ; Xiongfei WU ; Changying XING ; Gengru JIANG ; Junzhou FU ; Mei WANG ; Rong WANG ; Jianying NIU ; Ping FU ; Zhaohui NI ; Fanfan HOU ; Jiuyang ZHAO ; Jing CHEN ; Yuqing CHEN ; Wei SHI ; Jianghua CHEN ; Wenge LI ; Gang XU ; Ling ZHONG ; Wenhu LIU ; Guohua DING ; Yuichiro KONDO ; Changhe YUE ; Changlin MEI
Chronic Diseases and Translational Medicine 2022;08(2):134-144
Background::This study was to explore the clinical efficacy and safety of darbepoetin alfa injection replacing epoetin alfa injection (recombinant human erythropoietin injection, rHuEPO) for the treatment of anemia associated with chronic kidney failure in Chinese patients undergoing hemodialysis.Method::This study was a multicenter, randomized, open-label, intergroup parallel control phase III noninferiority trial from April 19, 2013 to September 9, 2014 at 25 sites. In this study, the members of the darbepoetin alfa group underwent intravenous administration once per week or once every two weeks. The members of the control drug epoetin alfa group underwent intravenous administration two or three times per week. All subjects underwent epoetin alfa administration during the 8-week baseline period. After that, subjects were randomly assigned to the darbepoetin alfa group or epoetin alfa group. The noninferiority in the changes of the average Hb concentrations from the baseline to the end of the evaluation period (noninferiority threshold: -1.0 g/dl) was tested between the two treatments. The time-dependent hemoglobin (Hb) concentration and the maintenance rate of the target Hb concentration (the proportion of subjects with Hb concentrations between 10.0 and 12.0 g/dl) were also evaluated. Iron metabolism, including changes in the serum iron, total iron-binding capacity, ferritin, transferrin saturation, and comparisons of the dose adjustments between the two groups during the treatment period were analyzed further. Adverse events (AEs) were also observed and compared, and the safety was analyzed between the two treatment groups. The conversion rate switching from epoetin alfa to darbepoetin alfa was also discussed. SAS ? software version 9.2 was used to perform all statistical analyses. Descriptive statistics were used for all efficacy, safety, and demographic variable analyses, including for the primary efficacy indicators. Results::Four hundred and sixty-six patients were enrolled in this study, and ultimately 384 cases were analyzed for safety, including 267 cases in the darbepoetin alfa group and 117 cases in the epoetin alfa group. There were 211 cases in the per-protocol set, including 152 cases in the darbepoetin alfa group and 59 cases in the epoetin alfa group. The changes in the average Hb concentrations from the baseline to the end of the evaluation period were -0.07 and -0.15 g/dl in the darbepoetin alfa group and epoetin alfa group respectively. The difference between the two groups was 0.08 g/dl (95% confidence interval [CI]: -0.22 to 0.39), and the lower limit of the 95% CI was -0.22 > -1.0 g/dl. The average Hb concentrations of the two groups were 10.88-11.43 g/dl (darbepoetin alfa) and 10.91-11.38 g/dl (epoetin alfa) during the study period of Weeks 0-28, with the maintenance rates of the target Hb concentration ranging within 71%-87% and 78%-95% in the darbepoetin alfa group and epoetin alfa group respectively. During the period of comparison between the two groups, the incidence of AEs in the darbepoetin alfa group was 61.42%, while in the epoetin alfa group it was 56.41%. All of the adverse events and reactions in the study were those commonly associated with hemodialysis.Conclusion::The overall efficacy and safety of darbepoetin alfa for the treatment of Chinese renal anemia patients undergoing hemodialysis are consistent with those of epoetin alfa.
6.Darbepoetin alfa injection versus epoetin alfa injection for treating anemia of Chinese hemodialysis patients with chronic kidney failure: A randomized, open-label, parallel-group, non-inferiority Phase III trail
Nan CHEN ; Changying XING ; Jianying NIU ; Bicheng LIU ; Junzhou FU ; Jiuyang ZHAO ; Zhaohui NI ; Mei WANG ; Wenhu LIU ; Jinghong ZHAO ; Ling ZHONG ; Xiongfei WU ; Wenge LI ; Yuqing CHEN ; Wei SHI ; Jianghua CHEN ; Aiping YIN ; Ping FU ; Rong WANG ; Gengru JIANG ; Fanfan HOU ; Guohua DING ; Jing CHEN ; Gang XU ; Yuichiro KONDO ; Yuliang SU ; Changlin MEI
Chronic Diseases and Translational Medicine 2022;08(1):59-70
Background::Erythropoietin is a glycoprotein that mainly regulates erythropoiesis. In patients with chronic renal failure with anemia, darbepoetin alfa can stimulate erythropoiesis, correct anemia, and maintain hemoglobin levels. This study was designed to demonstrate the efficacy and safety of darbepoetin alfa injections as being not inferior to epoetin alfa injections (Recombinant Human Erythropoietin injection, rHuEPO) when maintaining hemoglobin (Hb) levels within the target range (10.0-12.0 g/dL) for the treatment of renal anemia.Methods::Ninety-five patients were enrolled in this study from April 15, 2013 to April 10, 2014 at 25 sites. In this study, patients ( n = 95) aged 18-70 years were randomized into a once per week intravenous darbepoetin alfa group ( n = 56) and a twice or three times per week intravenous epoetin alfa group ( n = 39) for 28 weeks, who had anemia with hemoglobin levels between 6 g/dL and 10 g/dL due to chronic kidney disease (CKD) and were undergoing hemodialysis or hemofiltration with ESA-naive (erythropoiesis stimulating agent-naive). The primary efficacy profile was the mean Hb level (the non-inferiority margin was -1.0 g/dL, week 21-28); the secondary efficacy profiles were the Hb increase rate (week 0-4), the target Hb achievement cumulative rate and time, the change trends of the Hb levels, and the target Hb maintenance ratio. Adverse events (AEs) were observed and compared, and the efficacy and safety were analyzed between the two treatment groups. Additionally, the frequencies of dose adjustments between the darbepoetin alfa and epoetin alfa groups were compared during the treatment period. SAS? software version 9.2 was used to perform all statistical analyses. Descriptive statistics were used for all efficacy, safety, and demographic variable analyses, including for the primary efficacy indicators. Results::The mean Hb level was 11.3 g/dL in the darbepoetin alfa group and 10.7 g/dL in the epoetin alfa group, respectively; the difference of the lower limits of the 95% confidence intervals (CI) between the two groups was 0.1 g/dL (>-1.0 g/dL), and non-inferiority was proven; the Hb levels started to increase in the first four weeks at a similar increase rate; no obvious differences were observed between the groups in the target Hb achievement cumulative rates, and the Hb levels as well as the target Hb level maintenance rate changed over time. The incidence of AEs was 62.5% in the darbepoetin alfa group and 76.9% in the epoetin alfa group. All the adverse events observed in the study were those commonly associated with hemodialysis.Conclusion::Darbepoetin alfa intravenously once per week can effectively increase Hb levels and maintain the target Hb levels well, which makes it not inferior to epoetin alfa intravenously twice or three times per week. Darbepoetin alfa shows an efficacy and safety comparable to epoetin alfa for the treatment of renal anemia.
7.Efficacy and safety of darbepoetin alfa injection replacing epoetin alfa injection for the treatment of renal anemia in Chinese hemodialysis patients: A randomized, open-label, parallel-group, noninferiority phase III trial
Bicheng LIU ; Nan CHEN ; Jinghong ZHAO ; Aiping YIN ; Xiongfei WU ; Changying XING ; Gengru JIANG ; Junzhou FU ; Mei WANG ; Rong WANG ; Jianying NIU ; Ping FU ; Zhaohui NI ; Fanfan HOU ; Jiuyang ZHAO ; Jing CHEN ; Yuqing CHEN ; Wei SHI ; Jianghua CHEN ; Wenge LI ; Gang XU ; Ling ZHONG ; Wenhu LIU ; Guohua DING ; Yuichiro KONDO ; Changhe YUE ; Changlin MEI
Chronic Diseases and Translational Medicine 2022;08(2):134-144
Background::This study was to explore the clinical efficacy and safety of darbepoetin alfa injection replacing epoetin alfa injection (recombinant human erythropoietin injection, rHuEPO) for the treatment of anemia associated with chronic kidney failure in Chinese patients undergoing hemodialysis.Method::This study was a multicenter, randomized, open-label, intergroup parallel control phase III noninferiority trial from April 19, 2013 to September 9, 2014 at 25 sites. In this study, the members of the darbepoetin alfa group underwent intravenous administration once per week or once every two weeks. The members of the control drug epoetin alfa group underwent intravenous administration two or three times per week. All subjects underwent epoetin alfa administration during the 8-week baseline period. After that, subjects were randomly assigned to the darbepoetin alfa group or epoetin alfa group. The noninferiority in the changes of the average Hb concentrations from the baseline to the end of the evaluation period (noninferiority threshold: -1.0 g/dl) was tested between the two treatments. The time-dependent hemoglobin (Hb) concentration and the maintenance rate of the target Hb concentration (the proportion of subjects with Hb concentrations between 10.0 and 12.0 g/dl) were also evaluated. Iron metabolism, including changes in the serum iron, total iron-binding capacity, ferritin, transferrin saturation, and comparisons of the dose adjustments between the two groups during the treatment period were analyzed further. Adverse events (AEs) were also observed and compared, and the safety was analyzed between the two treatment groups. The conversion rate switching from epoetin alfa to darbepoetin alfa was also discussed. SAS ? software version 9.2 was used to perform all statistical analyses. Descriptive statistics were used for all efficacy, safety, and demographic variable analyses, including for the primary efficacy indicators. Results::Four hundred and sixty-six patients were enrolled in this study, and ultimately 384 cases were analyzed for safety, including 267 cases in the darbepoetin alfa group and 117 cases in the epoetin alfa group. There were 211 cases in the per-protocol set, including 152 cases in the darbepoetin alfa group and 59 cases in the epoetin alfa group. The changes in the average Hb concentrations from the baseline to the end of the evaluation period were -0.07 and -0.15 g/dl in the darbepoetin alfa group and epoetin alfa group respectively. The difference between the two groups was 0.08 g/dl (95% confidence interval [CI]: -0.22 to 0.39), and the lower limit of the 95% CI was -0.22 > -1.0 g/dl. The average Hb concentrations of the two groups were 10.88-11.43 g/dl (darbepoetin alfa) and 10.91-11.38 g/dl (epoetin alfa) during the study period of Weeks 0-28, with the maintenance rates of the target Hb concentration ranging within 71%-87% and 78%-95% in the darbepoetin alfa group and epoetin alfa group respectively. During the period of comparison between the two groups, the incidence of AEs in the darbepoetin alfa group was 61.42%, while in the epoetin alfa group it was 56.41%. All of the adverse events and reactions in the study were those commonly associated with hemodialysis.Conclusion::The overall efficacy and safety of darbepoetin alfa for the treatment of Chinese renal anemia patients undergoing hemodialysis are consistent with those of epoetin alfa.
8.Effects of intraoperative fluid therapy guided by different stroke volume variations on bleeding during laparoscopic hepatolobectomy and postoperative renal function
Gaofeng GUO ; Yangyang WANG ; Xiongfei RONG ; Wei ZHANG ; Jiaqiang ZHANG
Chinese Journal of Anesthesiology 2021;41(5):584-588
Objective:To evaluate the effects of intraoperative fluid therapy guided by different stroke volume variation (SVV)s on bleeding during laparoscopic hepatolobectomy and postoperative renal function.Methods:A total of 135 American Society of Anesthesiologists physical status Ⅰ-Ⅲ patients of both sexes, aged 25-64 yr, scheduled for elective laparoscopic hepatolobectomy under general anesthesia, were divided into 3 groups ( n=45 each) using a random number table method: low SVV group (group L), medium SVV group (group M) and high SVV group (group H). In group L, group M and group H, SVVs were maintained at 10%-15%, 16%-20% and more than 21%, respectively.Before surgery and at 1, 3 and 5 days after the surgery, blood samples from the peripheral vein were taken for determination of serum blood urea nitrogen, creatinine and procalcitonin (PCT) concentrations.The occurrence of conversion to laparotomy, intraoperative volume of blood loss, volume of blood transfused, urine volume, operation duration, length of hospital stay and time to first flatus were recorded.On admission to the operating room (T 0), at skin incision (T 1), at the beginning of resection of the liver (T 2), after resection of the lobes of the liver (T 3) and at the end of the surgery (T 4), mean arterial pressure (MAP), heart rate (HR) and lactic acid (Lac) were recorded.The consumption of intraoperative norepinephrine, hypotension, arrhythmia and postoperative adverse reactions were recorded. Results:Compared with group L, the intraoperative volume of blood loss and consumption of intraoperative norepinephrine in group M and intraoperative volume of blood loss, the total amount of fluid infused and urine volume in group H were significantly decreased, consumption of furosemide and nitroglycerin in group H and the total amount of red blood cells infused in M and H groups were increased, length of hospital stay and time to first flatus in group M were shortened, concentration of serum PCT at 1 day after surgery was decreased in group M, MAP at T 3, 4 was increased in group M, and Lac at T 2-4 was increased in group H ( P<0.05). Compared with group M, the intraoperative volume of blood loss, consumption of intraoperative norepinephrine and consumption of furosemide and nitroglycerin were significantly increased, the total amount of fluid infused and urine volume were decreased, length of hospital stay and time to first flatus in group M were prolonged, concentration of serum PCT at 1 day after surgery was increased, MAP at T 3, 4 was decreased in group M, and Lac at T 2-4 was increased in group H ( P<0.05). There was no significant difference in the incidence of postoperative adverse reactions and intraoperative hypotension and arrhythmia among the 3 groups ( P>0.05). Conclusion:Intraoperative fluid therapy guided by SVV at 16%-20% during laparoscopic hepatolobectomy can decrease the intraoperative volume of blood loss and has less effect on renal function, which is helpful for postoperative outcomes.
9.Improvement in outcomes by acupuncture-drug balanced anesthesia following radical correction of tetralogy of Fallot under cardiopulmonary bypass in pediatric patients
Yali YANG ; Guosong ZHU ; Xiongfei RONG ; Lin QIU
Chinese Journal of Anesthesiology 2020;40(4):462-465
Objective:To evaluate the efficacy of acupuncture-drug balanced anesthesia in improving the outcomes following radical correction of tetralogy of Fallot (TOF) under cardiopulmonary bypass (CPB) in the pediatric patients.Methods:A total of 100 pediatric patients, aged 3-8 yr, weighing 9-24 kg, with American Society of Anesthesiologists physical status Ⅱ or Ⅲ, scheduled for elective radical correction of TOF with CPB, were divided into 2 groups ( n=50 each) using a random number table method: acupuncture-drug balanced anesthesia group (group ADBA) and conventional anesthesia group (group CA). In group ADBA, transcutaneous acupoint electrical stimulation (disperse-dense wave, frequency 2/100 Hz, current intensity 6 mA, pulse width 0.2-0.6 ms) of Baihui (GV20) and bilateral acupoints of Neiguan (PC6), Hegu (LI4), and Ximen (PC4) acupoints was performed after induction of general anesthesia and maintained until the end of surgery.In group CA, the children received combined intravenous-inhalational anesthesia, and electrodes were only applied on the same acupoints without electrical stimulation.Venous blood samples were collected for blood routine examination and for determination of the concentrations of interleukin-6 (IL-6), IL-8 and tumor necrosis factor-alpha(TNF-α) at 30 min before surgery (T 1), 30 min after the start of surgery (T 2) and 1 h and 1, 2, 3 and 5 days after surgery (T 3-7). The length of hospital stay and development of postoperative major adverse events were recorded. Results:Compared with group CA, the plasma concentrations of IL-6, IL-8 and TNF-α at T 2-7 and white blood cell count, neutrophil count and neutrophil percentage at T 4-7 were significantly decreased, postoperative length of hospital stay was shortened ( P<0.05), and the incidence of acute lung injury was decreased obviously in group ADBA ( P<0.05). Conclusion:Acupuncture-drug balanced anesthesia can improve the outcomes following radical correction of TOF under CPB to a certain extent, and the mechanism is related to inhibiting inflammatory responses in pediatric patients.

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