Impact of colloids or crystalloids in renal function assessed by NGAL and KIM-1 after hysterectomy: randomized controlled trial

Abstract Background Hydroxyethyl starches are colloids used in fluid therapy that may reduce volume infusion compared with crystalloids, but they can affect renal function in critical care patients. This study aims to assess renal effects of starches using renal biomarkers in the perioperative setting. Methods This prospective, controlled, randomized study compared Hydroxyethyl starch 6% (HES) with Ringer's lactate (RL) in hysterectomy. Each episode of mean arterial pressure (MAP) below 60 mmHg guided the fluid replacement protocol. The RL group received 300 mL bolus of RL solution while the HES group received 150 mL of HES solution. All patients received RL (2 mL.kg−1.h−1) intraoperatively to replace insensible losses. Blood and urine samples were collected at three time points (preoperatively, 24 hours, and 40 days postoperatively) to assess urinary NGAL and KIM-1, as primary outcome, and other markers of renal function. Results Seventy patients were randomized and 60 completed the study. The RL group received a higher crystalloid volume (1,277 ± 812.7 mL vs. 630.4 ± 310.2 mL; p= 0.0002) with a higher fluid balance (780 ± 720 mL vs. 430 ± 440 mL; p= 0.03) and fluid overload (11.7% ± 10.4% vs. 7.0% ± 6.3%; p= 0.04) compared to the HES group. NGAL and KIM-1 did not differ between groups at each time point, however both biomarkers increased 24 hours postoperatively and returned to preoperative levels after 40 days in both groups. Conclusion HES did not increase renal biomarkers following open hysterectomy compared to RL. Moreover, HES provided better hemodynamic parameters using less volume, and reduced postoperative fluid balance and fluid overload.

Preventive effects of hydroxyethyl starch combined with methoxyamine on complications of combined spinal and epidural anesthesia in older adult patients and its influence on hemodynamics / 中国基层医药

Objective:To investigate the preventive effects of hydroxyethyl starch and methoxamine on complications of combined spinal and epidural anesthesia in older adult patients and its influence on hemodynamics.Methods:The clinical data of 120 older adult patients who underwent combined spinal and epidural anesthesia in General Hospital of Armed Police and Marine Police between February 2017 and April 2019 were retrospectively analyzed. The included patients were divided into two groups according to the adverse reactions of drugs used to induce anesthesia: control group (methoxamine injection, n = 55) and observation group (methoxamine + hydroxyethyl starch, n = 65). The changes in hemodynamic index, complications and cognitive function were analyzed in each group. Results:Systolic blood pressures measured at 5, 15 and 30 minutes after anesthesia were (127.53 ± 10.63) mmHg, (119.85 ± 10.86) mmHg, (125.45 ± 10.74) mmHg, respectively in the observation group, which were significantly higher than (118.23 ± 11.32) mmHg, (114.34 ± 10.32) mmHg, (119.01 ± 10.34) mmHg in the control group ( t = 3.66, 2.24, 2.63, all P < 0.05). Diastolic blood pressures measured at 5, 15 and 30 minutes after anesthesia were (76.65 ± 9.07) mmHg, (78.43 ± 9.32) mmHg, (80.19 ± 9.43) mmHg, respectively in the observation group, which were significantly higher than (63.30 ± 9.43) mmHg, (65.98 ± 9.26) mmHg, (70.38 ± 9.17) mmHg in the control group ( t = 6.24, 5.78, 4.55, all P < 0.05). Heart rates measured at 5, 15 and 30 minutes after anesthesia were (73.65 ± 7.67) beats/min, (83.27 ± 9.57) beats/min, (84.10 ± 9.67) beats/min respectively in the observation group, which were significantly higher than (69.76 ± 7.82) beats/min, (64.70 ± 9.38) beats/min, (65.80 ± 9.43) beats/min in the control group ( t = 2.17, 8.46, 8.27, all P < 0.05). The incidences of hypotension and bradycardia in the observation group were 3.08% (2/65) and 3.08% (2/65), respectively, which were significantly lower than 25.45% (14/55) and 21.82% (12/55) in the control group ( χ2 = 12.91, 10.15, both P < 0.05). The Mini Mental State Examination scores measured at 1, 6 and 24 hours after surgery were (26.69 ± 2.51) points, (26.74 ± 2.75) points, and (26.99 ± 2.36) points, respectively in the observation group, which were significantly higher than (23.17 ± 2.41) points, (23.43 ± 2.36) points, and (24.18 ± 2.12) points in the control group ( t = 6.17, 5.55, 5.39, all P < 0.05). Conclusion:Hydroxyethyl starch combined with methoxamine for combined spinal and epidural anesthesia in older adult patients can effectively reduce the hemodynamic fluctuations, decrease the incidences of hypotension and bradycardia, and does not produce a remarkable effect on postoperative cognitive function.

Aféresis terapéutica. Con una nueva técnica de reposición con hidroxietil almidón (voluven) / Therapeutic apheresis. With a new hydroxyethyl starch (Voluven) replacement technique

Resumen Introducción: la aféresis plasmática, ampliamente utilizada, con indicaciones renales y no renales, así mismo con diferentes niveles de evidencia descritos por la Sociedad Americana de Aféresis, siendo un tratamiento antiguo y muy utilizado, en la literatura se disponen de escasos estudios que comparen el uso de las diferentes soluciones de reposición (cristaloides, coloides, plasma, albúmina) en cuanto a su respuesta clínica y paraclínica, específicamente en resultados de la función renal. Objetivo: describir la experiencia de pacientes llevados a aféresis plasmática en una institución de cuarto nivel, haciendo énfasis en los desenlaces de función renal y seguridad, con una nueva estrategia de solución de reposición con voluven. Métodos: estudio tipo serie de casos, se incluyeron pacientes tratados con plasmaféresis, quienes ingresaron entre enero 2012 y abril 2019 al servicio de nefrología del Hospital San José. Se realizó un análisis descriptivo. Resultados: se realizaron 608 sesiones de plasmaféresis. La indicación más frecuente el rechazo humoral agudo en el trasplante renal. Al final del periodo de tratamiento, los pacientes en plasma e hidroxietil almidón (hydroxyethyl starch, HES por sus siglas en inglés) presentaron similar proporción de hipocalcemia y trombocitopenia, las pruebas de función renal se conservan normales después del tratamiento. Conclusión: los efectos secundarios de la aféresis terapéutica como los trastornos hematológicos (alteración de los factores de coagulación, trombocitopenia o anemia), además de hipocalcemia, o posibles alteraciones de la función renal comparados entre los diferentes líquidos de reemplazo plasmático, albúmina o HES, en nuestro trabajo demostró que las alteraciones no son mayores y la función renal se mantiene conservada durante la terapia, además, se encontró que el uso de HES no generó lesión renal aguda, al contrario, se observa estabilidad de la función renal, por lo tanto se debe considerar su uso, siendo un producto de bajo costo, con excelentes resultados clínicos. (Acta Med Colomb 2021; 46. DOI: https://doi.org/10.36104/amc.2021.2028).

Abstract Introduction: while plasma apheresis is a longstanding, widely used treatment for renal and non-renal indications, with different levels of evidence described by the American Society for Apheresis, there are few studies in the literature comparing the use of different replacement solutions (crystalloids, colloids, plasma, albumin) with regard to their clinical and paraclinical response, specifically in kidney function results. Objective: to describe the experience of patients undergoing plasma apheresis in a quaternary care institution with a new replacement solution strategy using Voluven, emphasizing kidney function and safety outcomes. Methods: a case series which included patients treated with plasmapheresis who were admitted to the nephrology service at Hospital San José between January 2012 and April 2019. A descriptive analysis was performed. Results: 608 plasmapheresis sessions were performed. The most common indication was acute humoral rejection in kidney transplantation. At the end of treatment, patients receiving plasma and hydroxyethyl starch (HES) had a similar proportion of hypocalcemia and thrombocytopenia. Kidney function tests remained normal after treatment. Conclusion: our study's comparison between the different plasma replacement fluids (albumin or HES) with regard to the side effects of therapeutic apheresis such as blood disorders (altered coagulation factors, thrombocytopenia or anemia), hypocalcemia or possible kidney function disorders, showed no major disorders and preserved kidney function during treatment. In addition, we found that HES did not cause acute kidney injury; on the contrary, kidney function was stable. Therefore, its use should be considered as a low-cost product with excellent clinical results. (Acta Med Colomb 2021; 46. DOI: https://doi.org/10.36104/amc.2021.2028).

Effect of acute hypervolemic hemodilution with 6% hydroxyethyl starch 130/0.4 on pharmacodynamics of propofol during successful laryngeal mask airway implantation / 中华麻醉学杂志

Objective:To investigate the effect of acute hypervolemic hemodilution (AHH) with 6% hydroxyethyl starch 130/0.4 on pharmacodynamics of propofol during successful laryngeal mask airway (LMA) implantation.Methods:American Society of Anesthesiology physical status Ⅰ or Ⅱ patients, aged 30-60 yr, with body mass index of 18.5-25.0 kg/m 2, undergoing elective extensive total hysterectomy under general anesthesia, were divided into 2 groups: AHH group (group A) and control group (group C). In group A, 6% hydroxyethyl starch 130/0.4 was infused at a rate of 20 ml/min for AHH, and the target hematocrit was 30%.In group C, lactated Ringer′s solution was infused according to the " 4-2-1" rule to supplement physiological requirements, and anesthesia induction was performed after 10 min of stabilization.Sufentanil was administered by target-controlled infusion using Bovil pharmacokinetic model with effect-site concentration (Ce) of 0.25 ng/ml, 3 min later propofol was given by target-controlled infusion using Schnider model.The Ce of propofol in the first patient was set at 5.0 μg/ml.Each time the concentration of propofol was increased/decreased by 0.5 μg/ml according to the sequential method.LMA was inserted following 1 min equilibration between plasma concentration and Ce of propofol.The trial was terminated when 8 consecutive inflection points of failed/successful LMA insertion occurred.The EC 5, EC 50, EC 95 and 95% confidence interval (95% CI) of propofol were calculated by probit regression analysis. Results:In group A, the EC 5 (95% CI), EC 50 (95% CI) and EC 95 (95% CI) of propofol when LMA was successfully placed were 4.237 (3.090-4.514) μg/ml, 4.802 (4.500-5.078) μg/ml and 5.443 (5.125-7.304) μg/ml, respectively.In group C, the EC 5 (95% CI), EC 50 (95% CI) and EC 95 (95% CI) of propofol when LMA was successfully placed were 2.408 (1.190-2.756) μg/ml, 3.120 (2.690-3.472) μg/ml and 4.042 (3.582-7.431) μg/ml, respectively.There was significant difference in EC 5, EC 50 and EC 95 between the two groups ( P<0.01). Conclusion:AHH with 6% hydroxyethyl starch 130/0.4 can decrease the efficacy of propofol when LMA is successfully implanted.

Rotational thromboelastometry assessment of ballanced crystalloid, hydroxyethyl starch and gelatin effects on coagulation: a randomized trial / Tromboelastometria rotacional na avaliação dos efeitos de cristaloides balanceados, hidroxietilamido e gelatina na coagulação: estudo randômico

Abstract Background and objectives Modern crystalloid and colloid solutions are balanced solutions which are increasingly used in perioperative period. However, studies investigating their negative effect on whole blood coagulation are missing, and vivid debate is going on about which solution has the minimal coagulopathy effect. The aim of our study was to assess the effect of modern fluid solutions on whole blood coagulation using rotational thromboelastometry. Methods Blood samples were obtained from 30 patients during knee arthroscopy before and after administration of 500 mL of crystalloid, Hydroxyethyl Starch and gelatin according to the randomization. Rotational thromboelastometry (Extem, Intem and Fibtem tests) was used to assess negative effect of fluid solutions on whole blood coagulation. Results In Extem test, the initiation phase of fibrin clot formation represented by CT parameter was not influenced by any fluid solution (p > 0.05). The speed of clot formation represented by CFT and α angle was impaired by Hydroxyethyl Starch and gelatin but not by crystalloids (p < 0.05). The strength of formatted coagulum represented by MCF parameter was impaired both in Extem and Fibtem test by HES and in Fibtem also by crystalloids (p < 0.05). Intem test was not negatively influenced by any crystalloid or colloid solution in any parameter (p > 0.05). Conclusion Extem test appears to be sensitive to coagulopathy effect of modern colloids and crystalloids. Hydroxyethyl starch has the most obvious negative effect on clot formation followed by gelatin and finally by crystalloids. Intem test seems to be insensitive to adverse effect of modern colloids and crystalloids.

Resumo Justificativa e objetivos Os cristaloides e coloides modernos são soluções balanceadas e cada vez mais utilizadas no período perioperatório. No entanto, não há estudos que avaliem seu efeito negativo na coagulação do sangue total e o intenso debate sobre a solução que cause um efeito mínimo na coagulopatia permanece. O objetivo de nosso estudo foi avaliar o efeito das soluções líquidas modernas na coagulação do sangue total com o uso da tromboelastometria rotacional. Métodos De acordo com a randomização, amostras de sangue foram colhidas de 30 pacientes durante a artroscopia de joelho, antes e após a administração de 500 mL de cristaloides, hidroxietilamido e gelatina. A tromboelastometria rotacional (testes Extem, Intem e Fibtem) foi utilizada para avaliar o efeito negativo das soluções líquidas na coagulação do sangue total. Resultados No teste Extem, a fase de iniciação da formação de coágulos de fibrina representada pelo parâmetro CT não foi influenciada por qualquer solução líquida (p > 0,05). A velocidade da formação de coágulos representada pelo CFT e pelo ângulo α foi prejudicada pelo hidroxietilamido e pela gelatina, mas não pelos cristaloides (p < 0,05). A força do coágulo formatado representado pelo parâmetro MCF foi prejudicada tanto no teste Extem quanto no teste Fibtem pelo HES e no teste Fibtem também pelos cristaloides (p < 0,05). O teste Intem não foi influenciado negativamente por nenhuma solução cristaloide ou coloide em nenhum parâmetro (p > 0,05). Conclusão O teste Extem parece ser sensível ao efeito de coagulopatia dos coloides e cristaloides modernos. O hidroxietilamido apresentou o efeito negativo mais óbvio na formação do coágulo, seguido pela gelatina e finalmente pelos cristaloides. O teste Intem parece ser insensível ao efeito adverso dos coloides e cristaloides modernos.

Safety of aerosol inhalation of recombinant human interferon alpha 2b injection(P.putida)and excipient hydroxyethyl starch 40 to healthy SD rats / 国际儿科学杂志

Objective@#To investigate the effects of recombinant human interferon alpha 2b injection(P.putida)and hydroxyethyl starch inhalation on physiological indexes and tissues and organs of SD rats, such as lungs, trachea and bronchus, and thus to explore the safety of the drug and excipients for inhalation.@*Methods@#Rats were randomly divided into two groups(hydroxyethyl starch 40 group and recombinant human interferon alpha 2b group).5 million IU/ml recombinant human interferon alpha 2b injection or 6% hydroxyethyl starch 40 injection were given respectively, which were diluted with 0.9% sodium chloride injection in a radio of 1: 2.Both groups were given aerosol inhalation for 30 minutes once a day for 14 days.Within 14 days after administration, the behavior of rats and the degree of toxicity were continuously observed.During the drug administration and recovery period, the clinical signs of the rats in each group were observed daily, and the body weight and food consumption were measured once a week.At the end of drug administration and the end of recovery period, hematology test, blood biochemical test, gross anatomical observation, organ weight determination, and histopathological examination were performed.@*Results@#The mass median aerodynamic diameter(MMAD)of the drug mist was 3.56 μm, and the geometric standard deviation(GSD)was 1.84 μm, which met the particle size requirements of arrival and deposition in the lower respiratory tract via atomization inhalation.No abnormality in clinical signs, body weight and food consumption, hematology and blood biochemical indexes were found in hydroxyethyl starch 40 group and recombinant human interferon alpha 2b group.No abnormal histopathological changes were observed in oral mucosa, tongue, nasal cavity(paranasal sinus), larynx, trachea, main bronchial tube, lung, heart, liver, spleen, kidney, reproductive system and other organs or tissues examined.@*Conclusion@#Results suggest the drug particle size of recombinant human interferon alpha 2b injection(pseudomonas)can reach the lower respiratory tract and deposit in the lower respiratory tract.Continuous atomization inhalation for 14 days has a good safety, and the excipient hydroxyethyl starch 40 has a high safety.

Safety of aerosol inhalation of recombinant human interferon alpha 2b injection (P. putida) and excipient hydroxyethyl starch 40 to healthy SD rats / 国际儿科学杂志

Objective To investigate the effects of recombinant human interferon alpha 2b injection ( P. putida) and hydroxyethyl starch inhalation on physiological indexes and tissues and organs of SD rats, such as lungs, trachea and bronchus, and thus to explore the safety of the drug and excipients for inhalation. Meth-ods Rats were randomly divided into two groups ( hydroxyethyl starch 40 group and recombinant human inter-feron alpha 2b group). 5 million IU/ml recombinant human interferon alpha 2b injection or 6％ hydroxyethyl starch 40 injection were given respectively, which were diluted with 0. 9％ sodium chloride injection in a radio of 1: 2. Both groups were given aerosol inhalation for 30 minutes once a day for 14 days. Within 14 days after administration, the behavior of rats and the degree of toxicity were continuously observed. During the drug ad-ministration and recovery period, the clinical signs of the rats in each group were observed daily, and the body weight and food consumption were measured once a week. At the end of drug administration and the end of re-covery period, hematology test, blood biochemical test, gross anatomical observation, organ weight determi-nation, and histopathological examination were performed. Results The mass median aerodynamic diameter ( MMAD) of the drug mist was 3. 56 μm, and the geometric standard deviation ( GSD ) was 1. 84 μm, which met the particle size requirements of arrival and deposition in the lower respiratory tract via atomization inhalation. No abnormality in clinical signs, body weight and food consumption, hematology and blood bio-chemical indexes were found in hydroxyethyl starch 40 group and recombinant human interferon alpha 2b group.No abnormal histopathological changes were observed in oral mucosa, tongue, nasal cavity ( paranasal sinus) , larynx, trachea, main bronchial tube, lung, heart, liver, spleen, kidney, reproductive system and other or-gans or tissues examined. Conclusion Results suggest the drug particle size of recombinant human interferon alpha 2b injection (pseudomonas) can reach the lower respiratory tract and deposit in the lower respiratory tract. Continuous atomization inhalation for 14 days has a good safety, and the excipient hydroxyethyl starch 40 has a high safety.

Effect of sodium carboxymethyl starch on erythrocyte rheology and oxygen carrying function / 国际药学研究杂志

Objective: To investigate the physicochemical properties of sodium carboxymethyl starch(CMS) and its effect on erythrocyte rheology and oxygen carrying function. Methods According to the requirements of Chinese Pharmacopoeia,the physicochemical properties were determined for CMS120,CMS380 and hydroxyethyl starch 130 (HES130),including pH value,osmotic pressure molar concentration and viscosity. Normal saline,CMS120,CMS380 and HES130 were mixed with whole blood(7:3,V/V),respectively,and the experimental groups were set as whole blood group,whole blood+normal saline(NSB)group,whole blood+CMS120(CMS120B)group,whole blood+CMS380 (CMS380B)group,and whole blood+HES130(HES130B)group. The colloid osmotic pressure,blood viscosity,eryth- rocyte deformation and aggregation,and the partial pressure of oxygen when blood oxygen saturation was 50%(P50)val- ue were measured for each of these groups. Results: The osmotic pressure molar concentration and the viscosity of CMS120 and CMS380 were both significantly higher than those of HES130(all P<0.05)as indicated by the determina- tion of physicochemical properties. Compared with the whole blood group,the colloid osmotic pressure was significantly increased in the CMS380B and CMS120B groups(P<0.05),which was also significantly higher than that in the HES130B group(P<0.05). At low shear rate(10/s),compared with the whole blood group,the whole blood and the plasma vis- cosities were significantly increased in the NSB,CMS380B and CMS120B groups(all P<0.05),but the whole blood viscosity was significantly decreased in the HES130B group(P<0.05). Under the conditions of shear rate 10/s,50/s and 150/s,compared with the HBS130B group,the whole blood and the plasma viscosities were both significantly in- creased in the CMS120B and CMS380 groups(all P<0.05). At the effect of high shear rate,both the CMS380 and HES130 groups showed a tendency to promote erythrocyte deformation,and the CMS120B and CMS380B groups promot- ed erythrocyte aggregation,while the HES130B group inhibited erythrocyte aggregation amplitude(P<0.05). The P50 value was significantly higher in the CMS380B group than in the HES130B group(P<0.05). Conclusion: CMS130 and CMS380 could improve the rheological properties of erythrocytes and CMS380 could also promote the oxygen release of erythrocytes.

Acid/base alterations during major abdominal surgery: 6% hydroxyethyl starch infusion versus 5% albumin / 대한마취과학회지

BACKGROUND: To compare the effects of intraoperative infusions of balanced electrolyte solution (BES)-based hydroxyethyl starch (HES) and saline-based albumin on metabolic acidosis and acid/base changes during major abdominal surgery conducted using Stewart’s approach. METHODS: Forty patients, aged 20-65 years, undergoing major abdominal surgery, were randomly assigned to the HES group (n = 20; received 500 ml of BES-based 6% HES 130/0.4) or the albumin group (n = 20; received 500 ml of normal saline-based 5% albumin). Acid-base parameters were measured and calculated using results obtained from arterial blood samples taken after anesthesia induction (T1), 2 hours after surgery commencement (T2), immediately after surgery (T3), and 1 hour after arriving at a postanesthetic care unit (T4). RESULTS: Arterial pH in the HES group was significantly higher than that in the albumin group at T3 (7.40 ± 0.04 vs. 7.38 ± 0.04, P = 0.043), and pH values exhibited significant intergroup difference over time (P = 0.002). Arterial pH was significantly lower at T3 and T4 in the HES group and at T2, T3, and T4 in the albumin group than at T1. Apparent strong ion difference (SIDa) was significantly lower at T2, T3, and T4 than at T1 in both groups. Total plasma weak nonvolatile acid (ATOT) was significantly lower in the HES group than in the albumin group at T2, T3 and T4 and exhibited a significant intergroup difference over time (P < 0.001). CONCLUSIONS: BES-based 6% HES infusion was associated with lower arterial pH values at the end of surgery than saline-based 5% albumin infusion, but neither colloid caused clinically significant metabolic acidosis (defined as an arterial pH < 7.35).

Efficacy of sequential dialysis combined with hydroxyethyl starch in the treatment of refractory edema of nephrotic syndrome / 中国基层医药

Objective To observe the efficacy of sequential dialysis combined with hydroxyethyl starch in the treatment of patients with refractory edema of nephrotic syndrome.Methods Eighty-eight patients with refractory edema of nephrotic syndrome were randomly divided into control group (n =44) and combination group (n =44)according to the digital table.The control group was treated with hydroxyethyl starch,and the combination group was treated with sequential dialysis combined with hydroxyethyl starch.The levels of urinary NAG,urinary KIM-1 and serum ICAM-1,TNF-,IL-6 were compared.And the clinical efficacy of the two groups was evaluated.Results The improvement time of clinical symptoms in the observation group was significantly shorter than that in the control group,and the average weight loss of the observation group was significantly higher than that of the control group(t =7.099,9.279,all P ＜ 0.05).Before treatment,the 24h urine,24h urine protein,Scr and BUN between the two groups had no statistically significant differences (all P ＞ 0.05).Compared with before treatment,24h urine of the two groups after treatment was increased (tcombination group =36.266,P ＜ 0.05;tcontrol group =7.906,P ＜ 0.05),and the 24h urine protein,Scr and BUN levels of two groups were decreased after treatment (tcombination group =21.031,25.629,26.099,P ＜0.05;tcontrol group =9.263,6.544,5.716,all P ＜ 0.05),and the improvement of the above indicators of the combination group was more significant (t =28.672,17.639,19.057,16.507,all P ＜ 0.05).The effective rate of the combination group was higher than that of the control group(x2 =8.494,P ＜ 0.05).Compared with before treatment,the urinary NAG enzyme and urinary KIM-1 of the combination group were statistically significantly decreased (tcombination group =29.146,19.256,all P ＜ 0.05).There were no statistically significant differences in urinary NAG and urinary KIM-1 between before treatment and after treatment in the control group (all P ＞ 0.05).After treatment,the serum levels of ICAM-1,TNF-and IL-1 β in the combination group were significantly lower than those before treatment and those in the control group (tcombination group=15.655,16.882,16.091,all P ＜ 0.05),while there were no statistically significant differences in the serum levels of ICAM-1,TNF-and IL-1β between before treatment and after treatment in the control group (all P ＞ 0.05).Conclusion Sequential dialysis combined with hydroxyethyl starch in the treatment of refractory edema of nephrotic syndrome can improve the clinical curative effect and improve the renal function of patients.It is worthy to be further promoted.

Overview of the Quality Study on Hydroxyethyl Starches / 中国药学杂志

Hydroxyethyl starches(HES) are modified natural polymer of amylopectin with volume expansion properties. It has been widely used in the treatment for prevention of hypovolemia and acute normovolemic hemodilution(ANH). However, the potential threats to kidney and coagulation have attracted much attention and controversy in recent years. This review will focus on the specification development and quality study of HES. The article will mainly talk about some quality control items: molecular weight (Mw) and molecular weight distribution, degree of hydroxyethyl (molar substitution, MS), the specific sites of hydroxyethylation (C2/C6 ratio) and assay, all of those are based on the domestic enterprise standards and Europe Pharmacopoeia(EP), and we will combine with the experimental data to give some suggestions on these items quality control. Hopefully to provide some ideas for improving and unifying the quality standard of hydroxyethyl starches.

Impacts of albumin synergized with hydroxyethyl starch on early microvascular albumin leakage after major abdominal surgery in rabbits

Abstract Purpose: To investigate the impacts of albumin synergized with hydroxyethyl starch (HES) on early microvascular albumin leakage after major abdominal surgery in rabbits. Methods: Forty male Japanese rabbits were randomly divided into four groups: the control group, the saline group, the albumin group, and the Syn group (hydroxyethyl starch+albumin). The latter three groups were performed gastrectomy plus resection of pancreatic body and tail and splenectomy. The serum albumin concentration was detected before and 48h after surgery, and the conditions of mesenteric microvascular leakage in these 4 groups were observed under microscope 48 h after surgery to calculate the leakage rate. Results: Compared with the saline group, the albumin group and the Syn group exhibited significantly increased serum albumin concentrations 48h after surgery (P<0.05). The albumin leakage rate was the most obvious in the albumin group, followed by the saline group, while that in the Syn group was the minimal, and there existed significant differences among these groups (P<0.05) . Conclusion: Simple administration of albumin in the early stage after major abdominal surgery could increase the albumin leakage, while the synergization of albumin and hydroxyethyl starch could reduce the albumin leakage.

Experimental Study on Anaphylactoid Reactions of Hydroxyethyl Starch 40 Sodium Chloride Injection / 中国比较医学杂志

Objective To evaluate the sensitizations of Hydroxyethyl Starch 40 Sodium Chloride Injection . Methods Active systemic anaphylaxis ( ASA) test, internal sensitive index ' s determination and screening and Passive Cutaneous Anaphylaxis ( PCA) test are carried out .Observe the allergy safety of the samples .Results We use guinea pigs to carry on ASA test and PCA test with Hydroxyethyl Starch 40 Sodium Chloride Injection from 45 batches of 3 companies and no changes have occurred .Measuring and comparing the sensitive index of HIS ,IgG, IgM and IgE in plasma, IgM and IgE are not obvious variation;HIS and IgG positive group and negative group and sample groups are different .Conclusions It is suggestion that Hydroxyethyl Starch 40 Sodium Chloride Injection safety evaluation should include allergic reactions , HIS and IgG sensitive index monitoring in clinical application of hydroxyethyl starch .

Influence of hydroxyethyl starch combined with strengthening anti-platelet therapy on the short-term clinical efficacy, TCD index and recurrence rate of patients with TIA secondary to cerebral artery stenosis / 中国基层医药

Objective To investigate the influence of hydroxyethyl starch combined with strengthening anti -platelet therapy on the short-term clinical efficacy,TCD index and recurrence rate of patients with TIA secondary to cerebral artery stenosis.Methods 80 patients with TIA secondary to cerebral artery stenosis were chosen,and they were randomly divided into two groups according to the digital table,each group in 40 cases.The control group received strengthening anti-platelet therapy alone,and the observation grouP received hydroxyethyl starch on the basis of control group.The short-term clinical efficacy,the blood flowvelocity of ACA and MCA before and after treatment,the TIA recurrence rate,the incidence of cerebral infarction and adverse reactions of both two groups were compared.Results The short-term effective rates of the control group and observation group were 77.50％,97.50％,respectively.The short-term effective rate of the observation group was significantly higher than that of the control group(x2 =12.33,P ＜ 0.05).The blood flow velocity of ACA and MCA of the control group after treatment were (51.05 ± 9.83) cm/s,(54.88 ± 6.62) cm/s,respectively,which were significantly lower than those of the observation group [(59.12 ± 12.07) cm/s,(62.65 ± 8.09) cm/s,t =3.17,2.96,4.03,4.74,3.67,4.05,all P ＜ 0.05].The TIA recurrence rate and the incidence rate of cerebral infarction of the control group were 22.50％,12.50％,respectively,which were significantly higher than those of the observation group(5.00％,0.00％,x2 =11.75,14.06,all P ＜ 0.05).The incidence rates of adverse reactions of the control group and observation group were 12.50％,10.00％,respectively.There was no significant difference in the incidence rate of adverse reactions between the two groups (x2 =1.75,P ＜ 0.05).Conclusion Hydroxyethyl starch combined with strengthening anti-platelet therapy in the treatment of patients with TIA secondary to cerebral artery stenosis can efficiently relieve the symptoms of neurological function,higher the level of cerebral blood perfusion,reduce the risk of TIA recurrence and cerebral infarction,and not increase the incidence of adverse reactions.

Rationality Analysis of Hydroxyethyl Starch Clinical Application in A Hospital / 中国药房

OBJECTIVE:To provide reference for the clinical rational application and preventing the adverse reactions of hy-droxyethyl starch(HES). METHODS:The HES application of inpatients in a hospital in Jul. 2014 were retrospectively analyzed, the usage and dosage,indications,and the changes of renal functions and blood coagulation function before and after HES treat-ment were detected,and the application rationality was evaluated. RESULTS:The usage of HES in the hospital was hydroxyethyl starch 200/0.5 and Sodium chloride injection,which was the second generation of HES. In the 347 patients,295 patients had moni-tored the renal functions before the HES treatment,the result was normal;and 21 patients had monitored the renal functions after HES treatment,the result was normal. Meanwhile,326 patients had monitored the blood coagulation functions before and after HES treatment,the results were normal. HES was not used for the patient of severe sepsis,renal dysfunctions and coagulopathy in this hospital. CONCLUSIONS:The application of HES can induce renal damage and coagulation disorder,so relevant indicators should be closely monitored before and after treatment to prevent the incidence of adverse reactions;further more,clinicians should strictly handle indications,usage and dosage and precautions during the clinical application;in addition,it is suggested to replace the second generation of HES by the third generation,which is more safer.

Effect of a rapid infusion of hydroxyethyl starch 130/0.4 on plasma concentration of propofol in target-controlled infusion / 中国生化药物杂志

Objective To investigate the effects of rapid colloid and crystalloid infusions on the plasma concentration of propofol( Cp) during target-controlled infusion.Methods Thirty-six patients were randomly assigned to three interventions(12 patients per group).At least 30 min after the start of propofol infusion,the hydroxyethyl starch solution group(HES)received HES of 24 mL/(kg· h),on the former 20 min,the sodium acetate Ringer’s injection group(AR)received AR of 24 mL/(kg· h),while HES group and AR group of later 20 min and the control group of whole course received AR of 2 mL/(kg· h).The plasma concentrations of propofol were recorded per 2 min and a half.The cardiac outputting,blood volume and clearance of indocyanine green were measured by pulsed dye density analyzer,the effective hepatic blood flow( EHBF) were obtained.Results The varying of Cp with time showed a significant treatment factor(F[2,33] =14.14,P<0.001)and time factor(F[16,528] =10.37,P<0.001)and interaction between the above factors(F[32,528] =2.82,P <0.001) by ANOVA for repeated measurement;the difference of Cp among each group,Cp in HES group was significantly lower than AR group(5-40 min)or control group(10-40 min),with significant difference(P<0.05).The varying of EHBF with time showed a significant treatment factor(F[2,28] =3.68,P=0.038)and time factor(F[2,56] =5.37,P=0.007)and interaction between the above factors(F [4,56] =3.67,P=0.010);while there was no significant difference in other groups.Conclusion Rapid HES infusion increases the effective hepatic blood flow,resulting in a decrease of propofol concentration during target-controlled infusion.Rapid HES infusion should be used cautiously as it may decrease the depth of anesthesia.

Hydroxyethyl Starch- Friend or Foe?.

Resuscitation with intravenous fluid therapy is considered a corner stone in the management of critically ill patients in most acute conditions. In daily practice, the assessment of individual thresholds in order to optimize cardiac preload and avoid hypovolemia or deleterious fluid overload remains a challenge. The choice of fluids for intravascular volume replacement has been debated for decades. More recently, this debate has focused not only on colloids versus crystalloids, but more specifically on the choice of colloid solutions. Hydroxyethyl starch (HES) solutions, developed as less-expensive alternatives to albumin, are commonly employed for volume resuscitation in the perioperative period as well as in ICU patients. However, lately, the resuscitation with HES has become controversial due to its adverse effect regarding impaired coagulation, renal insufficiency and mortality. Therefore, a narrative review of recent literature was undertaken to establish the current utility and efficacy of HES in clinical practice. Prospective randomized controlled trials published between January 2008 and March 2015 with measures of outcome/mortality and adverse effects of HES administration were included. This review aims at increasing awareness amongst anesthetists and critical care specialist about correct and careful fluid administration.

Impact of hydroxyethyl starch 70/0.5 on acute kidney injury after gastroenterological surgery / 대한마취과학회지

BACKGROUND: Previous studies reported a higher mortality risk and a greater need for renal replacement therapy in patients administered hydroxyethyl starch (HES) rather than other fluid resuscitation preparations. In this study, we investigated the association between 6% HES 70/0.5 use and postoperative acute kidney injury (AKI) in gastroenterological surgery patients. METHODS: We conducted retrospective full-cohort and propensity-score-based analyses of patients who underwent gastroenterological surgery between June 2011 and August 2013 in a Japanese university hospital. The study sample comprised 66 AKI and 2,152 non-AKI patients in the full-cohort analysis and 35 AKI and 1,269 non-AKI patients in the propensity-score-based analysis. Propensity scores were calculated using an ordered logistic regression model in which the dependent variable comprised three groups based on HES infusion volumes (0, 1–999, and ≥ 1,000 ml). The association between HES groups and postoperative AKI incidence was analyzed using multiple logistic regression models. Other candidate independent variables included patient characteristics and intraoperative measures. RESULTS: In the full-cohort analysis, 40 (60.6%) AKI patients were diagnosed as "risk", 15 (22.7%) as "injury," and 11 (16.7%) as "failure". In the propensity-score-based analysis, the corresponding values were 22 (62.9%), 8 (22.9%), and 5 (14.3%). There was no significant association between total infused HES and postoperative AKI incidence in either the full-cohort or the propensity-score-based analysis (P = 0.168 and P = 0.42, respectively). CONCLUSIONS: AKI incidence was not associated with clinical 6% HES 70/0.5 administration in gastroenterological surgery patients treated at a single center.

Effect of hydroxyethyl starch on blood glucose levels / 대한마취과학회지

BACKGROUND: Hydroxyethyl starch (HES), a commonly used resuscitation fluid, has the property to induce hyperglycemia as it contains large ethyl starch, which can be metabolized to produce glucose. We evaluated the effect of 6% HES-130 on the blood glucose levels in non-diabetic patients undergoing surgery under spinal anesthesia. METHODS: Patients scheduled to undergo elective lower limb surgery were enrolled. Fifty-eight patients were divided into two groups according to the type of the main intravascular fluid used before spinal anesthesia (Group LR: lactated Ringer's solution, n = 30 vs. Group HES: 6% hydroxyethyl starch 130/0.4, n = 28). Blood glucose levels were measured at the following time points: 0 (baseline), 20 min (T1), 1 h (T2), 2 h (T3), 4 h (T4), and 6 h (T6). RESULTS: Mean blood glucose levels at T5 in the LR group and T4, T5 in the HES group, increased significantly compared to baseline. There were no significant changes in the serial differences of mean blood glucose levels from baseline between the two groups. CONCLUSIONS: Administration of 6% HES-130 increased blood glucose levels within the physiologic limits, but the degree of glucose increase was not greater than that caused by administration of lactated Ringer's solution. In conclusion, we did not find evidence that 6% HES-130 induces hyperglycemia in non-diabetic patients.

Colloids versus crystalloids in objective-guided fluid therapy, systematic review and meta-analysis. Too early or too late to draw conclusions / Coloides versus cristaloides em fluidoterapia guiada por objetivos, revisão sistemática e metanálise. Demasiadamente cedo ou demasiadamente tarde para obter conclusões / Coloides versus cristaloides en fluidoterapia guiada por objetivos, revisión sistemática y metaanálisis. Demasiado pronto o demasiado tarde para obtener conclusiones

Several clinical trials on Goal directed fluid therapy (GDFT) were carried out, many of those using colloids in order to optimize the preload. After the decision of European Medicines Agency, there is such controversy regarding its use, benefits, and possible contribution to renal failure. The objective of this systematic review and meta-analysis is to compare the use of last-generation colloids, derived from corn, with crystalloids in GDFT to determine associated complications and mortality.

Foram feitos múltiplos ensaios clínicos em fluidoterapia guiada por objetivos (FGO), muitos deles com o uso de coloides para aprimoramento da pré-carga. Após a decisão da Agência Europeia de Medicamentos, existe ainda controvérsia sobre seu uso, seus benefícios e sua possível contribuição para a falência renal. O objetivo desta revisão sistemática e metanálise é comparar o uso de coloides de última geração, derivados de milho, com cristaloides em FGO para determinar as complicações e a mortalidade associadas.

Se han realizado múltiples ensayos clínicos en fluidoterapia guiada por objetivos (FGO), muchos de ellos con el uso de coloides para la optimización de la precarga. Tras la decisión de la Agencia Europea del Medicamento, existe cierta controversia en cuanto a su utilización, beneficios y su posible contribución al fallo renal. El objetivo de esta revisión sistemática y metaanálisis es comparar el uso de coloides de última generación, derivados del maíz, con cristaloides en FGO para determinar las complicaciones y la mortalidad asociadas.