国产舒芬太尼用于术后静脉自控镇痛的疗效和安全性——多中心、随机、双盲、平行对照临床研究

目的 采用多中心、随机、双盲、平行对照的方法评价国产舒芬太尼用于全麻术后静脉镇痛的有效性和安全性.方法 选择200例择期全麻手术患者,ASA分级Ⅰ～Ⅱ级,年龄18岁～55岁,体重50 kg～80 kg;随机分成实验组(国产舒芬太尼组)和对照组(进口舒芬太尼组),每组100例.手术结束前给0.1μg/kg的试验药,醒后VAS评分<3级.拔管后开始给药(国产或进口舒芬太尼200μg/50 ml,输注速度0.5 ml/h,PCA剂量0.5 ml,锁定时间15 min,连续给药48 h).给药开始作为评价起点(0 h),在0、1、4、12、24、48 h记录包括血压、心率、脉搏、SpO2;恶心、呕吐、尿潴留、皮肤搔痒、呼吸抑制等副作用发生情况;记录患者静息状态下和咳嗽或运动时的视觉模拟评分(VAS评分);在24 h记录患者PCA总次数、总有效次数及二者的比率和舒芬太尼消耗量;记录患者其他镇痛药物需求情况及其剂量和次数;记录患者对镇痛效果的满意度.结果 在0、1、4、12、24、48 h血压、心率、脉搏、SpO2两组患者均在正常范围,两组比较无统计学差异;镇痛过程中和镇痛结束后发生的恶心、呕吐、尿潴留、皮肤搔痒、呼吸抑制等副作用事件两组比较差异无统计学意义,两组均无明显副作用;两组患者静息状态下和咳嗽或运动时的视觉模拟评分无统计学差异、效果满意;在24 h两组患者PCA总次数和PCA总有效次数无统计学差异;舒芬太尼消耗量两组比较无统计学差异;患者需求其他镇痛药物情况及其剂量和次数两组比较无统计学差异;患者对镇痛效果的满意度两组比较无统计学差异.结论 国产舒芬太尼用于伞麻外科手术患者术后镇痛效果满意,无明显副作用;与进口舒芬太尼相比,镇痛效果及副作用方面无统计学差异,提示国产舒芬太尼可以用于临床术后静脉镇痛.     

国产舒芬太尼用于术后静脉自控镇痛的疗效和安全性——多中心、随机、双盲、平行对照临床研究

Objective To evaluate efficacy and safety of sulfentanyl (China) for PICA in surgical patients with general anes-thesia in a multiple-center, randomized, double-blind, parallel study. Methods 200 ASA grade Ⅰ -Ⅱ patients aged 18-55 undergo-ing surgery with general aneathesia enrolled from 3 hospitals were randomly and double-blindly divided into 2 groups: sulfentanyl (China, n=100) versus sulfentanyl(German, n=100). Sulfentanyl(China 0.1 μg/kg or German)was given before the end of surgery. VAS scores less than 3 after patient awake and PCA started after extubation(200 μg sulfentanyl was diluted with 50 ml saline solution, background dose 0.5 ml/h,bolus of 0.5 ml with lockout interval 15 min, continuous infusion 48 h). Vital signs including BP, HR, PR, SpO2 and side effects such as nausea, vomiting, urine retention, pruritus, breath depression, etc. And VAS scores with patients in quiet and cough were recorded at the beginning of infusion at 0, 1, 4, 12, 24, 48 h. The total number of PCA, the total effective number of PCA, and the ratio of both and other analgesics as well as the satisfactory degree of patients and the cumulative suffen-tanyl consumption were recorded at 24 h. Results There were no significant difference of BP, HR, PR, SpO2 and the adverse effect and VAS scores in quiet and cough between two groups at the beginning of infusion at 0, 1, 4, 12, 24, 48 h. There were no signifi-cant difference of the total number of PCA, the total effective number of PCA and other analgesics as well as the satisfactory degree of patients and the total dosage of sulfentanyl at 24 h. Conclusion The sulfentanyl (China) had satisfactory effects of postoperative analgesia and had no significant side effects compared with sulfentanyl (German). The efficacy and the side effects of both drugs had no significant difference.     

国产舒芬太尼用于术后静脉自控镇痛的疗效和安全性——多中心、随机、双盲、平行对照临床研究

Objective To evaluate efficacy and safety of sulfentanyl (China) for PICA in surgical patients with general anes-thesia in a multiple-center, randomized, double-blind, parallel study. Methods 200 ASA grade Ⅰ -Ⅱ patients aged 18-55 undergo-ing surgery with general aneathesia enrolled from 3 hospitals were randomly and double-blindly divided into 2 groups: sulfentanyl (China, n=100) versus sulfentanyl(German, n=100). Sulfentanyl(China 0.1 μg/kg or German)was given before the end of surgery. VAS scores less than 3 after patient awake and PCA started after extubation(200 μg sulfentanyl was diluted with 50 ml saline solution, background dose 0.5 ml/h,bolus of 0.5 ml with lockout interval 15 min, continuous infusion 48 h). Vital signs including BP, HR, PR, SpO2 and side effects such as nausea, vomiting, urine retention, pruritus, breath depression, etc. And VAS scores with patients in quiet and cough were recorded at the beginning of infusion at 0, 1, 4, 12, 24, 48 h. The total number of PCA, the total effective number of PCA, and the ratio of both and other analgesics as well as the satisfactory degree of patients and the cumulative suffen-tanyl consumption were recorded at 24 h. Results There were no significant difference of BP, HR, PR, SpO2 and the adverse effect and VAS scores in quiet and cough between two groups at the beginning of infusion at 0, 1, 4, 12, 24, 48 h. There were no signifi-cant difference of the total number of PCA, the total effective number of PCA and other analgesics as well as the satisfactory degree of patients and the total dosage of sulfentanyl at 24 h. Conclusion The sulfentanyl (China) had satisfactory effects of postoperative analgesia and had no significant side effects compared with sulfentanyl (German). The efficacy and the side effects of both drugs had no significant difference.     

国产舒芬太尼用于术后静脉自控镇痛的疗效和安全性——多中心、随机、双盲、平行对照临床研究

Objective To evaluate efficacy and safety of sulfentanyl (China) for PICA in surgical patients with general anes-thesia in a multiple-center, randomized, double-blind, parallel study. Methods 200 ASA grade Ⅰ -Ⅱ patients aged 18-55 undergo-ing surgery with general aneathesia enrolled from 3 hospitals were randomly and double-blindly divided into 2 groups: sulfentanyl (China, n=100) versus sulfentanyl(German, n=100). Sulfentanyl(China 0.1 μg/kg or German)was given before the end of surgery. VAS scores less than 3 after patient awake and PCA started after extubation(200 μg sulfentanyl was diluted with 50 ml saline solution, background dose 0.5 ml/h,bolus of 0.5 ml with lockout interval 15 min, continuous infusion 48 h). Vital signs including BP, HR, PR, SpO2 and side effects such as nausea, vomiting, urine retention, pruritus, breath depression, etc. And VAS scores with patients in quiet and cough were recorded at the beginning of infusion at 0, 1, 4, 12, 24, 48 h. The total number of PCA, the total effective number of PCA, and the ratio of both and other analgesics as well as the satisfactory degree of patients and the cumulative suffen-tanyl consumption were recorded at 24 h. Results There were no significant difference of BP, HR, PR, SpO2 and the adverse effect and VAS scores in quiet and cough between two groups at the beginning of infusion at 0, 1, 4, 12, 24, 48 h. There were no signifi-cant difference of the total number of PCA, the total effective number of PCA and other analgesics as well as the satisfactory degree of patients and the total dosage of sulfentanyl at 24 h. Conclusion The sulfentanyl (China) had satisfactory effects of postoperative analgesia and had no significant side effects compared with sulfentanyl (German). The efficacy and the side effects of both drugs had no significant difference.     

国产舒芬太尼用于术后静脉自控镇痛的疗效和安全性——多中心、随机、双盲、平行对照临床研究

Objective To evaluate efficacy and safety of sulfentanyl (China) for PICA in surgical patients with general anes-thesia in a multiple-center, randomized, double-blind, parallel study. Methods 200 ASA grade Ⅰ -Ⅱ patients aged 18-55 undergo-ing surgery with general aneathesia enrolled from 3 hospitals were randomly and double-blindly divided into 2 groups: sulfentanyl (China, n=100) versus sulfentanyl(German, n=100). Sulfentanyl(China 0.1 μg/kg or German)was given before the end of surgery. VAS scores less than 3 after patient awake and PCA started after extubation(200 μg sulfentanyl was diluted with 50 ml saline solution, background dose 0.5 ml/h,bolus of 0.5 ml with lockout interval 15 min, continuous infusion 48 h). Vital signs including BP, HR, PR, SpO2 and side effects such as nausea, vomiting, urine retention, pruritus, breath depression, etc. And VAS scores with patients in quiet and cough were recorded at the beginning of infusion at 0, 1, 4, 12, 24, 48 h. The total number of PCA, the total effective number of PCA, and the ratio of both and other analgesics as well as the satisfactory degree of patients and the cumulative suffen-tanyl consumption were recorded at 24 h. Results There were no significant difference of BP, HR, PR, SpO2 and the adverse effect and VAS scores in quiet and cough between two groups at the beginning of infusion at 0, 1, 4, 12, 24, 48 h. There were no signifi-cant difference of the total number of PCA, the total effective number of PCA and other analgesics as well as the satisfactory degree of patients and the total dosage of sulfentanyl at 24 h. Conclusion The sulfentanyl (China) had satisfactory effects of postoperative analgesia and had no significant side effects compared with sulfentanyl (German). The efficacy and the side effects of both drugs had no significant difference.     

国产舒芬太尼用于术后静脉自控镇痛的疗效和安全性——多中心、随机、双盲、平行对照临床研究

Objective To evaluate efficacy and safety of sulfentanyl (China) for PICA in surgical patients with general anes-thesia in a multiple-center, randomized, double-blind, parallel study. Methods 200 ASA grade Ⅰ -Ⅱ patients aged 18-55 undergo-ing surgery with general aneathesia enrolled from 3 hospitals were randomly and double-blindly divided into 2 groups: sulfentanyl (China, n=100) versus sulfentanyl(German, n=100). Sulfentanyl(China 0.1 μg/kg or German)was given before the end of surgery. VAS scores less than 3 after patient awake and PCA started after extubation(200 μg sulfentanyl was diluted with 50 ml saline solution, background dose 0.5 ml/h,bolus of 0.5 ml with lockout interval 15 min, continuous infusion 48 h). Vital signs including BP, HR, PR, SpO2 and side effects such as nausea, vomiting, urine retention, pruritus, breath depression, etc. And VAS scores with patients in quiet and cough were recorded at the beginning of infusion at 0, 1, 4, 12, 24, 48 h. The total number of PCA, the total effective number of PCA, and the ratio of both and other analgesics as well as the satisfactory degree of patients and the cumulative suffen-tanyl consumption were recorded at 24 h. Results There were no significant difference of BP, HR, PR, SpO2 and the adverse effect and VAS scores in quiet and cough between two groups at the beginning of infusion at 0, 1, 4, 12, 24, 48 h. There were no signifi-cant difference of the total number of PCA, the total effective number of PCA and other analgesics as well as the satisfactory degree of patients and the total dosage of sulfentanyl at 24 h. Conclusion The sulfentanyl (China) had satisfactory effects of postoperative analgesia and had no significant side effects compared with sulfentanyl (German). The efficacy and the side effects of both drugs had no significant difference.     

国产舒芬太尼用于术后静脉自控镇痛的疗效和安全性——多中心、随机、双盲、平行对照临床研究

Objective To evaluate efficacy and safety of sulfentanyl (China) for PICA in surgical patients with general anes-thesia in a multiple-center, randomized, double-blind, parallel study. Methods 200 ASA grade Ⅰ -Ⅱ patients aged 18-55 undergo-ing surgery with general aneathesia enrolled from 3 hospitals were randomly and double-blindly divided into 2 groups: sulfentanyl (China, n=100) versus sulfentanyl(German, n=100). Sulfentanyl(China 0.1 μg/kg or German)was given before the end of surgery. VAS scores less than 3 after patient awake and PCA started after extubation(200 μg sulfentanyl was diluted with 50 ml saline solution, background dose 0.5 ml/h,bolus of 0.5 ml with lockout interval 15 min, continuous infusion 48 h). Vital signs including BP, HR, PR, SpO2 and side effects such as nausea, vomiting, urine retention, pruritus, breath depression, etc. And VAS scores with patients in quiet and cough were recorded at the beginning of infusion at 0, 1, 4, 12, 24, 48 h. The total number of PCA, the total effective number of PCA, and the ratio of both and other analgesics as well as the satisfactory degree of patients and the cumulative suffen-tanyl consumption were recorded at 24 h. Results There were no significant difference of BP, HR, PR, SpO2 and the adverse effect and VAS scores in quiet and cough between two groups at the beginning of infusion at 0, 1, 4, 12, 24, 48 h. There were no signifi-cant difference of the total number of PCA, the total effective number of PCA and other analgesics as well as the satisfactory degree of patients and the total dosage of sulfentanyl at 24 h. Conclusion The sulfentanyl (China) had satisfactory effects of postoperative analgesia and had no significant side effects compared with sulfentanyl (German). The efficacy and the side effects of both drugs had no significant difference.     

国产舒芬太尼用于术后静脉自控镇痛的疗效和安全性——多中心、随机、双盲、平行对照临床研究

Objective To evaluate efficacy and safety of sulfentanyl (China) for PICA in surgical patients with general anes-thesia in a multiple-center, randomized, double-blind, parallel study. Methods 200 ASA grade Ⅰ -Ⅱ patients aged 18-55 undergo-ing surgery with general aneathesia enrolled from 3 hospitals were randomly and double-blindly divided into 2 groups: sulfentanyl (China, n=100) versus sulfentanyl(German, n=100). Sulfentanyl(China 0.1 μg/kg or German)was given before the end of surgery. VAS scores less than 3 after patient awake and PCA started after extubation(200 μg sulfentanyl was diluted with 50 ml saline solution, background dose 0.5 ml/h,bolus of 0.5 ml with lockout interval 15 min, continuous infusion 48 h). Vital signs including BP, HR, PR, SpO2 and side effects such as nausea, vomiting, urine retention, pruritus, breath depression, etc. And VAS scores with patients in quiet and cough were recorded at the beginning of infusion at 0, 1, 4, 12, 24, 48 h. The total number of PCA, the total effective number of PCA, and the ratio of both and other analgesics as well as the satisfactory degree of patients and the cumulative suffen-tanyl consumption were recorded at 24 h. Results There were no significant difference of BP, HR, PR, SpO2 and the adverse effect and VAS scores in quiet and cough between two groups at the beginning of infusion at 0, 1, 4, 12, 24, 48 h. There were no signifi-cant difference of the total number of PCA, the total effective number of PCA and other analgesics as well as the satisfactory degree of patients and the total dosage of sulfentanyl at 24 h. Conclusion The sulfentanyl (China) had satisfactory effects of postoperative analgesia and had no significant side effects compared with sulfentanyl (German). The efficacy and the side effects of both drugs had no significant difference.     

国产舒芬太尼用于术后静脉自控镇痛的疗效和安全性——多中心、随机、双盲、平行对照临床研究

Objective To evaluate efficacy and safety of sulfentanyl (China) for PICA in surgical patients with general anes-thesia in a multiple-center, randomized, double-blind, parallel study. Methods 200 ASA grade Ⅰ -Ⅱ patients aged 18-55 undergo-ing surgery with general aneathesia enrolled from 3 hospitals were randomly and double-blindly divided into 2 groups: sulfentanyl (China, n=100) versus sulfentanyl(German, n=100). Sulfentanyl(China 0.1 μg/kg or German)was given before the end of surgery. VAS scores less than 3 after patient awake and PCA started after extubation(200 μg sulfentanyl was diluted with 50 ml saline solution, background dose 0.5 ml/h,bolus of 0.5 ml with lockout interval 15 min, continuous infusion 48 h). Vital signs including BP, HR, PR, SpO2 and side effects such as nausea, vomiting, urine retention, pruritus, breath depression, etc. And VAS scores with patients in quiet and cough were recorded at the beginning of infusion at 0, 1, 4, 12, 24, 48 h. The total number of PCA, the total effective number of PCA, and the ratio of both and other analgesics as well as the satisfactory degree of patients and the cumulative suffen-tanyl consumption were recorded at 24 h. Results There were no significant difference of BP, HR, PR, SpO2 and the adverse effect and VAS scores in quiet and cough between two groups at the beginning of infusion at 0, 1, 4, 12, 24, 48 h. There were no signifi-cant difference of the total number of PCA, the total effective number of PCA and other analgesics as well as the satisfactory degree of patients and the total dosage of sulfentanyl at 24 h. Conclusion The sulfentanyl (China) had satisfactory effects of postoperative analgesia and had no significant side effects compared with sulfentanyl (German). The efficacy and the side effects of both drugs had no significant difference.     

舒芬太尼静脉给药用于术后自控镇痛分析

目的 探讨舒芬太尼静脉给药用于术后自控镇痛（PCIA）的效果。方法 术毕以BCDB-100自控镇痛泵连接静脉输液为1026例患者做PCIA。结果 1026例中镇痛效果优良率为90%。结论 舒芬太尼静脉给药用于PCIA效果确切，安全可靠，不良反应少。     

Efficacy and safety of percutaneous nephrolithotomy (PCNL): a prospective and randomized study comparing regional epidural anesthesia with general anesthesia

Objective: To compare the efficacy and safety of regional epidural anesthesia and general anesthesia in patients who underwent PCNL. Materials and Methods: Fifty patients submitted to percutaneous nephrolithotomy (PCNL) were randomized into two groups: Group I (N = 26) received general anesthesia and Group II (N = 24) received regional epidural anesthesia. Demographic and operative data including age, BMI, stone position, stone size, postoperative pain, amount of postoperative analgesic usage, length of hospital stay, patient satisfaction, preoperative and postoperative hemoglobin and hematocrit, adverse effects and surgical complications were compared between both groups. Results: Average pain score at 1 hour. was 6.88 in group I and 3.12 in group II (p < 0.001), at 4 hours. 5.07 in group I and 3.42 in group II (p = 0.025). Less morphine was required in the regional epidural anesthesia group compared to the general anesthesia group. Higher satisfaction was found in the regional epidural group. 6 (23.07 %) patients in Group I and 1 patient (4.19 %) in Group II had postoperative nausea and vomiting, respectively (p = 0.05). Pain score at 12 hours, 24 hours, 48 hours, 72 hours, preoperative and postoperative hemoglobin and hematocrit, length of hospital stay, and adverse effects were no different between the two groups. Conclusion: Regional epidural anesthesia is an alternative technique for PCNL which achieves more patient satisfaction, less early postoperative pain and less adverse effects from medication with the same efficacy and safety compared to general anesthesia.