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.     

FOLFOX-6与肝动脉灌注化疗对结直肠癌肝转移治疗效果的比较

Objective To compare the efficacy and side effects between systemic chemotherapy and hepatic arterial infusion by combination of oxaliplatin and 5-fluorouracil (FOLFOX-6) with 5-fluorouracil in the patients who have developed hepatic metastasis after colorectal cancer operation. The factors that would affect the prognosis without operational treatment were also analyzed. Methods 46patients who had signed the informed consents were allocated into two groups: the group with general chemotherapy (Trial Group includes 26 cases) and the one with hepatic arterial infusion chemotherapy (Control Group includes 20 cases). The total effective rate, the prognosis, the cytoxicitic side effects,quality of life, the total survival rate and the responses were the main parameters determined. Kaplan-Meier was used to analyze Mono-factor to the prognostic responses and the Cox mode was used to analyze poly-factor to the prognostic responses. Results The overall survival rate was significantly higher by using systemic treatment versus HAI(median, 15. 0 v 11.2 months;P＜0.05). The difference in overall responsive rate (CR+PR) between the two groups was statistically significant (50% v 10%;P=0. 011). No significant difference was found in PS scale during the treatment. (P=0. 126). Except for myelosuppression and abdominal pain, no significant difference was found in the other side effects. Univariate analysis revealed that the invasive lesions to serosa, the distribution of liver metastases, the size and number of liver metastases, primary carcinoma involving lymph nodes and the treatment were correlated with prognoses. Cox regression analysis showed that the larger diameter of liver metastases, the number of liver lesions, primary carcinomas involved in serosal layer and the treatment modules were independent prognostic factors. Conclusions The oxaliplatin-based FOLFOX-6 chemotherapy regiment has a better responsive rate and survival rate than the traditional infusion with 5-fluorouracil to the main hepatic artery for interventional therapy. The diameter of the hepatic metastasis larger than 5em, multiple hepatic metastasis and the primary lesions penetrating serosal layer suggest the poor prognosis. The oxaliplatin-based systematic chemotherapy has a better prognosis. Therefore,it is worth carrying on further study on modification of traditional hepatic arterial infusion and on evaluation of therapy by combination of the hepatic arterial infusion with the systematic chemotherapy.     

FOLFOX-6与肝动脉灌注化疗对结直肠癌肝转移治疗效果的比较

Objective To compare the efficacy and side effects between systemic chemotherapy and hepatic arterial infusion by combination of oxaliplatin and 5-fluorouracil (FOLFOX-6) with 5-fluorouracil in the patients who have developed hepatic metastasis after colorectal cancer operation. The factors that would affect the prognosis without operational treatment were also analyzed. Methods 46patients who had signed the informed consents were allocated into two groups: the group with general chemotherapy (Trial Group includes 26 cases) and the one with hepatic arterial infusion chemotherapy (Control Group includes 20 cases). The total effective rate, the prognosis, the cytoxicitic side effects,quality of life, the total survival rate and the responses were the main parameters determined. Kaplan-Meier was used to analyze Mono-factor to the prognostic responses and the Cox mode was used to analyze poly-factor to the prognostic responses. Results The overall survival rate was significantly higher by using systemic treatment versus HAI(median, 15. 0 v 11.2 months;P＜0.05). The difference in overall responsive rate (CR+PR) between the two groups was statistically significant (50% v 10%;P=0. 011). No significant difference was found in PS scale during the treatment. (P=0. 126). Except for myelosuppression and abdominal pain, no significant difference was found in the other side effects. Univariate analysis revealed that the invasive lesions to serosa, the distribution of liver metastases, the size and number of liver metastases, primary carcinoma involving lymph nodes and the treatment were correlated with prognoses. Cox regression analysis showed that the larger diameter of liver metastases, the number of liver lesions, primary carcinomas involved in serosal layer and the treatment modules were independent prognostic factors. Conclusions The oxaliplatin-based FOLFOX-6 chemotherapy regiment has a better responsive rate and survival rate than the traditional infusion with 5-fluorouracil to the main hepatic artery for interventional therapy. The diameter of the hepatic metastasis larger than 5em, multiple hepatic metastasis and the primary lesions penetrating serosal layer suggest the poor prognosis. The oxaliplatin-based systematic chemotherapy has a better prognosis. Therefore,it is worth carrying on further study on modification of traditional hepatic arterial infusion and on evaluation of therapy by combination of the hepatic arterial infusion with the systematic chemotherapy.     

Cher(e)s collègues, Cher(e)s ami(e)s,

Sans résumé

---

Cher(e)s collègues, Cher(e)s ami(e)s,