Efficacy and safety of inhaled dry-powder mannitol in adults with cystic fibrosis: An international,randomized controlled study

Background: Mannitol is a mucoactive hyperosmotic agent used as add-on therapy in patients with cystic fibrosis (CF), administered twice-daily (BID) via a small, portable, breath-actuated dry-powder inhaler. This study was conducted to provide confirmatory evidence of mannitol's efficacy and safety in adults.Methods: This multicenter, double-blind, randomized, parallel-group, controlled clinical trial recruited adults (aged ≥18 years) with CF, and forced expiratory volume in 1 second (FEV₁) 40–90% predicted. Subjects received either mannitol 400 mg or mannitol 50 mg (control), BID via dry-powder inhaler for 26 weeks. Primary endpoint: FEV₁ averaged over the 26-week treatment period.Results: Of 423 subjects randomized (209 or 214 receiving mannitol 400 mg BID or control, respectively), 373 (88.2%) completed the study, with a similar proportion completing in the two groups. For FEV₁ averaged over 26 weeks, mannitol 400 mg BID was statistically superior to control (adjusted mean difference 54 mL [95% CI 8, 100 mL]; p = 0.020). This was supported by sensitivity analyses of the primary endpoint, and by observed improvements in secondary pulmonary function endpoints (eg, absolute adjusted mean difference in percent predicted FEV₁ averaged over 26 weeks 1.21% [0.07%, 2.36%]; p = 0.037). Adverse events were mainly mild or moderate in severity, with treatment-related adverse events in 15.5 and 12.2% of subjects receiving mannitol 400 mg BID and control, respectively.Conclusions: In adults with CF, mannitol 400 mg BID inhaled as a dry-powder statistically significantly improved lung function (FEV₁) compared with control, with this improvement supported by sensitivity analyses and secondary pulmonary function endpoints. Mannitol had a good overall safety and tolerability profile. ClinicalTrials.gov: NCT02134353.     

Renal safety of adefovir dipivoxil in patients with chronic hepatitis B: two double-blind, randomized, placebo-controlled studies

BACKGROUND: The incidence of adefovir dipivoxil (ADV) nephrotoxicity has been previously reported with the 60 and 120 mg daily dose in human immunodeficiency virus (HIV). We report a complete analysis on the renal tolerance of ADV at the currently approved dose of 10 mg daily for the treatment of chronic hepatitis B. METHODS: To investigate the efficacy, safety, and the tolerability of two dosing regimens of ADV (10 mg daily or 30 mg daily), two double-blind, placebo-controlled studies were performed in patients with chronic hepatitis B and compensated liver disease who were not undergoing current treatment and who had evidence of hepatitis B virus (HBV) replication. RESULTS: There was no overall median change from baseline at week 48 in serum creatinine or serum phosphorus levels in the ADV 10 mg group. In the ADV 30 mg group there was a slight increase of 0.2 mg/dL in median serum creatinine levels, and decrease of 0.1 mg/dL in serum phosphorus levels at week 48. Serum creatinine increase and hypophosphatemia were more frequently observed in patients receiving ADV 30 mg daily compared with ADV 10 mg and placebo. There were no grade 4 proteinuria, hematuria, or glycosuria events. CONCLUSION: Mild nephrotoxicity was demonstrated with the dose of 30 mg daily. Nephrotoxicity, as defined by an increase >/=0.5 mg/dL from baseline in serum creatinine or a serum phosphorus value of <1.5 mg/dL on two consecutive occasions, was not observed in patients treated with ADV 10 mg for a median follow-up period of approximately 64 weeks.     

Experience using centralized spirometry in the phase 2 randomized, placebo-controlled, double-blind trial of denufosol in patients with mild to moderate cystic fibrosis.

BACKGROUND: Centralized spirometry may significantly improve quality of spirometry and reduce variability of this outcome measure in clinical trials in cystic fibrosis (CF). METHODS: Spirometry was performed during the phase 2 randomized, placebo-controlled, double-blind clinical trial of denufosol in patients with mild to moderate CF using American Thoracic Society guidelines. Uniform spirometers were used with electronic data transmission of all the data to a reading center. Spirometry was evaluated for quality by a central reader based on start of test, cough during the test, and evidence of a plateau. RESULTS: A total of 1418 spirometry values were assessed in 89 subjects during the trial. In only 5 instances did the central reading center need to give feedback to sites regarding the quality of spirometry. The study site data matched the central reading center's data for all but 78 (6%) spirometry values in 33 patients. Many of these differences were small with only 35 (3%) values differing by more than 50 mL in 26 patients. CONCLUSION: Spirometry in this clinical trial was of high quality with low rate of significant centralized over-read.     

Efficacy and cardiac safety of propiverine in elderly patients - a double-blind, placebo-controlled clinical study

The study investigated the efficacy and cardiac safety of propiverine in the elderly, because the induction of life-threatening ventricular arrhythmia has been reported for some drugs prescribed in the therapy of urinary incontinence. Ninety-eight patients (21 male, 77 female; 67.7+/-6.3 years of age) suffering from urgency, urge incontinence or mixed urge-stress incontinence were included in the double-blind, multicentre, placebo-controlled, randomized study. After a 2-week placebo run-in period, the patients received propiverine (15 mg t.i.d.) or placebo (t.i.d.) for 4 weeks. Before (V1, V2) and during the treatment period (V3, V4), standard ECGs and 24-hour long-term ECGs were recorded. Propiverine caused a significant reduction of the micturition frequency (V2: 8.7+/-4.2, V4: 6.5+/-3.2 ml; p< or =0.01), reflected in a significant increase in the average micturition volume (V2: 163.5+/-65.9, V4: 216.3+/-101.5 ml; p< or =0.01) and a significant decrease in episodes of incontinence (-54%; p = 0.048). These findings were confirmed by the overall assessment at V4, in which approximately 90% of patients under propiverine either had no urge incontinence or urge symptoms, or showed improvement. Resting and ambulatory electrocardiograms indicated no significant changes. Neither the frequency-corrected Q-T interval nor other cardiac parameters were relevantly altered. The frequency of cardiac events (Lown classes IVa/b) was random, revealing no difference between placebo and propiverine. The incidence of adverse events was very low (2% dryness of the mouth under propiverine) and confirmed by the findings from the quality of life questionnaires. A favourable benefit-risk ratio without the induction of any cardiac arrhythmia in the treatment of elderly patients suffering from urgency, urge incontinence or combined urge-stress incontinence is therefore proven for propiverine.     

Efficacy of trospium chloride in patients with detrusor instability: a placebo-controlled, randomized, double-blind, multicentre clinical trial

OBJECTIVES: To assess the efficacy and safety of trospium chloride (TCl, 20 mg twice daily) in the treatment of detrusor instability, compared with placebo. PATIENTS AND METHODS: In all, 208 patients were allocated at random to either TCl or placebo in a double-blind clinical study; the patients were treated for 3 weeks. Urodynamic values were measured at the beginning and end of the treatment period. Adverse events were recorded on patient diary cards. A confirmatory adaptive procedure with one planned interim analysis was used to evaluate efficacy. RESULTS: Trospium chloride produced significant improvements in maximum cystometric bladder capacity (median treatment effect 22.0 mL, mean 37.3 mL, one-sided P = 0. 0054) and urinary volume at first unstable contraction (median treatment effect 45.0 mL, mean 63.6 mL, one-sided P = 0.0015). The patients' assessment of efficacy showed significantly greater clinical improvement in the TCl group than in the placebo group (two-sided P = 0.0047). Furthermore, TCl was well tolerated, with similar frequencies of adverse events reported in both groups (68% in the TCl and 62% in the placebo group). CONCLUSION: Trospium chloride (20 mg twice daily) is an effective and safe option for the treatment of detrusor instability.     

Safety and pharmacokinetics of Roscovitine (Seliciclib) in cystic fibrosis patients chronically infected with Pseudomonas aeruginosa,a randomized,placebo-controlled study

BackgroundThe orally available kinase inhibitor R-roscovitine has undergone clinical trials against various cancers and is currently under clinical evaluation against Cushing disease and rheumatoid arthritis. Roscovitine displays biological properties suggesting potential benefits in CF: it partially corrects F508del-CFTR trafficking, stimulates the bactericidal properties of CF alveolar macrophages, and displays anti-inflammatory properties and analgesic effects.MethodsA phase 2 trial study (ROSCO-CF) was launched to evaluate the safety and effects of roscovitine in Pseudomonas aeruginosa infected adult CF patients carrying two CF causing mutations (at least one F508del-CFTR mutation) and harboring a FEV1 ≥40%. ROSCO-CF was a multicenter, double-blind, placebo-controlled, dose-ranging study (200, 400, 800 mg roscovitine, orally administered daily for 4 days/week/4 weeks).ResultsAmong the 34 volunteers enrolled, randomization assigned 11/8/8/7 to receive the 0 (placebo)/ 200/400/800 mg roscovitine doses, respectively. In these subjects with polypharmacy, roscovitine was relatively safe and well-tolerated, with no significant adverse effects (AEs) other than five serious AEs (SAEs) possibly related to roscovitine. Pharmacokinetics of roscovitine were rather variable among subjects. No significant efficacy, at the levels of inflammation, infection, spirometry, sweat chloride, pain and quality of life, was detected in roscovitine-treated groups compared to the placebo-treated group.ConclusionRoscovitine was relatively safe and well-tolerated in CF patients especially at the 200 and 400 mg doses. However, there were 5 subject withdrawals due to SAEs in the roscovitine group and none in the placebo group. The lack of evidence for efficacy of roscovitine (despite encouraging cellular and animal results) may be due to high pharmacokinetics variability, short duration of treatment, and/or inappropriate dosing protocol.     

Efficacy and safety of aildenafil citrate in Chinese men with erectile dysfunction: a multicenter,randomized, double-blind,placebo-controlled crossover trial

BackgroundTo evaluate the efficacy and safety of aildenafil citrate in the treatment of erectile dysfunction (ED) in Chinese population.MethodsA multicenter, randomized, double-blind, placebo-controlled, double-cycle crossover trial was conducted in three medical centers. Male patients with mild to moderate ED were randomized into two groups and received either aildenafil citrate or placebos, followed by a crossover administration after a 7-day washout. The primary outcome was the duration of penile rigidity over 60% measured by RigiScan^® Plus. Main secondary outcomes were the duration of penile rigidity over 80% and erectile hardness score (EHS).ResultsA total of 60 patients with mild to moderate ED were enrolled in the study and 57 of them completed the trial (30 in the aildenafil group and 27 in the placebo group). The median duration of penile tip rigidity over 60% was 4.25 (0.00, 19.00) min in the aildenafil group, as compared with 0.50 (0.00, 2.75) min in the placebo group (P<0.001). The median duration of penile base rigidity over 60% was 3.25 (0.00, 12.50) min in the aildenafil group, as compared with 0.00 (0.00, 2.50) min in the placebo group (P<0.001). The duration of penile base rigidity over 80% was significantly increased in the aildenafil group versus the placebo group (P=0.002). The EHS was significantly improved in the aildenafil group (P<0.001). No severe adverse events associated with aildenafil citrate occurred in both groups.ConclusionsThese results suggested that aildenafil citrate was efficient and well-tolerated in the treatment of Chinese men with mild to moderate ED.Trial RegistrationChinese Clinical Trial Registry ChiCTR1900026025.     

Physiological response during activity programs using Wii-based video games in patients with cystic fibrosis (CF)

Patients with cystic fibrosis (CF) are characterized by an abnormal ventilation response that limits the exercise capacity. Exercise training increases exercise capacity, decreases dyspnea and improves health-related quality of life in CF. Adherence to pulmonary rehabilitation programs is a key factor to guarantee optimal benefits and a difficult goal in this population.The aim of this study was to determine the physiological response during three Nintendo Wii™ video game activities (VGA) candidates to be used as training modalities in patients with CF.Method24 CF patients (age 12.6 ± 3.7 years; BMI 18.8 ± 2.9 kg m^− 2; FEV₁ 93.8 ± 18.8 %pred) were included.All participants performed, on two separate days, 3 different VGA: 1) Wii Fit Plus (Wii-Fit); 2) Wii Active (Wii-Acti), and 3) Wii Family Trainer (Wii-Train), in random order during 5 min. The obtained results were compared with the 6-min walk test (6MWT). The physiological variables [oxygen uptake (VO₂), minute ventilation (V_E), and heart rate (HR)] were recorded using a portable metabolic analyzer.ResultsDuring all VGA and 6MWT, VO₂ reached a plateau from the 3rd min. Compared with the 6MWT (1024.2 ± 282.2 mL m^− 1), Wii-Acti (1232.2 ± 427.2 mL m^− 1) and Wii-Train (1252.6 ± 360.2 mL m^− 1) reached higher VO₂ levels during the last 3 min (p < 0.0001 in both cases), while Wii-Fit (553.8 ± 113.2 mL m^− 1) reached significantly lower levels of VO₂ (p < 0.001). Similar effects were seen for the ventilatory volume (V_E). No differences in dyspnea and oxygen saturation were seen between the different modalities. All patients were compliant with all three Wii™ modalities.ConclusionActive video game are well tolerated by patients with CF. All the modalities evaluated imposed a constant load but were associated with different physiological responses reflecting the different intensities imposed. Wii-Acti and Wii-Train impose a significantly high metabolic demand comparable to the 6MWT. Further research is needed to evaluate the effects of VGA as a training program to increase exercise capacity for CF patients.     

Survival benefit in critically ill burned patients receiving selective decontamination of the digestive tract: a randomized, placebo-controlled, double-blind trial

OBJECTIVE: To evaluate whether selective digestive decontamination (SDD) reduces mortality from any cause, and the incidence of pneumonia among patients with severe burns. SUMMARY BACKGROUND DATA: SDD is a prophylactic strategy to reduce infectious morbidity and mortality in critically ill patients. Two meta-analyses and a recent randomized controlled trial demonstrated a mortality reduction varying between 20% and 40%. But this technique has never been properly evaluated in severely burned patients. METHODS: The design of this single-center trial was randomized, double blind, placebo controlled. Patients with burns > or =20% of total body surface and/or suspected inhalation injury were enrolled and assigned to receive SDD or placebo for the total duration of treatment in the burn intensive care unit (ICU). RESULTS: One hundred seventeen patients were randomized and 107 were analyzed (53 in the SDD group and 54 in the placebo group). The ICU mortality was 27.8% in the placebo group and 9.4% in the SDD group in the burn ICU. Treatment with SDD was associated with a significant reduction in mortality both in the burn ICU (risk ratio 0.25; 95% CI 0.08 to 0.76) and in the hospital (risk ratio 0.28; 95% CI 0.10 to 0.80), following adjustment for predicted mortality. The incidence of pneumonia was significantly higher in the placebo group: 30.8 and 17.0 pneumonias per 1000 ventilation days (P = 0.03) in placebo and SDD group, respectively. CONCLUSIONS: Treatment with SDD reduces mortality and pneumonia incidence in patients with severe burns.     

前列安栓治疗慢性前列腺炎的安全性和有效性:随机双盲安慰剂对照试验

目的　评价前列安栓治疗各型慢性前列腺炎的安全性、有效性和依从性。　方法　多中心随机双盲安慰剂对照研究。 12 5例慢性前列腺炎患者根据美国国立卫生院 (NIH)前列腺炎分型标准分型后随机分为治疗组和对照组 ,治疗组 (6 5例 )前列安栓 1粒 ,对照组 (6 0例 )安慰剂 1粒 ,肛内用药每晚 1次 ,疗程 1个月。以NIH慢性前列腺炎症状评分 (NIH CPSI)和前列腺按摩液 (EPS)白细胞计数为疗效评价指标。　结果　试验结束时 ,12 4例可评价病例中Ⅱ型 4 8例 (38.7% ) ,Ⅲa型 4 5例 (36 .3% ) ,Ⅲb型 31例 (2 5 .0 % )。治疗组NIH CPSI总分用药前后分别为 (2 5 .4 5± 5 .82 )和 (15 .0 8± 7.84 )分 ,平均降低 10 .37分 ,症状程度评分用药前后分别为 (16 .76± 4 .0 7)和 (9.4 2± 5 .38)分 ,平均降低 7.34分 ;对照组NIH CPSI总分用药前后分别为 (2 2 .87± 5 .79)和 (16 .2 2± 6 .2 3)分 ,平均降低 6 .6 5分 ,症状程度评分用药前后分别为 (15 .2 7± 3.86 )和 (10 .5 5± 4 .2 9)分 ,平均降低 4 .72分 ;治疗组NIH CPSI总分与症状程度评分的下降幅度均较对照组更明显 (P <0 .0 1)。治疗组总显效率2 8.1% (18/ 6 4 ) ,总有效率 71.9% (4 6 / 6 4 ) ,对照组总显效率 13.3% (8/ 6 0 ) ,总有效率 4 1.7% (2 5 / 6 0 )     

癃清片治疗慢性前列腺炎多中心双盲安慰剂对照试验研究

目的 评价癃清片治疗慢性前列腺炎的有效性和安全性.方法 多中心、随机、双盲、安慰剂对照临床设计.480例湿热兼瘀血型慢性前列腺炎患者按3:1的比例随机分为治疗组、安慰剂对照组.治疗组360例,口服癃清片,一次6片,每日2次.安慰剂对照组120例,服用安慰剂,一次6片,每日2次,疗程为4周.以美国国立卫生院前列腺炎症状评分(NIH-CPSI)、慢性前列腺炎中医证候评分作为主要疗效评价指标.结果 (1)治疗4周后,治疗组和对照组CPSI评分分别为(11.9±5.04)和(17.66±4.92),(P<0.05).治疗组和对照组治疗前后CPSI评分差值分别为(10.44±5.91)和(4.18±3.50),治疗组降幅大于对照组(P<0.05).治疗组在降低NIH-CPSI评分疗效优于对照组.(2)治疗4周后,治疗组和对照组中医证候评分分别为(9.87±3.95)和(14.43±4.14),治疗组低于对照组(P<0.05);治疗组和对照组治疗前后差值分别为(9.17±4.82)和(4.64±4.36),治疗组降幅大于对照组(P<0.05).(3)治疗组总有效率为82.4%,对照组为40.6%,总有效率治疗组优于对照组(P<0.05).(4)两组间不良事件发生率比较无差异(P>0.05).结论 癃清片治疗慢性前列腺炎安全、有效,值得在临床推广.     

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.