加压素注射液治疗分布性休克低血压的有效性和安全性的多中心、随机、双盲、安慰剂对照的验证性临床试验
[Translation] A multicenter, randomized, double-blind, placebo-controlled, confirmatory clinical trial of the efficacy and safety of vasopressin injection in the treatment of hypotension in distributive shock
评价加压素注射液治疗分布性休克低血压的有效性和安全性
[Translation] To evaluate the efficacy and safety of vasopressin injection in the treatment of distributive shock hypotension
布洛芬注射液治疗发热 有效性及安全性随机、双盲、安慰剂平行对照、多中心临床研究
[Translation] A randomized, double-blind, placebo-controlled, multicenter clinical study on the efficacy and safety of ibuprofen injection in the treatment of fever
1、以安慰剂为对照,以首次用药后 4 h 时体温低于 38.5℃( T<38.5℃)的受试者比例为主要疗效指标,评价布洛芬注射液治疗发热的有效性;
2、通过实验室检查、临床症状、体征、不良事件/严重不良事件等,评价布洛芬注射液的安全性。
[Translation] 1. Taking placebo as the control, and taking the proportion of subjects whose body temperature is lower than 38.5℃ (T<38.5℃) at 4 hours after the first administration as the main efficacy index, evaluate the effectiveness of ibuprofen injection in the treatment of fever;
2. Evaluate the safety of ibuprofen injection through laboratory examinations, clinical symptoms, signs, adverse events/serious adverse events, etc.
布洛芬注射液治疗术后中、重度疼痛有效性及安全性随机、双盲、安慰剂平行对照、多中心临床研究
[Translation] A randomized, double-blind, placebo-controlled, multicenter clinical study on the efficacy and safety of ibuprofen injection in the treatment of postoperative moderate and severe pain
以术后 24h 内吗啡总用量为主要疗效指标,以安慰剂为对照, 评价布洛芬注射液辅助治疗腹部或骨科术后中、重度疼痛的有效性和安全性。
[Translation] The total amount of morphine within 24 hours after operation was used as the main efficacy index, and the placebo was used as the control to evaluate the efficacy and safety of ibuprofen injection in the treatment of moderate and severe pain after abdominal or orthopedic surgery.
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