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Injectable cefoperazone sodium and tazobactam sodium (6∶1) in the treatment of moderate to severe acute respiratory bacterial infections: a blind, randomized controlled, multi-center clinical trial
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Feng CHEN1, Hai-ying YU2, Bi-wen MO1, Ji-fang SHENG2, Lian-ming DING3, Chong LI4, Qi YIN5, Wen-yuan LIU6, Xiu-hua FU7
Chinese Journal of New Drugs | 2021, 30(23) : 2194 - 2202
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Chinese Journal of New Drugs | 2021, 30(23): 2194-2202
Injectable cefoperazone sodium and tazobactam sodium (6∶1) in the treatment of moderate to severe acute respiratory bacterial infections: a blind, randomized controlled, multi-center clinical trial
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Feng CHEN1, Hai-ying YU2, Bi-wen MO1, Ji-fang SHENG2, Lian-ming DING3, Chong LI4, Qi YIN5, Wen-yuan LIU6, Xiu-hua FU7
Affiliations
  • 1Affiliated Hospital of Guilin Medical University, Guilin 541000, China
  • 2The First Affiliated Hospital of of Zhejiang University, Hangzhou 310003, China
  • 3The 81st Group Army Hospital of the Chinese People's Liberation Army (The 251st Hospital of the Chinese People's Liberation Army), Zhangjiakou 075000, China
  • 4The First People's Hospital of Changzhou, Changzhou 213003, China
  • 5Dongfang Hospital Affiliated to Tongji University, Shanghai 200120, China
  • 6Sichuan Provincial People's Hospital, Chengdu 610072, China
  • 7The Affiliated Hospital of Inner Mongolia Medical University, Hohhot 10050, China
Published: 2021-12-15
Outline
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Objective:

To evaluate the efficacy and safety of injectable cefoperazone sodium and tazobactam sodium (6∶1) for the treatment of moderate to severe acute respiratory bacterial infections.

Methods:

Totally 237 patients with respiratory tract infections were enrolled in a randomized, double blind, multi-centerand, parallel controlled study, in which 179 in experimental group and 58 in control group ([injectable cefoperazone sodium and tazobactam sodium (4∶1)]. During the screening period, cefoperazone sodium was uniformly injected for 3 d. During the treatment period, the experimental group was given the test drug 3.0 g by intravenous drip twice a day, and the control group was given 2.0 g of control drug by intravenous drip 3 times a day. The results of symptoms, signs, laboratory examination, chest X-ray examination and sputum bacterial culture were observed before and after treatment.

Results:

In experiment group and control group, the clinical cure rates were 87.65% and 78.85%, respectively. The bacterial clearance rates were 97.89% and 97.06%. Comprehensive efficacies were 86.32% and 73.53%. Incidences of adverse reaction were 13.79% (24/174 patients) in the test group and 14.29% (8/56 patients) in the control group. The main manifestations were elevated transaminase, leucopenia, eosinophilia and so on. All patients returned to normal after follow-up.

Conclusion:

Injectable cefoperazone sodium and tazobactam sodium (6∶1) is proved to be safe and effective in the treatment of moderate to severe acute bacterial infection of respiratory system after large-scale phase Ⅲ clinical trial, providing an effective drug for the control of drug-resistant bacterial infection.

cefoperazone sodium and tazobactam sodium for injection (6∶1)  /  drug-resistant bacteria infection  /  acute respiratory bacterial infections  /  blind  /  randomized controlled  /  multi-center clinical trial
陈峰, 俞海英, 莫碧文, 盛吉芳, 丁连明, 李翀, 尹琦, 刘文媛, 付秀华. 注射用头孢哌酮钠他唑巴坦钠(6∶1)治疗中重度呼吸系统急性细菌性感染的多中心随机对照临床试验. 中国新药杂志, 2021 , 30 (23) : 2194 -2202 .
Feng CHEN, Hai-ying YU, Bi-wen MO, Ji-fang SHENG, Lian-ming DING, Chong LI, Qi YIN, Wen-yuan LIU, Xiu-hua FU. Injectable cefoperazone sodium and tazobactam sodium (6∶1) in the treatment of moderate to severe acute respiratory bacterial infections: a blind, randomized controlled, multi-center clinical trial[J]. Chinese Journal of New Drugs, 2021 , 30 (23) : 2194 -2202 .
Year 2021 volume 30 Issue 23
46
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Article Info
  • Online Date:2026-10-28
  • Published:2021-12-15
Article Data
Affiliations
History
  • Accepted:2021-10-04
Funding
Affiliations
    1Affiliated Hospital of Guilin Medical University, Guilin 541000, China
    2The First Affiliated Hospital of of Zhejiang University, Hangzhou 310003, China
    3The 81st Group Army Hospital of the Chinese People's Liberation Army (The 251st Hospital of the Chinese People's Liberation Army), Zhangjiakou 075000, China
    4The First People's Hospital of Changzhou, Changzhou 213003, China
    5Dongfang Hospital Affiliated to Tongji University, Shanghai 200120, China
    6Sichuan Provincial People's Hospital, Chengdu 610072, China
    7The Affiliated Hospital of Inner Mongolia Medical University, Hohhot 10050, China
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表12种不同金属材料的力学参数
科
Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
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属
Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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