17、说明书撰写

药品说明书中[适应症]、[用法用量]、[不良反应]等各项内容撰写均基于临床试验结果。以说明书中的适应症为例，在ABSSSI适应症中需列出由何种病原菌所致者，可列入适应症的细菌种类必须是ABSSSI的目标病原菌，其所致感染临床疗效为治愈和微生物学疗效为细菌清除或假定清除。病例数需达该目标适应症观察例数的10％（至少10例）。有关说明书撰写详见《抗菌药物说明书撰写技术指导原则》中相关内容。

三、主要参考文献

1.  CFDA: 抗菌药物临床试验技术指导原则. 2015年.

2.  Itani KM, Shorr AF. FDA guidance for ABSSSI trials: implications for conducting and interpreting clinical trials. Clin Infect Dis. 2014;58 Suppl 1:S4-9.

3.  Sartelli M, Guirao X, Hardcastle TC, Kluger Y, Boermeester MA, Rasa K, et al. 2018 WSES/SIS-E consensus conference: recommendations for the management of skin and soft-tissue infections. World J Emerg Surg. 2018;13:58.

4.  Stevens DL, Bisno AL, Chambers HF, Dellinger EP, Goldstein EJ, Gorbach SL, et al. Practice guidelines for the diagnosis and management of skin and soft tissue infections: 2014 update by the infectious diseases society of America. Clin Infect Dis. 2014;59(2):147-59.

5.  Pollack CV, Jr., Amin A, Ford WT, Jr., Finley R, Kaye KS, Nguyen HH, et al. Acute bacterial skin and skin structure infections (ABSSSI): practice guidelines for management and care transitions in the emergency department and hospital. J Emerg Med. 2015;48(4):508-19.

6.  Suaya JA, Eisenberg DF, Fang C, Miller LG. Skin and soft tissue infections and associated complications among commercially insured patients aged 0-64 years with and without diabetes in the U.S. PLoS One. 2013;8(4):e60057.

7.  Fung HB, Chang JY, Kuczynski S. A practical guide to the treatment of complicated skin and soft tissue infections. Drugs, 2003,63(14): 1459-1480.

8.  CFDA：抗菌药物药代动力学/药效学研究技术指导原则.2017年.

9.  CFDA: 抗菌药物折点研究技术指导原则.2017年.

10.      FDA：Guidance For Industry: Evaluating Clinical Studies Of Antimicrobials In the Division Of Anti-infective Drugs Products.1997年.

11.      FDA: Guidance For Industry: Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment. 2013年.

12.      EMA: Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections. 2012年.

13.      EMA：Addendum to the note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 REV 2) to address indication-specific clinical data. 2013年.

14.      CFDA：抗菌药物说明书撰写技术指导原则. 2018年.

15.      EMA: Guidance On the Evaluation of Medicinal Products Indicated for Treatment of Bacterial Infections, Rev 3 (draft). December 2018.

16.      U.S. Department of Health and Human Services, National Institutes of Health, National Cancer Institute: Common Terminology Criteria  for Adverse Events (CTCAE) Version 5.0. November 2017.