Pazufloxacin Mesilate Ear Drops in Patients With Chronic Suppurative Otitis Media

Inclusion Criteria:

1. Age is 18-65 years old. Men and women are not restricted.

2. Clinical diagnosis of simple chronic suppurative otitis media with ear effusionsecretion, tympanic membrane perforation about 2 mm, the need for local use ofantibiotics in patients.

3. Voluntarily sign written informed consent.

4. Non-breast-feeding women volunteered to take appropriate contraceptive measures (including abstinence, intrauterine devices, diaphragms and spermicides) during thestudy period (screening period to one week after administration). Men are willing touse approved contraceptive methods (including the use of condoms and spermicides orthe use of oral, implantable or injectable contraceptives by their partners,intrauterine devices, diaphragms and spermicides) or sexual partner infertility.

Exclusion Criteria:

1. Quinolone antibiotics allergy and severe allergic constitution.

2. During the study, ear fluid could not be collected.

3. Patients with severe need for systemic use of antibiotics.

4. Infections caused by pathogens such as fungi and viruses (bullous tympanitis).

5. Patients with cholesteatoma.

6. Complicated with symptoms of extraaural infection (such as periaural cellulitis,mumps) or intracranial and extracranial complications (such as meningitis, brainabscess, thrombophlebitis of sigmoid sinus, subperiosteal abscess of the ear, Bezold'sabscess of the neck).

7. Suffer from severe brain, heart, lung, liver, kidney and blood diseases.

8. People suffering from severe diseases that affect their survival, such as malignanttumors or AIDS, etc.

9. Abnormal liver and kidney function (ALT, Angiotensin sensitivity test(AST) ≥ 1.5 timesthe upper limit of normal value), creatinine clearance rate < 60ml/min).

10. Use any local or systemic antibiotics in the first 3 days of the admission.

11. Use any quinolones within the first 7 days of admission.

12. There were smokers who smoked more than 5 cigarettes a day within one year.

13. There was a history of alcoholism and drug abuse within one year.

14. Diagnosis of diabetes or poor blood glucose control.

15. Those who are unable to cooperate or unwilling to cooperate with neuropsychiatricdisorders.

16. Pregnant or lactating women, those who do not use contraceptive measures as required,or those who are unwilling to take contraceptive measures.

17. Patients who took part in other clinical trials in the first 3 months.

18. Blood donation within three months before admission, or intended during or threemonths after the end of the trial or blood components.

19. Researchers believe that patients who are not fit to participate in this clinicaltrial.