Patients with cervical high-grade squamous intraepithelial lesion grade III (CIN3)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Photodynamic therapy group: (1) women aged 18-40 years with childbearing requirements, non pregnant and in good general condition; (2) Pathological diagnosis of cervical high-grade squamous intraepithelial lesion grade III (CIN3) patients, requiring systemic photodynamic therapy; (3) Signed informed consent. 2.The traditional surgical treatment group: (1) women aged 18-40 years with childbearing requirements, non pregnant and in good general condition; (2) Pathological diagnosis of cervical high-grade squamous intraepithelial lesion grade III (CIN3) patients; (3) Signed informed consent.
Exclusion criteria
Exclusion criteria: 1.Photodynamic therapy group: (1) patients with porphyria and other diseases worsened by light or allergic to porphyrins or any excipients; (2) Pregnancy and lactation; (3) Suffering from immune system diseases and using immunosuppressive or regulatory drugs (such as corticosteroids may reduce the efficacy of PDT); (4) Acute inflammatory stage and general infectious disease active stage; (5) Antithrombotic or antiplatelet agglutination drugs are being used in large doses; (6) Patients with obvious abnormal liver function, coagulation dysfunction and other serious uncontrolled medical comorbidities. (7) Those who have serious mental abnormalities and cannot cooperate; (8) The investigator considered it inappropriate to participate in this study; (9) The researcher, research assistant, research pharmacist, clinical research assistant or other personnel involved in this study. 2.The traditional surgical treatment group: (1) patients with porphyria and other diseases worsened by light or allergic to porphyrins or any excipients; (2) Pregnancy and lactation; (3) Suffering from immune system diseases and using immunosuppressive or regulatory drugs (such as corticosteroids may reduce the efficacy of PDT); (4) Acute inflammatory stage and general infectious disease active stage; (5) Antithrombotic or antiplatelet agglutination drugs are being used in large doses; (6) Patients with obvious abnormal liver function, coagulation dysfunction and other serious uncontrolled medical comorbidities. (7) Those who have serious mental abnormalities and cannot cooperate; (8) The investigator considered it inappropriate to participate in this study; (9) The researcher, research assistant, research pharmacist, clinical research assistant or other personnel involved in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lesion outcome;Pregnancy rate;Preterm birth rate;Abortion rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| HPV negative conversion rate; | — |
Countries
China
Contacts
Peking University Shenzhen Hospital