Evaluation of the efficacy and safety of Nocardia rubra cell wall skeleton immunotherapy for cervical high-risk HPV persistent infection.
10.3760/cma.j.cn112141-20230331-00154
- Author:
Fei CHEN
1
;
Wen DI
2
;
Yuan Jing HU
3
;
Chang Zhong LI
4
;
Fei WANG
4
;
Hua DUAN
5
;
Jun LIU
6
;
Shu Zhong YAO
7
;
You Zhong ZHANG
8
;
Rui Xia GUO
9
;
Jian Dong WANG
10
;
Jian Liu WANG
11
;
Yu Quan ZHANG
12
;
Min WANG
13
;
Zhong Qiu LIN
14
;
Jing He LANG
1
Author Information
1. Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, National Clinical Medical Research Center for Obstetrics and Gynecology, Beijing 100730, China.
2. Department of Obstetrics and Gynecology, Renji Hospital, Shanghai Jiao Tong University, Shanghai 200001, China.
3. Department of Gynecological Oncology, Tianjin Central Hospital of Gynecology Obstetrics, Tianjin 300199, China.
4. Department of Gynecology, Shandong Provincial Hospital Affiliated to Shandong First Medical University (Shandong Provincial Hospital), Jinan 250021, China.
5. Gynecological Minimally Invasive Surgery Center, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing 100006, China.
6. Department of Obstetrics and Gynecology, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100043, China.
7. Department of Gynecology, the First Affiliated Hospital of Sun Yat-sen University, Guangzhou 510080, China.
8. Department of Obstetrics and Gynecology, Qilu Hospital of Shandong University, Jinan 250012, China.
9. Department of Obstetrics and Gynecology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China.
10. Department of Gynecological Oncology, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing 100006, China.
11. Department of Obstetrics and Gynecology, Peking University People's Hospital, Beijing 100044, China.
12. Department of Obstetrics and Gynecology, Affiliated Hospital of Nantong University, Nantong 226001, China.
13. Department of Gynecology, Shengjing Hospital of China Medical University, Shenyang 110004, China.
14. Department of Obstetrics and Gynecology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou 510289, China.
- Publication Type:Journal Article
- MeSH:
Female;
Humans;
Adult;
Middle Aged;
Cervix Uteri/pathology*;
Uterine Cervical Neoplasms/pathology*;
Papillomavirus Infections/diagnosis*;
Cell Wall Skeleton;
Persistent Infection;
Powders;
Uterine Cervical Dysplasia/pathology*;
Immunotherapy;
Papillomaviridae
- From:
Chinese Journal of Obstetrics and Gynecology
2023;58(7):536-545
- CountryChina
- Language:Chinese
-
Abstract:
Objective: To evaluate the efficacy and safety of Nocardia rubra cell wall skeleton (Nr-CWS) in the treatment of persistent cervical high-risk human papillomavirus (HR-HPV) infection. Methods: A randomized, double blind, multi-center trial was conducted. A total of 688 patients with clinically and pathologically confirmed HR-HPV infection of the cervix diagnosed in 13 hispital nationwide were recruited and divided into: (1) patients with simple HR-HPV infection lasting for 12 months or more; (2) patients with cervical intraepithelial neoplasia (CIN) Ⅰ and HR-HPV infection lasting for 12 months or more; (3) patients with the same HR-HPV subtype with no CINⅡ and more lesions after treatment with CINⅡ or CIN Ⅲ (CINⅡ/CIN Ⅲ). All participants were randomly divided into the test group and the control group at a ratio of 2∶1. The test group was locally treated with Nr-CWS freeze-dried powder and the control group was treated with freeze-dried powder without Nr-CWS. The efficacy and negative conversion rate of various subtypes of HR-HPV were evaluated at 1, 4, 8, and 12 months after treatment. The safety indicators of initial diagnosis and treatment were observed. Results: (1) This study included 555 patients with HR-HPV infection in the cervix (included 368 in the test group and 187 in the control group), with an age of (44.1±10.0) years. The baseline characteristics of the two groups of subjects, including age, proportion of Han people, weight, composition of HR-HPV subtypes, and proportion of each subgroup, were compared with no statistically significant differences (all P>0.05). (2) After 12 months of treatment, the effective rates of the test group and the control group were 91.0% (335/368) and 44.9% (84/187), respectively. The difference between the two groups was statistically significant (χ2=142.520, P<0.001). After 12 months of treatment, the negative conversion rates of HPV 16, 18, 52, and 58 infection in the test group were 79.2% (84/106), 73.3% (22/30), 83.1% (54/65), and 77.4% (48/62), respectively. The control group were 21.6% (11/51), 1/9, 35.1% (13/37), and 20.0% (8/40), respectively. The differences between the two groups were statistically significant (all P<0.001). (3) There were no statistically significant differences in vital signs (body weight, body temperature, respiration, pulse rate, systolic blood pressure, diastolic blood pressure, etc.) and laboratory routine indicators (blood cell analysis, urine routine examination) between the test group and the control group before treatment and at 1, 4, 8, and 12 months after treatment (all P>0.05); there was no statistically significant difference in the incidence of adverse reactions related to the investigational drug between the two groups of subjects [8.7% (32/368) vs 8.0% (15/187), respectively; χ2=0.073, P=0.787]. Conclusion: External use of Nr-CWS has good efficacy and safety in the treatment of high-risk HPV persistent infection in the cervix.
