Article(id=1291707146949911251, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291707045514858818, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.23.004, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1746633600000, receivedDateStr=2025-05-08, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785896582590, onlineDateStr=2026-08-05, pubDate=1765900800000, pubDateStr=2025-12-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785896582590, onlineIssueDateStr=2026-08-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785896582590, creator=13701087609, updateTime=1785896582590, updator=13701087609, issue=Issue{id=1291707045514858818, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='23', pageStart='3301', pageEnd='3450', issueExtLink='null', onlineDate='null', pubDate='1765900800000', pubDateStr='2025-12-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785896558407, creator='13701087609', updateTime=1785896663780, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1291707487678390577, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291707045514858818, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1291707487682584882, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291707045514858818, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=3321, endPage=3327, ext={EN=ArticleExt(id=1291707149013508820, articleId=1291707146949911251, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Clinical trial of anlotinib combined with standard chemotherapy regimen in the treatment of patients with recurrent and metastatic cervical cancer, columnId=1246531407326105792, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Clinical and Basic Bridging Research, runingTitle=null, highlight=null, articleAbstract=
Objective

To observe the clinical efficacy and safety of anlotinib hydrochloride capsules combined with standard chemotherapy (cisplatin for injection+paclitaxel injection) in the treatment of patients with recurrent and metastatic cervical cancer.

Methods

The patients with recurrent and metastatic cervical cancer were divided into treatment group and control group according to the treatment methods. In control group, paclitaxel injection (175 mg·m-2, infused within 3 hours) and cisplatin for injection (infusion time≥1 h) were intravenously infused. In treatment group, based on the treatment in control group, anlotinib hydrochloride capsules (12 mg qd) were orally administered. Both groups were continuously treated for 4 courses. The clinical efficacy, tumor marker levels, tumor angiogenesis-related indicators, quality of life, short-term prognosis of the two groups were compared, and the safety was evaluated.

Results

The patients (n=125) were divided into control group (n=64) and treatment group (n=61). After treatment, the disease control rate (DCR) was 67.19% (43 cases/64 cases) in control group and 83.61% (51 cases /61 cases) in treatment group; the objective response rate (ORR) were 23.44% (15 cases /64 cases) and 40.98% (25 cases /61 cases), respectively; the median progression-free survival (PFS) were 6.40 and 11.31 months, respectively; and the median overall survival (OS) were 10.22 and 16.13 months, respectively. All the aforementioned indicators in treatment group were statistically significantly different from those in control group (all P<0.05). After treatment, the squamous cell carcinoma antigen levels in control group and treatment group were (2.80±0.53) and (2.56±0.47) ng·mL-1, respectively; the carcinoembryonic antigen levels were (3.09±0.62) and (2.85±0.45) μg·L-1, respectively; the carbohydrate antigen 19-9 levels were (21.08±3.04) and (19.59±2.72) U·mL-1, respectively; the cytokeratin 19 fragment antigen 21-1 levels were (26.09±3.44) and (24.63±3.01) μg·L-1, respectively; the vascular endothelial growth factor receptor levels were (461.93±97.86) and (415.74±101.87) pg·mL-1, respectively; the platelet-derived growth factor receptor levels were (69.68±12.15) and (64.87±11.39) pg·mL-1, respectively; the physiological condition scores were (18.66±4.04) and (21.49±4.15) points, respectively; the social/family situation scores were (17.16±4.03) and (19.57 ± 4.15) points, respectively; the functional status scores were (14.64±2.99) and (16.36±3.81) points, respectively; and the emotional state scores were (16.89±3.32) and (18.46±5.19) points, respectively. All the above-mentioned indicators in treatment group had statistically significant differences from those in control group (all P<0.05). No statistical significant difference in adverse drug reactions was observed between the two groups (P>0.05).

Conclusion

Anlotinib combined with the standard chemotherapy regimen has a remarkable efficacy in treating patients with recurrent and metastatic cervical cancer. It can reduce the levels of tumor markers in patients, inhibit tumor angiogenesis, improve their quality of life and short-term prognosis, and is highly safe.

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目的

观察安罗替尼胶囊联合标准化疗(顺铂冻干粉针剂+紫杉醇注射液)方案治疗复发转移性宫颈癌患者的临床疗效及安全性。

方法

将复发转移性宫颈癌患者按照治疗方法分为试验组和对照组。对照组静脉滴注紫杉醇注射液(175 mg·m-2,3 h内滴注完毕)和顺铂冻干粉针剂(滴注时间≥1 h);试验组在对照组的基础上口服盐酸安罗替尼胶囊(12 mg qd),均连续治疗4个疗程。比较2组的临床疗效、肿瘤标志物水平、肿瘤血管生成相关指标、生存质量和近期预后,并进行安全性评价。

结果

本研究共纳入125例,其中对照组64例,试验组61例。治疗后,对照组和试验组疾病控制率分别为67.19%(43例/64例)和83.61%(51例/61例),客观缓解率分别为23.44%(15例/64例)和40.98%(25例/61例),中位无进展生存期分别为6.40和11.31个月,中位总生存期分别为10.22和16.13个月;2组上述指标比较在统计学上差异均有统计学意义(均P<0.05)。治疗后,对照组和试验组的鳞状细胞癌抗原分别为(2.80±0.53)和(2.56±0.47)ng·mL-1,癌胚抗原分别为(3.09±0.62)和(2.85±0.45)μg·L-1,糖类抗原19-9分别为(21.08±3.04)和(19.59±2.72)U·mL-1,细胞角蛋白19片段抗原21-1分别为(26.09±3.44)和(24.63±3.01)μg·L-1,血管内皮生长因子受体分别为(461.93±97.86)和(415.74±101.87)pg·mL-1,血小板衍生生长因子受体分别为(69.68±12.15)和(64.87±11.39)pg·mL-1,生理状况评分分别为(18.66±4.04)和(21.49±4.15)分,社会/家庭状况评分分别为(17.16±4.03)和(19.57±4.15)分,功能状况评分分别为(14.64±2.99)和(16.36±3.81)分,情感状况评分分别为(16.89±3.32)和(18.46±5.19)分,2组上述指标比较,在统计学上差异均有统计学意义(均P<0.05)。2组的药物不良反应在统计学上差异无统计学意义(P>0.05)。

结论

安罗替尼胶囊联合标准化疗方案治疗复发转移性宫颈癌患者疗效显著,可以降低患者体内肿瘤标志物水平,抑制肿瘤血管生成,提升其生活质量和近期预后,且安全性较高。

, authors=孔守芳a, 蔡怡园a, 徐向前b, 袁汇a, authorsList=孔守芳, 蔡怡园, 徐向前, 袁汇, authorCompany=null, correspAuthors=袁汇, authorNote=

孔守芳(1980-),女,副主任医师,主要从事妇科肿瘤方面的临床工作和研究

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袁汇,副主任医师 MP: 13605326658 E-mail:
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安罗替尼联合标准化疗方案治疗复发转移性宫颈癌患者的临床研究
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孔守芳 a , 蔡怡园 a , 徐向前 b , 袁汇 a
中国临床药理学杂志 | 临床与基础桥接研究 2025,41(23): 3321-3327
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中国临床药理学杂志 |临床与基础桥接研究 2025 , 41 (23) : 3321 -3327
安罗替尼联合标准化疗方案治疗复发转移性宫颈癌患者的临床研究
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孔守芳a, 蔡怡园a, 徐向前b, 袁汇a
作者信息
  • a.青岛大学 附属青岛市海慈医院/青岛市中医医院 妇科,山东 青岛 266033
  • b.青岛大学 附属青岛市海慈医院/青岛市中医医院 泌尿外科,山东 青岛 266033
通讯作者:
袁汇,副主任医师 MP: 13605326658 E-mail:
作者简介:

孔守芳(1980-),女,副主任医师,主要从事妇科肿瘤方面的临床工作和研究

Clinical trial of anlotinib combined with standard chemotherapy regimen in the treatment of patients with recurrent and metastatic cervical cancer
Shou-fang KONGa, Yi-yuan CAIa, Xiang-qian XUb, Hui YUANa
Affiliations
  • a.Depatment of Gynaecology, Qingdao Hiser Hospital Affiliated of Qingdao University/Qingdao Traditional Chinese Medicine Hospital, Qingdao 266033, Shandong Province, China
  • b.Depatment of Urology Surgery, Qingdao Hiser Hospital Affiliated of Qingdao University/Qingdao Traditional Chinese Medicine Hospital, Qingdao 266033, Shandong Province, China
出版时间: 2025-12-17 doi: 10.13699/j.cnki.1001-6821.2025.23.004
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目的

观察安罗替尼胶囊联合标准化疗(顺铂冻干粉针剂+紫杉醇注射液)方案治疗复发转移性宫颈癌患者的临床疗效及安全性。

方法

将复发转移性宫颈癌患者按照治疗方法分为试验组和对照组。对照组静脉滴注紫杉醇注射液(175 mg·m-2,3 h内滴注完毕)和顺铂冻干粉针剂(滴注时间≥1 h);试验组在对照组的基础上口服盐酸安罗替尼胶囊(12 mg qd),均连续治疗4个疗程。比较2组的临床疗效、肿瘤标志物水平、肿瘤血管生成相关指标、生存质量和近期预后,并进行安全性评价。

结果

本研究共纳入125例,其中对照组64例,试验组61例。治疗后,对照组和试验组疾病控制率分别为67.19%(43例/64例)和83.61%(51例/61例),客观缓解率分别为23.44%(15例/64例)和40.98%(25例/61例),中位无进展生存期分别为6.40和11.31个月,中位总生存期分别为10.22和16.13个月;2组上述指标比较在统计学上差异均有统计学意义(均P<0.05)。治疗后,对照组和试验组的鳞状细胞癌抗原分别为(2.80±0.53)和(2.56±0.47)ng·mL-1,癌胚抗原分别为(3.09±0.62)和(2.85±0.45)μg·L-1,糖类抗原19-9分别为(21.08±3.04)和(19.59±2.72)U·mL-1,细胞角蛋白19片段抗原21-1分别为(26.09±3.44)和(24.63±3.01)μg·L-1,血管内皮生长因子受体分别为(461.93±97.86)和(415.74±101.87)pg·mL-1,血小板衍生生长因子受体分别为(69.68±12.15)和(64.87±11.39)pg·mL-1,生理状况评分分别为(18.66±4.04)和(21.49±4.15)分,社会/家庭状况评分分别为(17.16±4.03)和(19.57±4.15)分,功能状况评分分别为(14.64±2.99)和(16.36±3.81)分,情感状况评分分别为(16.89±3.32)和(18.46±5.19)分,2组上述指标比较,在统计学上差异均有统计学意义(均P<0.05)。2组的药物不良反应在统计学上差异无统计学意义(P>0.05)。

结论

安罗替尼胶囊联合标准化疗方案治疗复发转移性宫颈癌患者疗效显著,可以降低患者体内肿瘤标志物水平,抑制肿瘤血管生成,提升其生活质量和近期预后,且安全性较高。

安罗替尼胶囊  /  顺铂冻干粉针剂  /  紫杉醇注射液  /  复发转移性宫颈癌  /  疗效
Objective

To observe the clinical efficacy and safety of anlotinib hydrochloride capsules combined with standard chemotherapy (cisplatin for injection+paclitaxel injection) in the treatment of patients with recurrent and metastatic cervical cancer.

Methods

The patients with recurrent and metastatic cervical cancer were divided into treatment group and control group according to the treatment methods. In control group, paclitaxel injection (175 mg·m-2, infused within 3 hours) and cisplatin for injection (infusion time≥1 h) were intravenously infused. In treatment group, based on the treatment in control group, anlotinib hydrochloride capsules (12 mg qd) were orally administered. Both groups were continuously treated for 4 courses. The clinical efficacy, tumor marker levels, tumor angiogenesis-related indicators, quality of life, short-term prognosis of the two groups were compared, and the safety was evaluated.

Results

The patients (n=125) were divided into control group (n=64) and treatment group (n=61). After treatment, the disease control rate (DCR) was 67.19% (43 cases/64 cases) in control group and 83.61% (51 cases /61 cases) in treatment group; the objective response rate (ORR) were 23.44% (15 cases /64 cases) and 40.98% (25 cases /61 cases), respectively; the median progression-free survival (PFS) were 6.40 and 11.31 months, respectively; and the median overall survival (OS) were 10.22 and 16.13 months, respectively. All the aforementioned indicators in treatment group were statistically significantly different from those in control group (all P<0.05). After treatment, the squamous cell carcinoma antigen levels in control group and treatment group were (2.80±0.53) and (2.56±0.47) ng·mL-1, respectively; the carcinoembryonic antigen levels were (3.09±0.62) and (2.85±0.45) μg·L-1, respectively; the carbohydrate antigen 19-9 levels were (21.08±3.04) and (19.59±2.72) U·mL-1, respectively; the cytokeratin 19 fragment antigen 21-1 levels were (26.09±3.44) and (24.63±3.01) μg·L-1, respectively; the vascular endothelial growth factor receptor levels were (461.93±97.86) and (415.74±101.87) pg·mL-1, respectively; the platelet-derived growth factor receptor levels were (69.68±12.15) and (64.87±11.39) pg·mL-1, respectively; the physiological condition scores were (18.66±4.04) and (21.49±4.15) points, respectively; the social/family situation scores were (17.16±4.03) and (19.57 ± 4.15) points, respectively; the functional status scores were (14.64±2.99) and (16.36±3.81) points, respectively; and the emotional state scores were (16.89±3.32) and (18.46±5.19) points, respectively. All the above-mentioned indicators in treatment group had statistically significant differences from those in control group (all P<0.05). No statistical significant difference in adverse drug reactions was observed between the two groups (P>0.05).

Conclusion

Anlotinib combined with the standard chemotherapy regimen has a remarkable efficacy in treating patients with recurrent and metastatic cervical cancer. It can reduce the levels of tumor markers in patients, inhibit tumor angiogenesis, improve their quality of life and short-term prognosis, and is highly safe.

anlotinib hydrochloride capsule  /  cisplatin for injection  /  paclitaxel injection  /  recurrent and metastatic cervical cancer  /  efficacy
孔守芳, 蔡怡园, 徐向前, 袁汇. 安罗替尼联合标准化疗方案治疗复发转移性宫颈癌患者的临床研究. 中国临床药理学杂志, 2025 , 41 (23) : 3321 -3327 . DOI: 10.13699/j.cnki.1001-6821.2025.23.004
Shou-fang KONG, Yi-yuan CAI, Xiang-qian XU, Hui YUAN. Clinical trial of anlotinib combined with standard chemotherapy regimen in the treatment of patients with recurrent and metastatic cervical cancer[J]. Chinese Journal of Clinical Pharmacology, 2025 , 41 (23) : 3321 -3327 . DOI: 10.13699/j.cnki.1001-6821.2025.23.004
  • 山东省医药卫生科技发展计划基金资助项目(2016WS0303)
  • 青岛市医药科研指导计划基金资助项目(2018-WJZD041)
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doi: 10.13699/j.cnki.1001-6821.2025.23.004
  • 接收时间:2025-05-08
  • 首发时间:2026-08-05
  • 出版时间:2025-12-17
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  • 收稿日期:2025-05-08
基金
山东省医药卫生科技发展计划基金资助项目(2016WS0303)
青岛市医药科研指导计划基金资助项目(2018-WJZD041)
作者信息
    a.青岛大学 附属青岛市海慈医院/青岛市中医医院 妇科,山东 青岛 266033
    b.青岛大学 附属青岛市海慈医院/青岛市中医医院 泌尿外科,山东 青岛 266033

通讯作者:

袁汇,副主任医师 MP: 13605326658 E-mail:
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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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