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非小细胞肺癌RET靶向药用药指南Guidelines for RET Targeted Medicinal Drugs for NSCLC

发布日期:2020-09-30 | 点击数: 1048 次
2020年9月初被美国FDA批准上市的普拉替尼,是一款针对非小细胞肺癌RET基因融合突变的靶向新药。该药已于9月底同步特许进入海南博鳌乐城国际医疗旅游先行区的博鳌超级医院。 Plalsetinib, approved by FDA in early September 2020, is a new targeted drug treating RET gene fusion mutations in NSCLC.Through the end of September, the drug was licensed into the Boao Super Hospital in Hainan BoaoLecheng International Medical Tourism pilot zone.

NO.1、适应症、用法与用量、注意事项

NO.1 Indications, usage and dosage, precautions

适应症。该药是一种激酶抑制剂,适用于治疗采用FDA批准的检测法检测的转移性转染重排(RET)融合阳性、非小细胞肺癌(NSCLC)成人患者。

Indications: the drugs is a kinase inhibitor for the treatment of adult patients with metastatic RET fusion positive non-small cell lung cancer (NSCLC) detected by an FDA-approved assay.

用法与用量。成人推荐剂量为400 mg,每日一次,空腹状态下口服给药。

Usage and dosage: the recommended dose for adults is 400 mg once a day, given orally on an empty stomach.

注意事项。服药前至少2小时,服药后至少1小时不要进食。

Precautions: no food for at least 2 hours before and at least 1 hour after taking the medicine.


NO.2、治疗优势

NO.2 Therapeutic advantages

普拉替尼新药项目负责人、欧宝体育NBA肿瘤内(一)科主任、“海归”医学专家魏志霞教授介绍:普拉替尼是针对RET基因融合突变的一款创新型靶向治疗药物,与传统的化疗药物相比,具有副作用小,治疗缓解率高,口服使用方便等优点。

The medical expert Wei Zhixia, an overseas returnee, has been in charge of the implementation of Platinib project. She said: “ Pralsetinib is an innovative targeted therapy for RET gene fusion mutation. Compared with traditional chemotherapeutic drugs, it has the advantages of slight side effects, high therapeutic remission rate and convenient oral administration.

国内外临床试验表明,普拉替尼有良好的抑制作用,能极大延长患者的生存期,改善患者生存质量。实验有效数据达70%左右。

Clinical trials at home and abroad have shown that Pralsetinib has a good inhibitory effect. It can greatly prolong the survival time and improve the life quality of patients. The experimental effective data is about 70%.


NO.3、申请与就医流程

NO.3 Application and medical treatment process

(一)申请条件。凡适应症患者,均可申请。

(二)申请方式。新药服务电话(附后)或网络(二维码附后)申请。

(三)申请流程

()Application requirement: all patients with indications are eligible to apply.

()Application method: call new drug service (phone number attached) or through the network (QR code attached).

()Application process:     

  1. 提供既往诊疗资料

  2. 新药团队专家一对一咨询问诊

  3. 专家对患者病情和适应症初期评估

  4. 出具诊疗方案和知情告知书

  5. 患者自行在当地开通异地医保

1.Provide previous medical information.

2.One-on-one consultation with experts from the new drug team.

3.Experts assess the patient’s condition and indications at the initial stage

4.Issue a medical treatment plan and a notification letter.

5.The patient need to open the local medical insurance system by himself.


(四)就医流程

(四)Medical procedure

1、新药团队接诊

2、入住欧宝体育NBA新药专属病房(有接机送机服务)

3、进一步评估病情及完善实验室相关检验检查(出具规范诊疗报告)

4、MDT制定诊疗方案

5、与患者、亲属确认最终治疗方案

6、患者(亲属)签署治疗知情同意书

7、提交超级医院临床急需药品伦理审查

8、进入临床急需药品审批(一般3至7个工作日内完成)

9、患者打款购药

10、患者转入超级医院用药(新药专家团队全程监护)

11、院内用药观察(一般7天)

12、带药离园安全性评估

13、患者签署《带药离园区患者承诺书》

14、新药团队协助提交带药离园申请(一般3至5个工作日内完成)

15、患者返回原籍或欧宝体育NBA继续用药观察

1.The new drug medical experts team receive the patients for treatment.

2.Stay in the exclusive inpatient ward of Hainan Cancer Hospital (with airport service).

3.Further evaluate the condition and improve the relevant laboratory tests (issue standardized diagnosis and treatment reports).

4.MDT makes the treatment plan.

5.Finalize the treatment plan with patients and relatives.

6.Patients (relatives) sign treatment informed consent.

7.Submitthe treatment plan to super hospital for clinical drug ethical review.

8. Enter the review process for apply the clinical urgent need drug (generally completed within 3 to 7 working days).

9.Patientspay for drugs before treatment.

10.Patients transferred to super hospital for medication (whole process monitoring by new drug expert team).

11.Observation of drug use in hospital (7 days in general).

12.Safety evaluation of leaving the hospital with medicine.

13.Patients sign “the letter of commitment to leave the hospital with medicine”.

14.The new drug team will assist in submitting the application for taking medicine out of the hospital (usually completed within 3 to 5 working days).

15.Patient can goback home or return to Hainan Cancer Hospital to continue medication.


(五)用药流程

1、患者离园后,须每日实时视频打卡服药

2、根据治疗需要,随时联系医护团队专家复诊

(五)Medication process

  1. Patients should real time video clock in to take the medicine everyday after leaving the hospital.

  2. According to the treatment needs, contact the medical experts for further consultation at any time.


NO.4、服务机构简介

NO.4 Introduction to the organization

由博鳌超级医院、欧宝体育NBA和海南成美药业共同为患者提供特许用药审批、引进、诊疗和全程保障服务。

Boao Super Hospital, Hainan Cancer Hospital and Hainan ChengmeiMedicine Co., LTD provide patients with approval, introduction, diagnosis and treatment of licensed drugs and whole-process guarantee services together.


(一)博鳌超级医院

Boao Super Hospital

博鳌超级医院位于博鳌乐城国际医疗旅游先行试验区内,是一所政府控股的特许医疗机构,异地医保定点单位。承接“国九条”特许政策落地,为患者提供特许进口国际创新药械诊疗服务。从2018年3月31日开业运营至今,已引进十多个医疗院士专家团队,可为患者提供特需服务,引进各类新药、新器械和新技术共计52项,均为国内首次。

Boao Super Hospital, located in BoaoLecheng International Medical Tourism Pilot Zone, is a chartered medical institution controlled by the government and a designated unit of remoter medical insurance. It undertakes the implementation of the “Nine Policies of State Department” and provides patients with licensed imported international innovative medical device diagnosis and treatment services. Since March 31, 2018, it has introduced more than 10 experts team of medical academicians and provide special services for patients. A total of 52 new drugs, medical devices and technologies have been introduced. And all of them are for the first time in China.


(二)欧宝体育NBA

Hainan Cancer Hospital

欧宝体育NBA是海南省唯一一所三级肿瘤专科医院,异地医保定点单位。批准床位1200张,拥有7976台套诊疗设备,其中进口高端医疗设备1484台,全院拥有各类肿瘤专业的“海归”博士、博士后和国内肿瘤诊疗领域“领军”人才。与美国梅奥诊所、美国MD·安德森癌症中心、美国纪念斯隆凯特琳癌症中心、德国汉堡大学附属医院以及北京医学科学院肿瘤医院、北大肿瘤医院、广州中山肿瘤医院、天津肿瘤医院等国内外著名肿瘤医疗机构开通了远程会诊服务。医院以患者为中心的服务理念和院内MDT多学科会诊专业特色,让患者受益最大化。

作为博鳌超级医院的姊妹医院,承担着国内外特需患者用药前专家咨询、病情及适应症评估、整理病案资料、用药前辅助治疗和协助引进药品审批等全程诊疗服务职能。

Hainan Cancer Hospital is the only tertiary cancer hospital in Hainan province and a off-site medical insurance fixed unit. It has 1200 beds and 7976 sets of medical equipment, including 1484 imported high-end medical equipment. The hospital has a variety of tumor professional "overseas returnees" doctor, postdoctoral and domestic tumor diagnosis and treatment in the field of "leading" talents. Tele-consultation service has been established with Mayo Clinic, MD Anderson Cancer Center, Memorial Sloan-Kettering Cancer Center, Affiliated Hospital of University of Hamburg, Cancer Hospital of Beijing Academy of Medical Sciences, Peking University Cancer Hospital, Zhongshan Cancer Hospital of Guangzhou, Tianjin Cancer Hospital and other famous cancer medical institutions at home and abroad. The patient-centered service concept of the hospital and the characteristics of MDT multidisciplinary consultation in the hospital maximize the benefits to patients.

As a sister hospital of Boao Super Hospital, it undertakes the functions of pre-medication expert consultation, condition and indication assessment for special patients at home and abroad, collating medical record data, pre-medication auxiliary treatment and assisting the approval of imported drugs, etc.


(三)海南成美药业

HainanChengmeiMedicine Co., LTD

海南成美药业是博鳌乐城国际医疗旅游先行试验区内特许创新药器械进口采购商。自2016年成功引进全国首个临床急需进口药品PD-1以来,又陆续引进了十多个首例特许进口药品,满足了众多患者的特需用药。成美药业现与诺华、AZ、BMS、波科、法国PF、Lilly等国际知名药企以及国内众多知名创新药企都建立了良好合作关系,拥有畅通、高效的药械进口渠道,为博鳌乐城国际医疗旅游先行试验区持续开展“三同步”业务,提供了有力保障。

Hainan ChengmeiMedicine co., Ltd. is a licensed purchaser of innovative drugs and medical devices in BoaoLecheng International Medical Tourism Pilot Zone. Since successful import the first clinical urgent need drug PD-1 in China in 2016, more than a dozen licensed imported drugs have been also introduced successively, satisfying the special needs of many patients.Now,ChengmeiMedicine Co., Ltd. with novartis, AZ, BMS, wave, France PF, Lilly and other international well-known companies and domestic numerous innovative drug firms have established good relations of cooperation.and has a smooth and efficient import channel of new drugs and medical devices, which provides a strong guarantee for BoaoLecheng International Medical Tourism Pilot Zone to carry out the "three synchronizing" business continuously.


NO.5、医疗保障

NO.5  Health care

检查保障。欧宝体育NBA拥有目前国际最先进的二代分子测序仪等各类诊疗设备,可提供必要的精准诊断。

Inspection guarantee. Hainan Cancer Hospital has the world's most advanced second-generation molecular sequencer and other diagnostic and treatment equipment, which can provide necessary accurate diagnosis.

诊疗保障。欧宝体育NBA拥有“肺癌一体化诊疗中心”、先进的沃森诊断系统;有院内MDT多学科会诊团队;与梅奥、美国安德森、美国纪念斯隆凯特琳癌症中心、德国汉堡大学附属医院和国内各大肿瘤医院有远程会诊合作。

Medical guarantee. Hainan Cancer Hospital has an advanced Watson diagnosis and treatment center for lung cancer. The hospital has a MDT multidisciplinary consultation team. It also has tele-consultation cooperation with Mayo, Anderson, Memorial Sloan-Kettering Cancer Center, Affiliated Hospital of University of Hamburg, Germany and other major tumor hospitals in China.

生活保障。欧宝体育NBA和博鳌超级医院都是按照国际现代化医院规划设计建设的,环境优美,各项生活服务设施齐备。可为有需求患者提供家属陪床、餐饮服务。

Living guarantee. Hainan Cancer Hospital and Boao Super Hospital are both designed and constructed in accordance with international modern hospital planning and design, with beautiful environment and complete life service facilities. They provide family members with bed, catering services.

护理保障。专门挑选精干的护理队伍,为患者提供VIP专属服务,确保患者获得更好的就医体验。

Nursing guarantee. The competent nursing team provides VIP exclusive services to ensure better medical experience for patients.


NO.6、就医环境掠影

NO.6  photos of the environment


欧宝体育NBA

Hainan Cancer Hospital

医院外景.jpg

医院外景(Hospital location)

VIP专属病房客厅.jpg

VIP专属病房客厅(VIP living room)

VIP专属病房主房.jpg

VIP专属病房主房(VIP exclusive ward main room)

VIP专属病房亲属主卧.jpg

VIP专属病房亲属主卧(Bedroom for relatives in VIP exclusive wards)

VIP专属病房标间.jpg

VIP专属病房标间(VIP exclusive ward standard room)

VIP专属病房餐厅.jpg

VIP专属病房餐厅(VIP exclusive ward dining room)

VIP专属病房厨房.jpg

VIP专属病房厨房(VIP exclusive kitchen)

VIP专属病房楼顶花园.jpg

VIP专属病房楼顶花园(VIP roof garden)

VIP套房.jpg

VIP套房(VIP suit)

病房.png

病房(The ward)


博鳌超级医院

Boao Super Hospital

博鳌超级医院医院外景.jpg

医院外景(Hospital location)

博鳌超级医院诊区.jpg

诊区(Consultation area)

博鳌超级医院病房.jpg

病房(The ward)

 新药服务热线:0898-36627775  18689855930

 网络申请(扫描下方二维码)

New Drug Service hotline: 0898-36627775  18689855930

Online application (scan the QR code below)



二维码.png


地址:海南省海口市秀英区长滨西四街6号

24小时咨询热线:0898-96398 0898-36379999

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