NO.1、適應(yīng)癥、用法與用量、注意事項(xiàng)
NO.1 Indications, usage and dosage, precautions
適應(yīng)癥。該藥是一種激酶抑制劑，適用于治療采用FDA批準(zhǔn)的檢測(cè)法檢測(cè)的轉(zhuǎn)移性轉(zhuǎn)染重排（RET）融合陽(yáng)性、非小細(xì)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.
用法與用量。成人推薦劑量為400 mg，每日一次，空腹?fàn)顟B(tài)下口服給藥。
Usage and dosage: the recommended dose for adults is 400 mg once a day, given orally on an empty stomach.
注意事項(xiàng)。服藥前至少2小時(shí)，服藥后至少1小時(shí)不要進(jìn)食。
Precautions: no food for at least 2 hours before and at least 1 hour after taking the medicine.
NO.2、治療優(yōu)勢(shì)
NO.2 Therapeutic advantages
普拉替尼新藥項(xiàng)目負(fù)責(zé)人、海南省腫瘤醫(yī)院腫瘤內(nèi)（一）科主任、“海歸”醫(yī)學(xué)專家魏志霞教授介紹：普拉替尼是針對(duì)RET基因融合突變的一款創(chuàng)新型靶向治療藥物，與傳統(tǒng)的化療藥物相比，具有副作用小，治療緩解率高，口服使用方便等優(yōu)點(diǎn)。
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.
國(guó)內(nèi)外臨床試驗(yàn)表明，普拉替尼有良好的抑制作用，能極大延長(zhǎng)患者的生存期，改善患者生存質(zhì)量。實(shí)驗(yàn)有效數(shù)據(jù)達(dá)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、申請(qǐng)與就醫(yī)流程
NO.3 Application and medical treatment process
（一）申請(qǐng)條件。凡適應(yīng)癥患者，均可申請(qǐng)。
（二）申請(qǐng)方式。新藥服務(wù)電話（附后）或網(wǎng)絡(luò)（二維碼附后）申請(qǐng)。
（三）申請(qǐng)流程
(一)Application requirement: all patients with indications are eligible to apply.
(二)Application method: call new drug service (phone number attached) or through the network (QR code attached).
(三)Application process:
提供既往診療資料
新藥團(tuán)隊(duì)專家一對(duì)一咨詢問(wèn)診
專家對(duì)患者病情和適應(yīng)癥初期評(píng)估
出具診療方案和知情告知書(shū)
患者自行在當(dāng)?shù)亻_(kāi)通異地醫(yī)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）就醫(yī)流程
（四）Medical procedure
1、新藥團(tuán)隊(duì)接診
2、入住海南省腫瘤醫(yī)院新藥專屬病房（有接機(jī)送機(jī)服務(wù)）
3、進(jìn)一步評(píng)估病情及完善實(shí)驗(yàn)室相關(guān)檢驗(yàn)檢查（出具規(guī)范診療報(bào)告）
4、MDT制定診療方案
5、與患者、親屬確認(rèn)最終治療方案
6、患者（親屬）簽署治療知情同意書(shū)
7、提交超級(jí)醫(yī)院臨床急需藥品倫理審查
8、進(jìn)入臨床急需藥品審批（一般3至7個(gè)工作日內(nèi)完成）
9、患者打款購(gòu)藥
10、患者轉(zhuǎn)入超級(jí)醫(yī)院用藥（新藥專家團(tuán)隊(duì)全程監(jiān)護(hù)）
11、院內(nèi)用藥觀察（一般7天）
12、帶藥離園安全性評(píng)估
13、患者簽署《帶藥離園區(qū)患者承諾書(shū)》
14、新藥團(tuán)隊(duì)協(xié)助提交帶藥離園申請(qǐng)（一般3至5個(gè)工作日內(nèi)完成）
15、患者返回原籍或海南省腫瘤醫(yī)院繼續(xù)用藥觀察
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）用藥流程
1、患者離園后，須每日實(shí)時(shí)視頻打卡服藥
2、根據(jù)治療需要，隨時(shí)聯(lián)系醫(yī)護(hù)團(tuán)隊(duì)專家復(fù)診
（五）Medication process
Patients should real time video clock in to take the medicine everyday after leaving the hospital.
According to the treatment needs, contact the medical experts for further consultation at any time.
NO.4、服務(wù)機(jī)構(gòu)簡(jiǎn)介
NO.4 Introduction to the organization
由博鰲超級(jí)醫(yī)院、海南省腫瘤醫(yī)院和海南成美藥業(yè)共同為患者提供特許用藥審批、引進(jìn)、診療和全程保障服務(wù)。
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）博鰲超級(jí)醫(yī)院
Boao Super Hospital
博鰲超級(jí)醫(yī)院位于博鰲樂(lè)城國(guó)際醫(yī)療旅游先行試驗(yàn)區(qū)內(nèi)，是一所政府控股的特許醫(yī)療機(jī)構(gòu)，異地醫(yī)保定點(diǎn)單位。承接“國(guó)九條”特許政策落地，為患者提供特許進(jìn)口國(guó)際創(chuàng)新藥械診療服務(wù)。從2018年3月31日開(kāi)業(yè)運(yùn)營(yíng)至今，已引進(jìn)十多個(gè)醫(yī)療院士專家團(tuán)隊(duì)，可為患者提供特需服務(wù)，引進(jìn)各類新藥、新器械和新技術(shù)共計(jì)52項(xiàng)，均為國(guó)內(nèi)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）海南省腫瘤醫(yī)院
Hainan Cancer Hospital
海南省腫瘤醫(yī)院是海南省唯一一所三級(jí)腫瘤?？漆t(yī)院，異地醫(yī)保定點(diǎn)單位。批準(zhǔn)床位1200張，擁有7976臺(tái)套診療設(shè)備，其中進(jìn)口高端醫(yī)療設(shè)備1484臺(tái)，全院擁有各類腫瘤專業(yè)的“海歸”博士、博士后和國(guó)內(nèi)腫瘤診療領(lǐng)域“領(lǐng)軍”人才。與美國(guó)梅奧診所、美國(guó)MD·安德森癌癥中心、美國(guó)紀(jì)念斯隆凱特琳癌癥中心、德國(guó)漢堡大學(xué)附屬醫(yī)院以及北京醫(yī)學(xué)科學(xué)院腫瘤醫(yī)院、北大腫瘤醫(yī)院、廣州中山腫瘤醫(yī)院、天津腫瘤醫(yī)院等國(guó)內(nèi)外著名腫瘤醫(yī)療機(jī)構(gòu)開(kāi)通了遠(yuǎn)程會(huì)診服務(wù)。醫(yī)院以患者為中心的服務(wù)理念和院內(nèi)MDT多學(xué)科會(huì)診專業(yè)特色，讓患者受益最大化。
作為博鰲超級(jí)醫(yī)院的姊妹醫(yī)院，承擔(dān)著國(guó)內(nèi)外特需患者用藥前專家咨詢、病情及適應(yīng)癥評(píng)估、整理病案資料、用藥前輔助治療和協(xié)助引進(jìn)藥品審批等全程診療服務(wù)職能。
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）海南成美藥業(yè)
HainanChengmeiMedicine Co., LTD
海南成美藥業(yè)是博鰲樂(lè)城國(guó)際醫(yī)療旅游先行試驗(yàn)區(qū)內(nèi)特許創(chuàng)新藥器械進(jìn)口采購(gòu)商。自2016年成功引進(jìn)全國(guó)首個(gè)臨床急需進(jìn)口藥品PD-1以來(lái)，又陸續(xù)引進(jìn)了十多個(gè)首例特許進(jìn)口藥品，滿足了眾多患者的特需用藥。成美藥業(yè)現(xiàn)與諾華、AZ、BMS、波科、法國(guó)PF、Lilly等國(guó)際知名藥企以及國(guó)內(nèi)眾多知名創(chuàng)新藥企都建立了良好合作關(guān)系，擁有暢通、高效的藥械進(jìn)口渠道，為博鰲樂(lè)城國(guó)際醫(yī)療旅游先行試驗(yàn)區(qū)持續(xù)開(kāi)展“三同步”業(yè)務(wù)，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、醫(yī)療保障
NO.5 Health care
檢查保障。海南省腫瘤醫(yī)院擁有目前國(guó)際最先進(jìn)的二代分子測(cè)序儀等各類診療設(shè)備，可提供必要的精準(zhǔn)診斷。
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.
診療保障。海南省腫瘤醫(yī)院擁有“肺癌一體化診療中心”、先進(jìn)的沃森診斷系統(tǒng)；有院內(nèi)MDT多學(xué)科會(huì)診團(tuán)隊(duì)；與梅奧、美國(guó)安德森、美國(guó)紀(jì)念斯隆凱特琳癌癥中心、德國(guó)漢堡大學(xué)附屬醫(yī)院和國(guó)內(nèi)各大腫瘤醫(yī)院有遠(yuǎn)程會(huì)診合作。
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。海南省腫瘤醫(yī)院和博鰲超級(jí)醫(yī)院都是按照國(guó)際現(xiàn)代化醫(yī)院規(guī)劃設(shè)計(jì)建設(shè)的，環(huán)境優(yōu)美，各項(xiàng)生活服務(wù)設(shè)施齊備。可為有需求患者提供家屬陪床、餐飲服務(wù)。
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.
護(hù)理保障。專門(mén)挑選精干的護(hù)理隊(duì)伍，為患者提供VIP專屬服務(wù)，確?；颊攉@得更好的就醫(yī)體驗(yàn)。
Nursing guarantee. The competent nursing team provides VIP exclusive services to ensure better medical experience for patients.
NO.6、就醫(yī)環(huán)境掠影
NO.6 photos of the environment
海南省腫瘤醫(yī)院
Hainan Cancer Hospital
醫(yī)院外景（Hospital location）
VIP專屬病房客廳（VIP living room）
VIP專屬病房主房（VIP exclusive ward main room）
VIP專屬病房親屬主臥（Bedroom for relatives in VIP exclusive wards）
VIP專屬病房標(biāo)間（VIP exclusive ward standard room）
VIP專屬病房餐廳（VIP exclusive ward dining room）
VIP專屬病房廚房（VIP exclusive kitchen）
VIP專屬病房樓頂花園（VIP roof garden）
VIP套房（VIP suit）
病房（The ward）
博鰲超級(jí)醫(yī)院
Boao Super Hospital
醫(yī)院外景（Hospital location）
診區(qū)（Consultation area）
病房（The ward）
新藥服務(wù)熱線：0898-36627775 18689855930
網(wǎng)絡(luò)申請(qǐng)（掃描下方二維碼）
New Drug Service hotline: 0898-36627775 18689855930
Online application (scan the QR code below)
