懷特血寶注射劑 (PG2 Injection 500 mg)

簡介

Novel

Treatment

Drug for

Cancer-

Related

Fatigue

1st

TFDA

NDA

Approved

Botanical

New Drug

Injectable

Extracted,

Isolated &

Partially

Purified

from黃耆 Astragalus

陳信岳 藥師

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認識癌因性疲憊症Cancer-Related Fatigue

(CRF)

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Cancer-related Fatigue (1)

Cancer-related fatigue (CRF) is

A distressing persistent, subjective sense of physical, emotional and/or cognitive tiredness or exhaustion related to cancer or cancer treatment that is not proportional to recent activity and interferes with usual functioning.

more severe and distressing and less likely to be relieved by rest compared with the fatigue experiences by healthy individuals.

NCCN Clinical Practice Guidelines in

Oncology™: Cancer-related fatigue. v.1. 2008

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你累了嗎 ?

正常人也會累，休息就可以改善 =>Tiredness

癌症病人的累，無法藉由休息改善=>Fatigue

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Unmet Medical Need

CRF is characterized by feelings of tiredness, weakness, and lack of energy, which is the most common unmet need of cancer patients. Up to 90% of patients treated with radiation and up to 80% of those who treated with chemotherapy claim CRF.

Fatigue affected patients daily life more than pain, nausea and depression. In U.K.: only 14% of patients receive treatment or advice about the management of fatigue.

5

Semin Hematol, 1997

Psychooncology, 2010

Ann Oncol, 2000

The Oncologist, 2007

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Side effects of treatment anticipated by patients scheduled to receive chemotherapy or radiotherapy.

The Oncologist, 2007

Ann Oncol, 2000

6

疲憊比疼痛、噁心或嘔吐更常困擾患者的生活

患者面對的副作用百分比

疲

憊

噁

心

睡

眠

障

礙

掉 髮

沮

喪

憂

鬱

體

重

下

降

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CRF致病機轉

由於癌因性疲憊症的病理機轉複雜,各種假說林立,包括有:細胞激素假說、血清素假說、迷走神經假說、貧血假說、下視丘腦垂骼軸假說、生理節律假說、身體能量假說,但似乎還沒有任何一說取得決定性的關鍵證據。

「細胞激素假說」是最有可能的方向, 腫瘤細胞會增加強內促發炎細胞激素介白素 -6 (IL-6), 研究證實,癌症患者的血漿中普遍存有較高的lL-6

濃度。美國癌症研究學會(AACR)在2006年發現疲憊與IL-6相關的證據

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Potential mechanisms for CRF

Brain, Behavior, and Immunity 21 (2007) 863–871

Confidential 9 Jager A et al. European J of Cancer, 44 (175-181), 2008

Potential mechanisms on CRF

Confidential 10 Jager A et al. European J of Cancer, 44 (175-181), 2008

Potential mechanisms of PG2 on CRF

PG2 Treatment

relief

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ICD–10 Criteria for CRF

Psychosomatics

2008; 49:283–291

(A1+5 of A2~A11)

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如何診斷

癌因性疲憊症如何診斷

國際疾病分類第10版(ICD-10) - 癌因性疲憊症診斷準則

A : A1 加上 A2 ~ A11這 10 點至少有 5 點, 總共 6 點以上症状, 在過去1個月內至少

有 2星期的大部份天數裡連續存在著

A1 明顯的的疲勞，減少能量或增加休息，任何最近的活動程度不成比例的變化

A2 廣泛地虛弱、 肢體沉重

A3 減少專注或注意力

A4 減少從事日常活動的動機或興趣

A5 失眠或嗜眠的

A6 睡覺時有unrefreshing 或 無法恢復(nonrestorative)的經驗

A7 感覺需要掙扎才能克服處於非活動狀態

A8 顯著地情緒反應（例如，悲傷、 沮喪、 易怒) 致感覺疲勞

A9 由於感覺疲勞而難以完成日常任務

A10 感覺短期記憶有困難

A11 做了費力的事後,就感到病懕懕,不適症狀持續好幾個小時

B 這些症狀造成臨床意義的困擾或損害社會、 工作或其他重要功能的運作

C 從歷史、 體格檢查或化驗結果證實，這些症狀是一系列癌症或癌症治療所引起

D 這些症狀不是其他精神異常疾病的繼發結果, 如抑鬱症、 軀體化障礙、 軀體形式障礙或譫妄共患精神病

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如何評估

癌因性疲憊症如何評估

簡單的評估方式 –台灣版簡明疲憊量表(BFI-T)

簡單的思考下面三個問題.. • 1) 你現在有任何累或疲憊的感覺嗎?

• 2) 如果有.從0到10分(0分為完全不累,10分為想像中最疲憊的狀態)找出一個適合描述您每天疲憊狀態的分數。

• 3) 這樣的疲憑是否有影碧您日常生活的機能(例如工作、家務等)

• 評估您的癌因性疲憊症嚴重程度,把所有題目的分數加總再除以9,得出的平均分數可作為疲憊嚴重程度的依據

– 平均分數< 3分→ 輕度疲憊

– 平均分數4 - 6分→中度疲憊

– 平均分數> 7-9分→重度疲憊

– 平均分數= 10分→極度疲憊

• 若您的分數有達到中/重度疲憊,可能癌因性疲憊症已經影響到你的生活品質了喔!

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台灣版簡明疲勞量表(BFI-T)

您最近一週內是否有不尋常的疲勞或勞累?是 否

1請用X標記一個數值,最恰當的表示您現在的疲勞程度(乏力,勞累)

0 1 2 3 4 5 6 7 8 9 10

2請用X標記一個數值,最恰當的表示您在過去24小時內一般疲勞程度(乏力,勞累)

0 1 2 3 4 5 6 7 8 9 10

3請用X標記一個數值,最恰當的表示您在過去24小時內最疲勞程度〈乏力,勞累)

0 1 2 3 4 5 6 7 8 9 10

4請用X標記一個數值,最恰當的表示您在過去24小時內疲勞對您下述方面的影響..

A. 一般活動..

0 1 2 3 4 5 6 7 8 9 10

B. 情緒..

0 1 2 3 4 5 6 7 8 9 10

C. 行走能力..

0 1 2 3 4 5 6 7 8 9 10

D 正常工作(包括外出工作和戶內家務

0 1 2 3 4 5 6 7 8 9 10

E. 與他人關係..

0 1 2 3 4 5 6 7 8 9 10

F. 享受生活..

0 1 2 3 4 5 6 7 8 9 10

資料來源.. :Brief Fatigue Inventory (BFI-T) from Lin et al. (2006)

評估您的癌因性疲憊症嚴重程度,把所有題目的分數加總再除以9,得出的平均分數可作為疲憊嚴重程度的依據..

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SCREENING

如何治療

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非藥物治療(BFIT : 1~3分)

雖然目前沒有治療癌因性疲憊立即、有效的方法,但利用運動、節省體能搭配營養、睡眠等非藥物治療方式,也能幫助患者改善疲憊,獲得處理日常問題的能力,避免陷入認為自己「無用之人」、需要他人照預的情緒黑洞。

運動

• 對大多致的癌症患者而言,運動看似困雖度很高,但國內外不少研究都已經證賓,中強度運動(如瑜珈、健走、游泳等)

能夠明頭紓解疲憊症狀,每天保持規律運動習性,必有助眠效果。但實施運動前需與您的醫護人員討論您合適的運動

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治療貧血藥物 針對貧血造成之疲憊，如紅血球生成素（EPO）。

精神類藥物 用於沮喪或憂鬱造成的疲憊，如Fluoxetine(百憂解)。

神經傳導藥物 影響神經傳導物質的運作，如Methylphenidate類藥物（如：利他能Ritalin, Modafinil)。

植物藥 •西洋蔘 •人蔘 •黃耆多醣

類固醇藥物 Progestational steroids

Megace

Dexamethasone(DM)

(BFIT: 4-10分)

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150 IU/kg, 3 times/week, 4 weeks

(化學治療)

→改善fatigue

4000 U/d, 3 times/week, 4 weeks

(放射線治療)

→無法改善fatigue、血紅素及存活率

EPO對癌因性疲憊症的效果不一 注意EPO可能對腫瘤惡化的影響 對貧血相關的fatigue可能有效

J Clin Oncol, 2001

J Clin Oncol, 2009

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抗憂鬱藥或精神興奮劑

抗憂鬱劑或精神興奮劑:

- 雖可暫時緩解疲憊,增加食慾與協助減少某些止痛劑的鎮定作用

- 但高劑量或長期使用容易產生失眠、興奮、情緒改變,甚至心臟問題等副作用,

- 可用的藥物如治療過動症的Methylphenidate〈利他能)、治療憂鬱症之立普能或百憂解等

Dexamethasone (DM) for cancer-related fatigue: A

double-blinded, randomized, placebo-controlled trial. J Clin Oncol 30, 2012 (suppl; abstr 9002) Sriram Yennurajalingam et al.

Methods:

• Advanced cancer patients with fatigue ≥ 4/10 on the Edmonton

Symptom Assessment Scale (ESAS) and at least 2 other CRF-related

symptoms (pain, nausea, appetite, depression, anxiety or sleep

disturbance ≥ 4/10), normal cognition, no infections and hemoglobin

≥ 9 g/L were eligible for enrollment.

• Randomized to Dexamethasone 4 mg orally twice a day for 15 days

(primary end point) or matching placebo.

• The primary outcome was the day 15 change in Functional

Assessment of Chronic Illness-Fatigue (FACIT-F) subscale scores.

Results:

• N=83 (43 DM and 40 placebo). No difference in the demographics and fatigue (FACIT-F subscale) between DM and placebo groups except for sex (p=0.02).

• The mean (SD) FACIT-F subscores at baseline and at day 15 for DM were 18 (11) and 27 (11) (p<0.001) and for placebo were 21 (9) and 24 (12) (p=0.06), respectively.

• Mean improvement in FACIT-F subscale was significantly higher in the DM group compared to placebo (9.6 (11) vs. 3.1 (9.7), p=0.005).

• Significant difference in ESAS physical distress (p=0.02), but no differences in ESAS overall symptom distress (p=0.11) and ESAS psychological distress (P=0.88) between DM and placebo.

• Insignificantly higher numbers of grade ≥3 toxicities DM group than in placebo (20/42 vs. 18/47, p=0.37).

Conclusions: Dexamethasone was more effective than placebo in reducing CRF in patients with advanced cancer. Long-term safety studies are needed.

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• 沒有證據顯示類固醇可以治療癌因性疲憊症，但的確能改善疼痛問題

其他

Megesrol acetate or medroxyprogesterone acetate

J Natl Cancer Inst, 2008; The Oncologist, 2007

25

西洋参

人参

Phase III evaluation of American ginseng (panax

quinquefolius) to improve cancer-related fatigue:

NCCTG trial N07C2. ASCO 2012 Methods:

•Patients with cancer undergoing or having completed curative intent

treatment and experiencing fatigue, rated at least 4 on a numeric

analogue fatigue scale (1-10) for ≥1 month

•Randomized to 2,000 mg/d of American Ginseng or placebo in BID

dosing for 8 weeks. double blinded.

•Primary endpoint : change from baseline in the general subscale of the

Multidimensional Fatigue Symptom Inventory (MFSI) at 4 weeks.

•MFSI subscales and the fatigue-inertia subscale of the Profile of Mood

States (POMS) were also analyzed.

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27

• American Ginseng reduces general and physical CRF over 8 weeks

without side effects.

• The treatment did not provide significant reductions in fatigue at 4

weeks and did not impact mental, emotional, and vigor dimensions of

fatigue. => 對化療 / 放療中的病人，每1 ~4週就要治療一次，8 週太慢了

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臨床證實:懷特血寶注射劑，可以顯著改善癌因性疲憊症

0.00

10.00

20.00

30.00

40.00

50.00

60.00

70.00

80.00

73.08

44.44

The Results of Patients' Fatigue Improvement Evaluation at the end of Cycle 1 in PP Efficacy Subset Population

Treatment Group (n=26)

Control Group (n=27)

The

Per

cent

age

of F

atig

ure

Impr

ovem

ent

Res

pond

ers

(%)

P=0.034*

Method: Chi-square test (Compared between the two groups)

29%

* ) 治療組

控制組

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治療貧血藥物 紅血球生成素(EPO)=>對CRF沒有好很多,但副作用增加,不建議使用在CRF

精神類藥物 用於沮喪或憂鬱造成的疲憊，如 •Fluoxetine(百憂解,Lilly) •Paroxetine(Seroxat, GSK)=>沒甚差別

神經傳導藥物

•Ritalin/Dexmethylphenidate:需更大型的RCT Trial來証實 •Modafinil(Prvigil普衛醒,):小心嚴重皮疹及過敏 •Pemoline(Cylert):易導致致命性肝衰竭 •D-MP(Dimethyltryptamine):結構與Serotonin相似 之迷幻藥 •THR:對CRF有效,對QoL有正面影響

植物新藥 •Panax ginseng: 人數少(N=20) •Panax quinquefolius: BID for 8 weeks才有效(太慢了) •APS: 黃耆多醣PG2,能調節免疫功能及促進造血機制, 有效改善CRF、提昇生活品質及運動功能，改善化療病患副作用(疼痛、疲憊、惡心嘔吐、食慾降低) 。

類固醇藥物 •Progestational steroids=>沒甚效。 •Megace=>效果不明顯

•Dexamethasone(DM)=>需做長期使用之安全性研究

Summary : 藥物治療 CRF

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What is PG2 (懷特血寶注射劑) ?

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機轉:

增強免疫功能及刺激骨髓造血功能

適應症:

治療因癌症病情進展所導致之中重度疲憊症狀。

(目前仍無藥物可用，屬unmet medical need)

為國內第一件TFDA核准上市之新藥，亦為衛生署所核准上市之

第一件植物新藥產品 (衛署藥製字第054853號)

Astragalus membranaceus is one of the most popular TCM (Traditional Chinese Medicine), benefit the deficiency of

qi (vital energy) of the spleen that symptomatically presents with fatigue , diarrhea, and lack of appetite

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Structure and Chemistry(1)

從「膜莢黃耆 (Astragalus membranaceus (Fisch.) Bge.) 或 蒙古黃耆(Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao ) 」

經抽取、分離、部分純化所得的多醣。

- a-1,4(1,6)-linked glucan, arabinogalactan,

rhamnogalacturonan and arabinogalactan protein(AGP)

平均分子量：20,000至60,000 Daltons。

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Active Ingredient

Minutes

0 5 10 15 20 25 30 35 40

0.000

0.005

0.010

20.4

57

Detector A06J01-5mg-106J01-5mg-1

Retention Time

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Structure and Chemistry(2)

醣類組成：HPAEC (High Performance Anion-Exchange Chromatography )

33

Glu

co

se

Residue Glucose Arabinose Galactose Rhamnose Galacturonic

acid Glucuronic

acid

Composition (mole %)

75-95 5 - 15 2-9 < 2

Ara

bin

ose

Gala

cto

se

Chemical Constituent

34

Dried Root

Washing Cleaning Cutting Drying

Drink Chips

Drink Chips

Water extraction

Concentration

PG2 Crude

PG2 Crude

Filtration

Cation and anion exchange

Filtration, Concentration, and Ethanol precipitation

Drying and Blending

PG2 Substance

PG2 Substance

Sterile Filling

Package

PG2 Product

Drying

Ethanol precipitation

Dried Root

黃耆

傳統中藥

Dried Root Drink Chips Crude Extraction Purification Filling

藥材 (Raw Material) 原料藥 (Drug Substance) 成品 (Drug Product)

全程無菌

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懷特血寶注射劑 (PG2 Injection 500 mg)

Is

多功能、多靶點双向免疫調節劑

- 增強免疫(Enhance Immunity)

- 双向免疫平衡(Bi-Directional Immune Homeostasis)

- 調節三種血球( WBC, RBC and Platelet counts)

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Compound EC50 (mg/ml) PG2 733

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Pharmacology Studies (1) PG2 Increases Mice Spleen Cell Proliferation

Figure 1. Concentration response curve for the effect of PG2 on spleen cell proliferation assay.

Compounds Concentration (mg/ml)

Avg. % Stimulation

Vehicle control (incubation buffer)

100

Positive control (LPS+) 10 4550 Positive control (Con A++)

1 8098

PG2

10 110 30 115

100 165 300 437

1000 1041 3000 1597

10000 1615

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Pharmacology Studies (2)

In Vitro Study

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PG2 Stimulates PBMC Cytokine Production

PG2

mg/l

ELISA (S/C)

IL-1 IL-6 TNF-a IFN-g GM-CSF G-CSF

25 9.1 11.8 4.9 3.1 6.5 49.9

10 4.3 5.9 2.3 1.2 2.1 16.5

S: the amount of cytokine produced in PBMC

stimulated with PHA (3mg/ml) plus test sample

C: the amount of cytokine produced in PBMC

stimulated with PHA (3mg/ml) alone

PBMC culture for 1 day

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Pharmacology Studies (3) PG2 Increases Splenic NK Cell Activity

PG2 increases splenic NK cell activity Spleen cell cultures from C57/black

mice (n=5) inoculated with S-180 and injected with PG2 for 14 days were incubated

with tritiated thymidine labeled Yac-1 cells for 18 hours. Cells were then harvested

and counted. Control mice were inoculated with S-180 and injected with saline for 14

days. Normal mice were injected with saline only. NK activity was calculated as 1-

(experiment group cell cpm/Yac-1 cell cpm) x 100%.

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Pharmacology Studies (4)

39

Study drug treatment

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Cellular Immunity

(Pro-inflammation)

Th1

Th2 DM

ITP

RA

SLE

Th1

Th2

Humoral Immunity

(Anti-inflammation)

Sepsis

Cancer?

Fatigue?

Th1 Th2

Immune Homeostasis

Health

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Th1 Th2

Immune Homeostasis

Health

41

Biol Pharm Bull.

2007 Mar;30(3):470-6.

PLoS One.

2011;6(6):e19811.

Cellular Immunity

(Pro-inflammation)

Th1

Th1 Th2

Th2

Humoral Immunity

(Anti-inflammation)

PG2 Treatment

DM Model Sepsis Model

双 向 免 疫 平 衡

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Pharmacology Studies

PG2 Enhances Blood Cell Counts Recovery

PG2 enhances RBC counts recovery

0

1

2

3

4

5

6

7

8

9

10

11

0 5 10 15 20 25

Mean

RB

C c

ou

nt

(10

6 /m

m3)

Days post-irradiation

Control

PG2 300 mg/kg

PG2 100 mg/kg

0

2000

4000

6000

8000

10000

12000

0 5 10 15 20 25

Mean

WB

C c

ou

nt

( m

m3)

Days post-irradiation

PG2 enhances WBC counts recovery

Control

PG2 300 mg/kg

PG2 100 mg/kg

0

2

4

6

8

10

0 5 10 15 20 25

Mean

PL

T c

ou

nt

(10

5/m

m3)

Days post-irradiation

PG2 enhances PLT counts recovery

Control

PG2 300 mg/kg

PG2 100 mg/kg

Balb/c mice (n=6) were sub-lethally

irradiated (425 cGy) on day 0 and

different doses of PG2 were given

for 4 weeks. Animals were bled twice

weekly starting at day 7 post-

irradiation.

＊

＊＊＊

＊＊＊

＊＊＊

＊＊＊

＊＊

＊＊＊

＊＊＊

＊＊＊

＊＊＊

＊＊＊

＊＊＊

＊＊

＊＊＊

＊

＊

＊

＊＊

＊＊

＊＊

＊

＊

Comparison to Control (＊, P<0.01; ＊＊, P<0.005; ＊＊＊, P<0.001)

Comparison to Control (＊, P<0.05; ＊＊, P<0.01) Comparison to Control (＊, P<0.05; ＊＊, P<0.01; ＊＊＊, P<0.001)

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Multi-targeted Effect

PG2 inhibited the role of CD4+CD25+ T regulatory (Treg) cells in negative immune regulation via down-regulation of TLR4 ex vivo.

PLoS One. 2011;6(6):e19811.

PG2 Stimulated Activation of CD4+ T cells and Directed Polarization of CD4+ T cells to Th1 through Dendritic cells.

Journal of Ethnopharmacology 136 (2011) 457–464

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PG2 Phase I/II Trial

44

Study Objective: Dose finding and safety

Study Design

Phase I : Dose escalation trial (13 patients)

125 mg: 4 patients, 250mg: 3 patients, 500 mg: 6 patients

Phase II : Up to a total of 20 patients at 500 mg/day

All cancer types

Self-Control

PG2 dose up to 500 mg/day is safe and tolerable for patients.

2001.12-2003.10

三軍總醫院血液腫瘤科執行

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PG2 Pivotal Trial (Phase III)

Title: PG2 Treatment for Improving Fatigue among Advanced Cancer Patients under Standard Palliative Care

Objective: The objectives of this study are to evaluate the efficacy and safety of PG2 for relieving fatigue among advanced cancer patients who are under standard palliative care (SPC) at hospice setting and have no further curative options available.

計畫書編號：PH-CP012 衛生署核准發文字號：衛署藥字第0960326352號 (申請案號：9608127)

馬偕紀念醫院安寧緩和教育示範中心執行

Confidential

Study Design(1)

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Population • Advanced progressive cancer patients • Under standard palliative care (SPC) at hospice setting • have no further curative options available

The 2nd Treatment Cycle The 1st Treatment Cycle

1st week 2nd week 3rd week

3doses 3 doses 3 doses

4th week

3 doses

Double-Blind, Randomized, Placebo-Controlled

1st week 2nd week 3rd week

3 doses 3 doses 3 doses

4th week

3 doses

1st week 2nd week 3rd week

3 doses 3 doses 3 doses

4th week

3 doses

1st week 2nd week 3rd week

3 doses 3 doses 3 doses

4th week

3 doses

PG2 Arm

Placebo Arm

Open-Labeled

PG2 Treatment Placebo Treatment

PG2 Treatment

PG2 Treatment (n=30)

(n=30) (n=30)

(n=30)

Confidential

Study Design(2) Brief Fatigue Inventory-Taiwan (BFI-T) from Lin et al. (2006)

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Confidential

Efficacy Evaluation

Fatigue Status (by BFI-T, 0-10 score, averaged by 9 questions)

Fatigue Improvement Response

Fatigue Status Improvement: improve 10% from baseline

Fatigue Improvement Response Rate

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Fatigue Improvement Responder

Fatigue Improvement Responder + Non-Responder X100%

Reference:

Steensma et al., 2006,

「Modafinil to Reduce Persistent Fatigue in Patients Following Treatment for Cancer」(University of Rochester)

Analyzed by McNemar’s test.

PG2 treatment significantly improved fatigue among cancer patients.

The improvement of the fatigue status for the Treatment Group sustained for 8 wks.

49 Clin Invest Med 2012; 35 (1): E1-E11.

Fatigue Improvement Response (1)

Comparison between Cycles

Analyzed Population: PP Population

73.08

44.44

0.00

10.00

20.00

30.00

40.00

50.00

60.00

70.00

80.00

PG2-primed Group

(PG2, n=26)

Placebo-primed Group

(Placebo, n=27)

FIR

R (

%)

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Fatigue Improvement Response (2)

Higher fatigue improvement response rates in the Treatment Group as 29% more than that of the Control Group at the end of the First Treatment Cycle.

Comparison between Groups (Cycle 1)

* 29 % P=0.034

Analyzed Population: PP Efficacy Subset Population

Confidential 51

2011年於Med Oncol發表植物多醣APs注射劑(PG2)搭配vinorelbine

應用於advanced NSCLC病患其生活品質評量的研究

PG2 與化療藥併用對生活品質的改善研究 :

Confidential

PG2 improve HRQL among NSCLC patients under cisplatin-based chemotherapy

• Patient Type: NSCLC IIIb/IV (n=68/per group)

• Chemo regimen: Vinorelbine (20 mg/m2) on days 1, 8, and 15; Cisplatin (80 mg/m2) on day 15

• APS (250 mg/day) on day 1-day 7

By EORTC

QLQ-C30

Overall QoL Physical

Functioning Pain

Fatigue Nausea and Vomiting Loss of Appetite

*P = 0.003 *P = 0.01

*P<0.001 *P<0.001

*P = 0.007

*P = 0.023

* Compare between the two study groups after 3 cycles of treatment

Med Oncol. 2011 (Guo L et al. ) 52

PG2有效提昇生活品質改善化療病患副作用(疼痛、疲憊、恶心嘔吐、食慾降低)

Safety and Tolerability

More than 600-patient data were documented through the clinical trials.

The adverse events exclusively associated with PG2 administration were pruritis (2.38%), rash (5.95%) and dizziness (2.38%). Most of these adverse events were minor and the patients recovered without medical treatment.

PG2 has been shown to be safe through a complete series of toxicological studies

PG2 has been shown no inhibition to CYP1A2, CYP2C9, CYP2C19, CYP2D6 and CYP3A4 and no induction to CYP3A4 through in-vitro drug-drug interaction studies.

PG2 incubated alone or with other chemotherapy agent was no

effect on A549, Ca922, SKOV-3, HCT116 and MDA-MB231 cell

proliferation.

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包裝

500 毫克/小瓶， 1 至 24 瓶/盒。

用法及用量

成人每次劑量 500 mg，以 2.5至 3.5 小時點滴

靜脈滴注，每週二至四次。使用2週至4週。

靜脈滴注溶液製備

從 500 ml注射用生理食鹽水點滴瓶中抽取 10

ml，注入懷特血寶注射劑 500 mg 藥瓶中，

充分混合至完全溶液後，注射回原 500 ml 生

理食鹽水點滴瓶中，混合均勻，即完成製

備。

配製完成後在室溫保存24小時內可維持安

定。

Confidential

結 論 :

懷特血寶注射劑

多功能、多靶點双向免疫調節劑

為台灣第一件核准上市之植物新藥注射劑，可治療癌症病患因疾病進展所導致中重度疲勞症狀。

依歐美標準，由國內研究開發所得之醫師處方用藥。

臨床試驗證實安全性高，僅偶發搔癢、皮疹及頭暈等症狀。

臨床試驗證實除具疲勞症狀改善效果，亦顯示PG2有效提昇生活品質及運動功能，改善化療病患副作用(疼痛、疲憊、惡心嘔吐、食慾降低) 。 55