合成大麻可有效治療因化療引發之延遲性噁心及嘔吐


  May 24, 2005 (奧蘭多) - 美國臨床腫瘤學協會2005年年會上有一項發表,根據研究結果顯示,合成的tetrahydrocannabinol dronabinol (Marinol)可以有效的治療因化療所引發的延遲性及急性噁心及嘔吐症狀。
  
  主研究員Eyal Meiri醫師表示,我們發現dronabinol對於延遲性噁心及嘔吐的治療效果,相當於止吐藥aprepitant (Emend),Emend是較貴的藥物;對於無法負擔標準療法的患者,這項發現可能可以拓廣他們的選擇;Meiri是佛州貝什斯達紀念醫院的腫瘤專家。
  
  Dronabinol目前被核准用於噁心及嘔吐的治療,對象為對其他藥物無反應的患者;不論患者對於其他止吐藥物的反應為何,研究人員藉由以預防的方式使用該藥物,希望可以舒緩患者的症狀。
  
  因此,研究小組招募了64位癌症患者,皆接受過中度至重度的致吐性化療法,以雙盲、安慰劑控制作隨機分配,為一伸縮劑量的臨床試驗;在化療進行前,所有患者皆接受20mg的口服dexamethasone及ondansetron靜脈注射;然後,分為四組,分別為dronabinol單藥組、Ondansetron單藥組、Dronabinol及ondansetron合併用藥組及安慰劑組;患者在接受8到16mg的odansetron前後,皆接受了2.5mg的dronabinol。
  
  治療一直持續到化療週期的第5天,每天評估症狀;整體的藥物反應為本試驗的主要效果評估項目,即噁心的強度是否低於5mm的目視類比刻度(VAS),如此即可視為無嘔吐或無反胃,等同於不需要止吐藥輔助;研究人員也希望知道噁心發生的頻率,即強度及噁心或反胃發作的次數;將這些積極療法與其他療法作比較,同時也和安慰劑作評估。
  
  整體而言,有61位患者可供評估,所有的積極療法都明顯優於安慰劑;整體藥物反應率,Dronabinol單藥組為54%(7/13),Odansetron單藥組為58%,合併用藥組為47%,安慰劑組則為20%;Dronabinol組中,有71%完全沒有噁心的現象,Odansetron組為64%,合併用藥組為53%,安慰劑組則為15%;在於無噁心及噁心的強度評估上,積極治療組皆明顯優於安慰劑;VAS刻度,Dronabinol組為10.1mm,Odansetron組為24.0mm,合併用藥組為14.3mm,安慰劑組為48.4mm;在試驗期間,Dronabinol組的嘔吐或反胃,平均發作次數為0.2次,Odansetron組為1.3次,安慰劑組也是1.3次,合併用藥組則為0.7次。
  
  研究人員正計畫以更大型的試驗對這些結果作證實。
  
  Len Lichtenfeld醫師指出,Dronabinol及大麻在於治療癌症引發的噁心及嘔吐上,是多年來的研究者所積極進行的項目;雖然這不是一項確定性的試驗,但其結果顯示,這樣的醫療設定值得進一步探索;Lichtenfeld是喬治亞州美國癌症協會的醫療副執行長。
  
  本研究由輝瑞藥廠贊助,該藥廠為dronabinol的製造者。

Synthetic Marijuana Effective<

By Paula Moyer, MA
Medscape Medical News

May 24, 2005 (Orlando ) — The synthetic tetrahydrocannabinol dronabinol (Marinol) is effective in the treatment of delayed and acute chemotherapy-induced nausea and vomiting, according to investigators whose findings were presented here at the American Society of Clinical Oncology 2005 Annual Meeting.

"We found that dronabinol was as effective for delayed nausea and vomiting as aprepitant (Emend), which is more expensive," said principal investigator Eyal Meiri, MD, in an interview. "This finding may broaden options for patients who cannot afford standard therapy." Dr. Meiri is a staff oncologist at Bethesda Memorial Hospital in Boynton Beach, Florida.

Dronabinol currently is approved for the treatment of nausea and vomiting in patients who are unresponsive to other medications, and the investigators wanted to see if prophylactic use would provide relief regardless of patients' responses to other antiemetics.

Therefore, they recruited 64 cancer patients who were receiving moderate to high emetogenic chemotherapy and randomized them to a double-blind, placebo-controlled, flexible-dose trial. All subjects received 20 mg of dexamethasone orally and 16 mg of ondansetron intravenously before undergoing chemotherapy. In addition, the patients were divided into four groups: those who received only dronabinol, those who received only ondansetron, those who received a combination of dronabinol and ondansetron, and those who received placebo. Patients received 2.5 mg of dronabinol before and after treatment and 8 to 16 mg of odansetron.

Treatment continued through day 5 of the chemotherapy cycle, and patients' symptoms were assessed daily. The primary outcome measured was total response, which was defined as an intensity for the nausea that was less than 5 mm on a visual analog scale (VAS) and would be characterized by no vomiting or retching and no need to take a rescue antiemetic. The investigators also wanted to know how frequently nausea occurred, its intensity, and the number of vomiting or retching episodes. They compared the active treatments with each other and with placebo.

Overall, 61 patients were evaluable. All of the active treatments were statistically better than placebo; total response was observed in 54% (7/13) of dronabinol patients; 58% of the odansetron patients, 47% of the combination patients, and 20% of the placebo patients (P < .05). Complete absence of nausea was observed in 71% of the dronabinol patients, 64% of the odansetron patients, 53% of the combination group, and 15% of those taking placebo. All active treatments were statistically better than placebo with respect to absence of nausea and nausea intensity. The average nausea intensity on the VAS was 10.1 mm for the dronabinol group, 24.0 mm in the odansetron group, 14.3 mm in the combination group, and 48.4 mm in the placebo group. The dronabinol patients had an average of 0.2 vomiting or retching episodes during the study period; the odansetron group had an average of 1.3 such episodes, as did the placebo group; the combination group had an average of 0.7 such episodes.

The investigators are planning to validate these findings with a larger clinical trial.

"The medical use of marijuana and the use of dronabinol in cancer-induced nausea and vomiting have been of active interest for a number of years," said Len Lichtenfeld, MD, in an interview seeking outside comment. "Although this was not a definitive study, the findings show that it should be explored further in this setting." Dr. Lichtenfeld is the deputy chief medical officer for the American Cancer Society in Atlanta, Georgia.

The study was funded by Pfizer, the maker of dronabinol.

ASCO 2005 Annual Meeting: Abstract 8018. Presented May 15, 2005.

Reviewed by Gary D. Vogin, MD

    
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