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口服四氢大麻酚(THC):大麻素(CBD)大麻提取物辅助治疗化疗引起的恶心和呕吐(CINV):一项随机、双盲、安慰剂对照、交叉试验。

Oral Tetrahydrocannabinol (THC):Cannabinoid (CBD) Cannabis Extract Adjuvant for Reducing Chemotherapy-Induced Nausea and Vomiting (CINV): A Randomized, Double-Blinded, Placebo-Controlled, Crossover Trial.

作者信息

Sukpiriyagul Apichaya, Chartchaiyarerk Ratiporn, Tabtipwon Paluekpon, Smanchat Buppa, Prommas Sinart, Bhamarapravatana Kornkarn, Suwannarurk Komsun

机构信息

Department of Obstetrics and Gynecology, Bhumibol Adulyadej Hospital, Royal Thai Air Force Bangkok Thailand.

Department of Preclinical Science, Faculty of Medicine, Thammasat University Hospital, Pathum Thani, Thailand.

出版信息

Int J Womens Health. 2023 Aug 16;15:1345-1352. doi: 10.2147/IJWH.S401938. eCollection 2023.

DOI:10.2147/IJWH.S401938
PMID:37608911
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10440684/
Abstract

OBJECTIVE

To evaluate the effects of tetrahydrocannabinol (THC):cannabinoid (CBD) (1:1) oil in reducing chemotherapy-induced nausea and vomiting (CINV) in gynecologic cancer patients who received moderate-to-high emetogenic chemotherapy.

MATERIAL AND METHOD

This was a randomized, double-blinded, crossover and placebo-controlled trial. The study was conducted at the Gynecologic Oncology Units, Bhumibol Adulyadej Hospital (BAH), Royal Thai Air Force, Bangkok, Thailand, between August and November 2022. Participants had gynecologic cancer and received moderate-to-high emetogenic chemotherapy. Subjects were randomized and divided into two groups (A and B) based on the block of four randomization method. In the first cycle, groups A and B received THC:CBD extract oil 1:1 (TCEO) and placebo before chemotherapy administration. In the second cycle, groups A and B received placebo and TCEO before chemotherapy administration. Both groups received per protocol antiemetic medication during chemotherapy. Nausea score and side effects were recorded.

RESULTS

A total of 60 cases were recruited. After exclusion, 54 cases were included in the study. The mean age of participants was 54.4 years. The mean body mass index (BMI) was 26.5 kg/m. Fifty-nine (21/54) percent cases were the advanced stages of cancer. The nausea score of TCEO and placebo groups were 2.11 and 2.99, respectively (P < 0.05). More than half of the participants (36/54) reported dizziness and sedation side effects. Dry mouth, confusion, anxiety, and palpitation of both groups were comparable.

CONCLUSION

The cannabinoid extract (THC:CBD) was an appropriate adjuvant agent to reduce CINV in patients with gynecologic cancer who received high-emetogenic chemotherapy. Dizziness and sedation were the major side effects.

摘要

目的

评估四氢大麻酚(THC):大麻二酚(CBD)(1:1)油对接受中高度致吐性化疗的妇科癌症患者化疗引起的恶心和呕吐(CINV)的缓解效果。

材料与方法

这是一项随机、双盲、交叉和安慰剂对照试验。该研究于2022年8月至11月在泰国曼谷皇家泰国空军普密蓬·阿杜德医院(BAH)的妇科肿瘤科室进行。参与者患有妇科癌症并接受中高度致吐性化疗。受试者根据四人随机分组法被随机分为两组(A组和B组)。在第一个周期,A组和B组在化疗给药前分别接受THC:CBD提取油1:1(TCEO)和安慰剂。在第二个周期,A组和B组在化疗给药前分别接受安慰剂和TCEO。两组在化疗期间均按照方案接受止吐药物治疗。记录恶心评分和副作用。

结果

共招募60例患者。排除后,54例患者纳入研究。参与者的平均年龄为54.4岁。平均体重指数(BMI)为26.5kg/m。59(21/54)%的病例为癌症晚期。TCEO组和安慰剂组的恶心评分分别为2.11和2.99(P<0.05)。超过一半的参与者(36/54)报告有头晕和镇静副作用。两组的口干、意识模糊焦虑和心悸情况相当。

结论

大麻素提取物(THC:CBD)是接受高致吐性化疗的妇科癌症患者减轻CINV的合适辅助药物。头晕和镇静是主要副作用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3364/10440684/d2f41b0a065f/IJWH-15-1345-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3364/10440684/edd0fdb52944/IJWH-15-1345-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3364/10440684/d2f41b0a065f/IJWH-15-1345-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3364/10440684/edd0fdb52944/IJWH-15-1345-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3364/10440684/d2f41b0a065f/IJWH-15-1345-g0002.jpg

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