2017. 9. 17. 10:16
Gloss와 Vickery는 엄격한 검토방법을 사용하여, 사용가능한 보고서의 품질이 낮음에 따라 간질 치료에 있어 CBD의 효능 및 장기적 안전성에 관한 결론을 도출하는 데 사용할 수 있는 데이터가 충분하지 않다고 결론 내렸습니다(11).
이용 가능한 자료로부터, 짧은 기간 동안 이 작은 그룹의 환자들에서 200-300mg의 일일 투여량이 안전하다는 것을 보여주었습니다(14).
Using rigorous review methodology, Gloss and Vickery conclude that based on the low quality of the reports available, there is insufficient data available to draw any conclusions regarding the efficacy and or long-term safety of CBD in treating epilepsy (11). From the data available, it does appear that daily doses of 200 to 300 mg were safe in this small group of patients for a short period of time (14).
내약성 및 약물 상호작용 Tolerability and Drug Interactions
CBD는 인간에게 최대 600mg의 용량으로 내약성이 우수하여 정신을 자극 하지 않습니다(15).
몇 가지 수행된 작은 위약-제어 연구에서 유의한 중추신경계 영향은 발견되지 않았습니다.
경구 CBD는 생체 이용율이 6%인 CYP3A4를 통해 광범위한 1차 통과 신진대사를 겪습니다.
CBD는 CYP 2C와 CYP3A (16,17)를 포함하여 여러 개의 CYP 동종 효소 의 강력한 억제제임이 밝혀졌습니다.
이러한 시험관내 관찰이 환자에서 볼 수 있는 혈장 농도와 관련이 있는 지는 불분명합니다.
또한 CYP3A4를 통한 신진대사를 고려할 때, carbamazepine이나 phenytoin 등의 효소 유도 AED를 투여받는 환자의 CBD 임상시험에는 상세한 약물동학(pharmacokinetic) 연구가 필요합니다.
CBD is well tolerated in humans with doses up to 600 mg not resulting in psychotic symptoms (15). In the few small placebo-controlled studies performed, no significant CNS effects were noted. Oral CBD undergoes extensive first-pass metabolism via CYP3A4, with a bioavailability of 6%. Following single doses in humans, the half-life of CBD when taken orally is about 1 to 2 days.1 In vitro studies have shown that CBD is a potent inhibitor of multiple CYP isozymes, including CYP 2C and CYP3A (16, 17). Whether these in vitro observations are relevant at plasma concentrations likely to be seen in patients is unclear. In addition, given its metabolism via CYP3A4, clinical trials of CBD in patients receiving enzyme-inducing AEDs, such as carbamazepine or phenytoin, will require detailed pharmacokinetic studies.
간질에 대한 CBD 또는 마리화나 사용에 대한 발표된 데이터를 평가할 때 많은 어려움이 있습니다.
극도로 제한된 출판된 연구는 작았으며 적절하게 기술되지 않았으며 잘 설계되지 않았습니다.
발표된 연구의 해석의 어려움에 기여한 CBD 제품은GMP (Good Manufacturing Practice)의 지침에 따라 생산되지 않으며 라벨링, 순도 및 신뢰성을 규제하는 규제를 받지 않습니다.
즉, 현재는 제품간 일관성이 보장되거나 동일한 제조업체가 생산한 여러 로트를 일관되게 보장할 수 없습니다.
함량 및 순도에 대한 CBD 제품의 독립적 테스트(예: USP 인증) 및 특정 제품의 생체 이용률 테스트없이 일상적인 임상 환경에서 사용가능한 CBD 제품의 사용을 둘러싼 불확실성이 존재합니다.
A number of difficulties exist in evaluating published data on CBD or marijuana use for epilepsy. The extremely limited published studies were small, poorly described, and not well designed. Contributing to the difficulty of interpreting published studies, CBD products are not produced under the guidance of good manufacturing practices (GMP) and are not subject to regulations governing labeling, purity, and reliability. In other words, currently, there is no guarantee of consistency between products, or even differing lots produced by the same manufacturer. Without independent testing (e.g. USP certification) of CBD products for content and purity, as well as bioavailability testing of specific products, uncertainty surrounds the use of available CBD products in routine clinical settings.
CBD전문
돕자몰
www.dopza.com
결론 Conclusions
현재 CBD역할, 특히 난치성 간질 치료에 도움이 될 수 있는 기본적 약리적 자료가 늘어나는 것처럼 보입니다.
하지만 잘 통제된 시험이 없다는 점을 감안할 때, 스스로를 앞질러가고 있는지 물어봐야 합니다.
분명히 이것은 감정적 또는 정치적 문제입니다.
이것이 다른 어떤 조사되지 않은 제약 화합물이라면, 통계적으로 유효한 1등급 증거가 검토에 사용되기 전에 이 화합물이 폭넓게 이용되도록 해야 한다고 생각합니까?
잘 설계된 임상시험 자료가 유용하고 신뢰할 수 있을 때까지 GMP를 사용하여 표준화된 CBD 제품을 구할수 있을 때까지 CBD를 간질치료에 사용할 때 주의해야 합니다.
그 동안 유망한 예비자료에 근거하여 추가 임상연구가 진심으로 이루어져야 합니다.
At this time, there does seem to be a growing body of basic pharmacologic data suggesting there may be a role for CBD, especially in the treatment of refractory epilepsy. However, given the lack of well-controlled trials, we must also ask if we are getting ahead of ourselves. Clearly, this is an emotionally and politically charged issue. If this were any other uninvestigated pharmaceutical compound, would we feel as compelled to make the agent widely available before statistically valid class 1 evidence was available for review? Until data from well-designed clinical trials are available and reliable, and standardized CBD products that are produced using GMP are available, caution must be exercised in any consideration of using CBD for the treatment of epilepsy. In the meantime, based upon promising preliminary data, further clinical research should be wholeheartedly pursued.
Footnotes
Editor's Note: Authors have a Conflict of Interest disclosure which is posted under the Supplemental Materials link.
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Articles from Epilepsy Currents are provided here courtesy of American Epilepsy Society
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