- 帖子
- 79
- 积分
- 0
- 银子
- 158 两
- 精华
- 0
- 注册时间
- 2018-10-5
|
以下是美国Dr Kevin Pauza 诊所给我的回信，对我提出的疑问做了解答
Thank you for for inquiring about our Discseel Procedure. I have provided answers to your questions. Feel free to reply to this email or if you'd like we can set up a time to talk.
1. So far, how many patients have received discseel treatment, how about the effect and whether there are any side effects such as discitis?
Answer: We’ve treated thousands of discs... difficult to count, but in the last few years alone close to a thousand patients have had the treatment. Dr Pauza has been using fibrin in the discs for well over ten years. No patient ever treated by Dr. Pauza has ever had discitis nor any cross-contamination whatsoever using the non-autologous Fibrin.
2. I read a report saying that ”The proportions of successful patients that received BIOSTAT BIOLOGX Fibrin Sealant or saline injection were not statistically significantly different when analyzed at the 26-week primary endpoint”, I’m very confused about that.
“businesswire.com/news/home/20130718005215/en/Spinal-Restoration-Announces-Disappointing-Phase-III-Study”
Answer: This was a study done years ago when the protocol was totally different than what Dr. Pauza does today. Back then the study was flawed because it limited the procedure to only treating one or two discs and now we know on average patients have at least three torn discs. Therefore, if patients were only having one or two levels treated back then, they likely didn’t have all discs addressed that needed addressing. Also the protocol was flawed in the study because the investigation was done having the physicians inject the fibrin into the center of the disc rather than the outside portion of the disc where the tears reside. If you think about it, the tears reside in the anulus fibrosis which is the outer portion of the disc, so it makes sense to inject the fibrin exactly where the tears reside. So having said that, that is why the study many years ago did not have the outcomes we have today. Today in the lumbar disc, outcomes hover a little over 70% and cervical outcomes hover around 90%.
Also, we are currently doing a study looking at whether injecting PRP or bone marrow stem cells into the disc have value after having sealed the disc with fibrin. No on knows the answer to this to date because nobody has ever studied it.
3. When the fibrin sealant was injected into the degenerated lumbar disc, will the disc swell and cause compression of the dural sac, thus causing low back pain in the patient? From the results of MRI, my lumbar discs are swollen and has touched the dural sac.
Answer: just like when you blow up a somewhat flat tire, the tire goes up, not out. The same holds true with injecting the disc with fibrin. Dr Pauza adds it slowly and we have never had a patient made worse, not ever. If there’s concern that you have a disc bulge too large, Dr Pauza would recommend a patient have a discectomy first. But once a patient has a discectomy (where they remove a portion of the disc), the disc never regrows so we encourage patients to come see us after they’ve had a discectomy so we can help instigate regrowth of the tissue on the compromised disc.
4. Do you have any comparison of MRI images of patients before and after the discseel treatment?
Answer: 95% of our patients live from afar so it’s too difficult to have them get MRIs following the procedure so we do not have a follow up MRI but at the same time recognize that images do not always correlate with pain. The New England Journal of medicine July 1994 confirmed that MRI rarely correlated with symptoms . At that time most doctors didn’t understand why, and Dr Pauza realiZed it was because it was related to annular tears.
We look at MRI’s simply to rule out any major stenosis that may require surgery.
It’s important to recognize no procedure can promise to make you better, but we have had promising outcomes and helped many patients find relief.
|
|
[复制链接]
