Frequent Questions and Answers

Question:

Which recovers better early, the intracystic OK-432 injection therapy or the operation?

Answer:

In the intracystic OK-432 injection therapy, it usually reduces slowly after cyst is swollen further by OK-432 injection, and it will disappear four to eight weeks after treatment. Therefore, because 1 to 2 months is necessary by recovering in this treatment, it takes time more than the operations. (In Japan, operation of ranula usually needs one week of hospitalization.) OK-432 therapy usually does not need hospitalization.
Daily life can be continued without trouble, if a small amount of OK-432 (1.0 KE or less) was administrated. If large amount of OK-432 (more than 1 KE) was administrated, you need usually one to 2 days absent from work and the school.

Question:

Isn't OK-432 dangerous, because it is a drug for cancer? Will you come off the hair?

Answer:

OK-432 is different from a so-called anticancer drug that suppresses the cancer-cell multiplication. OK-432 is the immunotherapy agent for cancer. The drugs that suppresses the cancer-cell multiplication suppress multiplication of rapid turn over cells such as bone marrow and root of hair cells. But, OK-432 is not such type of drugs. OK-432 did not induce bone marrow suppression or reduction of hair.

Question:

After injecting OK-432, did you experience some cases who's swelling after treatment remained rather than before ?

Answer:

The OK-432 intracystic injection therapy is treatment that cause a strong inflammation in the cyst artificially. After injecting OK-432, the cyst will be swollen for one to 2 weeks than before treatment. However, this strong inflammatory reaction makes the cyst disappear. When reactive swelling after OK-432 injection doesn't appear, this treatment is not effective. After the second week, swelling by OK-432 is gradually reduced. Some patients worried that the swelling would never reduce when their swelling became maximum. But, I have never experienced the case who did not recover from post injection swelling. Please do not worry about such a case. One of the aim to open this HP is relief anxieties of patients by looking course of cure in many patients.

Question:

Does OK-432 have the influence in the pregnancy and birth?

Answer:

OK-432 is a lyophilized weak poison hemolytic streptococcus killed by penicillin. Doing the OK-432 intracystic injection therapy is like causing the infection of hemolytic streptococcus only in the cyst artificially. Hemolytic streptococcus is a typical cause of tonsillitis. Causing the tonsillitis during pregnancy is not so unusual, and usually passes without trouble. I experienced one patient who had this therapy and just after become pregnant. Her ranula was cured and she gave birth to healthy baby.

Question:

Do we need a removal of the sublingual gland after OK-432 intracystic injection therapy of ranula?

Answer:

In the OK-432 intracystic injection therapy, it is not necessary to do unifying operation, only injecting OK-432 is needed. The merit of this therapy is that cyst can be treated without having operation as an outpatient basis, however it takes more time to cure.

Question:

Which lesion should be injected to if there is a ranula in both submandible and oral floor ?

Answer:

As conclusion, it is OK if OK-432 was injected from each submandibular or oral floor. It is effective as long as OK-432 is surely injected into the ranula.
Plunging ranula 1 in this HP had also small sublingual ranula. I injected OK-432 to him from submandibular skin. Both ranula was disappeared.
Combined ranula 1, 2, 3 and 4 were injected OK-432 from oral floor. In all of them, both ranulas were disappeared.
Usually, oral ranula and plunging ranula are connected each other, so if OK-432 was injected from any side, the drug reaches to both ranula.
I am now having an easy method, puncture from oral floor by "highly concentated OK-432 injection without aspiration method".

Question:

Why the oral ranula doesn't recover easily by OK-432 ?

Answer:

The efficacy of OK-432 intracystic injection therapy is more excellent in plunging ranula though plunging ranula is more serious than oral ranula. 90 % of plunging ranula recovers within two times of injection. However, more than 50 % of oral ranula needed more than 2 times of injection, maximum 5 times. The reason why OK-432 is less effective in oral ranula is OK-432 flows out because of extremely thin cyst wall.
As for the report of Roh from Korea 2006, the reason why the efficacy in oral ranula was less than that of plunging ranula is rapture.
However, even if 5 times of treatment was needed, the cost was less than surgery and it can be treated as out patient basis. So, the interference for work and school are minimum.
Now, I am treating all oral ranula by "Highly concentrated OK-432 injection without aspiration method". By this mehod, the rapture after OK-432 became rare, and treatment results have improved now.

Question:

How much is the pain after OK-432 is injected?

Answer:

The pain is not the one as daily life can not be continued though the pain and increased swelling occurs usually after OK-432 injection. The pain usually disappears within 3 days after treatment. And, the pain in controllable by analgesics.

Question:

After OK-432 is injected, can I take the bath ?

Answer:

If you don't have fever up, you can take the bath as usual. If you have fever up more than 38 degrees C, I recommend to stop taking the bath because of physical consumption. The exercises (of course, the swimming also) etc. are not prohibited if there is no pain and no fever up.

Question:

Does traces of the injection remain?

Answer:

Traces doesn't remain at all usually. Very rarely, the injection site will become red, but it will disappear in about 2 to 4 week after injection.

Question:

What side effects OK-432 have?

Answer:

OK-432 is penicillin killed streptococcus. So after OK-432 injection, the same reaction as entering of the bacterium in the body takes place. That is, they are the inflammatory reactions such as fever up and pains. However, infection is never caused because it is a killed bacterium. About these side effects, using of analgesics is effective. The antibiotic is not necessary either. It is more usual that fever up do not appear in case of administering a small amount of OK-432 (0.5 KE or less).
However, this inflammatory reaction is an action that makes the cyst disappear. The stronger this reaction is, the more excellent the effect of this treatment becomes. Moreover, because penicillin is contained in OK-432, the person who has the penicillin allergy cannot use it.
When the cyst of the neck is treated with OK-432, airway stenosis is special side effect. A caution is needed when swelling strengthened temporarily by administering OK-432. The case who needed tracheotomy was reported in OK-432 treatment of cervical lymphangioma. So, in case of cervical lymphangioma, treating by hospitalization is safe. From my almost 100 cases of ranula treatment experience, I had no experience of airway stenosis. So, I am thinking that ranula can be treated safely as an outpatient basis.

Question:

I am worrying about the penicillin allergy. Is it dangerous ?

Answer:

As for the so called a penicillin allergy in old times, it is understood now that the most was actually allergy to impurities mixed with. Frequency has decreased sharply in place of the synthetic penicillin. We are treating after asking the allergic history of patient's antibiotic, and there is no past. If you worried about allergy, it is possible to test by using skin reaction beforehand.
I have treated more than 100 cysts with OK-432. I had no experience of penicillin allergy.

Question:

Why are there a cystic disease for which this treatment works and a disease not effective?

Answer:

From our experiences, pseudocyst which has no epithelium such as ranula, lingual cyst and cyst with thin epithelium such as lymphangioma and median cervical cyst are effective for OK-432 therapy. Cyst with thick epithelium such as lateral cervical cyst is not effective for OK-432. But, in some cases, OK-432 was effective. In our experiment, 33% was effective. And, from Korea, a report that 56% of lateral cervical cyst was effective for OK-432 therapy. My image of OK-432 intracystic injection therapy is like repair puncture spray. If OK-432 was injected into the cyst, strong inflammation will occur and some viscous inflammatory products like fibrin was produced. These inflammatory products will adhere the leakage point and stop leak. Another image is putty up ruptured water pipe. If the the power of leakage was strong, the saliva leak does not stop. This is the reason why OK-432 therapy must be repeated in some cases. After that, fluid collection will be absorbed gradually. I think the thick epithelium inhibit absorption of fluid and the leakage site with thick epithelium cannot be stopped easily.

Question:

Is there a case who can not be treated by OK-432, even if he has a disease which is an indication for OK-432 therapy ?

Answer:

OK-432 should stay inside the cyst cavity for a certain period to be effective. For example, in some cases (case 2 in median cervical cyst in this HP), fistulous opening was observed at first. In such a case, this treatment is not effective because it goes out even if OK-432 is injected.

Question:

How should we do, if OK-432 intracystic injection therapy was not effective ?

Answer:

Please do not give up if the first treatment was not effective. Please increase dose of OK-432 1.5 times higher and repeat therapy every 6 weeks. In almost all cases, repeat injection and increased dose will make good result. In plunging ranula, almost all cases were cured by within 2 times of injection. But, in oral ranula, almost half cases needed more than 2 injections ( maximum 5 injections ) to cure.

Question:

I was recommended to have the sclerosing therapy with alcohol. Which is effective OK-432 and alcohol?

Answer:

The sclerosing therapy with alcohol is widely done in the treatment of thyroid cyst, and it is really effective. From my experience. the power to make the cyst disappear is more than that of OK-432 . However, when alcohol was leaked to surrounding tissue, tissue necrosis and scar formation occurs. Alcohol is a toxic agent. However, OK-432 is a lyophilized agent of streptococcus. Usually, there is no scar formation after OK-432 intracystic injection therapy. Dr. Shuhei Ogita who is a pioneer of this therapy, insisted that OK-432 was cosmetically good compared to other sclelosing agents.

Question:

Is it possible to operate after OK-432 therapy?

Answer:

Certainly, the possibility that OK-432 treatment make it difficult to operate because of adhesion must be considered.
But, Roh from Korea reported that he operated 5 cases who's result were insufficient by OK-432 therapy. He wrote that "extensive scarring was not found around residual lesions after sclerotherapy, allowing no difficulty or increased morbidity of subsequent surgery" (Laryngoscope 116: 169-172, 2006). And in annual meeting of Japanese stomatopharyngology association in September, 2006, there was an important report from Tokyo Women's Medical College. They operated , removal of sublingual gland, two cases who had formerly OK-432 therapies. And, there was no interference of surgery. The trump card of operation for ranula is removal of sublingual gland. So, I think there is no reason why hesitating to choose OK-432 therapy now.

Question:

Sclerotherapy means that the injection site become hard?

Answer:

The scar is not usually formed after OK-432 intracystic injection therapy. After OK-432 therapy, the skin is soft as normal and no color change.

Question:

What clinical examinations are needed to have OK-432 intracystic injection therapy?

Answer:

In almost all oral ranula and otohematoma, special clinical examinations are not needed. Only inspection is enough. In plunging ranula, lymphangima and median cervical cyst, MRI or X-ray CT is needed to determine how the cyst is spreading. Moreover, it is necessary to take the photograph of swelling before and after treatment to understand the therapeutic effect accurately.

Question:

When is it suitable for receiving this treatment?

Answer:

It is easy to inject OK-432 into the cyst when the cyst is big. It is very important that OK-432 is surely injected into the cyst to be effective. Please do not have aspiration or incision of the cyst before OK-432 treatment, because the treatment would be difficult.

Question:

How much intervals do I need to go to hospital after receiving the injection treatment in the OK-432 cyst?

Answer:

You have better to consult a physician to check at the second day, 1 week, two weeks, four weeks, and six weeks after OK-432 treatment. Moreover, the effect will be judged at four weeks to six weeks after treatment. If the effect was insufficient, repeat OK-432 therapy every 6 weeks.

Question:

Where can I get this treatment?

Answer:

Treatment is easy, if you are living in Japan, OK-432 can be obtained anywhere. The technic is easy for a doctor of the otorhinolaryngology who is trained normally.
However, intracystic OK-432 injection therapy is only approved as a treatment for lymphangioma in Japan. It is not indicated to health insurance, so some doctor may hesitate to use OK-432.
But now, in many hospitals in Japan, OK-432 is used for treatment of ranula, especially plunging ranula.

Question:

Which treatment has higher recurrence rate, "Operation" or "OK-432 intracystic injection therapy" for ranula?

Answer:

This depends on a method of operation. A very important thing for treating ranula is that ranula in not tumor but leakage of saliva. So, only removal of the cyst has high recurrence rate. Parekh reported that recurrence rate after removal of plunging ranula from neck was 85 %. If sublingual gland is removed, recurrence rate will be reduced to 2%.
The recurrence rate of lymphangioma after OK-432 therapy was reported almost 9 %. In my experiences, that of ranula was almost the same. But, if the recurrence occurred, OK-432 is effective as former treatment.

Question:

How much the cost for OK-432 therapy?

Answer:

It depends on a cost for obtaining OK-432. In Japan, 1 KE of OK-432 is almost 40 US dollars. At now, OK-432 can be commercially obtained only in Japan, Korea and Taiwan. In countries other than these three countries, it is difficult to obtain OK-432. But in some hospitals where researching infant lymphangioma, OK-432 is used as an experimental drug for infant lymphangioma.
At least, the cost is low compare to that of operation.

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