Clinical efficacy evaluation of Ella

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1 Ella - photodynamic therapy, the doctor is how to operate?Ella photodynamic therapy for the treatment of SOPStep 1: solution: a bottle of

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1 Ella - photodynamic therapy, the doctor is how to operate?

Ella photodynamic therapy for the treatment of SOP

Step 1: solution: a bottle of medicine before treatment with 0.5ml injection dissolved in water is colorless transparent solution prepared into a concentration of 20%, the prepared solution should be prepared to use after 4 hours.

Step 2: wet compress:

A) to sterilize the wart and surrounding skin lesion local keep clean and dry.

B) placed in appropriate size in the skin lesion of the absorbent cotton, can completely cover the skin.

Ø for Male Urethra Condyloma acuminatum, can be made of thin strips of absorbent cotton, with tweezers to insert urethral lesions, a head exposed on the external urethral orifice, or to fine cotton swab inserted into the urethra, requiring cotton tampon can fully contact skin.

Ø for lesions outside the male urethral part, placing the appropriate size in skin lesions of the cotton ball, can completely cover the skin.

C) take the 1ml syringe to absorb the configured ALA solution. The ALA solution syringe directly or along the cotton drops on the cotton ball, wet cotton complete wetting skin lesions.

D) each time after adding the drug, the skin lesions were coated with plastic film to reduce the volatility of the solution. Cover the affected area or take other measures to avoid the affected by sunlight or other bright light.

E) respectively in the dressing after 0.5 hours, 1 hours, 2 hours to repeat 3, 4, 5, 6 steps.

Step 3: light exposure

A (light) 15 minutes before the opening of the therapeutic apparatus preheating.

B) treated after 3 hours irradiation treatment, irradiation should be fully exposed skin lesions, during the treatment, doctors and patients should wear protective goggles red.

C) energy density lesion light irradiation for 100-150J/cm2. The specific operation steps are as follows: the time of light irradiation is about 2cm from the skin lesions, vertical irradiation, spot diameter is 1cm, irradiation time is about 20 minutes.

2 notes on treatment procedures (factors that may affect the efficacy of treatment):

A each time the treatment must be fresh liquid preparation, preparation must be used immediately, the preservation time of not more than 4 hours.

B) for male urethral condyloma acuminatum outside the site, suggest dressing time and light exposure time prolonging an increase in drug absorption and strength.

C according to the size of lesions can be adjusted to adjust the diameter of the spot, the corresponding adjustment of irradiation time, but in order to ensure the quality of treatment, light time shall not be less than 15 minutes.

D) should protect the affected area to avoid continuous sunlight or other light ALA photodynamic therapy for at least 40 hours after the patient.

3 Ella's clinical efficacy of how to evaluate?

I. Ella multi center clinical trial, led by No.1 Hospital of Peking University in 2005, after the verification of 4 clinical pharmacology base. A total of 453 patients with condyloma acuminatum were enrolled in the trial of five centers. 442 patients were followed up, the experimental group of 331 cases, the control group of 111 cases. Here are the results of clinical trials:

Table 1 the removal of warts in the two groups after treatment

type

group

Before test

Fifteenth days

1 weeks after the last treatment

The number of cases

Number of warts

plantar wart

Clear number

Clearance rate (%)

plantar wart

Clear number

Clearance rate (%)

Male

Urethral orifice

test

One hundred and thirty-four

One hundred and seventy-five

One hundred and fifty-five

Eighty-eight point five seven

One hundred and seventy-four

Ninety-nine point four three

Contrast

Forty-four

Fifty-eight

Fifty-eight

One hundred

Fifty-eight

One hundred

wrong

Urethral orifice

test

One hundred and ninety-seven

Three hundred and thirty

Three hundred and five

Ninety-two point four two

Three hundred and twenty-three

Ninety-seven point eight eight

Contrast

Sixty-seven

One hundred and thirty-seven

One hundred and thirty-seven

One hundred

One hundred and thirty-seven

One hundred

Total

test

Three hundred and thirty-one

Five hundred and five

Four hundred and sixty

Ninety-one point zero nine

Four hundred and ninety-seven

Ninety-eight point four two

Contrast

One hundred and eleven

One hundred and ninety-five

One hundred and ninety-five

One hundred

One hundred and ninety-five

One hundred

Remove the wart rate = (total number, treatment of warts cleared the wart) * 100%.

Table 2 recurrence of warts in the two groups after treatment

type

group

Number of cured cases

Recurrence cases

No recurrence cases

Recurrence rate (%)

The value of P

Male

Urethral orifice

test

One hundred and thirty-three

Fourteen

One hundred and nineteen

Ten point five three

< 0.0001

Contrast

Forty-four

Sixteen

Twenty-eight

Thirty-six point three six

Non urethral orifice

test

One hundred and ninety-two

Twenty-one

One hundred and seventy-one

Ten point nine four

Zero point zero zero two one

Contrast

Sixty-seven

Twenty-one

Forty-six

Thirty-one point three four

Total

test

Three hundred and twenty-five

Thirty-five

Two hundred and ninety

Ten point seven seven

< 0.0001

Contrast

One hundred and eleven

Thirty-seven

Seventy-four

Thirty-three point three three

The recurrence rate (= number of patients cured after recurrence, after several patients cured) * 100%.

Table 3 treatment quality of the two groups after treatment

group

The number of cases

Complete recovery

Leave a scar

Pigment change

Comparison between two groups

test

Three hundred and thirty

Three hundred and twenty-six

Four

P < 0.0001

Contrast

One hundred and twelve

Ninety-three

Fourteen

Five

.

Table 4 the overall evaluation of efficacy

group

The number of cases

Very nice

good

secondary

Inadequate

Comparison between two groups

test

Three hundred and thirty-eight

Two hundred and fifty

Seventy-seven

Four

Seven

P < 0.0001

Contrast

One hundred and twelve

Forty-three

Fifty-six

Eleven

Two

.

Table 5 the overall evaluation of the curative effect

group

The number of cases

Very nice

good

secondary

Inadequate

Comparison between two groups

experimental group

Three hundred and thirty-eight

Two hundred and forty-seven

Seventy-eight

Six

Seven

P < 0.0001

control group

One hundred and twelve

Forty-one

Fifty-eight

Ten

Three

.

Ii. why is Ella so good?

Ella is able to selectively distribution and accumulation in condyloma acuminatum cells, and transformed into strong photosensitive material, light irradiation to specific wavelength and energy, and can produce to selectively kill the target cells of condyloma acuminatum, without damaging the surrounding normal tissue cells. In particular, subclinical infection may also be removed, thereby reducing the recurrence rate.

4 Ella - photodynamic therapy, so that doctors feel free to use

In theory, Ella photodynamic therapy (a) is safe.

Adverse effects of I. photodynamic therapy with anaphylaxis. The new photosensitizer represented by ALA is rapidly cleared in vivo, 24 hours of drugs and their metabolites can be completely ruled out in vitro. Because of local medication, no special measures to avoid light after treatment.

Another common adverse reaction of ii. is the local response of lesions and adjacent tissues, such as erythema, swelling, erosion, etc.. In the process of light and a few days later may appear local pain, patients with lesions occurred in the urethra may occur after treatment of dysuria. These reactions are usually mild to moderate and can be tolerated without any treatment.

III. overall, Ella photodynamic therapy of condyloma acuminatum is a local drug, its side effects are very light, the skin can be completely ruled out the photosensitive reaction, while the light is also a slight injury. Photodynamic therapy does not damage the function of the hematopoietic system and immune system, so the Ella product is safe to use.

IV. multicenter clinical trial data show its safety:

Table 7 Comparison and evaluation of the safety of the researchers

group

The number of cases

Very nice

good

secondary

Dissatisfied

Comparison between two groups

experimental group

Three hundred and thirty-eight

Two hundred and fifty

Eighty-five

One

Two

P < 0.0001

control group

One hundred and twelve

Thirty

Sixty

Twenty-one

One

Table 8 Comparison and evaluation of the safety of the subjects

group

The number of cases

Very nice

good

secondary

Dissatisfied

Comparison between two groups

experimental group

Three hundred and thirty-eight

Two hundred and forty-two

Eighty-five

Eight

Three

P < 0.0001

control group

One hundred and twelve

Thirty

Fifty-nine

Twenty

Three

B (Ella) - photodynamic therapy, so that doctors deal with the process of patients safer

In addition to I. when the operation will contact affected area outside, not in contact with patients during the treatment process, no burning of smoke, thus preventing iatrogenic infection;

Ii. hydrochloride is an endogenous physiological substances, completely non-toxic harmless, the use of high security. In addition to the wart abscission may be some discomfort, without any adverse reactions, the treatment of patients with satisfaction will be higher, therefore help doctors in the doctor-patient relationship is playing the respect and satisfaction of role.

 

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