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The Chinese Journal of Burns Wounds and Surface Ulcers 2000, 12(2): 29~30.

III phase clinical trial of MEBO report for treating burns


Wang Wen-song, Wang Hong
Dalian Burn Center, Dalian 4th Peoples Hospital, Dalian, Liaoning 116031, China

INTRODUCTION From January of 1997 to March of 1999 Dalian Burn Center carried out a phase III clinical trial on MEBO, in which 100 burn patients in therapeutic group were treated with moist exposed burn ointment (MEBO), and 50 cases were treated with silver sulfadiazine (SD-Ag) as control. GENERAL INFORMATION: Gender: Among 150 patients, there are 128 male and 22 female (Table 1).
Table 1. Ratio of both sexes in the 2 groups

Groups (Number) MEBO (100) SD-Ag (50)

Male (%) 85.0 86.0

Female (%) 15.0 10.0


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Male/Female 5.7/1 6.1/1

There was no significant difference between groups: <1, P>0.05

Age: Patients in the trial aged from 1~65 and details were showed in Table 2.
Table 2. Distribution of ages

Groups (Number) MEBO (100) SD-Ag (50)

1~18 (%) 18.0 20.0

18~35 (%) 48.0 50.0

36~50 (%) 22.0 18.0


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51~60 (%) 12.0 12.0

The case-age structure of patients in two groups is very similar: <1, P>0.05

Burn severity: Table 3 showed the comparison of burn severity in two groups.
Table 3. Comparison of burn severity in two groups

Groups (Number) MEBO (100) SD-Ag (50)


2

Mild (%) 54.0 56.0

Moderate (%) 30.0 34.0

Severe (%) 16.0 14.0

Compared between two groups: <1, P>0.05

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The Chinese Journal of Burns Wounds and Surface Ulcers 2000, 12(2): 29~30.

Causes of burn: The percentage distribution of burn causes in two groups was list in Table 4.
Table 4. Causes of burns in two groups (%)

Groups (Number) MEBO (100)

Hot Liquid 58.0

Flame 30.0

Hot solid 5.0

Acid/ Alkaline 3.0 4.0

Electricity 3.0 4.0

Radiation 1.0

Others 0 0

SD-Ag 54.0 34.0 6.0 (50) Compared between two groups: 2<1, P>0.05

1.0

Distribution of burn regions: Table 5 showed distribution of burn regions in two groups.
Table 5. Distribution of burn regions

Groups (Number) MEBO (100) SD-Ag (50)

Head & face (%) 53.0 52.0


2

Trunk (%) 42.0 46.0

Extremities (%) 66.0 58.0

Compared between two groups: <1, P>0.05

Laboratory test: Table 6 demonstrated the changes of white blood cells (WBC) after treatment in both groups. Though there was no difference in the incidence of abnormality between two groups (P>0.05), the significant test by Four-fold Table verified that the decrease of WBC in SD-Ag group had obviously higher.
Table 6. Changes of WBC after treatment in both groups (%)

Groups (Number) MEBO (100) SD-Ag (50)

Normal 60.0 90.0

Increase 10.00 2.00


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Decrease 0 8.0 *
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Abnormality 10 10

Note: Increase was marked as WBC>1010 /L; Decrease as WBC<410 /L Compared between two groups: * P<0.05

The above information revealed that there was no significant difference of two groups regarding sex, age, burn severity, burn regions and incidence of WBC abnormality, indicating two groups are comparable. RESULTS

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The Chinese Journal of Burns Wounds and Surface Ulcers 2000, 12(2): 29~30.

Average wound healing time: Table 7 displayed comparison of wound healing time without skin-grafting in two groups. It was showed that the extremely significant differences in comparison of healing time for superficial II, deep II and III degree wounds (P<0.01), disclosing the average wound healing time in MEBO treating group was superior to that in SD-Ag control group.

Table 7. Comparison of wound healing time without skin grafting in two groups (Days, xs)

Groups (Number) MEBO (100) SD-Ag (50)

Superficial II degree 9.02.5 13.02.3 **

Deep II degree 15.33.6 18.03.0 **

III degree 304.5 Skin grafting

Compared with MEBO treating group: ** P<0.01

Analgesic effect: Table 8.


Table 8. Analgesic effect in both groups (%)

Groups (Number) MEBO (100) SD-Ag (50)

Excellent 70.0 10.0 **


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Good 23.0 36.0 **

Fair 7.0 50.0

Poor 0 4.0

Very poor 0 0

Compared with MEBO treating group: =42.001, ** P<0.01

Incidence of scar formation: Comparison of incidences of scar formation in two groups after treatment was described in Table 9. Extremely significant difference was showed in the incidence of scar formation for deep II degree burns between two groups (P<0.01). It was verified no significant difference regarding the incidence of scar formation for III degree burns between two groups according to Abnormality Test of Four-fold Table (P>0.05).
Table 9. Comparison of incidences of scar formation in two groups

Groups (Number) MEBO (100) SD-Ag (50)

Superficial II degree 0 0
2

Deep II degree 18/56 18/21 **

III degree 19/21 15/15 (skin grafting)

Compared with MEBO treating group: =17.606, ** P<0.01

Wound infection: Either in cases of deep II degree or III degree wounds, there showed no significant difference in two groups concerning the incidence of wound infection (P>0.05).
Table 10. Comparison of wound infection

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The Chinese Journal of Burns Wounds and Surface Ulcers 2000, 12(2): 29~30.

Groups (Number) MEBO (100) SD-Ag (50)

Superficial II degree 0 0

Deep II degree 2/56 1/21

III degree 3/21 2/15

Safety assessment: Of all patients in MEBO treating group, only two developed skin rash during the drug application, which disappeared after discontinuation of ointment application. No irritation to surrounding normal skin or other side effect was observed in the trial. The laboratory test also found no side effect of MEBO ointment to routine test of blood and urine, liver function or renal function. DISCUSSION As a drug for topical use, the results of this clinical trial revealed that MEBO ointment had excellent analgesic effects, accelerated wound healing, prevented or decreased scar formation. It was considered mainly to be used for burns and scalds inflicted by various causes and best therapeutic results could be achieved for treating the superficial and deep II degree burn wounds. The superficial III degree burn wound involving whole dermis but subcutaneous fat layer could also healed spontaneously. The clinical observation showed that MEBO ointment was remarkably superior to SD-Ag in the respects of analgesic effect, accelerating wound healing and alleviating scar formation. Both groups had similar effects in anti-infection. It was agreed that MEBO ointment is an ideal medicine for burn management.

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