A randomized and controlled multicenter prospective study of the Chinese medicinal compound Fufang Xuelian Burn Ointment for the treatment of superficial and deep second-degree burn wounds.
The objective of this study was to evaluate the efficacy and safety of a traditional Chinese medicine, Fufang Xuelian Burn Ointment (FXBO), to treat superficial and deep second-degree burn wounds. A four-center, randomized, controlled, and prospective study was conducted. Overall, 240 patients with either superficial or deep second-degree burn wounds were enrolled consecutively in this study. Patients who were randomly assigned to the control group (superficial: 72, deep: 48) underwent common burn wound therapy, whereas those randomized to the treatment group (superficial: 72, deep: 48) received common burn wound therapy plus topical FXBO. The healing rate, healing time, effective rate, and safety data were compared between the two groups. The baseline characteristics were comparable for the two groups. The healing rate was 94.79(±7.50) in the control group and 98.60(±5.69) in the FXBO group after 14 days for patients with superficial second-degree burn wounds (P = 0.000), and 95.17(±9.68) versus 97.44(±9.81) at 28 for deep second-degree burn wounds (P = 0.025). The median healing time in the FXBO group were 9 and 21 days for superficial and deep second-degree burns, respectively, compared to 10.5 and 22.5 days, respectively, in control group (P(superficial) = 0.000 and P(deep) = 0.009). The results of the effective rate showed that comprehensive efficacy of the FXBO group was improved compared to the control group for either superficial or deep second-degree burns (P(superficial) = 0.035 and P deep = 0.003). There were no reported drug-related adverse events in both groups. Therefore, FXBO was well tolerated and more effective than control group for treating superficial and deep second-degree burn wounds.
Southwest Hospital, Third Military Medical University, Chongqing, 400038, China.
Jing
J
Ouyang
Yong-chuan
YC
Chen
Gao-xing
GX
Luo
Hong
H
Yan
Yi-zhi
YZ
Peng
Yue-sheng
YS
Huang
Pei-yuan
PY
Xia
Qin
Q
Zhang
Zhen-jiang
ZJ
Liao
Guo-hui
GH
Li
Xiao-dong
XD
Yang
Yong-qing
YQ
Cai
D000293:Adolescent; D000328:Adult; D000368:Aged; D002056:Burns / Q000188:drug therapy* / Q000503:physiopathology; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009824:Ointments; D011446:Prospective Studies; D012449:Safety; D016896:Treatment Outcome; D014945:Wound Healing / Q000187:drug effects; D055815:Young Adult
D004365:Drugs, Chinese Herbal; D009824:Ointments; C000600829:fufang xuelian