BACKGROUND: Compound cotton rose hibiscus leaf ointment is developed from the continuous optimization of the preparation process of traditional famous prescription "Xiaozhong San". Xiaozhong San has been used in Ruijin Hospital Affiliated to School of Medicine of Shanghai Jiaotong University for over 40 years and has achieved good clinical outcomes. OBJECTIVE: To verify the clinical efficacy and safety of compound cotton rose hibiscus leaf ointment, laying a foundation for its popularization and application in the treatment of acute soft tissue injury. METHODS: 112 cases of acute soft tissue injury were divided into trial group (n=55) and control group (n=57) according to the random number table method. The experimental group selected the compound cotton rose hibiscus leaf ointment, and the control group selected the compound Zijing ointment. RESULTS AND CONCLUSION: (1) There were no statistical differences in the primary outcomes, such as pain, tenderness, swelling, dysfunction and in the secondary outcomes, such as ecchymosis, insomnia, dry mouth, constipation, tongue coating and pulse condition, between the two groups before treatment, at 3 and 7 days of treatment and after treatment termination (P> 0.05). (2) The two groups achieved obvious clinical outcomes in the treatment of acute soft tissue injury, but there was no difference in the clinical efficacy between the two groups (P> 0.05). (3) The two groups had no obvious abnormalities in the routine of hematuria and stool and the function of the liver and kidney. (4) There were only five cases of mild skin allergy, including two cases in the trial group and three cases in the control group. To conclude, the compound cotton rose hibiscus leaf ointment has good clinical efficacy and safety, which is worthy of clinical application.

BACKGROUND:Previous studies have confirmed that the new compound cottonrose hibiscus leaf gel plaster has a good effect in the treatment of acute soft tissue swelling. OBJECTIVE:To observe the clinical efficacy of compound cottonrose hibiscus leaf gel plaster in the treatment of synovitis of the knee joint. METHODS:Seventy-two patients with knee synovitis were selected from Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine from December 2019 to May 2021.These patients were randomly divided into a trial group and a control group,with 36 cases in each group.The trial group was treated with compound cottonrose hibiscus leaf gel plaster,once a day,12 hours each time,while the control group was treated with Diclofenac Diethylamine Emulgel,twice a day.After 28 days of treatment,visual analog scale score,WOMAC Osteoarthritis Index score,quality of life score(SF-36),thickness of knee synovium and comprehensive curative effect were compared between the two groups. RESULTS AND CONCLUSION:(1)Visual analog scale scores after treatment were lower than those before treatment(P<0.05).Visual analog scale scores in the trial group after 7,14 and 28 days of treatment were lower than those in the control group(P<0.05).The WOMAC Osteoarthritis Index scores of the two groups after treatment were lower than those before treatment(P<0.05),and the WOMAC Osteoarthritis Index scores in the trial group after 7,14 and 28 days of treatment were lower than those in the control group(P<0.05).(3)The SF-36 quality of life score in the two groups after 28 days of treatment was higher than that before treatment(P<0.05).SF-36 quality of life score in the trial group after 28 days of treatment was higher than that in the control group(P<0.05).(4)After 28 days of treatment,the thickness of knee synovium in the trial group was less than that in the control group(P<0.05),and the effective rate in the trial group was higher than that in the control group(P<0.05).(5)These findings indicate that compared with Diclofenac Diethylamine Emulgel,the compound cottonrose hibiscus leaf gel plaster can better relieve knee pain,enhance knee joint function,reduce synovial hyperplasia,and elevate the overall quality of life of patients.