Yun-Xia GE, Xiao-Rong LIU, Bei WANG,Yong ZHANG, Jia-Jia TONG, Dou-Dou LI

1Department of Nursing, Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing, China; 2Department of Neurosurgery, Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing, China; 3Department of Outpatient, Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing, China

ABSTRACT

Objective: To assess the efficacy of compound Bai Yu San (CBYS) as a new treatment option, in healing diabetic skin ulcer.

Materials and Methods: A total of 64 diabetic patients with skin ulcer were enrolled and randomly assigned to experimental group (n = 33) and control group (n = 31).In the control group, normal saline (NS) was used to cleanse the wound.After debridement, the wound was dressed with modern materials.In the experimental group, the NS-cleansed wound was dressed with CBYS.The infection rate, healing rate, treatment cost, and patient satisfaction between the two groups were compared.

Results: On the 35th day after treatment, the infection rate and healing rate showed no between-group difference (P ＞ 0.05); the experimental group showed lower treatment cost and higher satisfaction than the control group (P ＜ 0.05).

Conclusion: As a new treatment option for diabetes-induced skin ulcer, CBYS can effectively control the infection, promote the healing, reduce treatment cost, and increase patient satisfaction.Dressing with CBYS can be clinically replicated in the treatment of diabetic skin ulcer.

Keywords: Compound Bai Yu powder, diabetic skin ulcer, patient satisfaction, treatment cost

INTRODUCTION

According to the data released by the WHO, diabetes was attacking a population of 425,000,000 in 2017 globally, mostly in China (over 114,000,000).Besides its direct hazardous effects, diabetes also damages the human body with its extensive complications, like skin ulcer that is hard to heal.[1]In China, the 1-year incidence of ulcer in diabetic patients reaches 8.1% and that in diabetic foot ulcer patients may rise up to 31.6%.[2]

Insulin secretion of diabetic patients is dysregulated, host defense system weakened, and the tissue’s self-healing ability destroyed, all hampering the recovery of ulcer.As a consequence, the disability and fatality rates increase largely, imposing a heavy financial pressure on the patient’s family and public health.[3]Diabetes-induced skin ulcer has long stayed in the research focus in this area.In the present study, we used compound Bai Yu San (CBYS, Patent No.ZL201110428490.1) to dress diabetic ulcer and evaluated its efficacy in promoting wound healing.

MATERIALS AND METHODS

This study was approved by the Ethics Committee of Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine (No.2018 LWKY034).

Baseline characteristics

Included were 64 patients who had developed diabetic ulcer between January 2016 and November 2018.Inclusion criteria were (1) patients meeting the diagnostic criteria of China guideline for type 2 diabetes (2013);[4](2) patients aged ≥18 years; (3) patients with no history of drug allergy; and (4) voluntary participants.Exclusion criteria were (1) patients with severe systemic infection or complications in vital organs (heart, brain, liver, kidney, etc.); (2) patients with a history of traditional Chinese medicine (TCM) allergy or allergic physique; (3) pregnant or breast-feeding women; and (4) patients with mental disorder (unable to follow the instructions).With opaque envelopes, all the participants were assigned to experimental group (n= 33) and control group (n= 31).No difference was found between the baseline characteristics of the two groups, such as ulcer status, age, and gender ratio (P＞ 0.05), as shown in Table 1.The two groups were comparable.

Table 1: Baseline characteristics

The ingredients of compound Bai Yu San

CBYS was composed of finely powered Baizhi (Angelica radix dahurica, decisive ingredient), Baiji (Bletillastriata, supportive ingredient), Calcined Shigao (gypsum, supportive ingredient), and Bingpian (Borneol, remissive ingredient).In TCM, Baizhi smoothens bloodstream and promotes new granulation tissue growth.Baiji and Calcined Shigao control bleeding, dispel dampness, and remove swelling to generate muscle.Bingpian dissipates heat and toxin.All the ingredients were mixed to facilitate the wound healing.

Methods

Both groups received general treatments, including antidiabetes therapy, reduction of psychological pressure, physical activities, and nutrition support.In the control group, normal saline (NS) was used to cleanse the ulcerated wound, where necrotic tissue was removed through debridement.The wound surface was dried with dry gauze.According to the status of exudation and infection in the ulcer, the wound was wrapped with modern dressings (such as silver ion dressings and moist dressings) that were changed every 3-5 days.In the experimental group, the ulcerated wound was treated in the same manner.After being dried, CBYS was sprayed onto the whole ulcer surface, till the CBYS layer reached 2 mm in thickness and was fixed with disposable oil gauze.The outer layer was fixed with common gauze (or cotton pad and adhesive tape).The dressings were changed every 2-3 days till the wound healed.

Observational indexes

Triangle of wound assessment was used to evaluate the infection on the 35thday after treatment.Infection referred to the presence of redness, swelling, heat, pain, fever, and increase in white blood cell count.The healing rate was calculated with the wound size.Healing rate = ([original area - unhealed area] ÷ original area) × 100%.[5]

Other indexes included the frequency of dressing changes, treatment expenses, and patient satisfaction (assessed by our self-made questionnaire covering dressing operation, treatment option, dressing usage, doctor’s advice, and humanistic care).The total score is 100 points.A higher score indicates a higher satisfaction.[6,7]

Statistical analysis

SPSS 20.0 software was used for statistical analysis.Quantified data were presented as mean ± standard deviation, and comparison between groups was carried out usingt-test.Enumeration data were presented as percentage (%), and Chi-square was performed for the comparison between groups.P＜ 0.05 was considered statistically significant.

RESULTS

On the 35thday after treatment, both the infection rate and healing rate showed no difference between groups (P＞ 0.05) [Table 2].The experimental group showed a lower treatment expense and a higher satisfaction than the control group (P＜ 0.05) [Table 3].

Table 2: Clinical efficacy on the 35th day after treatment (%)

Table 3: Treatment cost, dressing times, and patient satisfaction between two groups after treatment

DISCUSSION

Currently, the wound is often dressed with special-textured materials that are highly absorptive, antiseptic, and growth-promoting and make the interval between two dressing changes be shortened.Despite their good clinical efficacy, these widely-used dressings, either homemade or imported and especially those uncompensated by health insurance, are expensive which imposes heavy financial pressure on the patient’s family.This is the reason why some diabetic patients with skin ulcers refuse such expensive dressings.Once diabetic skin ulcer collapses, the high blood sugar could retard the healing process.In the present study, the infection rate and frequency of dressing change in the control group were lower than those in the experimental group; however, the expense in the control group was much higher.In the practice, this expensiveness often forces the patients to discontinue the dressing with new materials.We also found that CBYS showed no difference in therapeutic effects compared with silver ion dressings and moist dressings.However, CBYS, made of cheaper ingredients, lowered the treatment expense largely and increased the patient satisfaction.Furthermore, as a bottled spray, CYBS is convenient for doctors and patients.In family care, CYBS is especially suitable for patients with mobile difficulty.Following the doctor’s advice, they can just dress the wound in the family and do not have to make it in the hospital.In summary, CYBS achieved a higher satisfaction and a favorable comprehensive efficacy.

Among hazardous diabetic complications is skin ulcer that heals slowly.Once a diabetic patient gets traumatized, stress response is triggered, during which period the already-high blood glucose continues to rise.As a consequence, re-epithelialization retards and continuous epithelialization stops, both leading to refractory wound.[8]The smooth healing needs rich blood supply.Vascular endothelial growth factor (VEGF), a glycosylated secretory polypeptide, can promote angiogenesis on the molecular level through regulating cell proliferation, migration, chemotaxis, and proteinase production.[9]A study[10]has found that CBYS can effectively upregulate the expression of epidermal growth factor receptor and VEGF in the mucosal epithelial cells, increase microvessel density, and inhibit abscess formation and mucosal inflammation.Liuet al.[11]found that CBYS could control the infection by promoting granulation and epithelialization in diabetic foot ulcer.

In addition, Wanget al.[12]found that CBYS could inhibit the membrane formation ofStaphylococcus aureusdetected in the exudate out of diabetic foot ulcer.This inhibitive effect could be initiated even with a low concentration of CBYS and enhanced as the concentration increased.

CONCLUSION

As a new treatment option for diabetes-induced skin ulcer, CBYS can effectively control the infection, promote wound healing, reduce the treatment cost, and increase patient satisfaction.This treatment can be clinically replicated.

Declaration of patient consent

The authors certify that they have obtained all appropriate patient consent forms.In the form, the patients have given their consent for clinical information to be reported in the journal.The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.

Financial support and sponsorship

This study was supported by Jiangsu TCM Bureau Project (YB2015043) and Jiangsu Science and Technology Department Project (BK20161606).

Conflicts of interest

There are no conflicts of interest.