Systematic Evaluation And Meta-analysis Of The Treatment Of Stage 2-4 Pressure Ulcers With External Therapy Of Traditional Chinese Medicine

Background:Pressure ulcer refers to an open ulcer formed by the skin undergoing a certain pressure for a certain period of time resulting in ischemic hypoxia and necrosis of the tissue,which may be accompanied by pain,which usually occurs at the bone bulge or where the skin comes in contact with medical equipment.Blisters on the skin and non-whitening erythema,although not a real "ulcer",also belong to the category of pressure ulcers.According to statistics,the prevalence in emergency hospitals and nursing homes is 3%to 11%,and more than 50%of pressure ulcer patients are over 70 years of age.The cost of treatment also increases with the severity of the pressure ulcer disease,which not only increases the patient’s painful and,in severe cases,the incidence of complications is higher and life-threatening.At present,there are many methods for treating pressure ulcers.There is no ideal treatment scheme for western medicine alone.New treatments such as new dressings,clean debridement,negative pressure trauma treatment,hyperbaric oxygen,cells and growth factors,bioengineering and surgical reconstruction are used.Limited and expensive,Chinese medicine has the advantages of simplicity,convenience,cheapness and experience in its treatment.Recently Chinese medicine research on pressure ulcers has achieved certain results from basic to clinical with the gradual development of traditional Chinese medicine.Among them,various external Chinese medicines,such as plasters,ointments,powders,dressings,and acupuncture,fumigation,ironing,collapse Traditional Chinese medicine treatments such as stains are widely used in pressure ulcers,with significant effects and certain advantages.However,because the level of evidence is not high,it is difficult to evaluate its efficacy objectively and scientifically.Clinical studies with higher levels of evidence are still needed to demonstrate the efficacy and safety of traditional Chinese medicine treatment of pressure ulcers.Objective:Systematic review and meta-analysis of randomized controlled trials(RCTs)of TCM treatment of pressure ulcers were conducted to explore the effectiveness and safety of TCM treatment of pressure ulcers and provide evidence-based medical evidence for TCM treatment of pressure ulcers.Method:The computer searches 4 Chinese databases(CNKI,VIP,Wanfang,SinoMed)and 3 English databases(Pubmed,Embase,Cochrane Library).The retrieval time is from December 2009 to December 2019,and the search languages are limited to Chinese and English.Literature screening was performed according to the criteria of exclusion,and randomized controlled trials of clinical efficacy of external treatment of traditional Chinese medicine for treating stage 2-4 pressure ulcers were collected.Methodological quality evaluation was performed using the "Cochrane bias risk assessment" standard.Data,using Revman 5.3.5 software for Meta analysis and systematic evaluation,and finally reached reasonable conclusions.Result:After screening according to the inclusion and exclusion criteria,a total of 28 literatures related to 2486 cases were of average methodological quality.The total effective rate,healing rate,the average healing time,granulation time and adverse reactions were analyzed for their effectiveness and safety.The results show:① There are 26 studies in the literature that provide overall efficacy data.The results of the meta-analysis suggest that the total effective rate and cure rate of the experimental group of external treatment of traditional Chinese medicine are higher,[OR=5.13,95%CI(3.73,7.06),Z=10.02,P<0.01],[OR=3.42,95%CI(2.83,4.13),Z=12.77,P<0.01];the results of the subgroup analysis suggest that the different treatment methods of traditional Chinese medicine can be improved compared with conventional treatment methods of western medicine.The total effective rate and cure rate of pressure ulcers,the total combined statistics are the total effective rate[OR=4.84,95%(3.32,7.04),Z=8.24,P<0.01]，and the cure rate[OR=3.59,95%CI(2.77,4.64),Z=9.68，P<0.01].② There are 17 studies provided in the literature provided average healing time data,3 studies provided data on granulation growth time,and the results of the meta-analysis suggest that the experimental group of external treatment of traditional Chinese medicine can shorten the average healing time and granulation growth time of the wound,[OR=-5.64,95%CI(-7.07,-4.20),Z=7.69,P<0.01],[OR\-3.24,95%Cl(-4.05,-2.42),Z=7.76,P<0.01];subgroup The analysis results suggest that the average healing time of pressure ulcers treated with external treatment of Chinese medicine in different stages and different treatment periods is significantly shorter than that of conventional western medicine treatment methods,and the total combined statistics are[OR=-3.72,95%CI(-4.71,-2.73),Z=7.40,P<0.01],[OR=-5.64,95%CI(-7.07,-4.20),Z=7.69,P<0.01].③ In the included literature,3 studies provided data on pressure ulcer PUSH score changes,1 study provided data on wound surface area changes,2 studies provided data on visual analog scale changes,and 1 study provided each pressure.Data on the cost of sore treatment and the number of bed linen changes.Two studies provided data on the general situation of wounds and the average number of dressing changes,suggesting that the experimental group of external treatment of traditional Chinese medicine can significantly improve wound healing,reduce the number of dressing changes and the cost of dressing changes.However,some of the data in the above studies are incomplete,the sample size is small,the methodology is incomplete,and the evidence-based evidence is not sufficient.④ Only two studies included in the literature provided follow-up data,and five studies provided data on adverse reaction events,suggesting that external treatment of TCM has a certain degree of safety,but they were not specified in detail.The persuasive power is poor,and more is needed relevant research to strengthen the level of evidence.Conclusion:At this stage,compared with the conventional treatment methods of Western medicine,the treatment of stage 2-4 pressure ulcers with traditional Chinese medicine can significantly improve the overall clinical effectiveness and healing rate,reduce the average healing time of the wound surface,accelerate the growth of granulation tissue,and benefit ulcers.The wound is closed,repaired and healed;it also has certain advantages in nursing,reducing the number of dressing changes,reducing the consumption of medical resources,saving medical manpower and material resources;at the same time reducing the treatment cost of pressure ulcers,which is beneficial to patients and their families Life and health.Due to the limited availability of original research data,its safety assessment is insufficient,but there are no reports of serious adverse reactions.There are many methods of external treatment of traditional Chinese medicine for stage 2-4 pressure sores,including traditional Chinese medicine ointment,traditional Chinese medicine powder,traditional Chinese medicine stains or direct acupuncture smoked moxibustion.Although there are certain limitations,the results of this study suggest that TCM external therapy can indeed improve the overall efficacy in the treatment of pressure ulcers,speed up the wound healing process,and reduce the treatment cost.The methodological quality of some of the original research in this systematic review is relatively low.In the future,multi-center,large-sample,highly rigorous and high-quality clinical trials will be required to provide more rigorous evidence.