非药物干预治疗患者慢性创面疼痛效果的系统评价与贝叶斯网状荟萃分析

傅聪颖; 黎宁; 李茂君; 李海胜; 程林; 王丽华

doi:10.3760/cma.j.cn501225-20241213-00486

非药物干预治疗患者慢性创面疼痛效果的系统评价与贝叶斯网状荟萃分析

doi: 10.3760/cma.j.cn501225-20241213-00486

1.
贵州中医药大学护理学院,贵阳　　550005
2.
陆军军医大学（第三军医大学）第一附属医院全军烧伤研究所,创伤与化学中毒国家重点实验室,重庆　　400038
3.
陆军军医大学（第三军医大学）第一附属医院药剂科,重庆　　400038
4.
陆军军医大学（第三军医大学）第一附属医院院办公室,重庆　　400038

详细信息

通讯作者:
王丽华,Email：yiwa@tmmu.edu.cn

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出版历程
- 收稿日期: 2024-12-13

A systematic review and Bayesian network meta-analysis of the effectiveness of non-pharmacological interventions in treating chronic wound pain in patients

1.
School of Nursing, Guizhou University of Traditional Chinese Medicine, Guiyang 550005, China
2.
Institute of Burn Research, State Key Laboratory of Trauma and Chemical Poisoning, the First Affiliated Hospital of Army Medical University (the Third Military Medical University), Chongqing 400038, China
3.
Department of Pharmacy, the First Affiliated Hospital of Army Medical University (the Third Military Medical University), Chongqing 400038, China
4.
Hospital Office, the First Affiliated Hospital of Army Medical University (the Third Military Medical University), Chongqing 400038, China

More Information

Corresponding author: Wang Lihua, Email: yiwa@tmmu.edu.cn

摘要

摘要: 目的评价非药物干预治疗患者慢性创面疼痛的效果。方法该研究为系统评价与贝叶斯网状荟萃分析。检索中国知网、中国生物医学文献数据库、PubMed、Embase等数据库自建库起至2024年6月30日公开发表的有关非药物干预治疗患者慢性创面疼痛效果的随机对照试验研究。结局指标为疼痛评分。采用ADDIS 1.16.8统计软件和Stata 17.0统计软件进行成对荟萃分析和贝叶斯网状荟萃分析。结果共纳入30篇文献,包含1 929例患者,包括接受低水平激光疗法（LLLT）、频率节律电调制系统（FREMS）、虚拟现实技术（VRT）、非接触式低频率超声（NCLFU）、体外冲击波疗法、局部氧气疗法、低温大气压等离子体（CAP）、负压伤口疗法、间歇充气加压（IPC）、运动锻炼等非药物干预方式治疗的试验组1 016例患者及接受标准创面护理、安慰剂等治疗的对照组913例患者。成对荟萃分析显示,与对照组相比,接受LLLT、FREMS、VRT、NCLFU、CAP、IPC治疗的试验组患者慢性创面疼痛评分均明显降低（标准化均数差分别为-0.45、-4.09、-1.04、-0.61、-1.87、-0.64,95%置信区间分别为-0.76~-0.15、-5.94~-2.24、-1.56~-0.52、-0.88~-0.33、-3.16~-0.58、-1.03~-0.25）。贝叶斯网状荟萃分析显示,与标准创面护理相比,接受FREMS、CAP、NCLFU和LLLT治疗患者慢性创面疼痛评分均显著降低（标准化均数差分别为-3.13、-1.75、-1.22、-1.11,95%置信区间分别为-4.35~-1.98、-3.23~-0.26、-2.36~-0.06、-2.18~-0.06）；FREMS排第14位的概率最高,为75%；CAP排第12位的概率最高,为21%；NCLFU排第10位和第9位的概率均为最高,均为13%；LLLT排第8位的概率最高,为14%。结论 LLLT、FREMS、NCLFU、CAP等非药物干预方式均可有效减轻患者慢性创面疼痛,其中FREMS效果最优,随后依次为CAP、NCLFU和LLLT。
- 疼痛 /
- 伤口愈合 /
- 低强度光疗法 /
- 非药物干预 /
- 慢性创面 /
- 贝叶斯网状荟萃分析
Abstract: Objective To evaluate the effectiveness of non-pharmacological interventions in treating chronic wound pain in patients. Methods This study was a systematic review and Bayesian network meta-analysis. Randomized controlled trials on the effectiveness of non-pharmacological interventions in treating chronic wound pain in patients, published from the establishment of the database until June 30, 2024, were retrieved from databases including China National Knowledge Infrastructure, Chinese Biomedical Literature Database, PubMed, Embase, and other databases. The outcome indicator was pain score. Pairwise meta-analysis and Bayesian network meta-analysis were conducted using ADDIS version 1.16.8 and Stata version 17.0 statistical softwares. Results A total of 30 studies were included, involving 1 929 patients, including 1 016 patients in experimental group who received non-pharmacological intervention measures such as low-level laser therapy (LLLT), frequency rhythmic electrical modulation system (FREMS), virtual reality technology (VRT), non-contact low-frequency ultrasound (NCLFU), extracorporeal shock wave therapy, topical oxygen therapy, cold atmosphere plasma (CAP), negative pressure wound therapy, intermittent pneumatic compression (IPC), and exercise, and 913 patients in control group who received standard wound care, placebo treatment, etc. Pairwise meta-analysis showed that compared with that of control group, patients in experimental group who received LLLT, FREMS, VRT, NCLFU, CAP, and IPC had significantly reduced chronic wound pain scores (with standardized mean differences of -0.45, -4.09, -1.04, -0.61, -1.87, and -0.64, respectively, 95% confidence intervals of -0.76 to -0.15, -5.94 to -2.24, -1.56 to -0.52, -0.88 to -0.33, -3.16 to -0.58, and -1.03 to -0.25, respectively). Bayesian network meta-analysis showed that compared with that of standard wound care, patients who received FREMS, CAP, NCLFU, and LLLT had significantly reduced chronic wound pain scores (with standardized mean differences of -3.13, -1.75, -1.22, and -1.11, respectively, 95% confidence intervals of -4.35 to -1.98, -3.23 to -0.26, -2.36 to -0.06, and -2.18 to -0.06, respectively). FREMS had the highest probability of ranking 14^th, at 75%; the probability of CAP ranking 12^th was the highest, at 21%; the probability of NCLFU ranking 10^th and 9^th was the highest, both at 13%; LLLT had the highest probability of ranking 8^th, at 14%. Conclusions Non-pharmacological intervention measures such as LLLT, FREMS, NCLFU, and CAP can effectively relieve chronic wound pain in patients, among which, FREMS shows the best effect, followed sequentially by CAP, NCLFU, and LLLT.
- Pain /
- Wound healing /
- Low-level light therapy /
- Non-pharmacological intervention /
- Chronic wound /
- Bayesian network meta-analysis
傅聪颖：研究设计、论文撰写及文献检索；黎宁、李海胜、王丽华：研究指导、论文修改；李茂君、程林：资料收集、统计分析、数据提取

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图 1 纳入贝叶斯网状荟萃分析的30篇有关非药物干预治疗患者慢性创面疼痛效果的文献网络证据图

注：节点的大小与参与者的数量成正比；2个节点之间的连线表示这2种干预方式进行比较,线的粗细与比较2种干预措施的试验数量成正比

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图 2 纳入贝叶斯网状荟萃分析的30篇有关非药物干预治疗患者慢性创面疼痛效果的文献中不同干预方式疗效排序概率图

注：排位越高疗效越好,概率越高可能性越高；CAP为低温大气压等离子体,ESWT为体外冲击波疗法,FREMS为频率节律电调制系统,HFU为高频率超声,IPC为间歇充气加压,LLLT为低水平激光疗法,NCLFU为非接触式低频率超声,NPWT为负压伤口疗法,SWC为标准创面护理,TOT为局部氧气疗法,TOT^*为TOT+激光疗法+电磁疗法,VRT为虚拟现实技术

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Table 1. 纳入荟萃分析的30篇有关非药物干预治疗患者慢性创面疼痛效果的文献的基本资料及疗效指标

第1作者	患者数（例）		年龄（岁）		干预方式		干预频率	干预疗程	干预后疼痛评分（分,x¯±s）
第1作者	对照组	试验组	对照组	试验组	对照组	试验组	干预频率	干预疗程	对照组	试验组
Alencar^[10]	9	9	48.33±12.09	53.11±8.85	SWC	LLLT+SWC	每周4次	持续4周	2.33±2.29	0.77±1.71
Feitosa^[11]	8	8	—	—	SWC	LLLT+SWC	隔天1次	持续1个月	9.40±0.40	4.80±0.20
Vitse^[12]	11	13	65.80±11.17	67.92±14.78	安慰剂	LLLT+SWC	每周2次	持续12周	4.73±8.59	1.15±4.16
Metin^[13]	34	37	29.81±13.25	32.91±15.9	SWC	LLLT+SWC	每天1次	持续1周	1.19±1.08	0.88±1.07
Lu^[14]	25	37	52.62±16.32	54.36±14.43	SWC	LLLT+SWC	每天1次	持续3周	0.50±1.63	0.20±1.25
Santamato^[15]	10	10	72.70±5.5	73.1±5.6	SWC	FREMS+SWC	每周5次	持续3周	4.0±0.66	0.2±0.42
Janković^[16]	19	24	70.47±9.22	66.70 ± 4.46	SWC	FREMS+SWC	每周5次	持续3周	5.21±1.18	1.68±1.63
Magnoni^[17]	30	30	65.1±17.6	65.9±18.4	SWC	FREMS+SWC	每周3次	持续3周	3.40±0.20	0.40±1.03
郭春兰^[18]	45	45	52.03+22.5	52.03+22.5	SWC	VRT+SWC	每天1次	持续3次	3.63±1.10	2.73±1.15
沈晓星^[19]	37	38	75.1±11.2	74.5±10.5	SWC	VRT+新型伤口敷料	—	—	4.9±1.0	3.6±0.8
Prather^[20]	14	13	54.8±17.9	43.0±22.3	SWC	NCLFU+SWC	—	平均5次	1.00±1.15	0.04±1.50
Gibbons^[21]	40	41	18~90	18~90	SWC	NCLFU+SWC	每周3次	持续4周	2.40±0.45	0.60±1.00
White^[22]	19	17	68.2±12.2	70.5±12.7	SWC	NCLFU+SWC	每周3次	持续8周	1.69±1.96	1.08±1.50
Olyaie^[23]	30	30	39±10.9	40.4±8.5	SWC	NCLFU+SWC	每周3次	持续3个月	5.10±1.88	3.26±3.06
Jeppesen^[24]	11	10	67.8±9.7	65.3±12.9	SWC	ESWT+SWC	每周2次	持续3周	14.5±10.4	22.8±7.4
Taheri^[25]	22	22	57.3±11.8	56.1±15.1	SWC	ESWT+SWC	每周2次	持续3周	3.8±1.6	2.6±1.4
周建英^[26]	40	40	55~75	55~75	SWC	ESWT+SWC	每周1次	持续5周	4.13±0.62	1.82±0.46
Serena^[27]	64	81	62.69±12.56	64.20±14.15	SWC	TOT+SWC	—	持续12周	0.68±1.43	0.95±1.9
Song^[28]	56	56	41.9±6.2	43.3±5.4	SWC	TOT+SWC	每天1次	持续2周	3.97±1.13	2.20±0.74
Otaviano^[29]	34	39	45.4±14.3	47.3±16.6	SWC	TOT+SWC	每天1次	持续10 d	3.9±2.3	2.8±4.5
James^[30]	27	27	52.89±10.5	55.85±15	SWC	NPWT+SWC	—	—	4.00±1.25	3.00±1.00
Seidel^[31]	171	173	68.1±11.5	67.6±12.3	SWC	NPWT+SWC	—	持续16周	0.9±1.7	1.0±1.7
Abu Rached^[32]	20	23	66.5±11.2	72.2±10.9	SWC	CAP+SWC	每周3次	持续4周	5.00±1.25	3.00±0.75
Pasek^[33]	29	36	41~86	41~86	TOT+激光疗法+电磁疗法	TOT+SWC	每天1次	共45次	2.00±0.47	1.00±0.21
Alvarez^[34]	25	27	18~85	18~85	SWC	IPC+SWC	每天2次	持续8个月	2.50±1.13	1.50±1.63
Schuler^[35]	25	28	31~85	31~85	SWC	IPC+SWC	每天2次	持续6个月	3.1±2.3	2.0±1.4
Moelleken^[36]	10	13	73.74	66.82	安慰剂	CAP+SWC	每周3次	持续12周	1.00±3.71	0.01±0.56
Brehmer^[37]	7	7	51~83	51~85	SWC	CAP+SWC	每周3次	持续8周	2.30±0.67	0.60±0.11
Klonizakis^[38]	20	20	78	80	SWC	运动锻炼+SWC	每周3次	持续12周	22.17±22.71	18.50±28.38
Klonizakis^[39]	21	18	61.9±10.9	65.4±14.9	SWC	运动锻炼+SWC	每周3次	持续12周	30.5±36.6	7.9±22.8
注：文献[10]第1作者全姓为de Alencar Fonseca Santos；文献[23]为三臂研究,试验组2患者30例,年龄（38.2±9.9）岁,接受每周3次、持续3个月的高频超声+标准创面护理（SWC）,干预后疼痛评分为（3.96±2.88）分；文献[36]为三臂研究,试验组2患者14例,平均年龄65.21岁,接受每周1次、持续12周的低温大气压等离子体（CAP）+SWC,干预后疼痛评分为（0.01±0.19）分；“—”表示无此项；文献[10,12, 13, 14, 15, 16, 17, 18, 19, 20,22, 23, 24, 25,27, 28, 29, 30, 31, 32,39]年龄数据以x¯±s表示,文献[21,26,33, 34, 35,37]年龄数据以范围表示,文献[36,38]年龄数据以均值表示；TOT为局部氧气疗法,LLLT为低水平激光疗法,FREMS为频率节律电调制系统,VRT为虚拟现实技术,NCLFU为非接触式低频率超声,ESWT为体外冲击波疗法,NPWT为负压伤口疗法,IPC为间歇充气加压；文献[10, 11, 12, 13, 14, 15, 16, 17,19,21, 22,24, 25, 26, 27, 28, 29, 30,34, 35, 36, 37]采用视觉模拟量表进行疼痛评分,文献[18,20,23,31, 32]采用数字评定量表进行疼痛评分,文献[33]采用莱蒂宁疼痛量表进行疼痛评分,文献[38, 39]采用欧洲五维健康量表进行疼痛评分

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Table 2. 纳入分析的30篇文献中不同干预方式治疗患者慢性创面疼痛效果的成对荟萃分析结果

非药物干预方式	I²值（%）	标准化均数差（95%置信区间）
低水平激光疗法^{[10, 11, 12, 13, 14]}	9.0	-0.45（-0.76~-0.15）
频率节律电调制系统^{[15, 16, 17]}	88.1	-4.09（-5.94~-2.24）
虚拟现实技术^{[18, 19]}	60.7	-1.04（-1.56~-0.52）
非接触式低频率超声^{[20, 21, 22, 23]}	0.0	-0.61（-0.88~-0.33）
体外冲击波疗法^{[24, 25, 26]}	96.8	-1.73（-4.09~0.62）
局部氧气疗法^{[27, 28, 29,33]}	96.2	-0.66（-1.85~0.54）
负压伤口疗法^{[30, 31]}	89.9	-0.36（-1.29~0.56）
低温大气压等离子体^{[32,36, 37]}	80.1	-1.87（-3.16~-0.58）
间歇充气加压^{[34, 35]}	0.0	-0.64（-1.03~-0.25）
运动锻炼^{[38, 39]}	38.6	-0.42（-0.98~0.14）
注：试验组患者接受非药物干预,对照组患者接受标准创面护理、安慰剂或与试验组不同的非药物干预,表中数据为试验组与对照组比较所得；软件默认统一采用随机效应模型分析

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Table 3. 纳入贝叶斯网状荟萃分析的30篇有关非药物干预治疗患者慢性创面疼痛效果的文献中不同干预方式疗效的相对影响矩阵表[标准化均数差（95%置信区间）]

干预措施	CAP	ESWT	运动锻炼	FREMS	HFU	IPC	LLLT	NCLFU	NPWT	安慰剂	SWC	TOT+激光疗法+电磁疗法	TOT
CAP		—	—	—	—	—	—	—	—	—	—	—	—
ESWT	-0.55（-2.84~1.40）		—	—	—	—	—	—	—	—	—	—	—
运动锻炼	-0.50（-2.87~1.87）	0.06（-2.19~2.55）		—	—	—	—	—	—	—	—	—	—
FREMS	1.38（-0.46~3.32）	1.94（0.22~4.03）	1.91（-0.30~4.11）		—	—	—	—	—	—	—	—	—
HFU	-0.87（-3.53~1.72）	-0.33（-2.77~2.41）	-0.36（-3.21~2.51）	-2.26（-4.74~0.23）		—	—	—	—	—	—	—	—
IPC	-0.69（-2.93~1.46）	-0.16（-2.08~2.24）	-0.20（-2.59~2.24）	-2.10（-4.06~-0.15）	0.19（-2.51~2.87）		—	—	—	—	—	—	—
LLLT	-0.64（-2.36~1.16）	-0.10（-1.73~1.95）	-0.12（-2.31~2.00）	-2.03（-3.67~-0.44）	0.23（-2.19~2.69）	0.07（-1.81~1.93）		—	—	—	—	—	—
NCLFU	-0.54（-2.41~1.38）	0.02（-1.68~2.03）	-0.01（-2.20~2.16）	-1.92（-3.64~-0.27）	0.35（-1.88~2.52）	0.17（-1.79~2.12）	0.11（-1.47~1.65）		—	—	—	—	—
NPWT	-1.33（-3.37~0.72）	-0.78（-2.63~1.53）	-0.80（-3.22~1.57）	-2.72（-4.61~-0.86）	-0.46（-3.04~2.13）	-0.61（-2.74~1.52）	-0.69（-2.46~1.09）	-0.79（-2.62~1.03）		—	—	—	—
安慰剂	-3.25（-5.95~-0.58）	-2.67（-5.84~0.70）	-2.73（-6.18~0.67）	-4.65（-7.84~-1.54）	-2.40（-6.10~1.23）	-2.55（-5.88~0.76）	-2.61（-5.62~0.34）	-2.71（-5.86~0.38）	-1.93（-5.26~1.29）		—	—	—
SWC	-1.75（-3.23~-0.26）	-1.20（-2.54~0.44）	-1.24（-3.11~0.60）	-3.13（-4.35~-1.98）	-0.8（-3.04~1.28）	-1.04（-2.64~0.52）	-1.11（-2.18~-0.06）	-1.22（-2.36~-0.06）	-0.42（-1.87~1.04）	1.50（-1.39~4.41）		—	—
TOT+激光疗法+电磁疗法	0.10（-2.69~2.94）	0.66（-2.03~3.63）	0.64（-2.47~3.56）	-1.28（-3.99~1.30）	0.96（-2.27~4.15）	0.81（-2.01~3.59）	0.76（-1.90~3.26）	0.64（-2.03~3.25）	1.43（-1.42~4.16）	3.35（-0.35~7.13）	1.87（-0.59~4.19）		—
TOT	-0.88（-2.82~1.04）	0.33（-2.14~1.79）	-0.37（-2.66~1.81）	-2.29（-4.04~-0.59）	-0.02（-2.49~2.50）	-0.19（-2.12~1.82）	-0.25（-1.84~1.38）	-0.37（-2.01~1.36）	0.42（-1.48~2.34）	2.34（-0.81~5.57）	0.85（-0.40~2.10）	-1.00（-2.99~1.04）
VRT	-0.72（-2.84~1.27）	-0.20（-2.10~2.08）	-0.22（-2.60~2.14）	-2.13（-4.02~-0.33）	0.13（-2.50~2.73）	-0.03（-2.16~2.07）	-0.10（-1.92~1.69）	-0.20（-2.04~1.60）	0.57（-1.46~2.65）	2.52（-0.74~5.76）	1.01（-0.41~2.41）	-0.87（-3.58~1.97）	0.13（-1.76~2.06）
注：CAP为低温大气压等离子体,ESWT为体外冲击波疗法,FREMS为频率节律电调制系统,HFU为高频率超声,IPC为间歇充气加压,LLLT为低水平激光疗法,NCLFU为非接触式低频率超声,NPWT为负压伤口疗法,SWC为标准创面护理,TOT为局部氧气疗法,VRT为虚拟现实技术；空白表示不适用；“—”表示数据重复（以行比列表示）