加速康复外科在全膝关节置换术中的随机对照研究

doi:10.3877/cma.j.issn.1674-134X.2020.05.004

目的

通过临床随机对照研究，探讨加速康复外科(ERAS)在初次单侧人工全膝关节置换术中的应用效果。

方法

2016年1月至2018年1月，将南通大学附属建湖医院骨科88例拟定行人工全膝关节置换术患者纳入研究。纳入符合膝关节骨关节炎诊断标准，初次行全膝关节置换的患者；排除不符合诊断及纳入标准者。经随机余数法分组，其中44例采用ERAS围手术期方案(实验组)，44例采用传统围手术期方案(对照组)。对其进行临床评价，包括术后24 h血红蛋白及输血比例、住院时间(LOS)、术后并发症、术后24 h、1个月、6个月、12个月疼痛视觉模拟(VAS)评分、膝关节纽约特种外科医院(HSS)评分及膝关节活动度(ROM)。两组LOS、血红蛋白比较采用成组设计资料t检验，组内手术前后血红蛋白比较采用配对设计资料t检验，VAS评分、HSS评分、膝关节ROM的比较采用重复测量资料的方差分析，计数资料采用卡方检验或Fisher确切概率法。

结果

实验组术后24 h血红蛋白明显高于对照组，实验组输血比例、术后并发症发生率明显低于对照组，实验组LOS明显短于对照组。两组VAS评分、HSS评分、膝关节ROM的重复测量方差分析差异有统计学意义(VAS评分F＝9.87，P<0.001；HSS评分F＝10.98，P<0.001；ROM F＝9.94，P<0.001)，均为实验组优于对照组。分组上，术后24 h、1个月实验组和对照组的VAS评分的差异有统计学意义(t＝7.1392、3.9855，均为P<0.05)，术后24 h、1个月及6个月实验组和对照组的HSS评分和膝关节ROM的差异有统计学意义(HSS评分t＝6.6350、5.7948、3.5763，均为P<0.05；ROM t＝7.8032、3.9390、4.7654，均为P<0.05)，术后6个月及12个月实验组和对照组的VAS评分的差异不具有统计学意义(t＝0.5688、0.5180，均为P>0.05)，术后12个月实验组和对照组的HSS评分和膝关节ROM的差异不具有统计学意义(HSS评分t＝0.7687，P>0.05；ROM t＝0.9523，P>0.05)。时间上，实验组和对照组从手术前到术后12个月VAS评分呈降低趋势，实验组和对照组从手术前到术后12个月HSS评分和膝关节ROM呈升高趋势。

结论

ERAS理念干预下，患者初次单侧人工全膝关节置换术后失血少、住院时间短、并发症发生率低、术后短期疼痛轻，康复快，利于膝关节功能的早期恢复。

关键词: 加速康复外科, 关节成形术, 置换, 膝, 前瞻性研究

Objective

To investigate the effect of enhanced recovery after surgery (ERAS) in primary unilateral total knee arthroplasty (TKA).

Methods

From January 2016 to January 2018, 88 patients who underwent primary unilateral TKA from the orthopedic department of affiliated Jianhu Hospital of Nantong University were divided into two groups by random number method: ERAS group(experimental group, n=44)and routine group (control group, n=44). Inclusion criteria: the patients meet the diagnostic criteria for knee arthritis, and undergoing total knee replacement for the first time. Those who did not meet the diagnosis and inclusion criteria were excluded. Follow-up assessment included postoperative hemoglobin at 24 h after operation, blood transfusion ratio, length of stay (LOS), postoperative complications, visual analogue scale(VAS), the Hospital for Special Surgery (HSS) score and knee range of motion (ROM) at 24 h, one month, six months and 12 months after the operation. Group design data t test was used to compare LOS and hemoglobin between the two groups. Paired design data t test was used to compare hemoglobin before and after operation in the two groups. Analysis of variance of repeated measurement data was used to compare VAS score, HSS score and ROM of knee joint. Chi-square test or Fisher exact probability method was used for counting data.

Results

The postoperative hemoglobin after 24 h in the experimental group was significantly higher than that in the control group. The blood transfusion ratio and the incidence of complications in the experimental group were significantly lower than those in the control group. The LOS in the experimental group was significantly shorter than that in the control group. The total difference of VAS score, HSS score, knee ROM between the two groups were statistically significant(VAS score F=9.87, HSS score F=10.98, ROM F=9.94, all P<0.001) which showed that the experimental group were better than the control group. In terms of grouping, the difference of VAS score between the experimental group and the control group was statistically significant at 24 h, and one month postoperatively(t=7.1392, 3.9855, both P<0.05). The difference of HSS score and ROM of knee joint between the experimental group and the control group was statistically significant at 24h, one month, and six months postoperatively(HSS score t=6.6350, 5.7948, 3.5763, all P<0.05; ROM t=7.8032, 3.9390, 4.7654, all P<0.05). The difference of VAS score between the experimental group and the control group was not statistically significant at six and 12 months postoperatively(t=0.5688, 0.5180, both P>0.05). The HSS score and ROM of knee joint between the experimental group and the control group was not statistically significant at 12 months postoperatively(HSS t=0.7687, ROM t=0.9523, both P>0.05). In terms of time, the VAS score of the experimental group and the control group decreased from pre-operation to 12 months after operation, and the HSS score and ROM of the knee joint of the experimental group and the control group increased from pre-operation to 12 months after operation.

Conclusion

The application of ERAS in primary unilateral TKA can reduce blood loss and the incidence of complications, shorten hospital stay, cause less short-term pain after operation, and achieve faster recovery, which is beneficial to the early recovery of knee joint function.

Key words: Enhanced recovery after surgery, Arthroplasty, replacement, knee, Prospective studies

表1 两组患者术前临床资料比较

组别	例数	男/女(例)	年龄[岁，(±s)]	左/右(例)	血红蛋白[g/L，(±s)]	VAS评分(±s)	HSS评分(±s)	ROM[°，(±s)]
实验组	44	10/34	68.7±6.0	8/36	140.9±7.3	7.2±1.1	38.3±4.1	61.9±8.8
对照组	44	12/32	70.0±5.9	10/34	140.5±6.5	7.1±1.0	38.2±3.9	61.5±9.0
统计值		χ²＝0.2424	t＝1.0248	χ²＝0.2794	t＝0.2715	t＝0.4462	t＝0.1172	t＝0.2108
P值		>0.05	>0.05	>0.05	>0.05	>0.05	>0.05	>0.05

表1 两组患者术前临床资料比较

组别	例数	男/女(例)	年龄[岁，(±s)]	左/右(例)	血红蛋白[g/L，(±s)]	VAS评分(±s)	HSS评分(±s)	ROM[°，(±s)]
实验组	44	10/34	68.7±6.0	8/36	140.9±7.3	7.2±1.1	38.3±4.1	61.9±8.8
对照组	44	12/32	70.0±5.9	10/34	140.5±6.5	7.1±1.0	38.2±3.9	61.5±9.0
统计值		χ²＝0.2424	t＝1.0248	χ²＝0.2794	t＝0.2715	t＝0.4462	t＝0.1172	t＝0.2108
P值		>0.05	>0.05	>0.05	>0.05	>0.05	>0.05	>0.05

表2 两组患者手术后24 h血红蛋白、输血比例和住院时间比较

组别	例数	术后24 h血红蛋白[g/L，(±s)]	输血人数(例)	住院时间[d，(±s)]
实验组	44	114.0±12.4	2	7.6±1.5
对照组	44	101.2±18.2	8	9.6±2.0
统计值		t′＝3.8554	χ²＝4.0615	t＝5.3066
P值		<0.001	<0.05	<0.001

表2 两组患者手术后24 h血红蛋白、输血比例和住院时间比较

组别	例数	术后24 h血红蛋白[g/L，(±s)]	输血人数(例)	住院时间[d，(±s)]
实验组	44	114.0±12.4	2	7.6±1.5
对照组	44	101.2±18.2	8	9.6±2.0
统计值		t′＝3.8554	χ²＝4.0615	t＝5.3066
P值		<0.001	<0.05	<0.001

表3 两组患者手术前后VAS评分、HSS评分和ROM比较(±s)

组别	时间点	VAS评分	HSS评分	ROM(°)
	手术前	7.2±1.1	38.3±4.1	61.9±8.8
	术后24 h	4.0±1.0	59.1±6.1	80.9±5.6
实验组	术后1个月	3.4±0.9	68.2±4.9	103.4±10.4
	术后6个月	2.2±1.0	80.1±7.3	113.6±8.6
	术后12个月	1.3±0.8	90.2±6.4	122.8±6.6
	手术前	7.1±1.0	38.2±3.9	61.5±9.0
	术后24 h	5.6±1.1	50.4±6.2	71.5±5.7
对照组	术后1个月	4.4±1.4	61.5±5.9	92.94±14.3
	术后6个月	2.3±0.6	74.1±8.4	104.5±9.3
	术后12个月	1.4±1.0	89.3±4.4	121.5±6.2
	F_组间	44.29	37.43	24.23
F值	F_时间	402.60	1192.89	940.42
	F_{组间×时间}	9.87	10.98	9.94
P值		<0.001	<0.001	<0.001

表3 两组患者手术前后VAS评分、HSS评分和ROM比较(±s)

组别	时间点	VAS评分	HSS评分	ROM(°)
	手术前	7.2±1.1	38.3±4.1	61.9±8.8
	术后24 h	4.0±1.0	59.1±6.1	80.9±5.6
实验组	术后1个月	3.4±0.9	68.2±4.9	103.4±10.4
	术后6个月	2.2±1.0	80.1±7.3	113.6±8.6
	术后12个月	1.3±0.8	90.2±6.4	122.8±6.6
	手术前	7.1±1.0	38.2±3.9	61.5±9.0
	术后24 h	5.6±1.1	50.4±6.2	71.5±5.7
对照组	术后1个月	4.4±1.4	61.5±5.9	92.94±14.3
	术后6个月	2.3±0.6	74.1±8.4	104.5±9.3
	术后12个月	1.4±1.0	89.3±4.4	121.5±6.2
	F_组间	44.29	37.43	24.23
F值	F_时间	402.60	1192.89	940.42
	F_{组间×时间}	9.87	10.98	9.94
P值		<0.001	<0.001	<0.001

表4 两组术后并发症比较(例)

组别	例数	恶性呕吐	下肢深静脉血栓	肺部感染	切口红肿
实验组	44	2	1	1	0
对照组	44	8	8	2	1
χ²值		4.0615	4.4557	0	-
P值		<0.05	<0.05	>0.05	>0.05^*

表4 两组术后并发症比较(例)

组别	例数	恶性呕吐	下肢深静脉血栓	肺部感染	切口红肿
实验组	44	2	1	1	0
对照组	44	8	8	2	1
χ²值		4.0615	4.4557	0	-
P值		<0.05	<0.05	>0.05	>0.05^*

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Clinical study of enhanced recovery after surgery in total knee arthroplasty

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Clinical study of enhanced recovery after surgery in total knee arthroplasty