灸法治疗脊髓损伤后神经源性膀胱有效性和安全性Meta分析

Meta Analysis of Efficacy and Safety of Moxibustion on Neurogenic Bladder after Spinal Cord Injury

目的:通过Meta分析评价灸法治疗脊髓损伤(SCI)后神经源性膀胱(NB)的有效性和安全性,为改善SCI后NB预后提供循证依据。方法:运用计算机检索PubMed、Cochrane Library、Web of science、EMbase、OVID、中国知网数据库(CNKI)、中国生物医学文献数据库(CBMdisc)、万方数据库(Wanfang Data)、维普数据库(VIP),以SCI后NB患者为研究对象,纳入国内外有关灸法治疗SCI后NB的随机对照试验(RCTs)。检索时间为各数据库建库至2019年5月31日,同时追溯相关文献的参考文献。其中,主要结局指标为总有效率;次要结局指标为膀胱残余尿量、膀胱容量和膀胱压力。由2名研究人员独立筛选文献、提取数据、评价文献质量,采用RevMan 5.3软件进行数据分析,根据Cochrane协作网提供的系统评价手册,连续性变量以均数差(MD)及95%可信区间(CI)为效应指标,二分类变量采用风险比(RR)和95%CI为效应指标。通过χ2检验和I2检验综合判断是否存在异质性,当P≥0.1且I2≤50%时,采用固定效应模型;当P<0.1或I2>50%时,采用随机效应模型。结果:共纳入12项RCTs,均为中文文献,共740例受试者,试验组370例,对照组370例。Meta分析结果显示,与对照组比较,试验组治疗SCI后NB的总有效率更高[RR=1.38,95%CI(1.25,1.52),P<0.00001];可减少SCI后NB患者残余尿量[尿动力学检测组:MD=-37.00,95%CI(-43.48,-30.53),P<0.00001;B超检测组:MD=-29.88,95%CI(-36.26,-23.50),P<0.00001;导尿法测量组:MD=-33.28,95%CI(-57.03,-9.53),P=0.006];可增大SCI后NB患者膀胱容量[尿动力学检测组:MD=50.73,95%CI(14.47,87.00),P=0.006;B超检测组:MD=51.07,95%CI(30.06,72.07),P<0.00001];可有效调节SCI后NB患者膀胱压力[MD=2.03,95%CI(1.07,3.00),P<0.0001],差异均具有统计学意义(P<0.05)。结论:灸法治疗SCI后NB患者,可有效减少膀胱残余尿量、增大膀胱容量、调节膀胱压力,临床疗效高,安全性较好,但绝对疗效还不确切,仍需大样本、高质量的随机对照试验进一步验证,为临床提供更可靠的循证依据。

Objective:To evaluate the efficacy and safety of moxibustion in the treatment of neurogenic bladder(NB)after spinal cord injury(SCI)by Meta analysis,so as to provide evidence-based basis for improving the prognosis of NB after SCI.Methods:Data were searched from the databases of PubMed,Cochrane Library,Web of science,EMbase,OVID,China National Knowledge Infrastructure(CNKI),China Biomedical Literature Database(CBMdisc),Wanfang Database(Wanfang Data)and Chinese Scientific Journal Database(VIP).The patients with NB after SCI were included in the randomized controlled trial(RCT)who were treated with moxibustion at home and abroad.The retrieval time for each database was from the established time to May 31,2019,and the references of related literatures were traced back at the same time.The total effective rate was the primary outcome indicator.Residual urine volume,bladder capacity and bladder pressure were the secondary outcome indicators.Two researchers screened literature,extracted data and evaluated the quality of the literature,and analyzed the data using RevMan 5.3 software.According to the systematic review manual provided by the Cochrane Collaboration Network,continuous variables use mean difference(MD)and 95%confidence interval(CI)as indicators,and binary variables use risk ratio(RR)and 95%CI as indicators.The statistical heterogeneity was judged comprehensively by chi-square(χ2)test and Heterogeneity test(I2 test).If P≥0.1 and I2≤50%,a fixed effects model would be used.In contrast,if P<0.1 or I2>50%,a random effects model would be used.Results:A total of 12 Chinese RCT literatures were included.There were 740 subjects,including the experimental group(n=370)and the control group(n=370).The results of Meta analysis showed that the total effective rate of neurogenic bladder after spinal cord injury in the experimental group was higher than that in the control group[RR=1.38,95%CI(1.25,1.52),P<0.00001],could reduce the residual urine volume of NB patients after SCI[urodynamic test group:MD=-37.00,95%CI(-43.48,-30.53),P<0.00001;B-scan ultrasonography inspection group:MD=-29.88,95%CI(-36.26,-23.50),P<0.00001;urethral catheterization group:MD=-33.28,95%CI(-57.03,-9.53),P=0.006],could increase the bladder capacity of patients with NB after SCI[urodynamic test group:MD=50.73,95%CI(14.47,87.00),P=0.006;B-scan ultrasonography inspection group:MD=51.07,95%CI(30.06,72.07),P<0.00001],and could effectively regulate the bladder pressure of NB patients after SCI[MD=2.03,95%CI(1.07,3.00),P<0.0001],and the difference was statistically significant(P<0.05).Conclusion:Moxibustion can effectively reduce bladder residual urine volume,increase bladder capacity and regulate bladder pressure in patients with NB after SCI.It has high clinical efficacy and high safety,but the absolute effect is not exact.It still needs to be further verified by large samples and high-quality randomized controlled trials to provide more reliable evidence-based basis for clinical practice.