Expert consensus on diagnosis and treatment of postpartum diastasis recti abdominis
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摘要:
产后腹直肌分离(DRA)是分娩后的常见疾病。受临床研究不够深入、宣教工作不够规范等因素影响, 多数患者和医护人员对产后DRA的认识不足，其相关功能障碍和伴随症状易被忽略或与其他疾病混淆。本专科共识认为产后DRA的发病率和危害性仍被严重低估。本编写组通过对产后DRA相关基础理论和病理生理机制的深入研究，全面总结临床规范化诊疗经验，阐明相关解剖学基础、生物力学特征及影响因素; 创建产后DRA的诊断标准、分型和分类标准; 创立手法按摩治疗路径的技术流程、服务规范、质量标准、安全质控和疗效标准; 建立规范化临床综合康复治疗方案和科学合理的疗效评判标准; 多项规范和标准填补了国内空白，对指导和规范产后DRA的诊疗具有重要的意义。
Abstract:Postpartum diastasis recti abdominis (DRA) is a common disease after delivery. Influenced by factors such as inadequate clinical researches and non-standard propaganda and education, most patients and medical staff have insufficient understanding of postpartum DRA, and its related dysfunction and accompanying symptoms are easily ignored or confused with other diseases. The expert consensus believes that the incidence rate and harmfulness of postpartum DRA are still seriously underestimated. Through in-depth study on the basic theory and pathophysiological mechanism of postpartum DRA, this compiling group comprehensively summarized the clinical standardized diagnosis and treatment experience, clarified the relevant anatomical basis, biomechanical characteristics and influencing factors, and created diagnostic criteria, typing and classification criteria for postpartum DRA. Besides, we established the technical process, service specification, quality standard, quality control of safety and efficacy standard of manual massage therapeutic approach, created standardized clinical comprehensive rehabilitation therapeutic plan and scientific and reasonable evaluation standard for curative effect. A number of norms and standards have filled the gap in our country, and are of great significance to guide and standardize the diagnosis and treatment of postpartum DRA.
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系统性红斑狼疮(SLE)是累及多器官的自身免疫病, 超过50%的患者合并狼疮性肾炎(LN), 表现为蛋白尿、活动性尿沉渣、高血压、肾功能不全等一系列合并症[1]。糖皮质激素及免疫抑制剂已经广泛应用于治疗LN, 生物制剂、免疫吸附等有一定疗效。难治性LN是指经过适当的免疫抑制诱导治疗后，患者的肾脏始终不能获得临床缓解，该类患者进展为终末期肾脏疾病和死亡的风险显著增加。研究[2]显示，常规的免疫抑制剂治疗不能显著改善难治性LN预后，且长期使用糖皮质激素及免疫抑制剂的副反应较大，如医源性皮质醇增多症以及骨质疏松、继发感染，特别是真菌、结核感染[3]。研究[4-5]表明，脐带间充质干细胞(UC-MSC)具有高增殖和扩增能力，在自身免疫病治疗中有广阔的应用前景。研究[6]显示, UC-MSC治疗LN具有良好的安全性和有效性。本研究分析UC-MSC治疗难治性LN患者的远期疗效及安全性，并分析影响其预后的危险因素，现报告如下。
1. 资料与方法
1.1 一般资料
纳入2012年1月—2019年3月在南京鼓楼医院接受UC-MSC治疗的难治性LN患者92例为研究对象。所有患者符合2019年美国风湿病学会(ACR)修订的SLE分类诊断标准[7], 同时存在肾脏损害，具体表现为: ①肾功能下降[血肌酐(SCr)>106 μmol/L], 或24 h蛋白尿>0.5 g, 或显微镜下血尿(定义为>10个红细胞每高倍镜视野); ②根据国际肾脏病学会/肾病理学学会的标准肾活检符合Ⅲ型、Ⅳ-S或Ⅳ-G、Ⅳ型、Ⅴ型、Ⅲ+Ⅴ型或Ⅳ+Ⅴ型[8]; ③泼尼松维持量≥10 mg/d; ④环磷酰胺累计使用6 g无效，或其他免疫抑制剂(环孢素A、硫唑嘌呤、霉酚酸酯等)足量治疗3个月无效。本研究经医学伦理委员会批准同意，并符合现行的良好临床实践标准和《赫尔辛基宣言》所规定的原则。
1.2 方法
所有患者每次给予(1~2)×106个细胞/kg体质量静脉输注，输注时间为30~60 min。根据病情缓解情况部分患者可给予UC-MSC重复输注治疗。
根据3年后随访结果，将45例取得持续肾脏缓解的患者纳入有效组, 47例未缓解或复发的患者纳入无效组。比较2组患者基线资料、各项实验室指标，分析影响预后的因素。
1.3 观察指标
移植中及移植后1周内观察患者有无发热、寒战、皮疹、皮肤瘙痒、呼吸困难、胸闷、静脉炎等不良反应，并对其严重程度进行记录。记录患者移植前的实验室检查结果与一般情况，包括性别、年龄、病程、24 h尿蛋白水平、SCr、肾小球滤过率(eGFR)、血清白蛋白水平、补体C3、补体C4、抗ds-DNA抗体、抗核抗体(ANA)、系统性红斑狼疮疾病活动指数(SLEDAI) 评分、英国狼疮评定组(BILAG)肾脏评分等。治疗后(3、6、12、24及36个月)实验室指标的变化: 包括24 h尿蛋白水平、SCr。
完全缓解(CR): 24 h尿蛋白定量 < 0.4 g, 无活动性尿沉渣(尿红细胞计数>10万/mL或尿白细胞>5个/HP或红细胞管型)，血白蛋白>35.0 g/L, SCr正常或上升不超过基础值15%; 部分缓解(PR): 24 h尿蛋白定量下降至基础值50%以下且 < 3.0 g, 血白蛋白≥30.0 g/L, SCr正常或上升不超过基础值15%; 未缓解(NR): 未达到CR或PR标准。肾脏复发: CR患者24 h尿蛋白定量≥1.0 g, PR患者24 h尿蛋白定量上升≥2.0 g。
1.4 统计学分析
采用SPSS 21.0软件进行数据处理，生存质量分析采用Kaplan-Meier统计方法; 计数资料采用[n(%)]表示; 服从正态性分布的计量资料采用(x±s)表示，组间比较采用独立样本t检验; 不符合正态分布计量资料用[M(P25, P75)]描述，组间比较用Mann-Whitney U检验; 计数资料2组间的差异性采用卡方检验进行分析。所有检验均为双侧，检验水准α=0.05, P < 0.05表示差异有统计学意义。
2. 结果
2.1 病例特点
92例难治性LN患者均对常规方案无效。92例难治性LN患者中，女81例，男11例; 年龄12~63岁，平均29.9岁; 病程1~262个月，平均61个月，见表 1。
表 1 92例难治性LN患者的基线资料(x±s)[n(%)]病例特点 结果 平均年龄/岁 29.9 平均病程/月 61.0 性别 男 81(88.0) 女 11(12.0) 24 h尿蛋白/mg 4 738.8±480.1 血肌酐/(μmol/L) 141.6±13.4 补体C3/(g/L) 0.7±0.2 补体C4/(g/L) 0.2±0.1 抗ds-DNA抗体 75(81.5) ANA阳性 82(89.1) 并发疾病/症状 血液系统疾病 10(10.9) 皮疹 48(52.2) 关节炎 32(34.8) 狼疮性脑病 4(4.3) 肺动脉高压 11(12.0) 心包积液 13(14.1) 间质性肺炎 7(7.6) 既往用药史 羟氯喹 76(82.6) 环磷酰胺 68(73.9) 吗替麦考酚酯 43(46.7) 他克莫司 29(31.5) 2.2 总生存率、肾脏缓解率及复发率
所有患者随访3年, 4例患者死亡, 13例患者需透析维持，总生存率为95.7%(88/92)。治疗3个月后为23.9%(22/92)患者达到肾脏缓解; 治疗6个月后为37.0%(34/92); 治疗12个月后为40.2%(37/92); 治疗24个月后为47.8%(44/92); 治疗36个月后为48.9%(45/92)患者达肾脏缓解(图 1A)。在治疗6个月后的随访中, 4例患者复发; 12个月后8例患者复发; 24个月后9例患者复发; 36个月后10例患者复发，见图 1B。所有患者UC-MSC输注过程中均无不适。1例在移植后3个月出现带状疱疹病毒感染，经过抗病毒治疗后好转; 2例患者在随访过程中发生真菌感染，经过抗真菌治疗后好转; 1例患者1年后出现手指皮肤溃疡感染; 1例患者2年后发生骨梗死; 1例患者5年后行肾移植; 1例患者在随访过程中发生单侧肾癌，并行手术切除，以上事件均与UC-MSCT治疗无关。
2.3 SLE疾病活动度缓解及肾脏缓解
难治性LN患者经UC-MSC治疗前SLEDA评分为(16.4±4.8)分，经UC-MSC治疗3个月后为(7.1±4.2)分，治疗6个月后为(6.9±4.6)分，治疗12个月后为(6.5±4.6)分，治疗24个月后为(6.1±4.6)分。经UC-MSC治疗3、6、12、24个月后, SLEDAI评分低于治疗前，差异有统计学意义(P < 0.05)。治疗36个月后SLEDAI评分[(5.1±3.6)分]低于治疗前及治疗3、6、12、24个月后，差异有统计学意义(P < 0.05), 见图 2A。
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图 2 UC-MSC治疗难治性LN患者各项指标变化情况A: 92例难治性LN患者治疗前后SLEDA评分; B: 92例难治性LN患者治疗前后BILAG评分; C: 92例难治性LN患者治疗前后24 h尿蛋白水平的变化; D: 39例SCr>106 μmol/L患者治疗前后的SCr水平变化。难治性LN患者治疗前BILAG肾脏评分为(9.3±2.3)分，治疗3个月后为(6.5±2.5)分，治疗6个月后为(5.8±2.6)分，治疗12个月后为(5.2±2.8)分，治疗24个月后为(4.5±2.9)分，治疗36个月后为(4.3±2.9)分。所有患者治疗36个月后的BILAG肾脏评分低于治疗前及治疗后3、6、12、24个月，差异有统计学意义(P < 0.05), 见图 2B。
难治性LN患者治疗前24 h尿蛋白为4 672 (4 738, 4 605) mg, 治疗3个月后为2 940(2 161, 3 218) mg, 治疗6个月后为2 691(2 559, 2 824) mg, 治疗12个月后为2 632(2 563, 2 701) mg, 治疗24个月后为2 545(2 559, 2 531) mg, 治疗36个月后为2 465(2 317, 2 614) mg。治疗3、6、12、24、36个月后的24 h尿蛋白水平低于治疗前，差异有统计学意义(P < 0.05)，见图 2C。
39例SCr>106 μmol/L患者治疗前SCr水平为(254±129) μmol/L, 治疗后3个月后为(228± 133) μmol/L, 治疗6个月后为(224±134) μmol/L, 治疗12个月后为(219±136) μmol/L, 治疗24个月后为(214±138) μmol/L, 治疗36个月后为(208±140) μmol/L。39例SCr>106 μmol/L的患者经治疗3、6、12、24、36个月后SCr水平低于治疗前，差异有统计学意义(P < 0.05), 见图 2D。
2.4 预后影响因素分析
3年随访结果显示，治疗前有效组和无效组患者性别、年龄、病程、24 h尿蛋白水平、血沉、血红蛋白、血清白蛋白、补体C3、补体C4、SLEDAI评分、抗ds-DNA抗体、ANA等指标比较，差异无统计学意义(P>0.05)。无效组SCr水平、BILAG肾脏评分高于有效组，基线eGFR值低于有效组，差异有统计学意义(P < 0.05), 见表 2。经COX多因素回归分析发现，基线eGFR水平低是影响预后难治性LN患者疗效的危险因素(P < 0.05), 见表 3。
表 2 92例难治性LN患者治疗前影响UC-MSCT疗效的因素(x±s)[M(P25, P75)][n(%)]指标 有效组(n=45) 无效组(n=47) t/χ2 P 性别 女 5(11.1) 6(12.8) 0.060c 0.807 男 40(88.9) 41(87.2) 病程/月 69.0(24.0, 102.0) 60.0(36.0, 120.0) -0.399b 0.690 年龄 33.2±12.1 30.2±11.5 -1.253 0.395 24 h尿蛋白/mg 3 018.0(1 812.5, 8 148.5) 2 900.0(1 460.0, 5 000.0) -0.887b 0.375 SCr/(μmol/L) 51.0(45.0, 105.0) 170.0(78.0, 268.0) -5.423b < 0.001 eGFR/(mL/min) 126.5(55.8, 151.5) 36.5(20.6, 81.1) -5.147 b < 0.001 血沉/(mm/h) 33.0(18.5, 61.0) 38.0(22.0, 54.0) -0.445b 0.656 血红蛋白/(g/L) 120.0(82.5, 126.0) 100.0(78.0, 120.0) -1.708b 0.088 血清白蛋白/(g/L) 28.3(33.9, 34.6) 31.2(25.3, 35.0) -1.203b 0.229 补体C3/(g/L) 0.71±0.23 0.70±0.24 -0.025a 0.980 补体C4/(g/L) 0.18(0.11, 0.29) 0.20(0.13, 0.30) -0.704b 0.481 SLEDAI评分/分 15.0(12.0, 17.0) 16.0(14.0, 18.0) -1.883 0.060 BILAG肾脏评分/分 8.0(7.0, 10.0) 11.0(9.0, 12.0) -4.396 < 0.001 抗ds-DNA抗体 阴性 7(15.6) 10(21.3) 1.549c 0.461 阳性 38(84.4) 37(78.7) ANA 阴性 5(11.1) 5(10.6) 4.128c 0.127 阳性 40(88.9) 42(89.4) SCr: 血肌酐; eGFR: 肾小球滤过率; SLEDAI: 系统性红斑狼疮疾病活动指数; BILAG: 英国狼疮评定组; ANA: 抗核抗体。
a: t检验; b: Mann-Whitney U检验; c: 卡方检验。表 3 COX多因素回归分析指标 B SE 瓦尔德 自由度 显著性 Exp(B) 95%CI 下限 上限 SLEDAI -0.007 0.033 0.043 1 0.835 0.993 0.931 1.060 BILAG评分 -0.035 0.087 0.166 1 0.684 0.965 0.814 1.144 eGFR 0.013 0.003 16.558 1 0.000 1.014 1.007 1.020 性别 -0.111 0.485 0.053 1 0.819 0.895 0.346 2.313 年龄 0.013 0.012 1.076 1 0.300 1.013 0.989 1.037 3. 讨论
UC-MSC因其低免疫原性/高增殖能力，被广泛应用于自身免疫病治疗[9], 来自异体的UC-MSC在体内先天性和适应性免疫反应中发挥强大的免疫调节能力[10], UC-MSC可以直接抑制抗原特异性T细胞的功能，也可以通过上调T-reg细胞和白细胞介素-10表达B细胞，从而抑制过度活化的T细胞[11]。研究[12]表明, UC-MSC可以分泌细胞外囊泡(EVs), 转移到受损细胞中，抑制组织损伤、减少炎症、抑制凋亡，诱导细胞增殖、促进自我修复和再生，修复受损的肾脏组织。研究[13]显示, UC-MSC可以通过上调耐受性树突状细胞(DCs)从而抑制LN的炎症。笔者既往报道了针对难治性LN患者随访12个月的临床研究结果，在为期1年的随访中，患者的总生存率为95.1%(77/81), 60.5%(49/81)的患者获得了肾脏临床缓解, 49例患者中有11例患者在11个月内出现肾脏复发[14]。本研究对更多UC-MSC治疗的难治性LN患者进行3年随访观察，发现UC-MSC可以有效改善难治性LN患者的远期预后，降低LN患者24 h尿蛋白和SCr水平，改善患者肾功能; 同时改善患者SLEDAI评分，具有显著疗效。动物实验[15]表明, UC-MSC可以显著降低狼疮小鼠的抗ds-DNA、ANA、Scr、尿素氮、尿蛋白和肾硬化评分水平。同时有研究[16]表明，肾内直接注射间充质细胞(MSC)可以下调炎症因子白细胞介素-1β、白细胞介素-17的水平，上调细胞毒性T淋巴细胞相关抗原4(CTLA-4)水平，从而减轻肾脏组织的炎症，有效改善狼疮肾炎小鼠生存率。一项研究[17]显示，健康供体的UC-MSC可以适当降低MRL/lpr小鼠的T淋巴细胞过度增殖，上调T-reg水平，并在8周后发现经过MSC移植的MRL/lpr小鼠的抗ds-DNA水平和24 h尿蛋白水平显著下降。研究[18]表明，羧基荧光素二乙酸琥珀酰亚胺酯标记的骨髓间充质干细胞可以迁移到肾脏，在24 h检测水平最高，并持续1周, 11周后仍可以在肾脏中检测到输注的MSC。亦有研究[19]显示，负责肾脏修复的基因和生长因子也参与了MSC给药后的肾脏修复。
研究[20-21]表明, UC-MSC可以显著改善SCr和抗ds-DNA抗体，改善肾脏的病理损伤，减少新月体形成，降低单核细胞趋化因子(MCP-1)和高迁移率组蛋白-1(HMGB-1)在MRL/lpr小鼠中的表达，并显示早期治疗比晚期治疗的MPL/plr小鼠具有更高存活率，且早期治疗比晚期治疗更能降低蛋白尿发生率。本研究比较有效组和无效组(起始未缓解和持续未缓解)治疗前的实验室指标显示, SCr、GFR、BILAG肾脏评分相对较好的患者能获得更好的疗效。这与笔者既往研究得出结论相似。COX多因素回归分析表明，低eGFR水平是影响UC-MSC治疗难治性LN效果的危险因素。
UC-MSC治疗难治性LN的疗效较佳，但仍需要更多的数据，如炎症细胞因子等来深入探讨MSC在LN中的作用。UC-MSC的基因异质性和复杂的细胞免疫调节、体液免疫调节作用也有待进一步探索。
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表 1 改良产后DRA分型
分型 指测法 尺测或超声 正常 1~ < 2指 > 1.5~2.0 cm 疑似 2指 > 2.0~ < 3.0 cm 轻度 > 2~3指 3.0~5.0 cm 中度 > 3~5指 > 5.0~7.0 cm 重度 > 5~7指 > 7.0~10.0 cm 特重度 > 7指 > 10.0 cm 
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表 2 改良产后DRA类型
类型 分类 DRA距离 脐上 脐环部 脐下 Ⅰ型 脐上分离 > 3.0 cm > 3.0 cm < 3.0 cm 脐上 > 脐环 > 3.0 cm < 3.0 cm Ⅱ型 脐下分离 < 3.0 cm > 3.0 cm > 3.0 cm < 3.0 cm > 3.0 cm 脐下 > 脐环 Ⅲ型 脐环部分离 < 3.0 cm > 3.0 cm < 3.0 cm Ⅳ型 全腹直肌分离 > 3.0 cm > 3.0 cm > 3.0 cm Ⅳ-a 脐上=脐下 Ⅳ-b 脐上 > 脐下 Ⅳ-c 脐下 > 脐上 Ⅴ型 “8”字分离型 > 3.0 cm < 3.0 cm > 3.0 cm 脐上 > 脐环 > 3.0 cm 脐下 > 脐环
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