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Effect of Intraoperative Multimodal Analgesia on the Early Postoperative Quality of Recovery in End-stage Head and Neck Cancer Patients Undergoing Open Gastrostomy: A Prospective Randomized Controlled Study
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摘要:目的 评估术中多模式镇痛在终末期头颈部癌症患者开腹胃造瘘术后早期恢复中的作用。方法 本研究为前瞻性、平行、随机对照研究，研究对象为2022年11月—2023年5月首都医科大学附属北京同仁医院择期行开腹胃造瘘术的终末期头颈部癌症患者。按1∶1比例随机将其分为局麻组和多模式镇痛组。局麻组术中予以0.25%罗哌卡因20~30 mL局部浸润麻醉；多模式镇痛组麻醉方式为神经阻滞+静脉镇痛：在超声引导下行左侧腹横肌平面阻滞(0.25%罗哌卡因0.3 mL/kg)+双侧腹直肌鞘阻滞(每侧注射0.25%罗哌卡因0.3 mL/kg)+静脉注射羟考酮0.1 mg/kg、氟比洛芬酯1 mg/kg和地塞米松0.2 mg/kg。主要结局指标为术后24 h 15项恢复质量量表(quality of requirements-15, QoR-15)评分，次要结局指标为术后48 h QoR-15评分，术后不同时间点静息时与运动时疼痛数字评定量表(numerical rating scale, NRS)评分和Bruggemann舒适量表(Bruggrmann comfort scale, BCS)评分，术后首次补救镇痛时间，首次下床活动时间，首次排气时间及术后48 h内不良反应发生率。结果 最终入选符合纳入与排除标准的行开腹胃造瘘术终末期头颈部癌症患者46例，其中多模式镇痛组、局麻组均为23例。两组术前QoR-15评分差异无统计学意义(P＞0.05)，多模式镇痛组术后24 h[(81.77±8.91)分比(71.46±7.61)分, P＜0.05]、48 h[(86.26±7.92)分比(80.13±6.98)分, P＜0.05]QoR-15评分均高于局麻组，且术后24 h QoR-15评分差异具有临床意义。与局麻组比较，术后6 h、24 h时，多模式镇痛组静息时与运动时NRS评分降低，舒适度BCS评分升高(P均＜0.05)。相较于局麻组，多模式镇痛组术后首次补救镇痛时间延后，术后48 h内补救镇痛发生率降低，术后首次下床活动时间与术后首次排气时间均提前(P均＜0.05)。多模式镇痛组、局麻组不良反应发生率分别为8.70%、13.04%，差异无统计学意义(P＞0.05)。结论 术中多模式镇痛可减轻开腹胃造瘘术患者术后早期疼痛，提高舒适度，缩短术后下床活动时间和排气时间，继而提升术后早期恢复质量。Abstract:Objective To evaluate the effect of intraoperative multimodal analgesia on the early postoperative quality of recovery in end-stage head and neck cancer patients undergoing open gastrostomy surgery.Methods This was a prospective, parallel, randomized controlled study. The research subjects were end-stage head and neck cancer patients who underwent elective open gastrostomy at Beijing Tongren Hospital affiliated to Capital Medical University from November 2022 to May 2023. The patients were randomly divided into local anesthesia group and multimodal analgesia group at a 1∶1 ratio. For local anesthesia group, 0.25% ropivacaine 20-30 mL was administered for local infiltration anesthesia. For multimodal analgesia group, the anesthesia method was nerve block + intravenous analgesia: ultrasound-guided left transverse abdominis plane block (0.25% ropivacaine 0.3 mL/kg)+bilateral rectus abdominis sheath block (0.25% ropivacaine 0.3 mL/kg per side)+intravenous injection of oxycodone 0.1 mg/kg, flurbiprofen 1 mg/kg, and dexamethasone 0.2 mg/kg. The primary outcome measure was the quality of requirements-15 (QoR-15) score at postoperative 24 h, while the secondary outcome measures were the QoR-15 score at postoperative 48 h, the numerical rating scale (NRS) and Bruggemann comfort scale (BCS) scores at different time points after the surgery, the first time of rescue analgesia, the first time of off-bed activity and intestinal exhaust, as well as the incidences of adverse reactions within postoperative 48 h.Results A total of 46 patients with end-stage head and neck cancer who underwent open gastrostomy and met the inclusion and exclusion criteria were ultimately enrolled, with 23 patients in multimodal analgesia group and 23 patients in local anesthesia group. There was no statistically significant difference in preoperative QoR-15 scores between the two groups (P > 0.05). Multimodal analgesia group had higher QoR-15 scores at 24 h postoperatively[(81.77±8.91) vs. (71.46±7.61), P < 0.05] and 48 h postoperatively[(86.26±7.92) vs. (80.13±6.98), P < 0.05], and the difference in QoR-15 scores at 24 h postoperatively was clinically significant. Compared with local anesthesia group, at 6 h and 24 h after surgery, the multimodal analgesia group showed a decrease in NRS scores at rest and during exercise, while the comfort BCS score increased (all P < 0.05). Multimodal analgesia group also had a delayed time for the first rescue analgesia, a reduced incidence of rescue analgesia within 48 h after surgery, an earlier time for first postoperative off-bed activity and intestinal exhaust (all P < 0.05). The incidence of adverse reactions in multimodal analgesia group and local anesthesia group was 8.70% and 13.04%, respectively, but the difference was not statistically significant (P > 0.05).Conclusion Intraoperative multimodal analgesia can effectively alleviate postoperative pain, increase the comfortable degree, shorten the first time of postoperative off-bed activity and intestinal exhaust, and accordingly improve the quality of early postoperative recovery in patients undergoing open gastrostomy.
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1. 临床资料
1.1 病例1
患者女性, 51岁, 因“右乳肌纤维母细胞瘤术后3年, 再发右乳肿物1月余”收住北京协和医院乳腺外科。
患者于2013年8月因右乳肿物于外院行右乳肿物切除术, 术后病理诊断“右乳肌纤维母细胞瘤”, 规律复查。2016年1月自觉原手术瘢痕下方可及肿物, 直径约5 cm, 质韧, 边界欠清, 活动度尚可, 无乳腺疼痛及乳头溢液等症状; 2周后, 自觉肿物显著增大, 直径达10 cm, 遂至北京协和医院就诊。
乳腺超声检查示右乳4个象限见巨大低回声:边缘分别位于2点距乳头约3 cm、12点距乳头约5.5 cm、9点距乳头约11 cm、6点距乳头约3.6 cm、5点距乳头约1.2 cm处, 前后径约4 cm, 边界清蜥, 内部回声不均; 彩色多普勒血流显像示周边及内部有数条血流信号; 双侧腋下未见明确肿大淋巴结。右乳巨大实性占位, 结合病史初步考虑乳腺间质细胞来源肿瘤。乳腺钼靶检查:右乳见一巨大稍低密度肿块, 大小约5.9 cm×9.5 cm, 边界清晰; 双腋下未见明显肿大淋巴结; 考虑右乳巨大占位, 间叶肿瘤复发; 乳腺影像报告和数据系统4类。
患者于2016年3月行右乳肿物局部扩大切除术, 术中切除肿瘤组织及肿瘤周围部分正常组织, 术中未处理腋窝淋巴结, 手术过程顺利, 术后恢复良好。术后乳腺肿物病理免疫组化结果:AE1/AE3(-), Bcl-2(-), CD117(-), CD34(+), Caldesmon(-), Calponin(+), Desmin(-), ER(-), Ki-67(index 10%), MyoD1(-), PR(-), S-100(-), Vimentin(+), beta-catenin(胞浆+), CD31(血管+), D2-40(+), F8-R(+); 结合形态学表现, 肿物免疫组化上皮标志物(-)、CD34染色(+), 且具有较多核分裂, 病理诊断为右乳恶性梭形细胞肿瘤(图 1), 考虑为恶性孤立性纤维性肿瘤(solitary fibrous tumor, SFT)(核分裂20/10HPF); 术后未行辅助治疗, 随访至今肿瘤无复发表现。
1.2 病例2
患者男性, 63岁, 因“右乳肿物2年”于2013年2月收住北京协和医院乳腺外科。
患者于2011年自行触诊发现右乳肿物, 直径约10 cm, 无乳头溢液、乳腺疼痛等不适。乳腺超声检查示右侧乳腺外下象限可见低回声, 大小约9.3 cm×7.2 cm×3.5 cm, 呈分叶状, 边界尚清晰, 彩色多普勒血流显像示局部可见较丰富血流; 该结节外侧胸壁突起处可见混合回声, 无明确边界, 范围约6.3 cm×5.1 cm× 2.6 cm, 可见少许血流, 左侧未见明确腺体结构; 双侧腋下未见明显异常肿大淋巴结, 考虑右乳实性结节, 乳腺影像报告和数据系统4类, 右胸壁混合回声包块。
于局麻下行右乳肿物切除术, 术中切除肿瘤组织及周围部分正常组织, 未处理腋窝淋巴结, 手术过程顺利。免疫组化结果:Actin(-), CD31(+), CD34(+), CD68(+), HMB45(-), S-100(-), SMA(-), Vimentin(+), Ki-67(index约7%); 结合免疫组化结果, 病理诊断(右胸壁)SFT(低度恶性, 核分裂2/10HPF, 可见多形性肿瘤细胞), 术后未予辅助放化疗。
2013年8月, 患者再次出现右胸壁肿物, 未予诊治, 其后肿物逐渐增大, 伴胸壁皮肤红肿, 于2015年9月在外院行右乳肿物局部扩大切除术; 2016年6月, 患者再次出现局部复发, 多发肿物, 于外院行右乳腺及胸壁肿物扩大切除(包括部分胸肌及肋骨组织)。目前尚无远处转移证据。
2. 讨论
SFT是一类少见的特殊类型梭形细胞肿瘤, 其发生率在各类软组织肿瘤中小于2%[1]。SFT多发于成人, 高发年龄约为60岁, 其发病部位以胸腔为主, 其次为腹腔, 中枢神经系统及其他软组织亦有报道。目前报道的乳腺原发SFT不超过10例, 乳腺恶性SFT仅有1例[2]。SFT多数表现为无痛性肿物, 可呈分叶状, 以膨胀性生长为主。其临床表现与乳腺叶状肿瘤、纤维腺瘤及乳腺癌相似。病例2中, 患者近期出现肿物显著性增大, 提示病变为恶性可能, 这一临床表现与继往报道的1例乳腺恶性SFT类似[2]。SFT病理多表现为大量梭形细胞, 诊断需与其他类型乳腺间叶来源肿瘤, 如肌纤维母细胞瘤等相鉴别。
确诊SFT需依靠病理学检查, 免疫组化是与间皮瘤及其他肉瘤鉴别的重要手段, 与乳腺叶状肿瘤相类似, SFT往往不具备特征性影像学表现[3]。建议行肿瘤活检以获取病理, 细针穿刺活检仅能获得细胞学证据, 不能明确诊断; 粗针穿刺可明确诊断, 但因组织量有限, 可能难以准确判断SFT良恶性。SFT常见免疫组化特征为CD34, Bcl-2及CD99多呈阳性, Actin、S-100及上皮标记物(如上皮组织膜抗原, 小分子角质蛋白)等多为阴性[4]。恶性SFT的诊断应至少满足以下标准之一:(1)核分裂相大于4个/10HPF; (2)有出血或坏死; (3)肿瘤体积大于10 cm; (4)细胞数目增多(缺乏间质胶原, 细胞核增多及细胞拥挤); (5)细胞核呈多形性; (6)肿瘤组织突破假包膜形成间质浸润或侵犯血管[5]。本研究2例患者均符合SFT免疫组化特征, 病例1因细胞具有多形性, 病例2具有较高核分裂相(20/10HPF), 符合恶性SFT诊断标准。与其他软组织肉瘤相比, SFT中约30%基因表达有差异, DNA拷贝数变异较为少见; 其中表皮生长因子受体、人表皮生长因子受体-2、成纤维细胞生长因子受体1及JAK2等肿瘤相关激酶均有高表达, 且与SFT原发部位无关; 此外, SFT中可检测到干细胞标志ALDH1基因高表达。
针对各类型SFT, 手术完整切除是所有SFT治疗的主要手段[6]。鉴于目前乳腺恶性SFT相关报道较少, 参考非胸腔来源SFT相关研究, 手术完整切除为SFT治疗首选, 如出现局部肿瘤复发可考虑再次行手术切除。乳腺病灶处理可选择局部扩大切除或乳腺全切术; 鉴于恶性间叶组织来源肿瘤以血行播散为主要转移方式, 淋巴转移较为少见, 多项研究均未行区域淋巴结清扫。对于非胸腔来源SFT, 目前尚无研究证实辅助放疗及化疗可使患者获益; 对于不能彻底切除的病变可考虑予辅助放化疗。
约半数恶性SFT患者可通过手术彻底切除治愈。部分SFT含有未分化成分, 可转化成未分化型肉瘤, 并出现全身广泛转移。肿瘤大小、组织学分级、切缘阳性与否及病变部位为非胸腔来源肿瘤均为SFT复发的危险因素。鉴于文献报道部分患者可在发病后16个月出现肿瘤复发, 术后需进行规律随访监测。
作者贡献：胡春华负责病例收集、数据分析、论文初稿撰写；赵晓艳负责数据分析结果复核、文献查阅；吴黎黎、陈红芽、许鑫负责病例收集；王古岩负责研究设计及论文修订。利益冲突：所有作者均声明不存在利益冲突 -
表 1 两组患者一般临床资料比较
Table 1 Comparison of general data in two groups
组别 年龄
(x±s，岁)性别
(男/女，例)BMI
(x±s，kg/m2)ASA分级
(Ⅲ/Ⅳ，例)手术时间
(x±s，min)术中失血量
(x±s，mL)术中输液量
(x±s, mL)多模式镇痛组(n=23) 60.1±7.9 18/5 18.26±3.17 17/6 51.21±10.11 10.50±5.31 731.15±95.64 局麻组(n=23) 59.8±9.9 20/3 19.09±4.01 14/9 53.88±10.54 11.66±7.09 826.67±91.24 P值 0.316 0.697 0.358 0.345 0.698 0.883 0.209 BMI(body mass index)：体质量指数；ASA(American Society of Aneshesiologists)：美国麻醉医师协会 
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表 2 两组手术前后QoR-15评分比较(x±s，分)
Table 2 Comparison of QoR-15 scores before and after surgery in two groups(x±s, scores)
组别 术前 术后24 h 术后48 h 多模式镇痛组(n=23) 98.16±6.33 81.77±8.91# 86.26±7.92# 局麻组(n=23) 99.11±8.28 71.46±7.61*# 80.13±6.98*# QoR-15(quality of requirements-15)：15项恢复质量量表；*组间比较差异具有统计学意义(P＜0.05)，#组内与术前比较差异具有统计学意义(P＜0.05)
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表 3 两组术后NRS评分比较(x±s，分)
Table 3 Comparison of postoperative NRS scores in two groups (x±s, scores)
组别 术后6 h 术后24 h 术后48 h 多模式镇痛组(n=23) 静息时 1.3±0.6* 3.6±0.6* 3.1±0.7 运动时 1.7±0.5* 4.1±0.4*# 3.7±0.6# 局麻组(n=23) 静息时 2.9±0.5 4.0±0.5 3.2±0.6 运动时 4.7±0.7# 4.6±0.6# 4.0±0.5# NRS(numerical rating scale)：数字评定量表；*组间比较差异具有统计学意义(P＜0.05)；#组内同时间不同状态NRS评分比较具有统计学意义(P＜0.05)
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表 4 两组术后BCS评分比较(x±s，分)
Table 4 Comparison of postoperative BCS scores in two groups (x±s, scores)
组别 术后6 h 术后24 h 术后48 h 多模式镇痛组(n=23) 3.8±0.6* 1.8±0.5*# 2.3±0.6# 局麻组(n=23) 0.9±0.3 1.2±0.3# 2.2±0.5# BCS(Bruggrmann comfort scale)：Bruggemann舒适量表；*组间比较差异具有统计学意义(P＜0.05)；#与组内术后6 h比较，BCS评分差异具有统计学意义(P＜0.05)
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