FESS术后加用香菊胶囊与康复新液治疗慢性鼻窦炎伴有鼻息肉的对比研究

目的 评价对比慢性鼻窦炎伴有鼻息肉患者功能性鼻内镜手术后,分别加用香菊胶囊口服治疗与康复新液冲洗术腔治疗的有效性及安全性。 方法 选取择期行FESS治疗的90例CRSwNP患者,使用简单随机数字表法将其随机分成康复新组(n=30)、香菊组(n=30)、对照组(n=30)。所有患者均接受FESS及相同的术后常规处理。对照组在此基础上于FESS术后采取布地奈德鼻喷雾剂喷鼻治疗,香菊组在对照组基础上于FESS术后口服香菊胶囊治疗,康复新组在对照组基础上于FESS术后予以康复新液冲洗术腔,疗程均为12周。比较三组临床疗效、术后术腔黏膜转归情况、不良反应发生情况及随访复发情况。观察手术前后三组主观症状视觉模拟量表(VAS)评分和血清炎症因子［超敏C-反应蛋白(hs-CRP)、肿瘤坏死因子(TNF)-α、白介素(IL)-6和IL-10］水平变化,并进行统计分析。 结果 康复新组［96.7%(29/30)］、香菊组［93.3%(28/30)］和对照组［86.7%(26/30)］在总有效率上对比差异均无统计学意义(P>0.05)。随访12个月,康复新组和香菊组各失访1例,对照组失访2例。康复新组和香菊组的术后1年复发率分别为13.8%(4/29)、17.2%(5/29),低于对照组［28.6%(8/28)］,但差异均无统计学意义(P>0.05)。在术后1年复发率上,康复新组和香菊组比较,差异无统计学意义(P>0.05)。随着治疗时间的延长,三组主观症状VAS评分均逐渐降低(P<0.05)。康复新组和香菊组术后4、12周时主观症状VAS评分均显著低于对照组同期(P<0.05),且与香菊组同时点对比,康复新组术后4、12周时主观症状VAS评分均显著更低(P<0.05)。康复新组术后8周时术腔黏膜上皮化比率达65.6%(19/29),均显著高于香菊组及对照组同期［40.0%(12/30)、26.7%(8/30),P<0.05］。康复新组和香菊组术腔黏膜上皮化时间较对照组均显著缩短(P<0.05),且康复新组较香菊组对缩短术腔黏膜上皮化时间更有利(P<0.05)。随着治疗时间的延长,三组鼻内镜Lund-Kennedy评分均逐渐下降(P<0.05)。康复新组和香菊组术后8周时鼻内镜Lund-Kennedy评分较对照组同期均显著更低(P<0.05),且康复新组术后8周时鼻内镜Lund-Kennedy评分显著低于香菊组同时点(P<0.05)。康复新组和香菊组术后3、7、15 d时血清hs-CRP、TNF-α和IL-6含量均显著低于对照组同期(P<0.05),血清IL-10含量则较对照组同时点均显著更高(P<0.05);且康复新组术后3、7、15 d时以上血清炎症因子水平的改善效果均显著优于香菊组同期(P<0.05)。90例患者均无明显药物相关副作用发生。 结论 与加用香菊胶囊口服治疗相比,FESS术后在布地奈德鼻喷雾剂喷鼻治疗基础上加用康复新液冲洗术腔治疗在整体疗效、控制复发及安全性方面的优势均显著且相近,但加用康复新液冲洗更能快速减轻CRSwNP患者术后主观临床症状,加速术腔黏膜向良性方向转归,进一步缩短术腔黏膜上皮化时间,其作用机制可能是通过迅速纠正体内炎症因子失衡的途径来实现的。“布地奈德鼻喷雾剂喷鼻+康复新液冲洗术腔”有望成为FESS术后的标准治疗方案之一。

Comparative study of the Xiangju capsule and Kangfuxin liquid in the treatment of chronic rhinosinusitis with nasal polyps after functional endoscopic sinus surgery

Objective In order to evaluate the efficacy and safety of orally administered Xiangju Capsule and lavage with the Kangfuxin solution in patients with chronic rhinosinusitis with nasal polyps(CRSwNP)after functional endoscopic sinus surgery(FESS).Methods From January to December 2019,90 patients with CRSwNP were randomly divided into three groups:rehabilitation(n=30),Xiangju(n=30),and control(n=30).All patients underwent FESS and the same routine postoperative management.After FESS,the control,Xiangju,and Kangfuxin groups were treated with budesonide nasal spray,Xiangju capsule,and Kangfuxin solution,respectively.The course of treatment was 12 weeks.The clinical effects,postoperative mucosal outcome,adverse reactions,and recurrence were compared among the three groups.The visual analogue scale(VAS)score of subjective symptoms and levels of high-sensitivity C-reactive protein(hs-CRP),tumor necrosis factors,and interleukin(IL)-6 and IL-10 were measured before and after the operation.Results There was no significant difference in the total effective rate in 96.7%(29/30)of the rehabilitation group,93.3%(28/30)of the Xiangju group,and 86.7%(26/30)of the control group(P>0.05).Compared to the Xiangju group,there was no significant difference in the recurrence rate 1 year postoperatively in the group(P>0.05).As the treatment time prolonged,the VAS scores of subjective symptoms in all three groups gradually decreased(P<0.05).Four and 12 weeks postoperatively,the subjective symptom scores were significantly lower in the rehabilitation and Xiangju groups than in the control group(P<0.05)and in the rehabilitation group compared to the Xiangju group(P<0.05).Eight weeks postoperatively,the epithelialization rate was 65.5%(19/29)in the Kangfuxin group,which was significantly higher than that in the Xiangju or control group(40.0%12/30];26.7%8/30],P<0.05).Compared to the control group,the time of Mucosal epithelization in Kangfuxin group and Xiangju group was significantly shorter(P<0.05),and the time of mucosal epithelization in the Kangfuxin group was more favorable than that in the Xiangju group(P<0.05).The Lund-Kennedy score in all three groups decreased gradually with the treatment time(P<0.05).At the same time point,the Lund-Kennedy score in the rehabilitation and Xiangju groups were significantly lower than those in the control group(P<0.05)and in the rehabilitation group compared to the Xiangju group(P<0.05).The levels of serum hs-CRP,TNF,and IL-6 were significantly lower in the Kangfuxin and Xiangju groups than in the control group(P<0.05),and the levels of serum IL-10 were significantly higher in the Kangfuxin and Xiangju groups than in the control group(P<0.05).After 3,7,and 15 days,the improvement in serum inflammatory factors in the rehabilitation group was significantly better than that in the Xiangju group(P<0.05).There were no significant drug-related side effects in any patient.Conclusion Compared to the treatment with the oral Xiangju capsule,the overall efficacy,recurrence control,and safety of post-FESS nasal spray combined with budesonide nasal spray and Kangfuxin irrigation were similar.However,the clinical symptoms of patients with CRSwNP can be quickly alleviated using the Kangfuxin solution,which can speed up the improvement of the mucosa and further shorten the time of mucosal epithelization.The mechanism of action may be the rapid correction of the imbalance of inflammatory factors in the body.“Budesonide nasal spray plus rehabilitation fluid irrigation cavity”is expected to become a standard treatment after FESS.