Zhang Lu, Jiang Lei, Cheng Kai, Fu Jian-Hua, Jian-Wu Shen, Wang Ke-Jian, Song Yu-Juan, Meng Xian-Zhong, Xu Zhi-Xian, Chen Li-He, Guo Meng-Meng, Zhang Li-Juan, Zhang Li-Li, Shi Da-Zhuo
Xiyuan Hospital, China Academy of Chinese Medical Sciences, No. 1 Xiyuan Caochang Road, Haidian District, Beijing 100091, China.
Rehabilitation Department, Hannover Medical School, Carl-Neuberg-Strasse 1, Hannover 30625, Germany.
Evid Based Complement Alternat Med. 2020 Feb 20;2020:2975974. doi: 10.1155/2020/2975974. eCollection 2020.
To compare the efficacy and safety of pterygopalatine fossa puncture using one acupuncture needle inserted through the temporal fossa (intervention) and Chinese verum acupuncture (VA) in patients with moderate-to-severe persistent allergic rhinitis.
The patients were randomized to an intervention group receiving pterygopalatine fossa puncture with one acupuncture needle for 4 weeks (once or twice weekly, 4-8 sessions in total, with a second course performed if required) or to a control group receiving individualized VA for 4 weeks (twice weekly, eight sessions in total). Patients were followed up 4 weeks later.
Ninety-six participants were assigned to intervention ( = 48) or VA ( = 48) or VA ( > 0.05 in all cases). Compared with the VA, the time to onset of effect in the intervention group was shorter and the duration of effectiveness was longer. The mean clinical waiting time was significantly shorter in the intervention group than in the control group (6.640 ± 3.035 min and 31.19 ± 10.216 min, respectively). The total number of sessions in the VA group was 384; 7 episodes of subcutaneous bleeding occurred but did not require treatment. The total number of sessions in the intervention group was 185. Two cases of subcutaneous bleeding (one of local hematoma during the intervention and the other one of bruising in the palpebra inferior on the day after intervention) resolved upon withdrawal from the study.
Pterygopalatine fossa puncture using one acupuncture needle resulted in a shorter time to onset of effect, a longer duration of effectiveness, and less clinical waiting time when compared with VA. Though the significant differences for TNSS and TNNSS were shown within intervention and VA groups, there were no differences between the two groups. Although the rate of subcutaneous bleeding was low, these adverse events may influence patient compliance. This trial is registered with ISRCTN21980724.
比较经颞窝插入一根针灸针进行翼腭窝穿刺（干预组）与真穴针刺（VA）治疗中重度持续性变应性鼻炎的疗效和安全性。
将患者随机分为干预组，接受翼腭窝一根针灸针穿刺治疗4周（每周一次或两次，共4 - 8次，必要时进行第二疗程），或对照组，接受个体化真穴针刺治疗4周（每周两次，共8次）。4周后对患者进行随访。
96名参与者被分配至干预组（n = 48）或VA组（n = 48）（所有情况下P>0.05）。与VA组相比，干预组起效时间更短，疗效持续时间更长。干预组的平均临床等待时间显著短于对照组（分别为6.640±3.035分钟和31.19±10.216分钟）。VA组的总治疗次数为384次；发生7例皮下出血，但无需治疗。干预组的总治疗次数为185次。2例皮下出血（1例为干预期间局部血肿，另1例为干预后次日下睑瘀斑）在退出研究后自行缓解。
与VA相比，使用一根针灸针进行翼腭窝穿刺起效时间更短，疗效持续时间更长，临床等待时间更短。虽然干预组和VA组内TNSS和TNNSS有显著差异，但两组之间无差异。虽然皮下出血率较低，但这些不良事件可能影响患者的依从性。本试验已在ISRCTN21980724注册。
