艾灸机器人治疗原发性痛经的有效性和安全性：一项随机对照初步试验。
Effectiveness and Safety of Moxibustion Robots on Primary Dysmenorrhea: A Randomized Controlled Pilot Trial.
机构信息
School of Acupuncture Moxibustion and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, China.
Department of Rehabilitation, Chengdu Fifth People's Hospital, Chengdu, 611130, China.
出版信息
Chin J Integr Med. 2021 Aug;27(8):578-584. doi: 10.1007/s11655-021-3287-8. Epub 2021 Apr 10.
OBJECTIVE
To conduct a pilot trial to explore the effectiveness and safety of moxibustion robots in treating primary dysmenorrhea (PD) and evaluate its feasibility in clinic.
METHODS
A total of 70 participants with PD were allocated to either moxibustion robot (MR) group (35 cases) or manual moxibustion (MM) group (35 cases) using computer-generated randomization. One acupoint Guanyuan (CV 4) was selected to receive moxa heat stimulation. Two groups of participants were given 3 menstrual cycles of MM and MR treatment respectively (once a day, 5 days a session) and received another 3 menstrual cycles follow-up. The degree of pain was evaluated by short-form McGill pain questionnaire (SF-MPQ) and the symptoms of dysmenorrhea were evaluated by Cox Menstrual Symptom Scale (CMSS). The safety was measured by the occurrence rate of adverse events (AEs), including burns (blisters, red and swollen), itching, bowel changes, menstrual cycle disorder, menorrhagia and fatigue, etc. RESULTS: A total of 62 patients completed the trial, 32 in MR group and 30 in MM group. Compared with baseline, scores of SF-MPQ and CMSS significantly decreased in both groups (P<0.05), and no significant difference was observed between the two groups in the 3rd and 6th menstrual cycles (P>0.05). The total occurrence rate of AEs in MR group was 2.1%, which was significantly lower than MM group (7.2%, P<0.05).
CONCLUSIONS
MR has the same effect as MM at SF-MPQ and CMSS in patients with PD. However, MR is safer than MM (Trial registration No. ChiCTR1800018236).
目的
开展一项探索艾灸机器人治疗原发性痛经（PD）有效性和安全性的初步临床试验，并评估其在临床上的可行性。
方法
共纳入 70 例 PD 患者，采用计算机生成的随机数分配至艾灸机器人（MR）组（35 例）或人工艾灸（MM）组（35 例）。选择单穴关元穴（CV 4）进行艾热刺激。两组患者分别接受 3 个月经周期的 MM 和 MR 治疗（每日 1 次，每次 5 天），并进行 3 个月经周期的随访。采用简短 McGill 疼痛问卷（SF-MPQ）评估疼痛程度，采用 Cox 月经症状量表（CMSS）评估痛经症状。通过不良事件（AE）发生率来衡量安全性，包括灼伤（水疱、红肿）、瘙痒、肠道变化、月经周期紊乱、月经过多和疲劳等。
结果
共有 62 例患者完成了试验，MR 组 32 例，MM 组 30 例。与基线相比，两组的 SF-MPQ 和 CMSS 评分均显著降低（P<0.05），但在第 3 和第 6 个月经周期时，两组间无显著差异（P>0.05）。MR 组的 AE 总发生率为 2.1%，明显低于 MM 组（7.2%，P<0.05）。
结论
MR 在原发性痛经患者的 SF-MPQ 和 CMSS 评分上与 MM 具有相同的疗效，但 MR 的安全性优于 MM（试验注册号：ChiCTR1800018236）。
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