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1.北京中医药大学针灸推拿学院,北京 100029
2.北京小汤山医院中西医结合康复科,北京 102211
3.北京体育大学运动医学与康复学院,北京 100084
4.北京市海淀区芙蓉里社区卫生服务站,北京 100080
5.北京中医药大学附属护国寺中医医院针灸科,北京 100035
王鼎,男,26岁,硕士研究生。研究方向:针灸的作用原理。
孟笑男,E-mail:mengxiaonan.cn@gmail.com
收稿日期:2024-08-09,
纸质出版日期:2025-03-25
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王鼎,赵百孝,孙洁,等.新型梅花温针灸器治疗卒中后便秘的临床疗效观察[J].北京中医药,2025,44(3):301-306.
WANG Ding,ZHAO Baixiao,SUN Jie,et al.Clinical efficacy of a novel plum-blossom needling with mild moxibustion device in treatment of post-stroke constipation[J]. Beijing Journal of Traditional Chinese Medicine,2025,44(03):301-306.
王鼎,赵百孝,孙洁,等.新型梅花温针灸器治疗卒中后便秘的临床疗效观察[J].北京中医药,2025,44(3):301-306. DOI: 10.16025/j.1674-1307.2025.03.008.
WANG Ding,ZHAO Baixiao,SUN Jie,et al.Clinical efficacy of a novel plum-blossom needling with mild moxibustion device in treatment of post-stroke constipation[J]. Beijing Journal of Traditional Chinese Medicine,2025,44(03):301-306. DOI: 10.16025/j.1674-1307.2025.03.008.
目的
2
观察新型梅花温针灸器治疗卒中后便秘(PSC)的临床疗效。
方法
2
收集2023年10月—2024年4月北京中医药大学附属护国寺中医医院、北京小汤山医院、北京市海淀区芙蓉里社区卫生服务站3家医疗机构针灸门诊及病房招募的PSC患者88例,采用分层区组随机法将受试者按1∶1的比例分为针灸组和对照组。针灸组给予新型梅花温针灸器治疗,对照组给予假新型梅花温针灸器治疗。对比2组每周完全自主排便次数;治疗前后及治疗后1个月随访时便秘患者症状自评量表(PAC-SYM)评分、Bristol粪便性状评分、改良Barthel指数量表评分、汉密尔顿焦虑量表(HAMA)评分;安全性(不良反应、针灸部位表皮温度、诊室内PM10质量浓度);末次治疗结束后用Jame's BI指数(JBI)评价总体盲法成功情况,Bang's BI指数(BBI)评价2组盲法成功情况。
结果
2
针灸组临床总有效率高于对照组(
P
<
0.05)。针灸组治疗后及随访时,CSBMs、Bristol粪便性状评分、改良Barthel指数量表评分均较治疗前升高(
P
<
0.05),PAC-SYM评分、HAMA评分均较治疗前降低(
P
<
0.05);对照组治疗后及随访时CSBMs、PAC-SYM评分、Bristol粪便性状评分与治疗前比较差异无统计学意义(
P>
0.05),改良Barthel量表评分较治疗前升高(
P
<
0.05),HAMA评分较治疗前降低(
P
<
0.05)。针灸组治疗后及随访时CSBMs、Bristol粪便性状评分、改良Barthel指数量表评分高于对照组(
P
<
0.05),PAC-SYM评分、HAMA评分低于对照组(
P
<
0.05)。治疗过程中2组均未出现烫伤、过敏等不良反应。针灸组患者表皮温度和诊室内PM10质量浓度均大于对照组(
P
<
0.05)。针灸组41例患者中,40例认为自己接受了新型梅花温针灸器治疗,1例认为自己接受假新型梅花温针灸器治疗;对照组42例患者中,28例认为自己接受了新型梅花温针灸器治疗,14例认为自己接受了假新型梅花温针灸器治疗。JBI值为0.36
,95%
CI
为0.30~0.43。针灸组BBI值为0.95,95%
CI
为0.87~1.00;对照组BBI值为-0.40,95%
CI
为-0.64~-0.16。
结论
2
使用新型梅花温针灸器治疗可明显提高卒中后便秘患者每周自主排便频率,改善排便困难程度和粪便性状,缓解患者的焦虑状况,提高其生活质量,并具有较好的安全性。本研究盲法效果良好。
Objective
2
To observe the clinical efficacy of the novel plum-blossom needling with a mild moxibustion device in treating post-stroke constipation (PSC).
Methods
2
From October 2023 to April 2024, a total of 88 PSC patients were recruited from the Acupuncture Clinics and inpatient departments of three medical institutions, i.e., Beijing Huguosi Traditional Chinese Medicine Hospital affiliated to Beijing University of Chinese Medicine, Beijing Xiaotangshan Hospital, and Beijing Furongli Community Health Care Centre in Haidian District, Beijing. The patients were randomized in a 1:1 ratio into the acupuncture-moxibustion group and the control group using stratified block randomization. The acupuncture-moxibustion group was treated with the novel plum-blossom needling with mild moxibustion device, while the control group received the sham device treatment. The outcomes assessed included the weekly complete spontaneous bowel movements (CSBMs), PAC-SYM score, Bristol stool form score, modified Barthel index score, and Hamilton Anxiety Scale (HAMA) score before and after treatment, and at a 1-month follow-up. Safety measures (adverse reactions, skin temperature at acupuncture-moxibustion points, and PM10 concentration in the clinic room) were also monitored. The overall blinding success rate was evaluated using the James Blinding Index (JBI), and the blinding success of both groups was assessed using the Bang Blinding Index (BBI).
Results
2
The clinical total effective rate in the acupuncture-moxibustion group was higher than in the control group (
P
<
0.05). After treatment and during follow-up, the a
cupuncture-moxibustion group showed significant improvements in CSBMs, Bristol stool form score, and modified Barthel index score compared to those before treatment (
P
<
0.05), while the PAC-SYM score and HAMA score significantly decreased (
P
<
0.05). In the control group, there were no statistically significant differences in CSBMs, PAC-SYM score, or Bristol stool form score after treatment and during follow-up compared to those before treatment (
P
>
0.05), but the modified Barthel index score increased (
P
<
0.05) and the HAMA score decreased (
P
<
0.05). After treatment and during follow-up, the acupuncture-moxibustion group had higher CSBMs, Bristol stool form scores, and modified Barthel index scores, and lower PAC-SYM and HAMA scores than the control group (
P
<
0.05). No adverse reactions such as burns or allergies were observed in either group. The acupuncture-moxibustion group had higher skin temperature and PM10 concentration in the clinic room compared to the control group (
P
<
0.05). In the acupuncture-moxibustion group (41 patients), 40 patients believed they received treatment with the novel plum-blossom needling with mild moxibustion device, and 1 patient believed they received the sham device. In the control group (42 patients), 28 patients believed they received treatment with the novel device, and 14 patients believed they received the sham device. The JBI value was 0.36 (95%
CI
: 0.30-0.43). The BBI value for the acupuncture-moxibustion group was 0.95 (95%
CI
: 0.87-1.00), while the BBI value for the control group was -0.40 (95%
CI
: -0.64 to -0.16).
Conclusion
2
The novel plum-blossom needling with a mild moxibustion device significantly improves the frequency of CSBMs, alleviates the degree of constipation, improves stool form, reduces anxiety, and enhances the quality of life in PSC patients, with good safety. The blinding effect of the study was successful.
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