1.广州中医药大学第一临床医学院,广东省广州市白云区机场路12号,510405
2.广州医科大学附属中医医院
3.广州中医药大学华南针灸研究中心
4.广州中医药大学第一附属医院
5.深圳市南山区中医院
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收稿:2023-02-26,
修回:2023-06-20,
纸质出版:2023-09-02
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纪铠松,佘雅琳,陈悦轩等.针刺结合耳穴贴敷治疗中重度尼古丁依赖患者的随机对照临床研究[J].中医杂志,2023,64(17):1771-1776.
JI Kaisong,SHE Yalin,CHEN Yuexuan,et al.Acupuncture Combined with Auricular Acupoints Patches for Moderate to Severe Nicotine Dependence:a Randomized Controlled Study[J].Journal of Traditional Chinese Medicine,2023,64(17):1771-1776.
纪铠松,佘雅琳,陈悦轩等.针刺结合耳穴贴敷治疗中重度尼古丁依赖患者的随机对照临床研究[J].中医杂志,2023,64(17):1771-1776. DOI: 10.13288/j.11-2166/r.2023.17.009.
JI Kaisong,SHE Yalin,CHEN Yuexuan,et al.Acupuncture Combined with Auricular Acupoints Patches for Moderate to Severe Nicotine Dependence:a Randomized Controlled Study[J].Journal of Traditional Chinese Medicine,2023,64(17):1771-1776. DOI: 10.13288/j.11-2166/r.2023.17.009.
目的
2
比较针刺结合耳穴贴敷与尼古丁透皮贴治疗中重度尼古丁依赖者的临床疗效和安全性。
方法
2
采用前瞻性随机对照试验,将符合中重度尼古丁依赖标准的64例自愿戒烟受试者通过随机数字表按1∶1分为治疗组和对照组,每组32例。治疗组采用针刺结合耳穴贴敷治疗,每周2次,4周为1个疗程,共进行2个疗程;对照组采用尼古丁透皮贴治疗,每天使用1个贴片,持续24 h,共治疗8周。疗程结束后观察两组治疗后、随访时(治疗后第16周)的治愈率;分别于治疗前后及随访时观察每日吸烟量、呼出一氧化碳(CO)值、尼古丁依赖量表(FTND)、明尼苏达尼古丁戒断症状量表(MNWS)、匹兹堡睡眠指数量表(PSQI)评分,并记录不良反应。
结果
2
治疗组与对照组各30例完成治疗及随访。治疗组治疗后及随访时的治愈均为6例(治愈率均为20%);对照组分别为7例(23.3%)、5例(16.7%);两组治疗后及随访时的治愈率比较差异均无统计学意义(
P
>0.05)。两组治疗后和随访时的每日吸烟量、呼出CO值与治疗前比较均明显减少,差异具有统计学意义(
P
<0.05);而两组治疗后和随访时的组间比较差异均无统计学意义(
P
>0.05)。两组治疗后及随访时FTND、MNWS、PSQI评分较治疗前分值明显降低(
P
<0.05)。治疗后及随访时,两组FTND评分比较差异无统计学意义(
P
>0.05),而治疗组MNWS、PSQI评分均低于对照组(
P
<0.05)。
结论
2
针刺结合耳穴贴敷干预中重度尼古丁依赖者在提高中重度尼古丁依赖治愈率、降低尼古丁依赖程度上与一线药物尼古丁贴疗效相当,在缓解戒断症状及改善睡眠等方面优于尼古丁贴,且长期效果稳定。
Objective
2
To compare the efficacy and safety of acupuncture combined with auricular acupoints patches and nicotine transdermal patch in treating moderate to severe nicotine dependence.
Methods
2
In a rando-mized controlled trial, 64 quit smoking voluntary subjects with moderate to severe nicotine dependence were randomly divided at a ratio of 1∶1 into a treatment group and a control group, with 32 cases in each group. The treatment group was given acupuncture combined with auricular acupoints patches, twice weekly, four weeks as a course for two courses. The control group was given nicotine transdermal patch, one patch per day for 24 hours, 8 weeks. The cure rate was assessed after treatment and at follow-up (the 16th week after treatment).The daily smoking volume, exhaled carbon monoxide (CO) value, Nicotine Dependence Scale (FTND), Minnesota Nicotine Withdrawal Symptoms Scale (MNWS), and Pittsburgh Sleepiness Index Inventory (PSQI) were evaluated before and after treatment and at follow-up, and adverse effects were recorded.
Results
2
In terms of the cure rate, there were both six cured cases (20%) after treatment and at follow-up in the treatment group, while in the control group, seven (23.3%) and five (16.7%) patients were cured after treatment and at follow-up, respectively, with no statistically significant differences between the two groups both after treatment and at follow-up (
P
>0.05). The daily smoking volume and exhaled CO value significantly decreased after treatment and at follow-up in both groups (
P
<0.05), but were not significantly different between the groups after treatment and at follow-up (
P
>0.05). After treatment and at follow-up, FTND, MNWS, and PSQI scores were significantly reduced in both groups compared with those before treatment (
P
<0.05). There was no statistically significant difference in the FTND scale scores between the two groups after treatment and at follow-up (
P
>0.05), while the MNWS and PSQI scale scores were lower in the treatment group than in the control group (
P
<0.05).
Conclusion
2
Acupuncture combined with auricular acupoint patches for moderate to severe nicotine dependence has comparable effect with the first-line drug nicotine patch in terms of increasing the cure rate and decreasing the degree of nicotine dependence, and is superior to nicotine patch in terms of relieving withdrawal symptoms and improving sleep, with stable long-term effect.
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