The paper summarizes the authorized invention patents, device registration and the relevant published articles of acupuncture medical devices of TCM in recent 5 years, and analyzes the current status and challenges in this field. It is discovered that the optimization and substitution in diagnosis and treatment of acupuncture are involved in the development of acupuncture medical devices. The technology application of these devices are composed of traditional and emerging engineering technologies; and the theoretical guidance for their development requires the integration of traditional acupuncture principles with modern medical theories. The development of acupuncture medical devices highlights the characteristics of multidimensional integration, treatment for specific ailments, portability and wearability, painlessness and non-invasion, precision and personalization, as well as intelligent automation. Upon analysis, it is shown that in the development and product transformation of acupuncture medical devices in recent years, the theoretical principles of acupuncture of TCM have not been fully utilized yet, the transformation of patented product is low, the clinical evidence of product is insufficient, and the market competitiveness needs improvement. In the future, The theoretic guidance of acupuncture of TCM should be enhanced in the development of acupuncture medical devices, a production-education- research model with the combination of medicine and engineering be constructed, clinical verification of product be emphasized, and product development paradigms be advanced, so as to meet the demands of the medical market.

OBJECTIVE:To observe the effect of Fu's subcutaneous needling in the treatment of non-acute idiopathic facial paralysis and its effect on serum levels of nitric oxide (NO) and endothelin (ET). METHODS:A total of 76 patients with non-acute idiopathic facial paralysis were randomly divided into an observation group (38 cases, 2 cases dropped out) and a control group (38 cases, 2 cases dropped out). The patients in the control group received basic treatment (mecobalamin tablets orally, specific electromagnetic spectrum irradiation, facial muscle rehabilitation training). The patients in the observation group were treated with Fu's subcutaneous needling on the basis of the control group. The needling points included brachioradialis muscle, sternocleidomastoid muscle, trapezius muscle, etc., and the needling was inserted around the affected muscle, and the reperfusion activity was carried out at the same time, once every other day, 3 times a week. Both groups were treated for 4 weeks. The House-Brackmann (H-B) grade and H-B symptom score were observed before treatment, after 2 and 4 weeks of treatment in the two groups. The facial disability index (FDI) score [including physical function (FDIP) score and social life function (FDIS) score] and the serum levels of NO and ET were compared before and after 4 weeks of treatment in the two groups. The clinical effect and safety of the two groups were assessed. RESULTS:After 2 and 4 weeks of treatment, the H-B grade of the two groups was lower than that before treatment, and the H-B symptom scores were higher than those before treatment (P<0.001, P<0.05); the H-B grade of the observation group was lower than that of the control group, and the H-B symptom score was higher than that of the control group (P<0.01, P<0.05). After 4 weeks of treatment, the FDIP scores of the two groups were higher than those before treatment, and the FDIS scores were lower than those before treatment (P<0.05 ); the FDIP score of the observation group was higher than that of the control group, and the FDIS score was lower than that of the control group (P<0.05). After 4 weeks of treatment, the serum level of NO in the observation group was higher than that before treatment, and the serum level of ET was lower than that before treatment (P<0.05); the increase of serum level of NO and the decrease of serum level of ET in the observation group were greater than those in the control group (P<0.05). The cure rate of the observation group was 55.6% (20/36), which was higher than 22.2% (8/36) of the control group (P<0.05). There were no serious adverse reactions in both groups. CONCLUSION:Fu's subcutaneous needling combined with basic treatment can effectively improve the motor function of facial muscles in patients with non-acute idiopathic facial paralysis, which may be related to the regulation of serum NO and ET levels.

OBJECTIVES:To observe the efficacy of napex acupoint thread-embedding combined with metoprolol tartrate tablet for prophylactic treatment of migraine without aura, and to compare its efficacy with simple napex acupoint thread-embedding and simple metoprolol tartrate tablet. METHODS:A total of 105 patients with migraine without aura were randomized into a combination group (35 cases, 5 cases dropped out), a thread-embedding group (35 cases, 4 cases dropped out) and a western medication group (35 cases, 2 cases dropped out). In the thread-embedding group, napex acupoint thread-embedding was applied at bilateral Fengchi (GB 20) and points of 1.5 cun nearby to the lower edge of spinous process of cervical 2. In the western medication group, metoprolol tartrate tablet was given orally, 12.5 mg a time, twice a day. In the combination group, napex acupoint thread-embedding combined with oral metoprolol tartrate tablet was delivered. The treatment of 8 weeks was required in the 3 groups. The days of headache attacks, frequency of headache attacks, headache severity (visual analogue scale [VAS] score) and the migraine specific quality of life questionnaire version 2.1 (MSQ) score were observed during baseline period (4 weeks before treatment to before treatment), observation period (1-4 weeks and 5-8 weeks in treatment) and follow-up period (1-4 weeks after treatment completion) respectively, the proportions of the days of headache attacks/frequency of headache attacks relieved by 50% were calculated, and the safety was evaluated in the 3 groups. RESULTS:During the observation period and the follow-up period, the days of headache attacks, frequency of headache attacks and headache VAS scores in the 3 groups were reduced compared with those of the baseline period (P<0.05). During the observation period and the follow-up period, the days of headache attacks and the frequency of headache attacks in the combination group were lower than those in the thread-embedding group and the western medication group (P<0.05); during the observation period (1-4 weeks in treatment), the headache VAS scores in the combination group and the thread-embedding group were lower than that in the western medication group (P<0.05); during the observation period (5-8 weeks in treatment) and the follow-up period, the headache VAS scores in the combination group were lower than those in the thread-embedding group and the western medication group (P<0.05). During the observation period and the follow-up period, the scores of role restriction, role prevention and emotion function of MSQ in the combination group were increased compared with those of the baseline period (P<0.05); during the observation period (5-8 weeks in treatment) and the follow-up period, the role prevention scores of MSQ in the thread-embedding group and the western medication group were increased compared with those of the baseline period (P<0.05); during the follow-up period, the emotion function scores of MSQ in the thread-embedding group and the western medication group were increased compared with those of the baseline period (P<0.05). During the observation period and the follow-up period, the scores of role restriction, role prevention and emotion function of MSQ in the combination group were higher than those in the thread-embedding group and the western medication group (P<0.05). There was no statistical difference in the proportions of the days of headache attacks/frequency of headache attacks relieved by 50% among the 3 groups (P>0.05), and there were no serious adverse reactions in the 3 groups. CONCLUSIONS:Napex acupoint thread-embedding combined with metoprolol tartrate tablet, simple napex acupoint thread-embedding and simple metoprolol tartrate tablet all can reduce the days of headache attacks and the frequency of headache attacks, relieve headache severity and improve the quality of life in patients with migraine without aura. Napex acupoint thread-embedding combined with metoprolol tartrate tablet has a better effect.

OBJECTIVE To observe the therapeutic effect of horizontal penetration needling combined with rizatriptan monobenzoate tablets, simple horizontal penetration needling and simple rizatriptan monobenzoate tablets for migraine without aura in acute stage. METHODS A total of 99 patients with migraine without aura in acute stage were randomized into an acupuncture plus medication group, an acupuncture group and a western medication group, 33 cases in each one. In the acupuncture group, horizontal penetration needling was applied once at Hanyan (GB 4) to Xuanli(GB 6), Shenting (GV 24) to Yintang (GV 29), Baihui (GV 20) to Qianding (GV 21), etc. for 2 h. In the western medication group, oral rizatriptan monobenzoate tablets for 10 mg were given once. In the acupuncture plus medication group, treatment of acupuncture combined with rizatriptan monobenzoate tablets were given, the application was the same as the acupuncture group and the western medication group. Before treatment and 0.5, 2, 24 h after treatment, the visual analogue scale (VAS) score was observed, the remission rate and the disappearance rate of migraine of 2, 24 h after treatment were compared in the 3 groups. RESULTS Compared before treatment, the VAS scores of each time point after treatment were decreased in the 3 groups (P<0.05), and the changes in the acupuncture plus medication group were greater than those in the acupuncture group and the western medication group (P<0.05). The remission rates of 24 h after treatment and the disappearance rates of migraine of 2, 24 h after treatment in the acupuncture plus medication group were higher than those in the acupuncture group and the western medication group (P<0.05). CONCLUSION Horizontal penetration needling combined with rizatriptan monobenzoate tablets have significant therapeutic effect on rapid analgesia and continuous analgesia for migraine without aura in acute stage, its effect is superior to simple horizontal penetration needling and simple rizatriptan monobenzoate tablets.

目的:观察浮针配合再灌注活动治疗原发性痛经的临床疗效.方法:将64例原发性痛经患者随机分为治疗组和对照组,每组32例.治疗组予浮针配合再灌注活动治疗,对照组予布洛芬口服.2组均治疗3个月经周期.采用疼痛视觉模拟评分法(VAS)评价2组患者治疗前、治疗后30?min、12?h及疗程结束后的疼痛程度;采用COX痛经症状量表(CMSS)评价2组患者治疗前后痛经的症状改善情况.结果:2组患者治疗后30?min、12?h及疗程结束后VAS评分均较治疗前明显降低(P<0.05),且治疗组治疗后各时间点评分均明显低于对照组(P<0.05);2组治疗后CMSS评分均较治疗前明显降低(P<0.05),且治疗组评分明显低于对照组(P<0.05);2组不良反应发生率比较无统计学差异(P>0.05).结论:浮针配合再灌注活动治疗原发性痛经在急性期镇痛及痛经症状改善方面均优于口服西药治疗,且安全性良好.

目的:比较微针针刺眼睑局部联合常规针刺与常规针刺治疗面瘫恢复期眼睑闭合不全的临床疗效.方法:将100例面瘫恢复期眼睑闭合不全患者随机分为观察组和对照组,每组50例.对照组采用常规针刺方法,穴取患侧攒竹、阳白、瞳子髎、四白等.观察组在对照组基础上加用眼睑局部微针针刺.两组均每日治疗1次,留针30 min,每周5次,治疗4周后评定疗效.结果:治疗后,观察组总有效率为94.0％(47/50),高于对照组的78.0％(39/50,P<0.05).结论:眼睑针联合常规针刺能促进面瘫恢复期眼睑闭合功能的恢复,疗效优于常规针刺.

患者,男,72岁,退休职工,于2017年7月10日初诊.主诉:双侧胁肋部、右侧头颞部疼痛反复1年余,加重1个月.现病史:患者于2002年发现右侧肾癌,行右肾切除术后,一般情况良好,1年前患者自觉牙齿颜色变深,全身多处疼痛,遂于南京市第一医院查核素骨显像示:多发骨代谢异常;考虑多发骨转移可能.患者拒绝行放化疗,长期口服曲马多缓解疼痛,疗效不显.2017年6月9日于南京市中医院体检时查MRI示:①右侧第7、9肋骨,左侧第8肋骨及右侧肩胛骨破坏,左侧第6肋骨前段骨破坏伴皮下软组织肿块;②肾癌切除术后改变;胆囊结石.癌胚抗原(CEA):19.04 ng/mL;肾功能:肌酐(Crea):142.0 μmol/L,尿酸(UA):453.0 μmol/L;心电图:完全性右束支传导阻滞.刻下症:双侧胁肋部、右侧头颞部及背部疼痛明显,疼痛视觉模拟量表(VAS)评分为8～9分,四肢活动不受限,精神差,纳少,二便调,夜间疼痛明显,影响睡眠;舌尖红、苔黄腻,脉弦数.

目的 探讨女性压力性尿失禁患者电针适应症.方法 将32例女性压力性尿失禁患者按照3因素2水平的正交设计表L8 (27)随机分为8组,每组4例,予电针中髎、会阳穴治疗,隔日1次,每周治疗3次,共治疗8周.以1h尿垫试验漏尿量和国际尿控协会调查问卷(ICI-Q-SF)评分为指标,观察患者A(年龄:40～60岁、61～75岁)、B(膀胱残余尿量:0ml、1～30ml)、C(最大尿流率:＞30ml/s、20～30 ml/s)对电针疗效的影响. 结果 电针治疗后1h尿垫试验漏尿量直观分析值:RA=1.250、RB=0.300、RC =0.225;ICI-Q-SF评分直观分析值:RA=3.213、RB=2.413、RC=0.088.三因素间比较无统计学意义(P＞0.05).1h尿垫试验漏尿量提示最佳方案为年龄61 ～ 75岁,膀胱残余尿量0 ml,最大尿流率30 ml/s,ICI-Q-SF评分提示最佳方案为年龄40 ～ 60岁,膀胱残余尿量0ml,最大尿流率＞30 ml/s.结论 电针治疗女性压力性尿失禁最佳适应症为年龄40～60岁、膀胱残余尿量为0ml、最大尿流率＞30 ml/s.

Objective To observe the therapeutic effect of electronic moxibustion apparatus and stone needle for primary dysmenorrhea disease in 35 cases.Methods 70 patients were randomly divided into the treatment group of 35 cases by random number table ,using electronic moxibustion apparatus and stone needle for treatment;and con-trol group of 35 cases,only using electronic moxibustion apparatus for treatment from 5 days before menstruation ,the treatment was continuous for 5 days,a course including 3 menstruation cycles .The clinical therapeutic effect after one treatment course was observed .Results The curative effects of the two groups were respectively 91.42% and 88.57%(χ2 =0.16,P>0.05);recovery rates of the two groups were respectively 77.14%and 42.85%(χ2 =8.57, P<0.05).The scores of the VAS,CMSS of the treatment group were much lower than those of the control group after treatment (t=2.532,2.137,2.256,P<0.05).Conclusion Electronic moxibustion apparatus and stone needle therapy is an effective method to treat primary dysmenorrhea ,which is a safe and convenient method .