不同针灸方法治疗带状疱疹多中心随机对照的临床研究
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摘要
目的:本研究对不同针灸方法治疗带状疱疹的有效性、安全性以及卫生经济学方面进行综合评价,筛选出治疗带状疱疹的优势方案,为临床医生选择有效、安全、经济的医疗方案提供参考。
     方法:采用多中心、随机对照试验的方法,通过中央随机系统将符合纳入标准的500例带状疱疹患者随机分为A组(基础针刺疗法组)、B组(铺棉灸疗法组)、C组(火针疗法组)、D组(叩刺拔罐疗法组)和E组(西药疗法组)进行治疗。在研究周期的第1-10天进行临床治疗,第22天、30天、60天进行随访。以综合疗效评分、疱疹指标、疼痛指标等进行疗效评价,以综合疗效评分、疼痛强度(VAS),后遗神经痛(PHN)发生率进行随访评价,以安全性指标进行安全性评价,以成本-效果比进行经济学评价。
     结果:
     1.疗效评价
     (1)综合疗效比较:①综合疗效评分比较:五组疗效评分疗程前后比较具有统计学差异(P<0.05)。其中,第5天A组、C组评分改善值优于B组和E组(P<0.05)。②总有效率比较:治疗结束后五组总有效率A组为97.87%、B组为97.87%、C组为93.41%、D组为92.63%、E组为97.89%,五组间比较差异无统计学意义(P>0.05)。③疗效动态观察:A、C、D三组从治疗第3天~第6天总有效率优于E组(P<0.05);B组从治疗第5天-第6天总有效率优于E组(P<0.05);在第3天,A、C、D三组的总有效率优于B组(P<0.05);在第4天,C、D组的总有效率优于B组(P<0.05)。从第7天-10天,五组总有效率比较,差异均无统计学意义(P>0.05)。
     (2)疱疹评价指标比较:五组在止疱时间、结痂时间、脱痂时间上比较,差异均无统计学意义(P>0.05)。
     (3)疼痛评价指标比较:①五组在疼痛持续时间上比较,A、B、C、D四组均短于E组(P<0.05)。
     ②五组VAS评分疗程前后比较,差异均有统计学意义(P<0.05)。治疗结束时,A、B、C、D四组VAS评分均低于E组(P<0.05)。
     ③VAS评分动态观察:A组和B组从治疗第3天~10天,VAS评分均低于E组(P<0.05)。C组和D组从治疗第2天-10天,VAS评分均低于E组(P<0.05)。C组第2天VAS评分低于B组(P<0.05)。
     (4)单项指标比较:①“局部痛”评分比较,A、B、C、D四组在治疗第10天“局部痛”消失率高于E组(P<0.05)。②“水疱数目”评分比较,A、B、C、D四组在治疗第5天“水疱数目”消失率高于E组(P<0.05)。其中,C组“水疱数目”消失率高于A组和B组:D组“水疱数目”消失率高于B组(P<0.05)。③“水疱簇数”评分比较,A、B、C、D四组在治疗第5天“水疱簇数”消失率高于E组(P<0.05);其中,C组和D组“水疱簇数”消失率高于B组(P<0.05)。
     2.随访观察
     (1)痊愈率比较:随访第22天痊愈率比较,A、B、C、D四组均优于E组(P<0.05)。
     (2)VAS评分比较:随访第22天、30天、60天,A、B、C、D四组VAS评分均低于E组(P<0.05)。
     (3)PHN发生率比较:随访第30天,A、B、C、D四组PHN发生率均低于E组(P<0.05)。
     (4)后遗神经痛Logistic回归分析:通过单因素和多因素Logistic回归分析,确定年龄对应的Exp(B)=OR=1.035>1,P=0.01,有统计学意义(P<0.05);治疗前VAS评分对应的Exp(B)=OR=1.028>1,P=0.02,有统计学意义(P<0.05)。
     3.安全性指标比较
     四组针刺疗法不良事件发生率比较,差异均无统计学意义(P>0.05);五组在安全性评价上比较,差异均无统计学意义(P>0.05)。
     4.临床经济学比较
     与E组相比,A组对疼痛每提前缓解一天可节约21.90元,B组对疼痛每提前缓解一天可节约21.87元,C组对疼痛每提前缓解一天可节约26.00元,D组对疼痛每提前缓解一天可节约20.23元。
     结论:
     1.四种针灸疗法疗效确切,起效均优于西药疗法。其中,基础针疗法、火针疗法和叩刺拔罐疗法起效快于铺棉灸疗法。
     2.四种针灸疗法缓解疼痛、改善水疱症状均优于西药疗法。其中,在缓解疼痛方面,火针疗法优于铺棉灸疗法;在改善水疱症状方面,火针疗法优于基础针刺疗法、铺棉灸疗,叩刺拔罐疗法优于铺棉灸疗法。
     3.四种针灸疗法随访痊愈率、缓解疼痛强度、减少PHN发生率均优于西药疗法。
     4.四种针灸疗法均比较安全。
     5.四种针灸疗法成本-效果比西药疗法更合理,其中,火针疗法为最经济的疗法。
     综上,筛选出治疗带状疱疹的优势方案:①若疼痛剧烈且水疱数目较多,推荐使用火针疗法、叩刺拔罐疗法。②若以疼痛为主,推荐使用基础针刺疗法、火针疗法、叩刺拔罐疗法。③若以水疱为主,推荐使用火针疗法、叩刺拔罐疗法。④若考虑节约经济成本,推荐使用火针疗法。⑤若考虑起效快,推荐使用火针疗法、叩刺拔罐疗法、基础针刺疗法。⑥综合考虑,推荐使用火针疗法。
OBJECTIVE:To comprehensively evaluate the effectiveness, clinical safety and economics of different Acupuncture and Moxibustion therapies in treating herpes zoster, and screened out the advantaged program of treating herpes zoster, which could provide the references for clinical physicians to choose effective, safe and economic medical scheme.
     METHODS:Based on a multi-center,randomized-controlled trial, by the random system,this study randomly allocated five hundreds cases of patients with herpes zoster who met the inclusion criteria into five groups:Group A (Basic Acupuncture Therapy Group), Group B (Cotton-sheet Moxibustion Therapy group), GroupC (Fire needle therapy group), Group D (Tapping and cupping therapy group) and Group E (Western medicine therapy group). The clinical treatment would last for 10 days, and the follow-up visit would be set on the 22nd,30th and 60th day after treatment. Cura-tive effect was evaluated by comprehensive efficacy score, blister index, pain index, etc; Follow-up efficacy was determined by comprehensive efficacy score, Visual Analogue Score(VAS) and the incidence of postherpetic neuralgia (PHN); Safety indexs used to evaluate security; while the clini-cal economic evaluation used cost-effectiveness ratio.
     RESULTS:
     1. The Efficacy Evaluation
     (1) Comparison of Comprehensive Effect
     ①Comprehensive Efficacy Score
     There were significant difference between the anterior and posterior of treatment on comprehen-sive efficacy score among five groups (P<0.05). On the 5th day during the treatment period, the im-provement comprehensive efficacy score of Group A and C were better than Group B and Group E, the difference was significant(P<0.05).
     ②Total Effective Rates
     The total effective rates were as follow:Group A 97.87%, Group B 97.87%, Group C 93.41%, Group D 92.63%, Group E 97.89%. There was no significant difference among the five groups.
     ③Dynamic Oservation of the Efficacy
     From the 3rd day to the 6th day, the total effective rates of Group A, B and C were better than Group E(P<0.05). From the 5th day to the 6th day, Group B's total effective rate was superior to Group E(P<0.05). On the 3rd day, Group A,C and D'total effective rates were better than Group B, (P<0.05). By comparison, total effective rates of Group C and D were better than Group B on the 4th day(P<0.05). From the 7th day to the 10th day, the total effective rates of the five groups had no significant diffenrence (P>0.05)
     (2) Comparison of Herpes Evaluation Index:
     The time of new blister ceasing, old herpes incrustation and decrustation among the five grou-ps had no significant difference(P>0.05).
     (3) Comparison of Pain Evaluation Index
     ①There were significant diffenrence on pain duration time among the five groups (P<0.05) Group A,B,C and D were superior to Group E.
     ②There were significant difference on VAS between the pro-and -post treatment among the five groups(P<0.05). After treatment, VAS scores of Group A, B, C and D were lower than Group E, which has significant difference(P<0.05).
     ③Dynamic Observation on VAS Scores:Pain intensity(PI) decreased overall. From the 3rd day to the 10th day, VAS scores of Group A and B was significantly lower than Group E(P<0.05). From the 2nd day to the 10th day, VAS scores of Group C and D was significantly lower than Group E(P<0.05). Group C's VAS scores was significantly lower than B group on the 2nd day(P<0.05).
     (4) Comparison of Single Index
     ①"Partial pain" Index:On the 10th day, the disappearance rate of partial pain of Group A, B, C and D were higher than Group E, which has significant difference(P<0.05).
     ②"Number of blisters" Index:On the 5th day of the treatment, the disappearance of blister number of the four acupuncture groups were more than Group E(P<0.05),and Group C's number of blister was higher than Group A and B (P<0.05) while the blister number of Group D was higher than Group B (P<0.05).AND those difference had statistical significance.
     ③"Number of blister-clusters" Index:On the 5th day, disappearance rate of blister-clusters number of the four acupuncture groups were higher than Group E(P<0.05), which had significant difference:The blister-clusters number's disappearance rate of Group C and D were higher than Group B(P<0.05).
     2. Follow-up Observation
     (1) The comparison of Cure rate
     On the 22nd day, cure rate of Group A,B, C, D were better than Group E, and there were significant difference(P<0.05).
     (2) The comparison of VAS scores
     On the 22nd,30th and 60th day during follow-up visit period, VAS scores of the the four acupuncture groups were lower than Group E, which had significant difference(P<0.05).
     (3) The comparison of the incidence of postherpetic neuralgia(PHN)
     The incidence of postherpetic neuralgis of Group A, B, C and D were significantly lower than Group E on the 30th day of the treatment (P<0.05).
     (4) Logistic regression analysis of PHN:Single and multiple regression analysis showed age corresponding Exp(B)=OR=1.035>1, P=0.01, had significant difference (P<0.05), while VAS scores before treatment corresponding Exp(B)=OR=1.028>1, P=0.02 also had significant differe-nce(P<0.05).
     3. Comparison of safety index:
     The incidence of adverse events among the four acupuncture groups had no significant differen-ce (P>0.05). There were no significant differenrence on safety index of all the five groups(P>0.05).
     4. Comparison of clinical economics:
     Compared with western medicine therapy group (Group E), each precedent day of pain relief among four needle groups could separately retrench 21.90yuan,21.87yuan,26.00 yuan and 20.23 yuan RMB.
     CONCLUSION:
     1. The comprehensive efficacy of the four acupuncture groups all had definite therapeutic effect, and the onset of the acupuncture-moxibustion therapise were earlier than western medicine group. Thereinto, the onset time of basic acupuncture group, tapping and cupping group and fire-needle group were ealier than cotton-sheet moxibustion therapy group.
     2. These Four acupuncture therapy groups were better than western medicine therapy group on releasing pain and improving the symptoms of blisters, In releasing pain of the Herpes Zoster, Fire needle Therapy was superior to Cotton-sheet Moxibustion Therapy. In improving numbers of herpes zoster symptom, Fire needle Therapy was superior to Basic Acupuncture Therapy and Cotton-sheet Moxibustion Therapy while Tapping and Cupping Therapy superior to Cotton-sheet Moxibustion.
     3. The following-up cure rate, intensity of pain relief and the incidence of postherpetic neuralgia of four acupuncture therapy groups were better than western medicine therapy group.
     4. Four Acupuncture Therapies were all relatively safe.
     5. Cost-effectiveness of the four acupuncture therapy groups were more reasonable than Western medicine treatment.Besides, fire needle acupunture is the most economic one. The advantage program of treating herpes zoster in summary is as follow:
     ①In the condition of severe pain with numbers of blister, fire needle acupuncture, tapping and cupping therapy are recommended.
     ②If the chief complaint is pain, we recommend fire needle acupuncture, tapping and cupping acupuncture therapy, basic acupuncture.
     ③If the main symptom is blister, fire needle acupuncture, tapping and cupping therapy are recommended.
     ④In order to saving cost, give priority to fire needle acupuncture.
     ⑤Considering quicker effect, advice the fire needle acupuncture, tapping and cupping therapy, basic acupuncture.
     ⑥In conclusion, fire needle acupuncture is recommended.
引文
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