| Background:Chloasma is a common pigmentation disease.Symptomatic patches appear on both sides of the face.They are mostly distributed in the ankles and cheeks.They can be butterfly-shaped and can also be found in the frontal,nose,and perioral areas.Skin lesions of different sizes,clear boundaries,light-colored were yellow-brown,heavy dark brown,often aggravated in spring and summer,reduced in autumn and winter,no symptoms.Due to the disease on the face,the color is darker,detrimental to the appearance,and brings a great psychological burden to the patient’s mental and psychological pressure on the social psychological burden.There is no name for "Chloasma" in the ancient Chinese medicine literature,but there are many symptoms and disease names similar to those of chloasma,such as "black spots","face blemishes","face dust",and "face blemishes".Chinese medicine believes that the etiology of chloasma is mainly related to dryness,phlegm,and wind cult disease.The pathogenesis can be summarized as liver and kidney deficiency,liver qi stagnation,eating disorders,and Chong Ren disorders.The organs most involved in the disease are Liver,spleen,kidney.The methods used to treat chloasma by Chinese medicine include internal medicine,external use of medicine,acupuncture treatment,moxibustion treatment,catgut embedding treatment,ear acupuncture treatment,bloodletting therapy,acupoint injection and fire needle.Western medicine treatment of chloasma mainly include drug treatment,physical therapy and chemical peeling,etc.The long-term efficacyis not obvious,and it is easy to relapse,and some of the treatments have great stimulation to the skin,which is not conducive to the recovery of the disease.This research topic is based on the traditional meridian theory,through the literature and clinical studies of the chloasma of ancient and modern times,combining theoretical and clinical research on melasma.The etiology,pathogenesis,and treatment methods of melasma were systematically summarized from two aspects of Chinese medicine and modern medicine.Clinical research mainly focused on the observation of the curative effect of acupoint injection of asthma control and oral vitamin on the treatment of melasma in perimenopausal women.The randomized controlled method was used to obtain the optimal treatment plan,and the mechanism of the therapeutic effect was explored.It was easy to generalize to the clinic.The assessment indicators such as the area and color score of chloasma,serum sex hormone levels,etc.,as well as the accompanying symptoms,safety evaluation,and patient satisfaction evaluation of chloasma,etc.were used to comprehensively evaluate the clinical efficacy of the two groups of patients.ObjectiveTo observe the curative effect of acupoint injection of Chuankezhi in perimenopausal female with liver and kidney deficiency;By observing its effect on serum sex hormones FSH,LH and E2 to discuss the possible mechanism;The safety was evaluated by observing the adverse reactions after treatment or during treatment.This study provides a safe and effective treatment method for the treatment of chloasma in clinical treatment.Methods1.Study design methodsA randomized controlled trial was used.Qualified subjects are numbered from1 to 60 consecutively.The random number table generates 60 random Numbers.use the method of sample random,A 1:1 ratio was assigned to the treatment group and the control group.Each group had 30 cases,and then the clinical efficacy was observed.2.Therapeutic methodThe treatment group was treated with 30 cases,and the acupoints of Zu Sanli,San Yin jiao,Shen Shu,Gan shu and Guan Yuan were picked to do the acupointinjection with Chuan Kezhi,Use 5ml one-time syringe,injection of 1ml chuankezhi every acupoint every time,Alternate injection of bilateral acupoints.Treat 1time per day,5 times a week,5 times for 1 course of treatment,2 days of interval,4 courses of treatment in total.30 patients in control group take vitamin C200 mg orally and Vitamin E capsule 100 mg,3 times daily for 4 weeks.3.Observation methodBefore and after treatment,all patients were recorded the observation indexes of skin lesion area and color change,and the skin lesion area and color score were recorded before and after treatment;the blood of Patients were collected and serum sex hormone-promote follicle-stimulating hormone(FSH),luteinizing hormone(LH),estradiol(E2)levels were examed before treatment in1 week before(i.e.,luteal phase)menstrual,again measured hormone levels1 month after treatment ends 1 week before menstruation;The routine examination of blood and urine and the function of liver and kidney were measured before and after treatment.The curative effect and adverse reaction were observed after 1month of treatment,and the recovery patients were followed up for half a year to observe the recurrence situation.4.Method of determination of efficacy(1)The clinical diagnosis and curative effect standard of chloasma(revised in 2003)formulated by the pigment group of the committee on skin venereal diseases in the association of Chinese and western medicine(2)Total score = area score + color score.Index calculation method: index=(total integral before treatment-total integral after treatment)/total integral before treatment.5.Safety evaluation methods.The routine examination of blood and urine and the function of liver and kidney of all patients were measured before and after treatment.The incidence of adverse events was recorded in these two groups.6.statistical methodsUsing SPSS13.0 statistical software,measurement data using mean and standard deviation(?x + S),the Efficient comparison using X2 test,compared with paired t test in the group,independent sample t test was used to compare between groups.alpha < 0.05 for the difference is statistically significant.Results:1.baseline: the differences in age,course of disease,inducing factors,and concomitant symptoms of the two groups were not statistically significant(P <0.0.05),which was comparable.2.Chloasma area of grade: after the treatment,two kinds of therapies all can make area of chloasma narrow(P < 0.05),the comparison between two kinds of therapy,the therapeutic effect of point injection is better than the effect of oral vitamin C,vitamin E(P < 0.05),indicating that acupoint injection therapy improve chloasma area of effect is more apparent.3.Chloasma color grade: after the treatment,two kinds of therapy all can relieve chloasma color(P < 0.05),the comparison between two kinds of therapy,the therapeutic effect of acupoint injection than the effect of oral vitamin C,vitamin E better(P < 0.05),indicating that acupuncture point injection therapy improve chloasma color effect is more apparent.4.The comparison of curative effect index: after the treatment,the treatment group total effectiveness is 76.96%,control group total effectiveness is 56.67%,show that in the aspect of improving chloasma’s size and color,the curative effect of treatment group is better than that of control group,namely,the curative effect of acupoint injection therapy is better than oral vitamin group(P < 0.05).5.Comparison of serum sex hormone levels: after treatment,the level of serum sex hormone FSH,LH and E2 in the treatment group was significantly lower than that before treatment(P<0.05).There was no significant difference in serum sex hormone levels in the control group(P BBB 0 0.05).The comparison of serum sex hormones between the treatment group and the control group was statistically significant(P<0.05),indicating that the treatment group was superior to the control group in reducing serum sex hormone levels.Before treatment,the comparison between normal group and treatment group and the control group,there were significant differences in serum sex hormone levels(P<0.05),indicating that the serum sex hormone levels in patients with chloasma were higher than those of normal people.6.Comparison of symptoms of traditional Chinese medicine : the treatment group after treatment of traditional Chinese medicine with symptoms(dysphoriain chestpalms-soles,insomnia and amnesia,dizziness and tinnitus,soreness and weakness of waist and knees,constipation)were significantly improved(P < 0.05),the symptoms of dysphoria in chestpalms-soles and insomnia and amnesia of control group after treatment were significantly improved than before treatment(P < 0.05),but the dizziness tinnitus,soreness and weakness of waist and knees,constipation symptoms before and after treatment is no significant improvement(P > 0.05),which maybe related to the regulation of spirit of foundation treatment.Conclusion(1)There is a good clinical effect on the treatment of chloasma in the perimenopause with the treatment of acupoint injection with chuankezhi,and the effective rate is 76.96% after the end of treatment.(2)The injection of chuankezhi can effectively dilute the color spot,reduce the plaque area,and effectively improve the concomitant symptoms of perimenopolis,such as insomnia,hot flashes and so on.(3)The imbalance of serum sex hormone levels is one of the important indicators of chloasma,and this study has significantly reduced serum sex hormones FSH,E2 and LH levels in patients with acupoint injection.(4)This research observed the blood routine,urine routine and the function of liver abd kidney and so on many indicators of patients before and after treatment,no obvious difference compared with before treatment,which proved that acupoint injection with chuankezhi treating chloasma had no bad reaction.(5)We found that in the treatment,patients with brown spots stains or color depth and area is not only related with the sex hormone levels,but also is associated with mood changes and insolation,which illustrate that chloasma occurs when the result of joint action of many factors,so we should also according to various factors in the treatment for the corresponding treatment.this clinical experimental results show that chuankezhi acupoint injection can significantly improve patients with chloasma spot color and area,reduce the serum sex hormone levels and had no significant adverse reactions,the treatment is safe and effective,patient compliance is good,so it is worth popularizing in clinical. |
