| Objective:To appraise the clinical effect and security of Milk KANG Shu-capsuleon hyperplasia of mammary glands(Liver depression and kidney deficiency, as the imbalance), and offer the basis for clinical testing further.Methods:All experimenters are women. To select the patients of hyperplasia ofmammary glands whose age is from 18 to 50, and were diagnosed TCMdiscrimination as Liver depression and kidney deficiency, as theimbalance. According to the experimental plan, the patients were dividedrandly into two groups. The therapeutic group using Milk KANG Shu-capsulewas 55 cases, the controlled group using Milk Zeng Ning-capsule was 19cases. The course of treatment was 6 weeks, and do not take them in menses.Two groups can't use hormone, stopping the pain type Western medicine andsimilar traditional Chinese medicine during the treatment period.Observe target:1. The target of appraising the clinical effect: Appraise TCM symptomsand signs before treatment,after taking 3 weeks medicines and 6 weeks,after treatment 3 weeks(patients recovered). Observe color ultrasonic inbreast before treatment and after taking 6 weeks medicines.2. Safety Evaluation indicators: medication in the previous week, oneweek after the withdrawal of the inspection within a blood, urine, thenconventional liver function (ALT), renal function (BUN, Cr), ECG.Criteria for evaluation of curative effect:1. The criteria for evaluation of curative effect of Hyperplasia ofmammary glands:(1)Fully recover clinically: The lump disappears after treating, thepain disappears.(2) Show the result: Milk disappeared or significantly reduce the pain, and/or reduce tumor size≥half. (3)Progress: Milk alleviate pain, and/ or tumor shrinkage＜half.(4) Invalid: Milk not improve or add to the pain before treatment, nosignificant changes in mass2. The criteria for evaluation of curative effect of TCM symptoms andsigns:(1)Fully recover clinically: The curative effect rate of symptoms andsigns after treating≥90%.(2)Show the result: The curative effect rate of symptoms and signs aftertreating≥70%,＜90%.(3) Progress: The curative effect rate of symptoms and signs aftertreating≥30%,＜70%.(4) Invalid: The curative effect rate of symptoms and signs aftertreating＜30%.Results:Patients in the two groups general information, medication beforebreast pain, breast lumps, Chinese medicine syndromes score, BreastUltrasound examination of the gland area Statistically, there was nosignificant difference (P＞0.05), In addition, the merger or symptoms ofthe disease, laboratory tests for such Statistically, there was nosignificant difference (P＞0.05), comparable.1. Clinical comparison: Treatment group, the control group, the totalefficiency of the mammary glands were 100.00%, the two groups have a goodeffect, the difference was not statistically significant (P＞0.05), suggesting that the two similar effect.2. TCM Syndrome: The effective treatment of Chinese medicine syndromesimprove the overall efficiency of 92.16%. TCM Syndrome total control groupimproved the efficiency of 94.74%. the difference between the two groupswas not statistically significant (P＞0.05), the two groups are similar.3. TOM treatment designate total score after treatment: comparisongroup, the difference was statistically significant (P＜0.01); after treatment between the two groups, the difference was not statisticallysignificant (P＞0.05), suggesting that the two groups can significantlyimprove symptoms. Clinical two groups are similar.4. Before treatment, after Chinese sovereignty Card (breast lumps, breast pain) dropped, the two groups before and after treatment: thedifference was statistically significant (P＜0.01); after treatmentbetween the two groups, the difference was not statistically significant(P＞0.05), suggesting that the two groups could significantly improvebreast pain, breast lumps narrow. Clinical two groups are similar.5. Safety Observation: Both before and after the treatment of blood, urine, conventional, liver and kidney function and ECG revealed noanomalies. Medication process of the treatment group had one patient hadmild diarrhea, untreated, withdrawal symptoms disappeared, The patientswith a history of chronic enteritis history; two groups of patients afterthe drug occasionally stomach discomfort, hot flushes, nervous reaction.Conclusion:The clinical trial results of the study showed: Milk KANG Shu-capsuletreatment of mammary glands (Liver depression and kidney deficiency, as theimbalance) better Bushen Shugan, Qi auoxue causes—permanent, SanjieZhitong function. Can effectively alleviate breast pain, breast lumpsnarrow, and significantly improved symptoms in patients with no obvioustoxicity. |
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