| Backgroundmale infertility has become a global issue imposing a negative effect on couples and family, and its morbidity is still rising. In China, the morbidity of male infertility is about10%, and half of which is due to the factor of male according to latest data.Speaking of the aetiological agent and pathogenesis of male infertility, modern medicine can’t explain it completely. Andrology Sub-Association of Chinese Medical Association divides the aetiologial agents into testicular before, testicular, testicular after and idiopathic factor. While for the pathogenesis, researchers brought out theory like oxygen radical, trace elements, nitric oxide, endocrine disorder, immunity, radiation etc, but none of which has been known clearly.According to the theory of Chinese Traditional Medicine, the courses of male infertility can be classified into seven kinds:innate factor, fleshiness, emotional disorder, improper diet, aeipathia, exogenous evil, trauma. And it’s commonly accepted that its pathogenesis is "the deficiency of kidney is radical course, while the stagnation of liver qi, damp and hot, blood stasis are the superficial courses, and the male infertility is coursed by multi-courses.When coming to the treatment of male infertility, TCM takes the treatment based on syndrome differentiation with the fundamental method of tonifying kidney (warming and invigorating kidney-yang, nourishing the kidney-yin, filling kidney essence) by using the wuziyanzong pill, zuoguipill, jinguishenqi pill, yougu i pill etc.The latest pharmacological experiments have gained many breakthrough about Chinese medicine and some of which may be the the mechanism of Chinese medicine for warming and invigorating kidney-yang:①restrain the allergic reaction by balancing the immune system;②adjusting the hypothalamic-pituitary-gonadal axis;③antioxidant function:reducing the injury of the sperm by removing the free radicals generated by oxidation reaction;④improving the reproductive capacity by enhancing the function of reproductive glands.PurposeObserve and evaluate the curative effect and safety of new yougui pill for patients with male infertility and deficiency of kidney-yang objectively. MethodPatients aged from23to50years old from the Andrology department of Heijing University of Chinese Medicine Dongzhimen Hospital between February2012and April2013, they were all included in the study according to some standards The Western diagnostic standard,exclusion standards and TCM standards were based on " WHO manual for the standardized investigation, diagnosis and management of the infetile male"," Andrology" edited by YingLu Guo and LiQuan Hu, Chinese medicine clinical diagnosis and treatment terminology (syndromes part)(national standards publish by State Bureau of Technical Supervision GB/T16751.2-1997) and refercd to TCM diagnostics of Chinese Medicine edited by ShaoLiang Ji and ZhaoZhi Cheng. According to the above criteria,60patients was included in the study and determined whether to suspend the study of patients Patients in the study will be given recipe particle therapy, and0-7days after the start of the study,30±5days,60±5days,90±5days, inspection and TCM syndrome score to evaluate the efficacy according to the efficacy standard. The efficacy standard was based on "World Health Organization male infertility standardization check with the clinic manual" and "Traditional Chinese Drug Guidelines for clinical research".ResultThe research included60cases, and all of which have been completed.11cases were ineffective, the ineffective rate was18%;22cases were effective, the effective rate was36%;21cases were remarkably effective, the significant efficiency rate was35%;6cases were cured, the cure rate was10%, the total number of effective cases was44, and the total effective rate was82%. General ly speaking, the new yougui pill has a positive effect on patients of male infertility with deficiency of kidney-yang significantly. The difference of semen volume and sperm density before and after the treatment, was statistically significant (P<0.001); and the semen liquefaction after the treatment was improved significantly (P<0.001); the rale of A level sperm, total sperm activity were improved remarkably when compared with the previous (P<0.001); while the change of forward movement sperm number was not obvious (p+0.325>0.05). There were30cases had taken the Hormone tost. Statistic showed that there was no significant, difference of E2level, FSH level, LH level, PRL level before and after the treatment (P>0.05). The difference of T level before and after the treatment was statistically significant (P<0.001); TCM symptoms like intolerance of cold, sallow complexion, frequent urination at night, mental degradation, erectile dysfunction, the pale tongue, white coating, deep and weak pulse etc, were improved significantly (P<0.001).ConclusionThe new yougui pill has a remarkabl y positive effect on semen volume, density, liquefaction, the rate of A level sperm, and total sperm activity, as for the forward movement sperm number, the improvement was not so obvious, maybe because of the small sample. And it does not impose a great effect on the E2level, FSH level, LH level and PRL level, but can improve the T level remarkably. Meanwhile it can relieve TCM symptoms like intolerance of cold, sallow complexion, frequent urination at night, mental degradation, erectile dysfunction, the pale tongue, white coating, deep and weak pulse etc significantly. |
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