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                    <p style="text-align: center;"><img src="http://www.dinglu.com/uploads/uploads/image/2021/11/30/039316/%E8%8A%AA%E9%AA%A8%E8%83%B6%E5%9B%8A.png" title="/uploads/image/2021/11/30/039316/芪骨膠囊.png" alt="芪骨膠囊.png"/></p><p>[drug name]</p><p>Common name: Qigu capsule</p><p>Pinyin: Qigu Jiaonang</p><p>[ingredients] epimedium, prepared Polygonum multiflorum, astragalus, Dendrobium, Cistanche deserticola, Rhizoma Drynariae, chrysanthemum.</p><p>【 properties 】 this product is a hard capsule, and its content is brownish yellow or brownish powder; It tastes bitter.</p><p>【 function indications 】 nourish liver and kidney, strengthen tendons and bones. It is used for the syndrome of liver and kidney deficiency of female postmenopausal osteoporosis. The symptoms include weakness of waist and knee, pain of waist and back, difficult walking and inability to take care.</p><p>[Specification] 0.55g per capsule</p><p>[usage and dosage] oral. 3 capsules at a time, 3 times a day; the course of treatment is 6 months.</p><p>[adverse reactions] during medication, some patients may have gastrointestinal reactions such as abdominal pain, abdominal distension, diarrhea, constipation and stomach discomfort; some patients may have sweating, dry mouth, skin pruritus, oral ulcer, etc.; occasionally, reversible alanine aminotransferase (ALT) and blood urea nitrogen (BUN) increase slightly.</p><p>[taboo]</p><p>1. It is forbidden for patients with liver and kidney dysfunction.</p><p>2. It is forbidden for those who are allergic to this product.</p><p>[precautions]</p><p>1. People with allergic constitution should use it with caution.</p><p>2. The drug takes a long time, and the liver and kidney functions are tested regularly during the medication.</p><p>3. Those with deficiency of yin and vigorous fire should use it with caution.</p><p>4. During the test, there was 1 case of mild spontaneous sweating, night sweats, dizziness, insomnia and 1 case of urinary tract infection, and the relationship with drugs could not be determined.</p><p>[clinical trial]</p><p>The clinical trial of this product was approved by the State Food and Drug Administration in 2003. From June 2003 to June 2006, 720 patients with primary osteoporosis were tested in phase II and III clinical trials. After the trial, the selected cases were mainly female postmenopausal patients. The trial adopted a randomized, double-blind, positive drug control and multi center research method. Administration method: Qigu capsule, oral, 3 capsules at a time, 3 times a day, taken with warm water. Control group: Xianling Gubao capsule, oral, 3 capsules at a time, 2 times a day (once in the morning and once in the evening), plus 3 Xianling Gubao simulant (once at noon) , take it with warm water for 6 months. Phase II: 117 cases in the experimental group, 113 cases completed; 118 cases in the control group, 112 cases completed. Phase III: 360 cases in the experimental group, 335 cases completed; 120 cases in the control group, 114 cases completed. The diagnostic criteria refer to the recommended diagnostic criteria for Chinese osteoporosis (second draft) formulated by the osteoporosis Committee of the Chinese gerontology society , the bone mineral density of L2 ~ 4 or any part of hip is 2.0sd lower than the peak bone mass; the syndrome of liver and kidney deficiency in traditional Chinese medicine is the inclusion standard.</p><p>Effectiveness results: phase II: there was no significant difference in bone mineral density between the experimental group and the control group (P > 0.05). There was significant difference in bone mineral density and bone peak percentage of greater trochanter between the two groups before and after treatment (P < 0.05). There was significant difference in bone mineral density and bone peak percentage of ward triangle between the two groups before and after treatment (P < 0.05); there was no significant difference in the control group (P > 0.05). There was no significant difference in the total score of traditional Chinese medicine syndrome between the two groups after treatment (P > 0.05). There was no significant difference in the single symptoms of traditional Chinese medicine syndrome (low back pain, head vertigo, difficult walking, inability to hold weight, tinnitus, tongue coating, tongue quality and pulse) between the two groups (P > 0.05).</p><p>Phase III: there was no significant difference in bone mineral density between the two groups (P > 0.05) The BMD of femoral neck and ward's triangle in the experimental group were significantly improved after treatment, and the difference was statistically significant before and after treatment (P < 0.05); the BMD of ward's triangle in the control group was significantly improved after treatment, and the difference was statistically significant before and after treatment (P < 0.05).</p><p>Safety results: routine blood, urine and stool tests, ECG, liver and kidney function tests were performed in both groups before and after the test. In the test group, except for 3 cases of abnormal ALT and Bun1 cases of mild abnormalities, which may be related to the drug and can be relieved by themselves after stopping the drug, no abnormal detection indicators related to the test drug were found. Several adverse reactions occurred in both groups during the medication. Among them, phase II test group There were 2 cases of hyperhidrosis, 1 case of dry mouth, 3 cases of gastric discomfort and 1 case of slight increase of alt. in the phase III test group, there were 3 cases of constipation, 10 cases of gastric discomfort or gastric distention pain, 1 case of skin pruritus, 1 case of diarrhea, 2 cases of slight increase of ALT and 1 case of slight increase of bun. Among the above adverse events, except 1 case of diarrhea was moderate, the others were mild, which were judged to be related to the test drug. The above differences are different Often relieved after drug withdrawal. 1 case had mild spontaneous sweating, night sweats, dizziness, insomnia, 1 case had urinary tract infection, and the relationship with drugs could not be determined.</p><p>[pharmacology and toxicology] animal experiments show that this product can improve the bone mineral density of ovariectomized rat osteoporosis model.</p><p>[storage] sealed and placed in a cool and dry place (no more than 20 ℃).</p><p>[packaging] medicinal aluminum plastic blister. 12 capsules / plate × 3 boards / boxes.</p><p>[validity period] 24 months</p><p>[executive standard] State Food and drug administration standard ybz10052009</p><p>[approval No.] gyzz z20090656</p><p>[listing Permit Holder] Xiamen Traditional Chinese Medicine Co., Ltd.</p><p>Registered address: No. 97 Baiyun Avenue, Tong'an District, Xiamen</p><p>[manufacturer]</p><p>Company name: Xiamen Traditional Chinese Medicine Co., Ltd.</p><p>Production address: No. 97 Baiyun Avenue, Tong'an District, Xiamen, Fujian</p><p>Postal Code: 361100</p><p>Tel: 0592-7266588</p><p>Fax No.: 0592-7266567</p><p>Registered address: No. 97 Baiyun Avenue, Tong'an District, Xiamen</p><p><br/></p>
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