AIM: To explore the patterns of the usage of traditional Chinese medicines in prevention and treatment of osteoporosis (OP) so as to give full play of their superiority, in view of the drawbacks of the severe toxic side-effect,the doubtful long-term therapeutic effect and the expensive drug cost in the western study of therapy of OP.METHODS: To study the patterns of the use of traditional Chinese medicines in prevention and treatment of OP, correlative data between 1979 and 2002 were collected, and statistical analysis was performed on 208 prescriptions (totaling 1 522 counts of herbs) of confirmed efficacy,which were prescribed by experts and renowned Chinese medical practitioners. Special attention was placed on the 127 herbs that were prescribed most frequently. Their uses and collocations were analyzed with the aim to reveal their medical regularities.RESULTS: [1] In treating OP, the principle should be using drugs that were able to nourish liver and kidney, cultivating blood and essence, and strengthening sinews and bones as the mainstay, and supplementing them with drugs that were able to activate blood and remove blood stasis, dredge collaterals to relieve pain, and dispel wind and eliminate dampness. More than 10 classes of drugs had been used, including tonics, drugs that activated blood and removed blood stasis, drugs that cleared excess heat, drugs that cleared excess wind and dampness, drugs that regulated flow of qi,drugs that eliminated dampness through diuresis, drugs for indigestion, and drugs that soothed liver and stopped endopathic wind. The tonics and drugs activating blood and removing blood stasis were used most frequently, accounting for 69.71% and 15.67% respectively. Among the tonics, the most frequently used (＞ 50 in 422 counts) were Herba Epimedii, Cortex Eucommiae, Radix Astrag ali and Fructus Psoraleae. Among drugs of activating blood and removing blood stasis, prepared rhizome of RadixRehmanniae, Radix Angelicae sinensis and Radix Salviae Miltiorrhizae were used most frequently. [2] It was showed that the property of herbs used to treat OP was mainly warming, and a small number of them calming character. Flavour of the drugs was chiefly sweet and pungent, and a small number of them had bitter and salty flavours; Channel tropism of the drugs was classified under liver primarily, and a small number of them classified under heart, spleen and lung. The main functions of the most frequently used 16 herbs were chiefly tonifying liver and kidney, strengthening sinews and bone, activating blood and alleviating pain. There were many literatures reporting Herba Epimedii, Radix Rehmanniae, Radix Astragali, Cortex Eucommia, and Fructus Psoraleae about their applications in the treatment of OP. Through clinical trials and animal studies, it was proved that these herbs had steroid-like actions, and antibacterial, anti-inflammatory,pain-killing, smooth-muscles relaxing, anti-platelet aggregation, vasodilation, enhancing immune system actions, etc. [3] Treatments were on the basis of rectifying deficiency as the primary, and rectifying excess as the secondary. Totally 45 kinds of yang tonic, accounting for 40.04% were selected firstly. This category of all the herbs was classified under the channel tropism of kidney. Of 18 kinds of yin tonic, accounting for 32.73%, amounted to 403 herb counts (38.24% of the total employment of tonic). This kind of drugs was classified under the kidney and liver channel tropism. Ten kinds of qi tonics, accounting for 18.18%, amounted to 189 herb counts(17.93% of the total employment of tonic). This kind of drugs was classified under the spleen channel tropism. Six kinds of blood tonics, accounting for1.09%, amounted to 40 herb counts (3.79% of the total employment of tonic). Therapy should be supplemented with herbs that enrich blood.CONCLUSION: Treatment of OP should place prime emphasis on replenishing deficiency, and supplementing it with removal of blood stasis. It is also advocated that replenishing deficiency of kidney is beneficial to producing essence and nourishing liver; replenishing deficiency of bone is beneficial to invigorating the spleen and activating blood and so on. Yang tonic is selected firstly, then yin tonic, qi tonic and blood tonic.

According to the Ethical Review Measures for Life Sciences and Medical Research Involving Humans jointly issued by the National Health Commission, the Ministry of Education, the Ministry of Science and Technology and the State Administration of Traditional Chinese Medicine in 2023, to optimize the ethical review process and reduce the burden on clinical researchers, it is proposed that some eligible situations can be "exempted from ethical review". This is a breakthrough progress in China’s ethical review management measures that firstly aimed at "exemption from ethical review". This paper reviewed and sorted out the relevant situations about exemption from review at home and abroad, focused on analyzing and exploring the four situations of exemption from review, especially discussed and analyzed the understanding of anonymization and personal sensitive information in exemption from review, and proposed practical suggestions for the four situations. Based on the actual situation of ethical review work, this paper also explored the establishment of practical standards and processes for exemption from review, providing reference for other medical institutions to implement the exemption from ethical review process.